Bridging the Gap From Postpartum to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic Disease Management Among Postpartum Women
Phase: NA
Conditions: Hypertension, Hypertension in Pregnancy, Diabetes Mellitus, Gestational Diabetes, Obesity, Depressive Disorder, Anxiety Disorders
Sponsor: Massachusetts General Hospital

Bridging the Gap From Postpartum to Primary Care 
NCT05543265
Study Protocol
Approved 7/26/22

Study Protocol and Amendments 
Postpartum Primary Care Engagement using Default Scheduling and Tailored Messaging: 
A Randomized Clinical Trial
PIs: Mark Clapp, MD MPH; Jessica Cohen, PhD
Institutional Review Board: Mass General Brigham (MGB)
Original IRB protocol approved: 7/26/2022 
Date of first patient enrollment: 11/3/2022 
Date of last patient enrollment: 4/24/2023 
The initial IRB protocol and approved updates to the original protocol are included below. Staff 
and funding IRB amendments are not included. 
Number 
Submitted 
Approved Summary of Changes 
AME1 
 9/8/22 
9/8/22 
Staff amendment 
AME2 
 9/13/22 
9/14/22 
The following updates were made: 
1) minor adjustments to the enrollment criteria
2) minor updates to the language in the patient messages
3) added additional component to intervention arm (study team messages PCP
that their patient is recently postpartum and an appointment has been scheduled 
for them) 
4) added explicit language on the possibility of PCP visit cost to study messages
and study fact sheet at request of project funder 
5) minor sample size adjustments after more accurate estimates on potential
eligible patients 
6) study schema changed to reflect accurate outcome assessment time point
AME3 
10/6/22 
10/7/22 
Updated baseline survey after initial piloting 
AME4 
10/12/22 
10/14/22 
Added Spanish versions of the IRB-approved documents (study invitation letter, 
patient messages, study fact sheet) 
Added clinicaltrials.gov registration number 
AME5 
10/17/22 
10/26/22 
Single IRB (sIRB) set-up 
AME6 
10/26/22 
10/28/22 
Added Spanish translation of baseline survey 
Updated patient messages 
AME7 
10/28/22 
11/2/22 
Added sIRB child site: Harvard School of Public Health 
AME8 
12/1/22 
12/2/22 
Amended the study protocol to add clarity and ensure consistency in the 
language of eligibility criteria related to due date (not delivery date) 
AME9 
1/26/23 
2/2/23 
Added the finalized version of the endline survey for participants enrolled in the 
study 
AME10 
2/9/23 
2/22/23 
Updated project sponsor fund number 
AME11 
3/12/23 
3/12/23 
Staff amendment 
AME12 
3/17/23 
3/24/23 
After piloting, the endline survey questions were modified. 
Renumeration was decreased from $25 to $20 after finding the survey could be 
completed in 5-10 minutes rather than 10-20 minutes 
AME13 
4/1/23 
4/2/23 
Staff amendment 
AME14 
4/2/23 
4/3/23 
Added the endline survey materials translated into Spanish with certification of 
translation 
AME15 
4/25/23 
5/4/23 
Updated study status: study enrollment closed 
Edited SMS endline survey messages to include the link to the REDCap survey 
link, which was sent via email 
AME16 
5/2/23 
5/31/23 
Staff amendment 
AME17 
9/12/23 
9/12/23 
Staff amendment 
AME18 
9/20/23 
9/21/23 
Staff amendment 
AME19 
9/25/23 
10/11/23 
Added additional funding source 

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Electronic IRB Submission Generated On April 16, 2024 
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Title: Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to 
Improve Chronic Disease Management among Postpartum Women (the Bridge Study)  
Sponsor Name: 
PI Name: Clapp, Mark A  
Protocol #: 2022P001723 
Type: Initial Review (IR) 
Date Received: July 09, 2022 
 
Study Staff Added 
Name 
Role 
Degree 
Organization 
Training 
Clapp, Mark 
Principal Investigator MD, MPH 
MGH > OB/GYN Service 
08/24/22 
Cohen, Jessica 
Co-Investigator 
James, Kaitlyn 
Data 
Coordinator/Manager Ph.D, MPH
MGH > OB/GYN Service 
09/13/22 
Ray, Alaka 
Co-Investigator 
MD 
MGH > Medical Services 
02/06/24 
Siegel, Molly 
Co-Investigator 
MD 
MGH > OB/GYN Service 
08/13/23 
Warsame, Fowsia Research Assistant 
BWH > Medicine > Endocrine 
11/10/21 
 
Non Study Staff Added 
Name 
Degree 
Organization 
Murphy, Jamie 
BS, MBA 
MGH > OB/GYN Service 
 
Funding source 
Record # 
Fund 
Project 
Period 
PI Name
Sponsor 
Record 
Type 
Process Link
Date 
Link 
Status 
2022A001786 241846 06/01/22-
05/31/23 
Clapp, 
Mark A 
MASSACHUSETTS 
INSTITUTE OF 
TECHNOLOGY 
RM – 
Funded 
Agreement 
IR 
Pending 
2021A018645 241621 06/01/22-
05/31/23 
Clapp, 
Mark A 
National Bureau of 
Economic 
Research (NBER) 
RM – 
Funded 
Agreement 
IR 
Pending 
Signatures 
PI Name: Clapp, Mark A, MD, MPH 
Authenticated: July 05, 2022 
 
Department Chair: Ecker, Jeffrey L, MD 
Authenticated: July 09, 2022 
InitialReview 
Title: 
Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to 
Improve Chronic Disease Management among Postpartum Women (the Bridge Study) 
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The Mass General Brigham Institutional Review Board has created several forms for review of human 
subjects research. This questionnaire includes a series of questions to identify the form (s) you need to 
complete for your research project.  
1. Intervention/Interaction
2. Health / Medical Information
3. Excess Human Material and Related Health / Medical Information
4. Secondary Use of Research Samples and/or Data (samples/data from another research study)
5. Research Data Repository (collecting and storing health/medical information for future research)
6. Tissue or Sample Repository
7. Coordinating Center / Core Labs
8. Emergency / Single Patient Use of Investigational Products
1. Intervention and/or Interaction
Does your research involve an intervention and/or interaction with subjects for the collection of specimens 
or biological material or data (including health or clinical data, surveys, focus groups or observation or 
behavior)? 
NOTE: Do not answer YES if this protocol is to establish a Research Data Repository or 
Sample/Tissue  Repository. There are separate forms for Data and Tissue Repositories. 
◉Yes
⚪No
Will the study population include children? 
⚪Yes
◉No
Will the study population include adults with impaired decision-making capacity for whom 
permission for participation will be obtained from their legally authorized representative (surrogate 
consent)? 
⚪Yes
◉No
Will the study population include neonates of uncertain viability and/or nonviable neonates? 
⚪Yes
◉No
Will the study population include pregnant women and/or fetuses? 
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◉  Yes  
 
⚪  No  
 
 
 
Will the study population include any of the following: 
• Patients who are in the hospital at any time during the study (inpatients) 
• Patients seen in the Emergency Department 
• Patient Care Services Staff, e.g. nursing staff asked to complete surveys on patient care or 
nursing practice 
⚪  Yes  
 
◉  No  
 
 
 
Will you be doing either of the following: 
• Testing a drug, biologic, dietary supplement or other agent for safety and/or efficacy 
• Administering a drug, biologic, dietary supplement or other agent to study human 
physiology 
⚪  Yes  
 
◉  No  
 
 
 
Will you be doing any of the following: 
• Testing a medical device for safety and/or efficacy 
• Using a marketed device in a non-standard (off-label) way 
• Using a commercially available device that is not approved for use in humans 
⚪  Yes  
 
◉  No  
 
 
 
Will the study involve ionizing radiation, e.g. x-ray, radioactive drug, fluoroscopy? 
 
⚪  Yes  
 
◉  No  
 
 
 
Will the study involve non-ionizing radiation, e.g. MRI, ultrasound, laser, ultraviolet light emitting 
device or microwave? 
 
⚪  Yes  
 
◉  No  
 
COVID-19/SARS-CoV-2  
 
Is this research related in any way to the novel coronavirus, COVID-19, SARS-CoV-2 or, any impact or 
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consequences related to the outbreak and pandemic? 
  
⚪  Yes   
◉  No  
 
Sponsor Funding: MASSACHUSETTS INSTITUTE OF TECHNOLOGY [Non-Profit]  
 
Select the source of funding that will be used to support the proposed research: 
◉  Government / Foundation / Other Non-Profit  
 
⚪  Corporate  
 
⚪  Institutional Award  
 
⚪  Department Funds  
 
⚪  None   
 
Indicate application type: 
◉  Grant / Contract (direct award to an Institution)  
 
⚪  Subcontract (from another Institution)  
 
Indicate the applicant institution: 
⚪  BWH  
 
◉  MGH   
⚪  SRH  
 
⚪  McLean  
 
⚪  Faulkner  
 
⚪  Broad Institute  
 
⚪  Other  
 
 
  
Enter Principal Investigator name (if different): 
Enter title of proposal (if different): 
Bridging the Gap to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic 
Disease Management among Postpartum Women 
  
Enter grant number (if known): 
Example of NIH grant number: 
 
Insight Agreement Proposal Number (read-only field): 
2022A001786 
 
Has the project been awarded at the time of this submission? 
⚪  Yes  
 
◉  No  
 
  
Explain: 
Under review 
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For NIH-sponsored cooperative group multi-center trials: The IRB requires a copy of the 
cooperative group protocol and sample informed consent documents be submitted for review 
and comparison with the documents submitted for local IRB review. 
For guidance, refer to, “IRB Review of Applications for HHS Support.”  
Medicare Coverage Analysis Requirement 
Does the protocol for this study involve any items or services that will be billed to Medicare/private 
insurance, including study-specific procedures or those considered usual and customary care 
("standard of care") outside the trial context?  
⚪Yes
◉No
NOTE: If you are unsure how to answer this question, please contact Sarah Bednar at Mass 
General Brigham Clinical Trials Office at 617-954-9364, or for NWH investigators, please 
contact Jayita Sen at 617-243-6517 for more information.  
Is this the primary source of funding? 
⚪Yes
◉No
⚪Not applicable
Sponsor Funding: National Bureau of Economic Research (NBER) [Non-Profit] 
Select the source of funding that will be used to support the proposed research: 
◉Government / Foundation / Other Non-Profit
⚪Corporate
⚪Institutional Award
⚪Department Funds
⚪None
Indicate application type: 
◉Grant / Contract (direct award to an Institution)
⚪Subcontract (from another Institution)
Indicate the applicant institution:
⚪BWH
◉MGH
⚪SRH
⚪McLean
⚪Faulkner
⚪Broad Institute
⚪Other
Enter Principal Investigator name (if different): 
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Enter title of proposal (if different): 
Bridging the Gap to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic 
Disease Management among Postpartum Women 
  
Enter grant number (if known): 
Example of NIH grant number: 
 
Insight Agreement Proposal Number (read-only field): 
2021A018645 
 
Has the project been awarded at the time of this submission? 
⚪  Yes  
 
◉  No  
 
  
Explain: 
Under review 
 
For NIH-sponsored cooperative group multi-center trials: The IRB requires a copy of the 
cooperative group protocol and sample informed consent documents be submitted for review 
and comparison with the documents submitted for local IRB review. 
For guidance, refer to, “IRB Review of Applications for HHS Support.”  
 
  
Medicare Coverage Analysis Requirement 
  
Does the protocol for this study involve any items or services that will be billed to Medicare/private 
insurance, including study-specific procedures or those considered usual and customary care 
("standard of care") outside the trial context?  
⚪  Yes  
 
◉  No  
 
  
NOTE: If you are unsure how to answer this question, please contact Sarah Bednar at Mass 
General Brigham Clinical Trials Office at 617-954-9364, or for NWH investigators, please 
contact Jayita Sen at 617-243-6517 for more information.  
  
 
Is this the primary source of funding? 
◉  Yes  
 
⚪  No  
 
⚪  Not applicable  
 
  
Will the funding cover all subject study-related drugs, devices, procedures, tests, and visits? 
⚪  Yes  
 
⚪  No  
 
◉  Not applicable (no subject study-related costs)  
 
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Digital Health  
Please consider ALL applications, systems or technologies being used in your study when completing these 
questions. Applications, systems and technologies include: 
• Touchable or wearable devices collecting physiological and/or health data 
• Apps on mobile phones, tablets or iPads 
• Websites where people answer surveys/questions 
• Externally hosted data collection tools, such as Survey Monkey or Qualtrics 
• Interactive social media websites where people enter health data or connect with healthcare 
workers, researchers, or other research participants 
• Communications/outreach to participants performed by external vendors  
 
For guidance on technologies, please refer to: 
• Guidance on Research Using the Internet - Survey Research Using Web-Based Survey Tools 
• Guidance on Research Using the Internet - Informed Consent in Online Research 
• Research Computing Information Security (RISO) Website 
• Research Information Security Review for IRB Applications 
• Email: riso@partners.org 
 
NOTE: Not all IRB applications require an information security risk assessment.  Also, the Research 
Information Security (RISO) does not get triggered to conduct a data security review/assessment at 
the same time the initial IRB application is submitted.  The average timeline for review is 2-6 weeks 
from the time that RISO receives the request and the ServiceNow risk assessment form is 
submitted.  To open up a ServiceNow ticket, click here.  If there are any pressing timelines 
associated with starting the study, please contact riso@partners.org directly. 
 
 
DATA COLLECTION, STORAGE AND SECURITY 
 
Collection of Protected Health Information (PHI) or Sensitive Information 
 
Will you be using applications, systems or technologies outside Mass General Brigham to collect, share or 
store protected health information (PHI) and/or sensitive information? 
⚪  Yes   
◉  No  
 
 
Protected health information (PHI) includes the following: 
• Names, including initials 
• Social security numbers 
• Medical record numbers 
• Addresses by street location 
• Addresses by city, county, precinct, zip code 
• All elements of dates (except year) related directly to individuals including, but not limited to, 
dates of birth, death, admission, discharge, or any service 
• All ages over 89 and all elements of dates (including year) indicative of such age 
• Telephone numbers 
• FAX numbers 
• Electronic email addresses 
• Web URLs 
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• Internet protocol (IP) addresses 
• Account numbers 
• Certificate/license numbers 
• Vehicle identification numbers and serial numbers including license plates 
• Medical device identifiers and serial numbers 
• Biometric identifiers, including finger and voice prints 
• Full face photographs and any other comparable images 
• Any other unique identifying numbers, characteristics or codes including, but not limited to, 
globally unique identifiers (GUID) and universally unique identifiers (UUID) or equivalent 
 
 
Digital Health Technology 
 
Will you be using mobile and wireless devices, wearable devices, smartphone apps, digital health tools, 
health-related IT, new healthcare software and related new technologies to generate, use and/or 
disseminate health information or physiological data?  Note: Wearable devices can include activity trackers 
(i.e., FitBit), free-standing monitors or sensors worn on body which connect through wireless, Bluetooth or 
other method to passively collect data. 
⚪  Yes   
◉  No  
 
 
Are any of the technologies developed in-house by Mass General Brigham employees? 
⚪  Yes   
◉  No  
 
 
Will any of the digital health technologies communicate with and/or be integrated with any clinical systems 
(e.g., EPIC, EMRs, etc.)? 
⚪  Yes   
◉  No  
 
 
 
Social Media Data Collection Tools 
 
Will you be using social media tools to collect data for this study? 
⚪  Yes   
◉  No  
 
 
NOTE: This question does not include the use of social media to post advertisements and contact 
information for the study. This question is specifically asking about the collection of data using 
social media tools. Social media tools can include Facebook, Twitter, chat/text messages, message 
boards, interactive web pages and blogs.  
 
 
Web-Based Data Collection Tools 
 
Will you be using web-based survey or data collection tools to administer a survey or questionnaire? 
◉  Yes  
 
⚪  No  
 
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Indicate your collection methods (check all that apply): 
☑ Survey / Data collection tool hosted inside Mass General Brigham firewall 
 
Indicate: 
☑ REDCap or StudyTRAX through Mass General Brigham 
☐ 
Other survey / data collection tool 
☐ 
Survey / Data collection tool hosted outside Mass General Brigham firewall 
 
 
Non-US Data Collection and/or Storage 
 
Will you be collecting and/or storing data in countries outside of the United States? 
⚪  Yes  
 
◉  No  
 
 
 
Data Storage 
 
Describe data storage (physical location, security controls) and data transmission if data is sent/received 
to/from multiple sites/collaborators, etc. 
The primary storage device for study information will be the system-issued, password-protected, 
encrypted desktop computer (Clapp) located behind the MGB firewall in his physical, locked office on a 
secure administrative floor (Austen 438). Online data collection tools will use REDCap software. Data 
shared with outside collaborators (Cohen) will be deidentified and not include any personal information 
or patient-level identifiers. 
 
Will your research involve the use of any cloud-based technology (i.e., Amazon Web Services, Azure, 
Google Cloud, etc.)? 
⚪  Yes   
◉  No  
 
 
Will your research involve the use of any removable media for data storage (i.e., external hard drive, USB 
flash drive, etc.)? 
⚪  Yes   
◉  No  
 
 
Note: Mass General Brigham policy requires that all devices used to store data be encrypted. 
 
 
Data Sharing 
 
Will any data sharing take place with external non-Mass General Brigham collaborators? 
◉  Yes  
 
⚪  No  
 
 
Check all that apply: 
☑ MGB DropBox for Business 
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☐ 
MGB OneDrive for Business 
☐ 
MGB Secure File Transfer 
☐ 
MGB Syncplicity 
☐ 
Other 
 
 
STUDY COMMUNICATIONS: Email Distribution Lists / Text Messaging 
 
Will you be using an external third-party vendor to send communications/perform outreach to participants? 
⚪  Yes   
◉  No  
 
 
Will you be communicating with participants via text message? 
◉  Yes  
 
⚪  No  
 
 
Check all that apply: 
☐ 
Imprivata Cortext 
☐ 
Twilio 
☑ SMS 
☐ 
Other 
Conflicts of Interest  
 
  
1. Is this study being funded or supported in whole or in part by an Outside Entity?  NOTE: Support 
includes providing funds, drug, device, or other resources.  Outside Entity means any corporation, 
foundation or other entity or organization that is not a Mass General Brigham entity including any 
governmental entity or non-profit. 
◉  Yes  
 
⚪  No  
 
a. Name(s) of the Outside Entities 
National Bureau Economic Research  
Massachusetts Institute of Technology (MIT)  
 
  
2. Are you studying or are you using in any significant way a drug or device or other technology that is 
owned, developed or licensed by an Outside Entity?  NOTE: Technology that is used in a significant way 
includes, for example, imaging equipment that, while not the focus of the study, is an important part 
of the study design and will need to be described and identified in the methods section of a 
publication.  This includes licensed intellectual property such as patents, patent applications, and 
copyrighted materials, including technology licensed through Mass General Brigham. 
⚪  Yes   
◉  No  
 
Study Details  
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Study Classification  
  
The following information is being collected to allow the IRB to provide research administration with reports 
on the type of clinical research being conducted by Mass General Brigham investigators.  This is self-
reported information and will not affect what form questions you are presented with later in the 
application.  Please select all that apply. 
  
  
Type of Study: Select all that apply 
  
Intervention  
Content of Study: Select all that apply 
Women’s Health  
Diabetes Mellitus  
Prevention  
Hypertension  
Psychiatry  
 
  
Will your research be limited to any of the following:   
• Collection of one or more blood samples.   
• Prospective collection of biological specimens for research purposes by noninvasive means.   
• Collection of data through noninvasive procedures (not involving general anesthesia or sedation) 
routinely employed in clinical practice.   
• Collection of data from voice, video, digital, or image recordings made for research purposes.   
• Research on individual or group characteristics or behavior or research employing survey, interview, 
oral history, focus group, program evaluation, human factors evaluation, or quality assurance 
methodologies.   
◉  No  
 
⚪  Yes   
  
NOTE: You must attach a Detailed Protocol on the Attachments page of this submission using the 
Attachment Type 'Detailed Protocol.' If the study is industry sponsored, the sponsor protocol must 
be attached as the Detailed Protocol, and a Site Addendum must also be attached using the 
Attachment Type Site Addendum.  
 
  
Is this a randomized controlled clinical trial? 
⚪  No  
 
◉  Yes  
 
  
NOTE:  
1. You must attach a schema on the attachments page of this submission using the Attachment 
Type 'Schema;'   
2. You must attach a Detailed Protocol on the Attachments page of this submission using the 
Attachment Type 'Detailed Protocol.' If the study is industry sponsored, the sponsor protocol must 
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be attached as the Detailed Protocol, and a Site Addendum must also be attached using the 
Attachment Type 'Site Addendum.' 
 
  
Does the research involve the use of human embryonic stem cells? 
◉  No  
 
⚪  Yes   
 
  
Does the research involve issues related to women's health? 
⚪  No  
 
◉  Yes  
 
 
  
Is this a cancer-related trial? 
⚪  Yes   
◉  No  
 
 
NOTE: If this is a cancer-related trial, this study must be withdrawn and submitted to the Dana-
Farber/Harvard Cancer Center (DF/HCC) Office for Human Research Studies (OHRS)  for review.  The 
DF/HCC conducts centralized protocol review and monitoring for all cancer-related hypothesis-
driven clinical research studies undertaken by investigators at DF/HCC institutions. Brigham and 
Women's Hospital (BWH) and Massachusetts General Hospital (MGH) are DF/HCC institutions. As 
such the following categories of research must be reviewed by the DFCI IRB, pursuant to the DF/HCC 
Cancer Center Support Grant: 
1. Cancer-relevant research 
2. Research funded by NCI, even if not cancer-relevant; or 
3. Research utilizing DF/HCC infrastructure or DFCI facilities 
The DF/HCC Office for Human Research Studies (OHRS) is the office at DFCI that manages DF/HCC 
Scientific Review Committee review and DFCI IRB review. For information on how to proceed with your 
submission, please contact: Dana-Farber Cancer Institute - Office for Human Research Studies (OHRS) at 
OHRS@dfci.harvard.edu [Attn: Lara Sloboda / Caroline Kokulis]. For detailed information about the 
above requirement, please review this guidance. 
 
  
Study Design 
  
Who designed the study? 
⚪  Other   
◉  Mass General Brigham Investigator  
 
⚪  Corporate Sponsor  
 
⚪  Cooperative Group / Consortium  
 
NOTE: When the corporate sponsor designs the study, the corporate sponsor's protocol must be 
submitted to the IRB for review. Before the research can begin, the IRB must approve the sponsor's 
protocol and Mass General Brigham Clinical Research Office must execute the Agreement with the 
sponsor. 
 
  
Will any data generated from this study be submitted to the FDA? 
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◉  No  
 
⚪  Yes   
Clinical Trials Registration  
 
Clinical Trials Registration and Results Reporting 
 
Investigator–initiated clinical trials must be registered on ClinicalTrials.gov to comply with federal FDA 
requirements in FDA 42 CFR 11 (Final Rule) and/or NIH Policy. Studies that falls under both FDA and NIH 
requirements only need to be registered once. The information posted on ClinicalTrials.gov (CT.gov) must be 
updated and verified at least every 12 months. 
 
The following information is used to identify studies that require clinical trials registration and results 
reporting, and to inform Principal Investigators (PI) of their responsibilities for registration and results 
reporting. 
 
IMPORTANT NOTE: Even if your investigator-initiated clinical trial does not meet the NIH or FDA 
clinical trials registration requirements, you are strongly advised to read and consider registering 
your trial to comply with the following additional requirements: 
• A non-federal sponsor may require registration as part of the award's terms and conditions 
• International Committee of Medical Journal Editors (ICMJE) for publication purposes  
• Center for Medicare & Medicaid for research billing claims for qualifying clinical trials (Mass 
General Brigham Clinical Trials Office will notify you if applicable)  
• Research funders now requiring registration and results reporting: May 18, 2017 Joint 
Statement 
 
For additional information, please see the Human Research Affairs Compliance and Education Office 
website for Clinical Trials Registration. 
  
 
  
Is this a Mass General Brigham investigator – initiated research study? 
 
⚪  No  
 
◉  Yes  
 
 
 
Is this research funded in whole or in part by NIH AND does this research meet the NIH's definition of 
clinical trial? 
 
NIH defines a clinical trial as any research study that meets all of the following criteria: 
• The study involves human participants;  
• The participants are prospectively assigned to an intervention;  
• The study is designed to evaluate the effect of the intervention on participants; AND 
• The effect being evaluated is a health-related, biomedical or behavioral outcome. 
 
⚪  No  
 
◉  Yes  
 
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The responses to the questions above indicate this study meets the NIH Policy 
requirements for clinical trials registration and results reporting. Mass General Brigham 
Institutions have delegated responsibility for clinical trials registration, periodic updates, 
and results and adverse event reporting to the Principal Investigator ("Responsible Party"). 
This study must be registered on ClinicalTrials.gov prior to the first subject being enrolled 
into the study. 
 
Additional information is available from the NIH: 
• NIH's Definition of a Clinical Trial | grants.nih.gov 
• NIH Definition of Clinical Trial Case Studies | 
grants.nih.gov 
 
  
Responsible Party 
 
Enter Name of MGB investigator who will be the Responsible Party, for example Jane Doe, MD: 
  
Mark Clapp, MD 
 
Enter the full name of the MGB Institution of the MGB investigator, for example, Massachusetts 
General Hospital: 
  
Massachusetts General Hospital 
 
 
Documentation of ClinicalTrials.gov Registration 
 
Have you submitted registration information to ClinicalTrials.gov? 
 
◉  No  
 
⚪  Yes   
 
Results Reporting 
 
ClinicalTrials.gov results reporting is required within 12 months of the primary endpoint 
completion date defined as the date that the final subject was examined or received the 
intervention for the purposes of collection of primary outcome. Early consultation is 
strongly advised. Please contact the HRA Compliance and Education Office for assistance: 
  
Mass General Brigham Human Research Affairs Compliance and Education Office: 
QIProgramCTgovTeam@partners.org  
  
 
Additional information can be found at: 
HRA Compliance and Education Office website for Clinical Trials Registration 
www.ClinicalTrials.gov 
Study Population  
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How many subjects do you plan to enroll at Mass General Brigham' sites? 
360 
NOTE: Target enrollment at Mass General Brigham sites is the number of subjects you expect to 
provide written or verbal consent, or implied consent by voluntary completion of a survey or 
participation in a focus group. 
 
How many subjects will be enrolled study-wide? 
360 
 
What is the age range of eligible subjects who will be enrolled at Mass General Brigham sites?   
  
Enter 'None' if there is no maximum age. 
Minimum age: 
18 
Maximum age: 
None 
 
Equitable Selection of Subjects 
 
Will both males and females be enrolled? 
⚪  Yes   
◉  No  
 
 
Which gender will be enrolled? 
◉  Females only  
 
⚪  Males only  
 
 
Indicate below whether the study population that is being targeted for the research is any of the following 
groups that require additional protections: 
☐ 
Children (less than 18 years of age) 
☐ 
Economically or Educationally Disadvantaged 
☐ 
Embryos 
☐ 
Employees under the direct supervision of the investigators conducting the research 
☐ 
Employees (physician, nurses, or other healthcare workers) in the course of, or related to, their 
employment related duties 
☐ 
Individuals with Impaired Decision-Making Capacity 
☐ 
Neonates -age up to 28 days 
☐ 
Non-English Speakers 
☐ 
Patients from the Medical Practice of the Investigator 
☑ Pregnant Women / Fetuses 
☐ 
Prisoners 
☐ 
Students of Harvard Medical School 
☐ 
U.S. Military Personnel 
☐ 
None of the above 
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Performance Sites / Facilities  
Where will investigators covered by this IRB consent/enroll subjects and perform study procedures?   
☐ BWH 
 
☐ Cooley Dickinson Hospital 
 
☐ Faulkner 
 
☐ MEE 
 
☑ 
MGH 
MGH facilities/resources. Check all that apply. 
☐ 
Emergency Department 
☐ 
Translational and Clinical Research Center 
☑ 
Health Centers 
Indicate MGH Health Centers: 
☑ Charlestown Health Center 
☑ Chelsea Health Center 
☐ 
Everett Health Center 
☑ Revere Health Center 
☐ 
Other 
☐ 
Inpatient 
☐ 
Labor & Delivery / Post Partum Floors 
☐ 
NICU 
☐ 
Operating Room / Recovery Room 
☑ 
Outpatient 
Indicate MGH Outpatient Locations: 
☑ Hospital Main Campus 
☐ 
Building 149 Charlestown Navy Yard 
☐ 
1 Bowdoin Square 
☐ 
165 Cambridge Street – Charles River Plaza East 
☐ 
175 Cambridge Street – Charles River Plaza South 
☐ 
185 Cambridge Street - Simches Building 
☐ 
275 Cambridge Street – Professional Office Building 
☐ 
Charles River Park (i.e., Emerson, Longfellow, Hawthorne, Whittier) 
☐ 
101 Merrimac Street 
☐ 
151 Merrimac Street 
☐ 
50 Staniford Street 
☐ 
60 Staniford Street 
☐ 
Lurie Center - Lexington 
☐ 
MGH Back Bay 
☐ 
MGH Downtown 
☑ MGH West - Waltham 
☑ North Shore Center for Outpatient Care - Danvers 
☐ 
Other 
 
☐ NSMC 
 
☐ NWH 
 
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☐ PCHI 
 
☐ Shriners 
 
☐ SRH 
 
☐ IHP 
 
☐ McLean 
 
☐ Broad Institute 
 
☐ Wentworth-Douglass Hospital 
 
☐ Network Sites (e.g. NeuroNEXT and Stride) 
 
☐ Off-site Research (off-site means sites other than those owned or controlled by Mass General 
Brigham entities) 
  
NOTE: When more than one Mass General Brigham site is included in the submission, designate a 
Site-Responsible Investigator (not Residents, Fellows, or Trainees) for each site on the Staff & 
Access page. 
 
Is this a Mass General Brigham investigator-initiated multi-site study? 
⚪  Yes   
◉  No  
 
Recruitment  
 
 
Source of Subjects 
  
Indicate whether you will use any of the following resources to identify prospective subjects: 
☐ 
Census / Public Records 
☐ 
Commercial Mailing Lists 
☐ 
Emergency Department 
☐ 
Inpatient Units 
☑ Medical Records 
☑ Outpatient Clinics 
☐ 
Primary Physician / Physician Specialist 
☐ 
Registries / Patient Databases (e.g. cancer registry) 
☑ Research Patient Data Registry (RPDR) 
☐ 
Research Match (Vanderbilt Recruitment Tool) 
☐ 
RSVP for Health 
☐ 
Research Studies 
☐ 
None of the above 
 
Note: For more information about ResearchMatch, see https://www.researchmatch.org/about/ 
  
 
  
Methods / Materials 
  
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Indicate whether you will use any of the following methods / materials to recruit subjects: 
☐ 
Advertisements - E-Mail 
☐ 
Advertisements - Internet 
☐ 
Advertisements - Rally https://rally.partners.org (Contact rallyforresearch@partners.org for more 
information) 
☐ 
Advertisements - Newspaper (e.g. Metro, Boston Globe) 
☐ 
Advertisements - Radio 
☐ 
Advertisements - Television 
☐ 
Flyers / Postings (e.g. within BWH or MGH) 
☑ Patient Gateway - Personalized Letters 
☐ 
Patient Gateway - Targeted Research Announcements 
☐ 
Mail 
☐ 
ResearchMatch Volunteer Message (see https://www.researchmatch.org/researchers/) 
☐ 
Telephone Calls to Prospective Subjects (who have previously agreed to be contacted, e.g. RSVP 
for Health) 
☐ 
None of the above 
  
NOTES: 
1. The text of all advertisements, letters, and telephone calls/scripts used to recruit subjects 
must be submitted for IRB approval.  You may attach these documents to the application on 
the Attachments page.  For guidance on recruitment and advertising, please see the following 
MGB IRB web pages Recruitment of Research Subjects and Guidelines for Advertisements 
for Recruiting Subjects. 
2. When using Research Match, you must submit the contact message template for Research 
Match advertisement to the IRB for approval.  The contact message template is available to 
registered researchers on the ResearchMatch website. 
 
  
Pre-Screen of Subjects During Recruitment 
 
Will you ask prospective subjects pre-screening questions over the phone to determine eligibility? 
⚪  Yes   
◉  No  
 
 
 
Will you ask prospective subjects to complete an online pre-screening tool to determine eligibility? 
⚪  Yes   
◉  No  
 
 
Note: Refer to Mass General Brigham Guidance on Pre-Screening of Subjects During Recruitment.  
Remuneration  
 
Will subjects be paid or receive any type of remuneration / compensation for their time and expenses? 
◉  Yes  
 
⚪  No  
 
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Payment for Participation in Research 
  
Indicate the type and total amount of compensation for completion of the study. 
☐ Cash 
 
☐ Check 
 
☑ 
Gift Certificate 
Amount e.g., $50, enter 50.00 
20 
 
☐ Other 
  
NOTE: Payments to subjects must be made by check if payment involves a one-time payment of 
greater than $50 OR multiple payments of any amount.  See policies Payments to Human 
Subjects for Participation in Research and Cash Control and Accountability for Payments to 
Human Subjects for Participation in Research. 
 
Reimbursement for Expenses Related to Participation in Research 
 
If there is not a set amount for meals, parking, and transportation, then estimate or enter the maximum 
amount budgeted per subject.  
☐ Meals 
 
☐ Parking 
 
☐ Transportation 
 
☐ Other 
Informed Consent  
  
For guidance, refer to the MGB IRB web page Informed Consent of Research Subjects. 
  
 
Will informed consent and authorization for participation in research be obtained verbally (oral consent), or 
by use of a written consent form approved by the MGB IRB and signed by the subject or the subject's 
legally authorized representative? 
◉  Yes  
 
⚪  No  
 
  
Indicate how informed consent and authorization will be obtained: 
⚪  Written   
◉  Verbal (oral consent)  
 
 
Indicate who will obtain the informed consent of the subject or the subject's legally authorized 
representative. 
☑ Licensed Physician Investigator 
☑ Non-Physician Investigator 
☐ 
Other 
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Indicate from whom informed consent will be obtained. Check all that apply: 
☑ Adult Subject 
☐ 
Parent(s) / Guardian for Child 
☐ 
Court-Appointed Guardian for Adult 
☐ 
Surrogate for Adult, other than Guardian (e.g. health care proxy, person with durable power 
of attorney, spouse, adult child, or close family member). 
NOTE: When surrogate consent for adults is obtained, the individuals with impaired decision-
making capacity form must be completed.  For guidance, refer to the following MGB IRB web 
pages, Surrogate Consent to Research for Individuals with Impaired Decision-making Capacity 
 
Will the research target a non-English speaking group? 
⚪  Yes  
 
◉  No  
 
  
NOTE: When investigators can reasonably expect that more than an incidental number of 
subjects speaking the same non-English language will be enrolled (for example, if the research 
is targeting a non-English speaking group), the use of a written translation of the entire English 
version of the consent form is required.  The MGB IRB must approve all written translated 
versions of the consent from and recommends that the written translation be done by an in-
house medical translator from Interpreter Services or other qualified person or service 
recommended by Interpreter Services. Refer to the MGB IRB guidance on Obtaining And 
Documenting Informed Consent Of Subjects Who Do Not Speak English. 
  
 
Will a study subject advocate participate in the consent process? 
⚪  Yes  
 
◉  No  
 
NOTE: A study subject advocate may be used, for example, because subjects have limited time 
to consider participation in a study involving significant risk, or may feel obligated to participate. 
 
Will subjects have less than 12 hours to decide whether or not to participate? 
⚪  Yes  
 
◉  No  
 
  
NOTE: The IRB may waive the requirement to obtain a signed written consent / authorization form if it 
finds either: (1) the only record linking the subject and the research is the consent form and the 
principal risk would be potential harm resulting from a breach in confidentiality; or (2) the research 
presents no more than minimal risk of harm to subjects and involves no procedures for which 
written consent is normally required outside the research context. 
Diaries  
 
Will subjects be asked to complete a diary(ies)?  For example, a drug diary, pain diary, symptom diary, etc. 
⚪  Yes   
◉  No  
 
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Privacy / Confidentiality  
 
 
Health/Medical Records 
 
Will medical history / clinical information be obtained from the subject's health / medical record for study 
purposes? 
 
◉  Yes  
 
⚪  No  
 
 
Explain what information will be abstracted from health / medical records: 
 
Age 
Race 
Ethnicity 
Primary language 
Primary insurer 
Address 
Pregnancy information 
Primary care provider/address 
Number of PCP visits prior to start of pregnancy 
Medical history, including diabetes, hypertension, mood/anxiety disorders 
Prenatal clinic 
Prenatal care provider 
Number of prenatal care visits 
Pregnancy-related medical conditions, including gestational diabetes and pregnancy-induced 
hypertensive disorders 
Height / weight / BMI 
Delivery information, including delivery-related complications 
Number of postpartum care visits 
Primary care provider encounters before and after delivery 
Urgent / unscheduled visits before and after delivery 
 
 
Will sensitive personal health information resulting from this study become part of the subject's 
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health/medical record?  
 
⚪  Yes   
◉  No  
 
  
Sensitive personal information obtained for research purposes typically does not become part of the 
subject’s health/medical record.  Rather, these data are retained in the research records only. 
  
NOTE: Certain categories of medical information are commonly recognized as potentially sensitive, 
such as information related to mental health; sexual behaviors or sexual orientation; illegal 
behaviors; and substance abuse.  Some genetic test results may be viewed similarly.  When 
applicable, investigators are reminded to inform subjects in the consent form that sensitive personal 
health information may become part of their health/medical record, e.g., routine testing for HIV 
infection. 
 
 
Will you enroll subjects in the study in Epic? 
 
◉  Yes  
 
⚪  No  
 
 
Do you wish to receive notifications when subjects enrolled in the study are admitted to an Emergency 
Department or admitted for a day procedure or inpatient stay at a hospital that uses the Mass General 
Brigham version of Epic? 
 
◉  Yes  
 
⚪  No  
 
 
NOTE: If you wish to receive notifications about the death of subjects enrolled in your 
study, submit a ticket to the Research-DHeC. 
 
Who do you want to receive the notifications? 
 
⚪  PI Only  
 
◉  All Study Staff  
 
 
NOTE: Epic is both the Mass General Brigham electronic medical record and the billing system, 
including research billing. For more information about Epic/eCare, refer to Research Information 
Services & Computing's Support & Training page eCare Research FAQs. 
 
 
Do you consider this to be a sensitive study that requires the title of the study be masked in the electronic 
medical record (eCare)? 
 
⚪  Yes   
◉  No  
 
 
NOTE: The title of studies determined to be sensitive will be masked in the Mass General Brigham 
eCare system (e.g., Psychiatry Study 1 will appear as MGB 2017P001234).  The IRB is responsible for 
making the final determination whether a study is sensitive.  Examples of studies that may be 
considered sensitive are studies that collect information about:  
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• sexual practice 
• sexual victimization 
• illegal behaviors 
• alcohol, drugs, or other addictive products 
• stigmatizing illnesses 
 
 
Certificate of Confidentiality 
 
NIH funded research that collects or uses identifiable sensitive information is automatically issued a 
Certificate of Confidentiality as part of the terms and conditions of the award. The NIH considers research 
that is reviewed by the IRB to involve identifiable sensitive information requiring a Certificate. 
 
If you do NOT have NIH funding, do you have or do you plan to obtain a Certificate of Confidentiality to 
protect the data from disclosure (e.g., by court order or subpoena)? 
 
 
 
⚪  Yes   
◉  No  
 
 
NOTE: For information on Certificates of Confidentiality, refer to the OHRP website. 
 
 
Sending Health Information to Research Collaborators Outside Mass General Brigham 
 
 
Will identifiable information be shared with research collaborators outside Mass General Brigham? 
 
⚪  Yes   
◉  No  
 
 
NOTE: Data that includes any of the identifiers listed below are considered identifiable. 
 
• Names, including initials  
• Social security numbers  
• Medical record numbers  
• Addresses by street location  
• Addresses by city, county, precinct, zip code  
• All elements of dates (except year) related directly to individuals including, but not limited to, 
dates of birth, death, admission, discharge, or any service  
• All ages over 89 and all elements of dates (including year) indicative of such age  
• Telephone numbers  
• FAX numbers  
• Electronic email addresses  
• Web URLs  
• Internet protocol (IP) addresses  
• Account numbers  
• Certificate/license numbers  
• Vehicle identification numbers and serial numbers including license plates  
• Medical device identifiers and serial numbers  
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• Biometric identifiers, including finger and voice prints  
• Full face photographs and any other comparable images  
• Any other unique identifying numbers, characteristics or codes including, but not limited to, 
globally unique identifiers (GUID) and universally unique identifiers (UUID) or equivalent 
 
For guidance, refer to the MGB IRB web page on the HIPAA Privacy Rule. 
  
 
  
 
NOTE: Non-institutional email services are not approved to transmit confidential data.  Use “Send 
Secure” to transmit confidential data to non-institutional email domains (e.g., gmail, yahoo, icloud, 
etc.).  For more information on appropriate methods of transmitting research information/data to 
research collaborators, refer to the Research Information & Computing website. 
 
 
Business Associates 
 
Will identifiable information be shared with persons or entities outside of Mass General Brigham who are not 
research collaborators or who are not part of the research team, but who will perform some aspect of the 
research on behalf of Mass General Brigham, e.g., a private recruitment agency, outside laboratory or data 
analysis group? 
 
⚪  Yes   
◉  No  
 
 
NOTE: In this situation, the persons or entities referred to above are considered business associates 
of Mass General Brigham, therefore a Business Associate Agreement is required. 
Instruments / Questionnaires  
 
  
Will the research involve the development of instruments, questionnaires, surveys, interviews, and/or focus 
group topics? 
⚪  Yes   
◉  No  
 
 
Will the research involve the use of instruments, questionnaires, surveys, interviews, and/or focus group 
topics? 
◉  Yes  
 
⚪  No  
 
 
  
List of Instruments / Questionnaires / Surveys / Interviews / Focus Group Topics 
 
 
Enter the name of each of the instruments, questionnaires, surveys, interviews and/or focus 
group topics. Upload each of the instruments, questionnaires, surveys, interviews and/or focus group 
topics to the Attachments page.  Do not list any that are under development. 
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Baseline Survey  
Ancillary Drugs  
 
Will you be using FDA-approved drugs for research-related ancillary/supportive care? 
⚪  Yes   
◉  No  
 
 
NOTE:  An ancillary drug is a commercially available drug that is being used for a research-related 
ancillary test or for supportive care (e.g. methacholine challenge tests, lidocaine for research-related 
biopsies, EMLA cream for venipuncture, contrast agent for scans or x-rays).  The Research Consent 
Form should include the risks of ancillary drugs being administered as part of the research. 
Ancillary Devices  
 
Will any non-hospital inventory FDA-approved medical devices be used to obtain measurements, collect 
data, or monitor subjects?   
⚪  Yes   
◉  No  
 
  
NOTE: When the sponsor (or another party) provides a medical device for use to obtain 
measurements, collect data, or monitor subjects, the investigator must request a zero dollar 
purchase order to track receipt of the medical device and to document BME inspection for electrical 
safety, when necessary. For more information, refer to the Zero Dollar Purchase Order Policy. 
Non-Intervention / Non-Interaction Group  
In addition to the intervention/interaction group that provides informed consent to participate in the research, 
do you plan to also review the health/medical records or other private/confidential information of any subjects 
with whom you will have no contact at any time?  
◉  Yes  
 
⚪  No  
 
 
Source of Health / Medical Information 
  
Check all that apply: 
☐ 
BWH 
☐ 
Faulkner 
☑ MGH 
☐ 
NWH 
☐ 
NSMC 
☐ 
PCHI 
☐ 
SRH 
☐ 
Shriners 
☐ 
McLean 
☐ 
MEE 
☐ 
Other 
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Data To Be Collected / Obtained 
  
Check all that apply: 
  
Administrative: 
☐ 
Billing Data 
☑ Coded encounter data (diagnoses, procedures, dates) 
☑ Demographic data (age, gender, vital status) 
☑ Personal data (name, address, PCP) 
  
Health / Medical: 
☑ Allergies 
☑ Discharge Summary 
☐ 
Doctors Orders 
☐ 
History / Physical 
☐ 
Immunizations 
☑ Medication List 
☑ Office / Clinic Notes 
☐ 
Operative / Procedure Notes (e.g. endoscopy) 
☑ Pharmacy 
☑ Problem List 
  
Health/Medical Reports/Results 
☑ Blood Bank 
☑ Laboratory 
☑ Pathology 
☑ Radiology 
  
Sensitive/Personal Information: 
☑ HIV Status 
☑ Mental Health 
☑ Reproductive History (e.g., abortions) 
☑ Sexual Behavior/Sexually Transmitted Diseases 
☐ 
Substance Abuse (e.g., drug or alcohol abuse) 
☐ 
Other potentially stigmatizing behaviors 
 
☐ Other Information 
 
Have you defined data variables to be collected/obtained? 
◉  Yes  
 
⚪  No  
 
  
NOTE: You must attach a document that lists all data variables to be collected / obtained in 
the Attachments section before submission. 
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Data To Be Requested From The Following Time Period 
  
Indicate the time period over which the health / medical information was / will be created as part of 
clinical care. 
  
From (mm/yyyy): 
07/2022 
To (mm/yyyy): (For future data, use anticipated project end date) 
12/2023 
  
NOTE: This information is needed for the MGB IRB to determine whether the research use of the 
health/medical information meets the criteria for an exemption from the requirements for IRB 
review.  For more information about HUMAN SUBJECTS RESEARCH or EXEMPT RESEARCH, 
see the OHRP website. 
 
  
Protected (Identifiable) Health Information 
  
PHI refers to health/medical information that is accompanied by any of the listed 18 HIPAA identifiers or 
by a code (where the key to the code is accessible to investigators) that links to the identifiers. DE-
IDENTIFIED DATA (without any identifiers or codes that link back to individuals) are not considered 
PHI, and are not subject to HIPAA regulations. 
 
Will you be recording any of the identifiers listed below with the data or using a code to link the data to 
any of the identifiers? 
• Name, including initials 
• Social Security Number (SSN) 
• Medical record number 
• Address by street location 
• Address by city, county, precinct, zip code 
• All elements of dates (except year) related directly to individuals including, but not limited to 
dates of birth, death, admission, discharge, or any service 
• All ages over 89 and all elements of dates (including year) indicative of such age 
• Fax number 
• Electronic email address 
• Web URL 
• Internet provider (IP) address 
• Health plan beneficiary number 
• Account number 
• Certificate / license number 
• Vehicle identification number and serial number 
• Biometric identifiers, including finger and voice print 
• Full face photographic images and any other comparable images 
• Any other unique identifying number, characteristic or code, including, but not limited to, globally 
unique identifier (GUID) and universally unique identifier (UUID), or equivalent identifier 
NOTE: If you are recording medical record number or other identifiers, even if temporarily for QA 
purposes or to avoid duplicating records, then answer "Yes". 
◉  Yes  
 
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⚪  No  
 
 
  
Check the identifiers that will be recorded with or linked by code to the data. 
☐ 
Name 
☐ 
Social Security Number 
☑ Medical record number 
☐ 
Address by street location 
☐ 
Address by town / city / zip code 
☑ Dates (except year), e.g., date of birth; admission / discharge date; date of procedure; 
date of death 
☐ 
Telephone number 
☐ 
Fax number 
☐ 
Electronic email address 
☐ 
Web URLs 
☐ 
Internet protocol (IP) address 
☐ 
Health plan beneficiary number 
☐ 
Account number 
☐ 
Certificate / license number 
☐ 
Vehicle identification number and serial number, including license plate number 
☐ 
Medical device identifiers and serial numbers 
☐ 
Biometric identifiers (finger and voice prints) 
☐ 
Full face photographic image 
☐ 
Any other identifier; or combination of identifiers likely to identify the subject (e.g., 
Pathology Accession #) 
 
Explain why it would be impossible to conduct the research without access to and use of 
identifiable health / medical information.  
  
For example, the data cannot be obtained from electronic health / medical records or databases 
without access to identifiers or identifiers are needed for prospective data collection. 
It would be impossible to conduct this research without access to identifiable health 
information as this information will be use to track which patients in the practice are eligible for 
recruitment, who has been approached, and who has consented/declined. 
 
How will the protected health information (PHI) recorded for the research be stored and protected?  
 
For paper-based information, describe where the identifiable information will be stored, who has 
access to the storage area, and how that access will be audited.  If the information is stored off-
site, describe how security at the facility is maintained and whether or not a business associate 
agreement has been or will be signed.  At a minimum, consider storing the PHI in locked drawers, 
cabinets, or offices with access restricted to the princiapl investigator (PI) and study staff 
designated by the PI.  
  
For electronic information, describe how electronic security is maintained, including what 
password protections and antivirus software are enabled.  Describe how the system will be 
audited.  At a minimum, consider storing PHI in a password-protected Mass General Brigham 
computer with anitvirus software. 
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All data will be stored in REDCap. 
All data collection involving HPI with identifiers will occur at MGH on MGB-managed 
computers, whose security profile is managed by MGB Information Systems (password 
protections, antivirus, etc). All data identified data will be stored and analyzed on a MGB 
computer (Clapp - stored in MGH AUS 438). Identifiable data will be limited to MGB study staff 
by use of password protected files or restricted shared file areas. De-identified data will be 
analyzed on computers/networks in accordance with MGB policies. 
 
Will identifiers be removed from the data and destroyed after all of the data has been collected, the 
study has been completed, or all regulatory and sponsor obligations have been met, consistent 
with regulatory and institutional research record keeping requirements? 
 
For guidance, see the Recordkeeping and Record Retention Requirements document. 
◉  Yes   
⚪  No   
  
NOTE: Federal regulations mandate that, under a Waiver of Consent / Authorization, 
identifiers be destroyed as early as possible.  De-identified datasets may be retained 
indefinitely. 
 
  
Waiver of Informed Consent / Authorization 
  
Explain why the risk to subjects, specifically the risk to privacy, is no more than minimal risk. 
MRNs will be the primary personal identifier that will be used in the data collection process. 
Once the data collection is completed, the MRN will be replaced by a unique patient identifier 
before any analyses are performed and all other identifying information will be removed. All 
data collection involving HPI with identifiers will occur at MGH on MGB-managed computers, 
whose security profile is managed by MGB Information Systems (password protections, 
antivirus, etc). All data identified data will be stored and analyzed on a MGB computer (Clapp - 
stored in MGH AUS 438). Identifiable data will be limited to study staff by use of password 
protected files or restricted shared file areas. De-identified data will be analyzed on 
computers/networks in accordance with MGB policies. 
  
Explain why the research could not practicably be carried out without the waiver of consent / 
authorization. 
We anticipate that we will screen over 1000 patients to determine eligibility; the costs, time, 
and resources to locate and obtain consent for reviewing a patients medical record to 
determine eligibility criteria would be prohibitive for this study. Furthermore, the bias 
introduced by studying only consenting patients will limit the interpretability and generalizability 
of the findings. To protect the private of subjects, MRN will be the only identifier collected and 
PHI will be destroyed after the data set is constructed.  
  
NOTE: “Only in a few research studies would it be impossible to obtain informed consent; 
however in many studies the financial cost would be prohibitive and a potentially poor use 
of limited research resources.” Ensuring Voluntary Informed Consent and Protecting 
Privacy and Confidentiality, National Bioethics Advisory Commission. 
  
Explain why the rights and welfare of the subjects will not be adversely affected by the waiver of 
consent / authorization. 
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The welfare and rights of the subjects will not be affected by the waiver of consent because 
the study is retrospective and will occur after the pregnancy episode has completed. 
Information gathered will not directly affect the individual patients in the study. Lastly, study 
subjects' privacy will be protected by limiting the identifiable data to the study staff and having 
this data stored securely within the MGB Healthcare IS system. Study subjects will remain 
anonymous; patients will not be personally identifiable from any published or produced data 
from this project. 
NOTE: If the research uncovers information about the subjects that has important health / 
medical implications for them, contact the MGB IRB to discuss the appropriate process for 
providing subjects with additional pertinent information. 
 
  
Sending Health / Medical Information to Collaborators Outside Mass General Brigham 
  
Will any health / medical information be sent to collaborators outside Mass General Brigham? 
◉  Yes  
 
⚪  No  
 
Explain what health information will be sent, and to whom. 
Deidentified data collected in this study will be sent to Dr. Jessica Cohen (HSPH) to assist in 
the analysis and made publicly available via the funder, as part of their federal data sharing 
policy. No data will be shared without oversight/approval/DUA by the IRB and Office of 
Research Management. 
 
  
HIPAA And Tracking Disclosures Of Identifiable Health Information (PHI) 
  
1.  Disclosures of PHI to persons or entities outside Mass General Brigham without the written 
authorization of the subject must be tracked in accordance with Mass General Brigham policy 
“Accounting of Disclosures.” (MGB Intranet link) 
  
2.  Tracking is NOT required for disclosure of LIMITED DATA SETS under a DATA USE 
AGREEMENT.  For more information about LIMITED DATA SETS and DATA USE AGREEMENTS, 
refer to Mass General Brigham policy “Limited Data Sets Policy/Data Use Agreements."  
  
NOTE: Mass General Brigham (MGB) is the HIPAA covered entity.  MGB includes BWH, Faulkner, 
MGH, McLean, PCHI, SRH, NSMC, and NWH, among others.  MGB does not include other 
Harvard affiliated hospitals, such as BIDMC, DFCI, HSPH, CHB, or MEEI. 
Pregnant Women or Human Fetuses  
 
Federal regulations require the IRB to provide additional protections for pregnant women and human fetuses 
involved in research [45 CFR 46.204].   
  
Assessing Risks And Benefits 
When assessing risks and benefits, consider the variability in health status of the subjects to be enrolled, 
their medical experiences, and the extent to which the research procedures will be a burden to the subjects 
in the context of their daily lives and/or routine medical care.  Procedures that usually present no more than 
minimal risk include: urinalysis, obtaining a small amount of blood, EEGs, allergy scratch tests, minor 
changes in diet or daily routine, and/or the use of standard psychological or educational tests.  The 
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assessment of the probability and magnitude of the risk, however, may vary depending on the diseases or 
conditions the subjects may have. 
  
Minimal Risk 
As defined in the regulations 45 CFR 46.102(i), “minimal risk means the probability and magnitude of harm 
or discomfort anticipated in the research are not greater in and of themselves than those ordinarily 
encountered in daily life or during the performance of routine physical or psychological examinations or 
tests.”   
  
 
Pregnant women or fetuses may be involved in research if all of the following conditions listed below are met 
[45 CFR 46.204].  Please provide study-specific information with your explanations. 
  
(a) Where scientifically appropriate, pre-clinical studies, including studies on pregnant animals, and clinical 
studies (including studies on non-pregnant women) have been conducted and provide data for assessing 
potential risks to pregnant women and fetuses. 
  
Provide a brief description of relevant prior pre-clinical and clinical studies, and based on this information, 
what you think the risks to pregnant women and to the fetus are in your research.  
This study is minimal risk for all individuals. There are no additional, specific risks to pregnant women or 
fetuses as part of this research.  
  
(b) The risk to the fetus is caused solely by the interventions or procedures that hold out the prospect of 
direct benefit for the woman or the fetus; if there is no such prospect of direct benefit, the risk to the fetus is 
not greater than minimal and the purpose of the research is the development of important biomedical 
knowledge which cannot be obtained by other means. 
  
Does the research hold out the prospect of direct benefit for the woman, or to the fetus? 
⚪  Yes   
◉  No  
 
Explain why you believe the risk to the fetus is not greater than minimal risk. 
This study will enroll pregnant individuals and involve sending them messages about the 
importance of primary care follow-up.  
Explain what new important knowledge will be gained, and why the information could not be obtained by 
any other means. 
This study aims to improve care transitions between pregnancy/postpartum providers and primary 
care providers. By its nature, there is no other way this information could be gained without 
studying pregnant individuals. 
  
(c) Any risk is the least possible for achieving the objectives of the research. 
  
Explain how the risks have been minimized to the least possible to achieve the research objectives.   
The risks have been minimized such that only the minimum necessary information will be collected. To 
protect the privacy of subjects, MRN will be the only identifier collected and PHI will be destroyed after 
the study has completed.  
 
Informed Consent  
Check all that apply:   
☑ Informed consent will be obtained from the pregnant woman in accordance with the consent 
provisions of Federal regulation 45 CFR 46.116. 
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☐ 
When the research holds out the prospect of direct benefit solely to the fetus, informed consent 
will be obtained from the father in accordance with the consent provisions of 45 CFR 46.116, 
except, if he is unable to consent because of unavailability, incompetence, or temporary 
incapacity, or the pregnancy resulted from rape or incest. 
☐ 
Each individual providing consent will be fully informed regarding the reasonably foreseeable 
impact of the research on the fetus. This information is included in the Mass General Brigham 
Research Consent Form. 
 
MASSACHUSETTS GENERAL LAW CHAPTER 112, SECTION 12J   
  
Experimentation on human fetuses prohibited; medical procedures authorized; consent; approval; civil and 
criminal liability and proceedings; severability.    
  
(a)I. No person shall use any live human fetus whether before or after expulsion from its mother's womb for 
scientific, laboratory, research or other kind of experimentation. This section shall not prohibit procedures 
incident to the study of a human fetus while it is in its mother's womb, provided that in the best medical 
judgment of the physician, made at the time of the study, said procedures do not substantially jeopardize the 
life or health of the fetus, and provided said fetus is not the subject of a planned abortion. 
(a)II. No experimentation may knowingly be performed upon a dead fetus unless the consent of the mother 
has first been obtained, provided, however, that such consent shall not be required in the case of a routine 
pathological study. 
(a)III. No person shall perform or offer to perform an abortion where part or all of the consideration for said 
performance is that the fetal remains may be used for experimentation or other kind of research or study.   
Attachments 
 
Name 
Mode 
Study Fact Sheet_071522 (Consent Fact/Information Sheet)  
Electronic  
Detailed Protocol_071522  
Electronic  
Roybal DSMB Charter Final (DSMB/DMC Report)  
Electronic  
DSMP_Cohen_Clapp (DSMB/DMC Report)  
Electronic  
Prescreening Information (Data Collection Form)  
Electronic  
PCP Study Baseline Survey (Instrument/Questionnaire)  
Electronic  
Patient Gateway Research Invitation Letter (Recruitment Letter)  Electronic  
Schema (Schema)  
Electronic  
Patient Messages (Document for review)  
Electronic  
 
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Research Study Fact Sheet
Bridging the Gap from Postpartum to Primary Care (The Bridge Study)
Principal Investigators
Mark Clapp, MD MPH (Massachusetts General Hospital)
Jessica Cohen, PhD (Harvard School of Public Health)
Overview
This is a research study being conducted among pregnant and recently postpartum 
individuals who receive care at MGH.
Purpose
Your primary care provider (PCP) is responsible for managing and overseeing your 
current and long-term health, and many people do not regularly see their PCP after a 
pregnancy. The purpose of this project is to improve the transition of care between 
your obstetric care and PCP after your delivery. 
Sponsor
This research is being sponsored by the MIT Roybal Center for Translational 
Research to Improve Health Care for the Aging and the NBER Roybal Center for 
Behavior Change in Health.
Contact
We sent you a Patient Gateway message about this study because you have or may 
be at risk for health conditions later in your life, such as high blood pressure, diabetes, 
obesity, or anxiety or depression.
Study Details
If you agree to participate, you we will ask you a few questions about your health and 
visit history at the time of enrollment, which are all optional.
You will then be randomly assigned (50/50 chance) to be in the “standard care” group 
or the “facilitated transition” group. You will not be informed which group you have 
been assigned.
In the “standard care” group, you will continue to receive standard postpartum care 
from your primary obstetric provider. In addition, you will receive Patient Gateway and 
optional SMS (text) messages from the study team. 
In the “facilitated transition” group, you will continue to receive standard postpartum 
care from your primary obstetric provider. In addition, you will receive Patient 
Gateway and optional SMS (text) messages from the study team between your 
enrollment and up to four months after your delivery. The study team will also assist in 
connecting you with your primary care provider after your postpartum visit with your 
obstetric provider. Specifically, we may call your primary care provider’s office on your 
behalf and request a “health care maintenance” or “annual exam” appointment be 
scheduled. You always have the option to change or cancel this appointment.
Messages we send you via Patient Gateway will also appear in your medical record 
for other members of your care team to see.
For both groups, we will review your medical record after your delivery to see if/when 
you received any care within the Mass General Brigham health system and 
information on your health status for up to two years after your delivery.
We also may contact you once between four and twelve months after your delivery to 
ask you questions about your postpartum to primary care transition experience. You 
can decline to participate or answer any or all questions.
You may opt out of receiving messages or decline to participate in any survey, and/or 
withdraw from the study at any point without penalty.
A total of 360 people will participate in this study.
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Privacy/Confidentiality
We are required by the Health Insurance Portability and Accountability Act (HIPAA) to 
protect the privacy of health information obtained for research. More details related to 
the privacy of your health information is included on Pages 3-4 of this fact sheet.
All information collected as a part of this study will be kept confidential and secure. As 
with all studies, there is a very low risk that others may become aware of your 
participation or health information. The study procedures and its protections of your 
information have been approved by the Mass General Brigham Human Subjects 
Research committee. Once the study has completed, all information that could 
identify you, such as your name or medical record number, will be deleted. 
Study Information
We will collect information on your health and pregnancy history, including about visits 
you have with providers within the Mass General Brigham health system. Data 
collected as a part of this study will not affect your clinical care directly. Any 
messages sent from the study team will be visible to you and your care team within 
the electronic medical record. Your de-identified information may be used or shared 
with other researchers without your additional informed consent.
Risks
There are minimal risks to participate. 
Although we will make every effort to protect participant privacy and confidentiality, it 
is possible that your involvement in the study could become known to others. We will 
be sending messages via Patient Gateway, which is a HIPAA-compliant method for 
communicating with you. You have the option to also receive SMS text messages that 
will not have any identifiable or personal health information. There is a rare possibility 
that study participation or health information could become known to others despite 
the use of firewalls, password protection, and other security measures.
Costs
You do not have to pay to take part in this research study. By attending a PCP visit, 
there is a possibility that you will incur a charge. Under the Affordable Care Act, 
commercial health plans are required to cover an annual Preventive Health Exam at 
no cost to the patient (no co-payment, co-insurance or deductible). MassHealth also 
covers these visits without a cost. However, if this visit turns into a “sick” or “disease 
management” visit, you may be billed for some or all aspects of the services provided, 
depending on your insurer. We will provide you information on how to check potential 
costs with your insurer prior to your visit.
Participation
Those who participate will receive a $20 gift card after enrollment. 
Participation is voluntary, and you can withdrawal or stop the study at any time. 
Deciding not to participate won't affect medical care they receive at Mass General 
Brigham now or in the future, or any benefits they receive now or have a right to 
receive.
Study Contact
Mark Clapp, MD MPH, is the person at MGH who in charge of this research study. 
You can call him at 617-724-4531 (M-F 9a-5p). You can also call the study 
coordinator (Fowsia Warsame) at 617-643-5483 (M-F 9a-5p) with questions about 
this research study.
If you’d like to speak to someone not involved in this research about your rights as a 
research subject, or any concerns or complaints you may have about the research, 
contact the Mass General Brigham IRB at (857) 282-1900.
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3
Option to Receive Text (SMS) Messages
Text messages by mobile/cell phones are a common form of communication. The Bridging the Gap from 
Postpartum to Primary Care study would like to send you no more than 3 text (SMS) messages as a part of the 
study, though this is optional and not required to participate in the Bridge Study. Texting over mobile/cell 
phones carries security risks because text messages to mobile/cell phones are not encrypted.  This means that 
information you send or receive by text message could be intercepted or viewed by an unintended recipient, or 
by your mobile/cell phone provider or carrier. 
Below are some important points about texting in as a part of a research study:
•
Receiving text messages is optional in this study and not required to participate.
•
Text messages are not encrypted, and therefore carry security risks. This research study and Mass 
General Brigham are not responsible for any interception of messages sent through unencrypted text 
message communications.  
•
You will be responsible for all fees charged by your carrier’s service plan for text messaging.  This 
research study and Mass General Brigham are not responsible for any increased charges, data 
usage against plan limits or changes to data fees from the research texts.
•
Text messaging should not be used in case of an emergency.  If you experience a medical emergency, 
call 911 or go to the nearest hospital emergency department.  
•
You may decide to not send or receive text messages with staff associated with this research study at any 
time. You can do this in person or by sending the research number a text message that says “Stop 
Research Text.” 
•
Your agreement applies to this research study only.  Agreeing to other texts from Mass General Brigham, 
for example appointment reminders, is a separate process.  Opting out of other texts from Mass General 
Brigham is a separate process as well.
•
It is your responsibility to update your mobile/cell phone number with this research study in the event of a 
change.
Information Regarding the Privacy of Your Health Information
Federal law requires Mass General Brigham and its affiliated hospitals to protect the privacy of health 
information and related information that identifies you.  We refer to this information as “protected health 
information.” Your protected health information will be used and shared with others as explained below.  You 
are agreeing to the collection, use, and sharing of your protected health information as described in this 
information sheet. If you have questions, you may ask the researcher who is reviewing this information sheet 
with you or you can contact the researcher listed above. 
In this study, we may collect protected health information about you from:
•
Past, present, and future medical records
•
Research procedures, including but not limited to research visits, tests, interviews, and questionnaires
Why will protected health information about you be used or shared with others?
The main reasons include:
•
to conduct and oversee the research described in this information sheet for this study;
•
to ensure the research meets legal, institutional, and accreditation requirements; and 
•
to conduct public health activities (including reporting of adverse events or situations where you or 
others may be at risk of harm).
Who may see, use, and share your protected health information and why they may need to do so?
•
Mass General Brigham researchers and staff involved in this study
•
The sponsor(s) of the study, and people or groups it hires to help perform this research or to audit the 
research
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4
•
Other researchers and medical centers that are part of this study
•
The Mass General Brigham ethics board 
•
A group that oversees the data (study information) and safety of this study
•
Non-research staff within Mass General Brigham who need identifiable information to do their jobs, 
such as for treatment, payment (billing), or hospital operations (such as assessing the quality of care or 
research)
•
People or groups that we hire to do certain work for us, such as data storage companies, accreditors, 
insurers, and lawyers
•
Federal agencies (such as the U.S. Department of Health and Human Services (DHHS) and agencies 
within DHHS like the Food and Drug Administration, the National Institutes of Health, and the Office for 
Human Research Protections), state agencies, and foreign government bodies that oversee, evaluate, 
and audit research, which may include inspection of your records
•
Public health and safety authorities, if we learn information that could mean harm to you or others (such 
as to make required reports about communicable diseases or about child or elder abuse)
Some people or groups who get your protected health information might not have to follow the same privacy 
rules that we follow and might use or share your protected health information without your permission in ways 
that are not described in this form.  We share your protected health information only when we must, and we 
ask anyone who receives it from us to take measures to protect your privacy.  However, once your protected 
health information is shared outside Mass General Brigham, we cannot control all the ways that others use or 
share it and cannot promise that it will remain private.
The results of this research study may be published in a medical book or journal or used to teach 
others.  However, your name or other identifiable information will not be used for these purposes without your 
specific permission.
For how long will protected health information about you be used or shared with others?
Because research is an ongoing process, we cannot give you an exact date when we will either destroy or stop 
using or sharing your protected health information.  Your permission to use and share your protected health 
information does not expire.
Your Privacy Rights
You have the right not to agree to our use and sharing of your protected health information for research; 
however, if you don’t agree, you can’t take part in this research study. However, refusing to agree will not affect 
your present or future care and will not cause any penalty or loss of benefits to which you are otherwise 
entitled.
You have the right to withdraw your permission for the further use or sharing of your protected health 
information for this research study. If you want to withdraw your permission, you must notify the person in 
charge of this research study in writing at the name and address listed above.  Once permission is withdrawn, 
you cannot continue to take part in the study.
If you withdraw your permission, then to the extent that we have retained any protected health information that 
can be linked to you, we will stop using and sharing the protected health information further for the 
research.  However, we will not be able to take back information that has already been used or shared with 
others, and such information may continue to be used for certain purposes, such as to comply with the law or 
maintain the reliability of the study.
You have the right to see and get a copy of your protected health information that is used or shared for 
treatment or for payment.  To ask for this information, please contact the person in charge of this research 
study identified above.  You may only get such information after the research is finished.
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Version 2021.06.10
Page 1 of 16
Institutional Review Board
Intervention/Interaction Detailed Protocol
Principal Investigator:
Mark Clapp, MD MPH (MGH), Jessica Cohen, PhD (HSPH)
Project Title:
Bridging the Gap from Postpartum to Primary Care: A Behavioral 
Science Informed Intervention to Improve Chronic Disease Management 
among Postpartum Women
Version Date:
07/15/2022
Version Name/Number:
v1.2
1.
 Background and Significance
Burden of Chronic Disease and the Role of Primary Care
Chronic health conditions affect millions of people in the US each year. In 2018, 51.8% of adults 
had at least 1 chronic condition, and 27.2% had multiple conditions.1 The prevalence of chronic 
disease was higher in women compared to men, older adults (87.6% in adults ≥65 years old), 
and people with public insurance.1 Many chronic conditions, by their nature, develop over time 
and have risk factors that can be identified prior to the onset of disease. Strong evidence 
underpins prevention strategies for many conditions, which are advanced by the US 
Preventative Services Taskforce.2 While the long-term health of a patient is the responsibility of 
an entire health system, primary care providers (PCPs) provide an integral role in preventing, 
screening for, and managing disease across the lifespan. Studies have shown the health 
benefits of receiving regular care under a PCP.3–6
Despite the known benefits of having an identifiable usual source of care and the value of health 
care maintenance, the percent of the population with a PCP has been decreasing over time.7 
Consistently, adults who are younger (age 20-40 years) have the lowest rates of primary care 
use. In 2015, 44% and 36% of 20- and 30-year-olds had no identifiable source of primary care.7 
The proportion without primary care were also higher among racial/ethnic minority populations 
and among those who had less education, lower incomes, and no known comorbidities.7 The 
number of adults and the time elapsed without regular primary care follow-up can be considered 
missed opportunities to improve a patient’s current and long-term health. The disproportionate 
lack of primary care among certain subgroups of the population, often groups who already have 
worse health outcomes, only serves to widen the pre-existing disparities.
Pregnancy as a Window to Future Health
In the US, 98.2% of pregnant women receive some form of prenatal care, with the average 
patient having >10 visits during their pregnancy.8 During a pregnancy, women are screened for 
pre-existing and pregnancy-related conditions.9 In adults ages 18-39, the prevalence of obesity, 
hypertension, prediabetes/diabetes, and mental illness are estimated at 39%, 7.5%, 28%, 25%, 
respectively.10–13 Even for those who have no prior identified comorbidities, the most common 
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pregnancy-related conditions—pregnancy-related hypertension and gestational diabetes (8% 
and 10% of pregnancies, respectively)—indicate a predisposition to or confer health risks that 
persist as women age. For example, over 25% of women with gestational diabetes will develop 
Type 2 diabetes mellitus, and women with pre-eclampsia have more than a two-fold risk of 
significant cardiovascular disease later in life.14,15 For these reasons, pregnancy is often 
considered a “window” into a woman’s future health and presents a unique opportunity to 
optimize a woman’s health status early in her life when she otherwise may not have been 
engaged in care.16 
Pregnancy as on Opportunity for Engagement with a Long-term Care Provider
Pregnancy is a period when women are highly engaged and active participants in their health 
care.17 It has been described as a “golden opportunity” to motivate women towards positive 
health behaviors, including prevention and management of chronic disease. However, women 
often fall off a “postpartum cliff” of health system engagement after the early postpartum 
period.18 A range of systemic, financial, and behavioral barriers often prevents patients from 
effectively transitioning to primary care. Postpartum women are often simply told to follow-up 
with their PCP without much information regarding the importance of this follow up care, without 
assistance in scheduling an appointment (or identifying a PCP if they don’t have one), and often 
without a direct transfer of relevant health information or accountability across providers. 
Postpartum women are left largely on their own to navigate this transition to primary care and, in 
particular, to navigate it at a time when they face the high cognitive and physical demands of 
caring for an infant. At this time of limited cognitive bandwidth, the importance of continuity of 
care for chronic conditions and active engagement in one’s longer-term health and wellbeing is 
unlikely to be salient and top-of-mind. These critical moments of unsupported health care 
transition can exacerbate pre-existing disparities in health and health care, with patients who 
are the least able to navigate the US health care system most likely to fall through the cracks.  
Momentum is building in US health and social safety net policy to facilitate healthy transitions 
from pregnancy to parenthood. For example, federal and state initiatives to expand pregnancy-
related Medicaid coverage from 60 days to one year postpartum have been proposed, and 
access to paid family leave is increasing. However, very little evidence exists on effective and 
cost-effective approaches to facilitating transitions to primary care and management of chronic 
diseases in the postpartum year.  
2.
Specific Aims and Objectives 
The objective of the proposed study is to increase patient engagement in primary care after the 
immediate postpartum period for women with pregnancy-associated conditions that convey a 
long-term health risk. Specifically, we aim to evaluate the efficacy of an intervention bundle 
(patient-tailored health information, automatic scheduling of PCP appointment after delivery, 
and appointment reminder nudges) to increase patient attendance at a routine health care 
maintenance appointment (i.e., “annual exam”) within 4 months of delivery for women with 
obesity, diabetes, hypertension, and/or a mental health condition. 
Specific Aims:
1) Test the efficacy of an intervention bundle (patient-tailored health information, automatic 
scheduling of PCP appointment after delivery, and appointment reminder nudges) to 
increase patient attendance at a routine health care maintenance appointment within 4 
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months of delivery for women with obesity, diabetes, hypertension, and/or a mental 
health condition
2) Test the efficacy of the intervention bundle to improve compliance with the condition-
specific, guideline-based health screenings
3) Test the efficacy of the intervention bundle to reduce unscheduled or urgent encounters 
(e.g., emergency department visits) within the health system
3.
General Description of Study Design
We will conduct a randomized controlled trial comparing this intervention bundle to the receipt of 
generic information on the importance of primary care follow-up after delivery.  
Women will be randomized with equal probability into either a treatment or control arm, stratified 
by whether their pregnancy is covered by Medicaid or a commercial insurer and by patient race 
(white vs. non-white). The intervention combines several features designed to target reasons for 
low take-up of primary care among postpartum women (see Logic Model). We leverage the 
potential value of defaults/opt-out, pre-commitment, salient information, and reminders to 
encourage use of primary care within 4 months of delivery. Women in both the intervention and 
control arms will receive information via MGH’s patient portal toward the end of the pregnancy 
regarding the importance and benefits of primary care in the postpartum year. This information 
will be similar to, but reinforcing, the information they would receive from their obstetrician about 
following up with their primary care physician. In addition to this initial message, women in the 
treatment arm will receive the following intervention components, developed based on recent 
evidence regarding behavioral science approaches to activating health behaviors:19–21
➢
Targeted messages about the importance and benefits of primary care, tailored to her 
condition(s). For example, for women with hypertensive disorders, the intervention will 
include information about the risk of developing chronic hypertension and the importance of 
blood pressure screenings to detect and manage this condition. 
➢
Default scheduling into a primary care appointment at approximately 3-4 months after 
delivery. The patient will be scheduled for a primary care visit with their assigned primary 
care provider in the Mass General Brigham system. They will be given the opportunity to 
cancel the appointment, change the appointment day/time, or change the care provider 
either through the patient portal or over the phone with a research assistant working with the 
study (whichever they choose). 
➢
Reminders about the appointment and importance of follow up primary care at 2-4 points 
during the postpartum period via the patient portal. 
➢
Tailored language in the reminders based on recent evidence from behavioral science about 
the most effective approaches to increasing take-up. For example, messages will inform the 
patient that an appointment is being held for them at their doctor. 
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The Logic Framework that underpins the basis for this study is shown below:
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The flow of study activities is shown below:
4.
Subject Selection
Pregnant patients receiving prenatal care at Massachusetts General Hospital (MGH) will be 
targeted for recruitment. MGH conducts approximately 3500 deliveries per year, with roughly 
one-third of patients identifying as non-white and 35% of pregnancies covered by Medicaid.
Approximately 40% of the clinic population may ultimately be eligible to be approached.
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The eligibility criteria include:
•
Estimated date of delivery and the following 4-month postpartum outcome 
assessment window completed prior to study end date
•
Currently pregnant or within 2 weeks of delivery
•
Have one or more of the following conditions: 
o
Chronic hypertension
o
Hypertensive disorders of pregnancy or risk factors for hypertensive disorders 
of pregnancy per the USPTF aspirin prescribing guidelines (e.g., history of 
pre-eclampsia, kidney disease, multiple gestation, autoimmune disease)22
o
Type 1 or 2 diabetes
o
Gestational diabetes
o
Obesity (body mass index ≥30 kg/m2)
o
Depression or anxiety disorder 
•
Have or be willing to be assigned a primary care provider within the Mass General 
Brigham network 
•
Receive obstetric care at an MGH-affiliated outpatient prenatal clinic
•
Has access to and be enrolled in the electronic health record patient portal and 
consents to be contacted via these modalities
•
Able to read/speak English or Spanish language
•
Age ≥18 years old
All women, regardless of race/ethnicity, who meet the eligibility criteria will be included. In 2019, 
3,789 women gave birth at the study institution, of whom 57% were white, 7% were black, 12% 
were Asian, 18% were Hispanic, and 6% declined to report their race/ethnicity. A similar 
distribution is expected for this study.
The study will distribute materials in English and Spanish languages. This encompasses >95% 
of patients who deliver at the study institution.
5.
Subject Enrollment
This study will rely on recruiting for research through Patient Gateway and follow the IRB 
guidance and DHeC Research Checklist and training for this process.
In the month prior to the start of enrollment, all potentially eligible individuals (based on the 
criteria above) will be identified using RPDR and Epic Reporting search queries. This list (the 
“potentially eligible” list) will be provided to the DHeCare Research Team to build an RSH 
Record in Epic. This list will be updated monthly to identify newly eligible individuals (e.g., new 
diagnosis of gestational diabetes or new patient transferring into the practice) during the 
recruitment months and fed back to the DHeCare team to update “potentially eligible” list.
Once built and each month during recruitment phase, the study’s research coordinator (not 
study investigators) will send the IRB-approved Research Invitation Letter to patients who are 
eligible, not already enrolled, and have not declined to be sent research notifications through the 
portal. The Research Letter will employ an opt-out approach, asking individuals who do not wish 
to be approached in clinic or remotely to respond via PG messaging, email, or phone within 2 
weeks of receipt of the letter. Those who have “read” the letter and not opted out after 2 weeks 
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will be moved from the “potentially eligible” list to the “waiting to be approached” list in the study 
workflow.
During recruitment months, the study coordinator will keep a log of patient’s upcoming 
appointments for those on the “waiting to be approached” list. They will then attempt to 
approach individuals for enrollment when they present for an in-person encounters (preferred). 
Patients will ideally be approached between 32-36 weeks of gestation, when feasible; however, 
priority will be given to patients at the latest gestation. For those Spanish-speaking patients, a 
hospital-based interpreter will be used when approaching/consenting patients.
The study staff will introduce the study and review the purpose of the study, the nature of the 
subject’s participation, the possible risks and discomforts associated with participation, the 
potential benefits of participation, a statement of the voluntary nature of participation, and a 
description of the mechanisms used to ensure confidentiality. 
All patients will receive study-related messages through Patient Gateway. In addition, patients 
will be asked if they would be willing to receive no more than 3 SMS messages to their personal 
cell phone during the first 4 months of the postpartum period. The study staff will review the 
specific concerns and risks about receiving unencrypted text messaging communications, as 
outlined by the MGB IRB. 
A waiver of documentation of informed consent is requested, as the study presents no more 
than minimal risk of harm to subjects and involves no procedures for which written consent is 
normally required outside of the research context. Verbal consent will be obtained for 1) overall 
study participation and 2) optional SMS message participation, separately. Verbal consent will 
be obtained from both in-person and phone recruitment efforts.
A Study Fact Sheet, which summarizes the study details, risks, and benefits, will be provided to 
all subjects who are approached, either in-person, by mail, or electronically. This Study Fact 
Sheet also includes information supplied by the MGB IRB specifically related to the concerns 
and risks of receiving unencrypted SMS/text messages.
For tracking verbal consent, the study staff will keep a detailed log in REDCap documenting:
1) name of study staff performing consent,
2) date of attempted approach,
3) the method of attempted approach (in-person or via phone),
4) use of Spanish interpreter (yes/no),
5) subject agreement to be approached (agree/disagree),
6) attestation to full review of the study procedures/risks/benefits with the subject, as would 
be done during the process of reviewing a written consent form, 
7) attestation to review of supplemental consent to receive unencrypted SMS messages 
with the subject,
8) subject overall study participation status (enrolled, declined, deferred – agrees to be 
recontacted, deferred – wishes not to be recontacted),
9) if enrolled, unencrypted SMS text messaging participation (consents, declines),
10) attestation to Study Fact Sheet provided,
11) method by which Study Fact Sheet was provided (in-person, mail, electronic),
12) date in which Study Fact Sheet was provided (in-person, mail, electronic).
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6.
STUDY PROCEDURES
The RA will keep a detailed log of all patients in the practice, if they are eligible, if they have 
been approached, and if they consented.
For those that agree to be enrolled, patients will be asked to complete a baseline survey to 
obtain voluntarily reported information on their demographics, socioeconomic status, health care 
visit history, and preferred primary care provider. Patients will also be asked to consent to being 
contacted by the research team via Patient Gateway messaging. A $20 gift card will be given at 
the time of enrollment for those that complete the questionnaire and receive the information 
sheet.
Randomization will occur via a prespecified random allocation sequence within strata. Within 
each stratum, the PIs will generate a random sequence of treatment-control allocation prior the 
enrollment of subjects. Then, as patients within strata are enrolled, they will be assigned to the 
intervention arm associated with that enrollment number. 
Control Group
Approximately 2 weeks before a patient’s estimated due date (EDD) or as soon as enrolled if 
this date has passed, the patient will be sent an information via the Patient Gateway on the 
importance of postpartum care and follow-up with their PCP.
Intervention Group
1.
Tailored Information:
Approximately 2-4 weeks prior to the EDD (or later for those who are enrolled beyond 38 
weeks gestation or postnatally), the patient will be sent an information via the Patient 
Gateway on the importance of postpartum care and follow-up with their PCP, which also 
includes the name and phone number of their primary care provider and tailored 
information regarding their specific condition(s) (diabetes, hypertension, obesity, mental 
health).
2.
Scheduled PCP Appointment:
Between 2-3 weeks after their delivery, the RA will call the patient’s PCP office and 
make an appointment for them between 3-4 months after delivery based on the 
scheduling preferences obtained in the initial survey.
3.
Targeted Appointment Message:
After the PCP appointment has been made, the patient will be sent a Patient Gateway 
message saying that a PCP appointment has been reserved for them with the 
date/time/location information.
For those consenting to receive SMS messages, an unencrypted text message will also 
be sent simultaneously.
4.
Nudge Reminders: 
Patient Gateway messages will be sent at approximately 4-8 weeks (goal: 4 weeks) and 
1-4 week (goal: 1 week) prior to their PCP appointment, reminding a patient of their 
upcoming appointment. 
For those consenting to receive SMS messages, an unencrypted text message will also 
be sent simultaneously.
All messages will be made available in English and Spanish.
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The text for these Patient Gateway messages is included in the submission. At the end of each 
patient message, patients will be given the opportunity to stop receiving study-related messages 
by emailing or calling the study staff. “Opt out” requests will be logged and patients removed 
from future planned study-related contact. 
The text for 3 SMS messages is included in the submission. SMS messages will be sent via 
Google Voice. We will follow standard recommendations from the MGB Research Information 
Security for using this system (included under Privacy and Confidentiality section).
The study team will review the patient’s EHR record for the primary and secondary outcome 
assessments. Patients will be asked to consent to have records reviewed up to 2 years after the 
date of their delivery to allow for long-term effects of the intervention on primary care use and 
health status. 
During the initial consent process, patients will be asked to agree to be potentially contacted at 
the end of the first 4-month follow-up period for a survey. Currently, this endline survey is not 
planned due to funding limitations; however, if funding becomes available, an IRB amendment 
will be submitted for review of the endline survey prior to being administered to any study 
subjects.
Deidentified data from this project may be shared outside of MGB with 1) Harvard T. H. Chan 
School of Public Health (Dr. Jessica Cohen) and 2) the study funders (J-PAL/NBER/NIA) for 
data sharing and reproducibility requirements and secondary statistical analysis. All data will be 
stripped of patient identifiers, per IRB guidance. No data will be shared without a formal Data 
Use Agreement with MGB.
5.
Risks and Discomforts
There are minimal risks to participants. 
Patients will be reassured that nonparticipation will not affect clinical care. Patients will also be 
informed that the researchers with whom they will interact (e.g., during consent, face-to-face, 
during telephone interviews) are not health care providers. Participants will be consistently 
reminded that responses to any queries deemed sensitive or uncomfortable (e.g., country of 
origin/immigration status, income, previous history of abortion) should be considered optional, 
and they may decline to answer any question(s) and can refuse to continue the study at any 
point. Participants will be reassured that neither their opportunities for continued health care nor 
their relationships with health care providers will be jeopardized by study participation.
Health information collected as part of this study will be stored in REDCap. No identifiable data 
will be stored or downloaded on any personal or unauthorized computers. Study staff will 
access the data on institutionally purchased and managed computers that operate behind the 
health system’s security and firewall protections. Only the MGH study staff will have access to 
the identifiable data set. Once the study is completed, data will be deidentified such that it can 
be analyzed without risk of a breach of privacy or confidentiality. Any data that is shared outside 
of MGH will require a data use authorization.
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Although we will make every effort to protect participant privacy and confidentiality, it is possible 
that participants' involvement in the study could become known to others. For those in the 
intervention group, we will be sending personalized messages via the patient portal; for those 
providing additional consent, we will be sending unencrypted SMS messages that will not 
contain any personal protected health information. There is the rare possibility that study 
participation or health information could become known to others despite the use of firewalls, 
password protection, and other security measures. Standard procedures, as outlined by the 
MGB Research Information Security Office, will be followed to reduce this risk.
Those in the intervention arm will receive condition-specific information on pregnancy 
comorbidities and their implications on their long-term health. This information may cause 
anxiety or worry among patients; however, this same information is routinely reviewed by 
obstetric providers at visits. 
Individuals in the intervention group will be scheduled for an appointment with a primary care 
doctor. There is the possibility that this visit may result in a charge/cost for the patient. Under 
the Affordable Care Act, commercial health plans are required to cover an annual Preventive 
Health Exam at no cost to the patient (no co-payment, co-insurance or deductible). MassHealth 
also covers these visits without cost-sharing. However, if this visit turns into a “sick” or “disease 
management” visit, the patient may be billed for some or all aspects of the services provided, 
depending on their insurer. We will provide a link to the standard MGH information sheet on 
billing and charges for health care maintenance and directions for patients to contact their 
insurers prior to a visit to inquire about potential cost-sharing and/or deductibles for their visit. 
Patients will also be advised that some clinics may penalize individuals for not showing to a 
scheduled appointment (“no show” fee) and be given opportunities to request the appointment 
be canceled with each appointment reminder.
6.
Benefits
Participants in the control group will receive information on the importance of postpartum care 
and transitioning to primary care after their delivery.
Participants in the intervention group will receive a bundle of interventions designed to increase 
attendance at primary care visits and facilitate the transition of care after their delivery.
The goal and potential benefits to the subjects in this trial is to increase patient engagement and 
connection with their primary care provider, receive recommended health screenings and 
directed counseling, and reduce unscheduled or urgent visits in the postpartum period.
7.
Statistical Analysis
Statistical Methods
Analyses will be performed according to the intention-to-treat principle.
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Standard independent, two-sided, two-group comparison testing will be used to compare 
baseline characteristics between the two groups (chi squared tests, t tests, Wilcoxon rank sum 
tests, when appropriate).
The primary outcome will be attendance rates at PCP visit within 4 months after delivery, which 
will be compared between the groups using chi squared tests. Relative risks and 95% 
confidence intervals will be reported. 
Secondary outcomes will include measures of long-term health and health care use after the 
postpartum period. 
Subgroup analyses will be performed by a variety of patient characteristics including gestational 
age at enrollment, prenatal risk factors, morbidity types, patient race-ethnicity, payer, and 
enrollment location. 
P-value of less than 0.05 will be considered to indicate statistical significance.
Power Calculation
Most study calculations were estimated from the MGH 2020 delivery population. The rates of 
PCP follow-up were estimated from a randomly selected cohort of 50 patients who met the 
inclusion criteria. We plan to recruit patients into the study for a period of 4 months and expect 
1200 unique patients to be at the targeted gestational age during this period. Among these, we 
expect 88% to already have an assigned PCP in the network, leaving roughly 1,056 patients. 
Among these, we estimate that 40% have at least one of the targeted health conditions, leaving 
a target study population of 422 over the 4-month period. Based on previous studies conducted 
at MGH, we expect an 85% willingness to participate in the research, leaving an expected 
recruited population of 360 individuals. Based on our record extraction, we estimate that 33% of 
the targeted study population has a primary care visit within 4 months of delivery. Assuming an 
alpha of 0.05 and a baseline mean of 33%, with this expected sample size and power of 80%, 
our study has a minimum detectable effect size of roughly 15 percentage points (from 33% to 
48%). A previous study found that default scheduling into postpartum care appointments (with 
an OBGYN, not a PCP) increased postpartum care take-up by 24 percentage points; since our 
intervention incorporates defaults and other activating interventions, an MDE of 15 percentage 
points is reasonable.
8.
  Monitoring and Quality Assurance
This is a minimal risk study in which the intervention involves default scheduling of 
appointments and patient messaging. Adverse events are not expected, and there is no 
physiologic plausibility for this intervention to cause any NIH-defined serious adverse events 
(e.g., death, prolonged hospitalization, significant disability).
No interim analyses are planned.
Adverse events will be defined and classified in accordance with NIH guidelines:
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Definition of Adverse Events (AE): Any untoward or unfavorable medical occurrence 
in a human subject, including any abnormal sign, symptom, or disease, temporally 
associated with the subject’s participation in the research, whether considered 
related to the subject’s participation in the research or not.
Definition of Serious Adverse Events (SAE): Any AE that (1) results in death, (2) is life-
threatening, (3) results in inpatient hospitalization or prolongation of existing 
hospitalization, (4) results in persistent or significant disability/incapacity, (5) results in a 
congenital anomaly/birth defect, and/or (6) may jeopardize the subject’s health and may 
require medical or surgical intervention to prevent one of the other five outcomes listed 
here.
In the unlikely event an AE or SAE occurs, it will be brought to the PI's attention, and the PI 
will classify the AE/SAE by severity, expectedness, and relatedness, as listed above. All events 
that are both serious and unexpected will be reported to Mass General Brigham's IRB, the NIA 
PO, and to the NIA Roybal DSMB within 48 hours of the research team's knowledge of the 
SAE. The summary of all other SAEs will be reported to the NIA and to the DSMB quarterly 
unless otherwise specified by the DSMB. Any unanticipated problem, defined as an issue 
related to the research suggesting the research places participants or others at greater risk 
than expected, will be reported to the IRB, the NIA PO, and to the Roybal DSMB within 48 
hours of discovery. If the problem involves death then reporting will occur within 24 hours, and 
this report will include a plan to correct the problem and prevent its occurrence. Any breach of 
PHI will be reported to the PI, who will report to the IRB and NIA PO within 24 hours of 
discovery.
The Roybal DSMB oversight is provided by the Standing Roybal DSMB, which includes the 
members listed: Andrea B. Troxel, ScD (chair); Abby King, PhD; Jerry Gurwitz, MD; Hae-Ra 
Han, PhD, RN, FAAN; Hang Lee, PhD; Ezra Golberstein, PhD; David Kim,  MD PhD; 
Christopher Celano, MD.
DSMB members will have no direct involvement with the study or conflict of interest with the 
investigators or institutions conducting the study. Each member has signed a COI statement 
which includes current affiliations, if any, with pharmaceutical or biotechnology companies 
(e.g., stockholder, consultant), and any other relationship that could be perceived as a conflict 
of interest related to the study and/or associated with commercial interests pertinent to study 
objectives.
Data presented to the DSMB will be deidentified as to protect individual participants’ privacy and 
health information. Should the identity of a deidentified subject need to be  revealed, the DSMB 
request will be reviewed and ultimately at the discretion of the Mass General Brigham IRB.
9.
  Privacy and Confidentiality
☒Study procedures will be conducted in a private setting
☒Only data and/or specimens necessary for the conduct of the study will be collected
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☒Data collected (paper and/or electronic) will be maintained in a secure location with 
appropriate protections such as password protection, encryption, physical security 
measures (locked files/areas)
☐Specimens collected will be maintained in a secure location with appropriate protections 
(e.g. locked storage spaces, laboratory areas)
☒Data and specimens will only be shared with individuals who are members of the IRB-
approved research team or approved for sharing as described in this IRB protocol
☒ Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password 
protection, using chain-of-custody procedures, etc.)
☒   All electronic communication with participants will comply with Mass General Brigham 
secure communication policies
☒Identifiers will be coded or removed as soon as feasible and access to files linking 
identifiers with coded data or specimens will be limited to the minimal necessary 
members of the research team required to conduct the research
☒All staff are trained on and will follow the Mass General Brigham policies and procedures 
for maintaining appropriate confidentiality of research data and specimens
☒The PI will ensure that all staff implement and follow any Research Information Service 
Office (RISO) requirements for this research
☒Additional privacy and/or confidentiality protections
The following procedures (as provided by MGB RISO) will be used for sending SMS messages 
via Google Voice:
•
Google Account:
o
A separate account should be created just for the purpose of the effort/study (in 
other words, personal Gmail accounts should not be used) 
o
For the Google Voice portal, make sure you are not using the same password as 
your MGB account and ensure the password is strong. (Minimum of 8 characters, 
alphanumeric, uppercase, lowercase, special character).
▪
Two-factor authentication must be enabled
o
Google account will not be shared
o
The Google account used for Google Voice should not be used for emailing or 
using any other Google Service (i.e., YouTube, Calendar, Contacts, etc.)
o
No credit cards should be added to the Google Account
o
The Google account must be deleted at the end of the study / project
•
Participants will be informed not to send personal or health related information via text
•
Siri will not be integrated with Google Voice
•
Text messages will not address participants by their first name
•
Text messages will be sent through the McLean email within the Google account that is 
created
•
Only phone numbers and a unique subject ID will be stored in Google Voice
o
Log records should be deleted manually after 30 days
•
No PHI or sensitive information will be communicated via text message
o
Content will not include anything where a healthcare condition or diagnosis can 
be inferred
•
Text message history should be deleted from Google Voice account when no longer 
needed (within 30 days)
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•
Study staff will track opt-out requests and delete phone numbers from Google Voice as 
necessary
•
Study staff must not communicate with participants via a group text message
•
Access to the portal and overall research must be done from systems that meet MRB 
RISO compliance requirements; encryption, MobileIron (if Smartphone/Tablet), up to 
date malware protection, Crowdstrike.
o
https://rc.partners.org/security/secure-your-computer
•
Participants:
o
Participants will be texted only if they consent
o
Participants should be informed to delete text messages when no longer needed 
and hide text push notifications
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12.   References
1.
Boersma P. Prevalence of Multiple Chronic Conditions Among US Adults, 2018. Prev 
Chronic Dis. 2020;17. doi:10.5888/pcd17.200130
2.
Home page | United States Preventive Services Taskforce. Accessed December 15, 2021. 
https://www.uspreventiveservicestaskforce.org/uspstf/
3.
Blewett LA, Johnson PJ, Lee B, Scal PB. When a usual source of care and usual provider 
matter: adult prevention and screening services. J Gen Intern Med. 2008;23(9):1354-1360. 
doi:10.1007/s11606-008-0659-0
4.
O’Malley AS, Mandelblatt J, Gold K, Cagney KA, Kerner J. Continuity of care and the use 
of breast and cervical cancer screening services in a multiethnic community. Arch Intern 
Med. 1997;157(13):1462-1470.
5.
DeVoe JE, Saultz JW, Krois L, Tillotson CJ. A medical home versus temporary housing: 
the importance of a stable usual source of care. Pediatrics. 2009;124(5):1363-1371. 
doi:10.1542/peds.2008-3141
6.
Atlas SJ, Grant RW, Ferris TG, Chang Y, Barry MJ. Patient-physician connectedness and 
quality of primary care. Ann Intern Med. 2009;150(5):325-335. doi:10.7326/0003-4819-
150-5-200903030-00008
7.
Levine DM, Linder JA, Landon BE. Characteristics of Americans With Primary Care and 
Changes Over Time, 2002-2015. JAMA Internal Medicine. 2020;180(3):463-466. 
doi:10.1001/jamainternmed.2019.6282
8.
NVSS - Birth Data. Published June 14, 2021. Accessed September 1, 2021. 
https://www.cdc.gov/nchs/nvss/births.htm
9.
Prenatal care and tests | Office on Women’s Health. Accessed December 15, 2021. 
https://www.womenshealth.gov/pregnancy/youre-pregnant-now-what/prenatal-care-and-
tests
10.
Centers for Disease Control and Prevention (CDC). Adult Obesity Facts. Published August 
29, 2017. Accessed February 14, 2018. https://www.cdc.gov/obesity/data/adult.html
11.
Mental Illness. National Institute of Mental Health (NIMH). Accessed December 17, 2021. 
https://www.nimh.nih.gov/health/statistics/mental-illness
12.
Products - Data Briefs - Number 289 - October 2017. Published June 6, 2019. Accessed 
December 17, 2021. https://www.cdc.gov/nchs/products/databriefs/db289.htm
13.
National Diabetes Statistics Report 2020. Estimates of diabetes and its burden in the 
United States. Published online 2020:32.
14.
Sattar N, Greer IA. Pregnancy complications and maternal cardiovascular risk: 
opportunities for intervention and screening? BMJ. 2002;325(7356):157-160. 
doi:10.1136/bmj.325.7356.157
15.
Kim C, Tabaei BP, Burke R, et al. Missed Opportunities for Type 2 Diabetes Mellitus 
Screening Among Women With a History of Gestational Diabetes Mellitus. Am J Public 
Health. 2006;96(9):1643-1648. doi:10.2105/AJPH.2005.065722
16.
Media BKK. Publications & Guidelines | SMFM.org - The Society for Maternal-Fetal 
Medicine. Accessed October 18, 2021. https://www.smfm.org/publications/225-smfm-
statement-implementation-of-the-use-of-antenatal-corticosteroids-in-the-late-preterm-birth-
period-in-women-at-risk-for-preterm-delivery
17.
Yee LM, Simon MA, Grobman WA, Rajan PV. Pregnancy as a “golden opportunity” for 
patient activation and engagement. American Journal of Obstetrics & Gynecology. 
2021;224(1):116-118. doi:10.1016/j.ajog.2020.09.024
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18.
Cohen JL, Daw JR. Postpartum Cliffs—Missed Opportunities to Promote Maternal Health 
in the United States. JAMA Health Forum. 2021;2(12):e214164. 
doi:10.1001/jamahealthforum.2021.4164
19.
Milkman KL, Patel MS, Gandhi L, et al. A megastudy of text-based nudges encouraging 
patients to get vaccinated at an upcoming doctor’s appointment. PNAS. 2021;118(20). 
doi:10.1073/pnas.2101165118
20.
Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl 
J Med. 2018;378(3):214-216. doi:10.1056/NEJMp1712984
21.
Thaler RH, Sunstein CR. Nudge: The Final Edition. Revised edition. Penguin Books; 2021.
22.
Henderson JT, Vesco KK, Senger CA, Thomas RG, Redmond N. Aspirin Use to Prevent 
Preeclampsia and Related Morbidity and Mortality: Updated Evidence Report and 
Systematic Review for the US Preventive Services Task Force. JAMA. 2021;326(12):1192. 
doi:10.1001/jama.2021.8551
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Roybal Centers Program DSMB Charter 
The Roybal Data and Safety Monitoring Board (DSMB) will act in an advisory capacity to the 
National Institute of Aging (NIA) Director to monitor participant safety, data quality and progress 
of the Roybal Centers. The Roybal DSMB would review and monitor pilot clinical trials that are 
determined by NIA to require DSMB oversight, and that are supported through the: 
 
Roybal Centers for Translational Research on Aging (P30 Center Core Grants, under 
RFA-AG-19-006),  
 
Roybal Centers for Translational Research on Dementia Care Provider Support (P30 
Center Core Grants, RFA-AG-19-007), and  
 
Edward R. Roybal Coordinating Center (R24 Resource-Related Research Projects, 
RFA-AG-19-008).  
DSMB Responsibilities 
 
Prior to each DSMB meeting, DSMB members will confirm that no conflict of interest 
exists with investigators or key personnel of the pilot trials that will be discussed. 
Interests that may create a potential conflict of interest should be disclosed to the DSMB 
prior to any discussion. The DSMB will determine how to handle any such potential 
conflict. The DSMB can require that a member with a potential conflict be present during 
discussions but abstain from voting or take other means deemed appropriate. NIA or 
DSMB Chair may request a member of the DSMB to leave the meeting in the event of 
unmanageable potential conflict or appearance of conflict. At the beginning of every 
DSMB meeting, DSMB members will reconfirm that no conflict of interests exists. 
 
Review the entire IRB-approved study protocols and the MOP, with regard to participant 
safety, recruitment, randomization, intervention, data management, quality control and 
analysis and the informed consent documents. 
 
Recommend changes to the protocol and the informed consent form, when applicable. 
 
Identify the relevant data parameters and the format of the information to be regularly 
reported. 
 
Recommend participant recruitment be initiated after receipt of a satisfactory protocol. If 
the need for modifications to the protocol, the MOP, consent form, DSMP or any other 
study document is indicated by the DSMB and/or the NIA Program Officer (PO), the 
DSMB will postpone its recommendation for the initiation of participant recruitment until 
after the receipt of a satisfactory revised protocol(s) or other study documents. 
 
Presentations by PIs for pilot trials will be limited to 20 min, including questions and 
answer from DSMB members. Pilot PI will provide overview of the study; data and safety 
related issues and presentation will be limited to 15 min. At the discretion of the Chair, 
discussions may continue.  
 
Review periodic (safety) reports from Safety Officers, as needed. 
 
Review masked and unmasked data. These data can be related to safety, recruitment, 
randomization, retention, protocol adherence, trial operations, data completeness, form 
completion, intervention effects, gender and minority inclusion. 
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 
Identify needs for additional data relevant to safety issues and request these data from 
the study investigators.  
 
Propose additional analyses and periodically review developing data on safety and 
endpoints. 
 
At each meeting, consider the rationale for continuation of the study, with respect to 
progress of randomization, retention, protocol adherence, data management, safety 
issues, and outcome data (if relevant) and make a recommendation for or against the 
trial's continuation.  
 
Review and make recommendations on proposed protocol changes, and/or new 
protocols proposed during the trial. When the DSMBs are unblinded, the Boards may 
recommend to NIA to appoint a blinded working group of the DSMB to review the 
proposed protocol changes and make recommendations to NIA on whether to approve 
the requests. 
 
Provide advice on issues regarding data discrepancies found by the data auditing 
system or other sources. 
 
Review manuscripts of trial results if requested by the Board or the NIA PO who may 
seek DSMB review of manuscripts reporting major outcomes prior to their submission for 
publication. 
The DSMB will discharge itself from its duties when the study is complete. 
Membership 
Membership consists of persons completely independent of the investigators who have no 
financial, scientific, or other conflict of interest with the trial. Collaborators or associates of the PI 
are not eligible to serve on the DSMB. Written documentation attesting to absence of conflict of 
interest is required and will be collected by NIA. This DSMB will consist of [insert number] 
members having been approved by the Director of NIA.  
The DSMB includes experts in or representatives of the fields of: 

Geriatrics  

Dementia 

Psychiatry 

Health policy 

Psychology 

Biostatistics 
Dr. Andrea B. Troxel has been selected by NIA to serve as the Chairperson and is responsible 
for facilitating the meetings, reviewing the first draft of the meeting notes with the NIA Program 
Official and any decision making in the case of a tie vote. The Chair and NIA Program Officer 
are the contact people for the DSMB. The Feinstein Institute for Medical Research will provide 
the logistical management and support for the DSMB.  
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Meeting Format 
Meetings of the DSMB will be held regularly (e.g., every six to nine months) at the call of NIA or 
the DSMB Chair. The NIA Program Officer or designee (NIA staff) will be present at every 
meeting. An emergency meeting of the DSMB may be called at any time by the Chair or the 
NIA, should participant safety questions or other unanticipated problems arise. The DSMB 
should discuss the definition of a quorum. 
DSMB meetings will consist of open, closed and optional executive sessions, all closed to the 
public because discussions may address confidential participant data. The study PI and key 
staff members, DSMB members and NIA Program Officer and/or authorized NIA staff attend the 
open sessions. Discussions at these sessions focus on the review of the aggregate data, 
conduct and progress of the study, including participant accrual, protocol compliance, and 
problems encountered. Data by treatment group are not presented in the open session. 
The closed session will be attended by unblinded study staff, the DSMB members and the NIA 
PO or designee(s). The NIA PO attends the closed and open sessions as an observer, not as a 
DSMB member, to answer any policy or administrative questions the DSMB members may 
have. The primary objective of the closed sessions is to review data by study group. To ensure 
participants safety and well-being, DSMBs for NIA-funded trials are required to review safety 
data by the actual treatment group. In many instances, safety data could also be the outcome 
data. Therefore, the unblinded Boards no longer review and provide recommendations to NIA 
on any, but safety-related protocol changes. All other protocol modifications are subject to 
review by the blinded working groups of the DSMBs. DSMBs’ working groups are appointed by 
NIA and provide their recommendations to NIA Director who makes decisions about whether to 
approve or decline proposed modifications.  
If necessary, an executive session may be requested by the DSMB and will be attended only 
by voting DSMB members. The NIA Program Officer or designee is not permitted to attend the 
executive sessions. 
The NIA PO, DSMB Chair or the Principal Investigator will prepare the meeting agenda that 
usually includes the following: 
1. Welcome and introduction – study team, DSMB members, NIA and KAI staff  
2. Open session (review study protocol and its amendments, consent form, open study 
report, etc.) - study team, DSMB members, NIA and KAI staff  
3. Closed session (review closed session report, including unblinded data, etc.) – 
unblinded study statistician, DSMB members, NIA and KAI staff 
4. Executive session (optional, upon DSMB request) – DSMB members only 
5. Debriefing (optional, upon DSMB request, time permitting) - study team, DSMB 
members, NIA and KAI staff 
The DSMB may modify its processes and procedures at any time with the approval of the NIA 
POs. Pilot studies to be presented to the DSMB for review would be determined by NIA, 
annually, through an internal process that culminates in a meeting for Roybal studies. 
Meeting Materials  
DSMB interim report templates developed by the study staff or study-specific versions of NIA 
report templates for both the open and closed sessions and plans for interim analyses will be 
reviewed and either approved at the initial DSMB meeting or changes requested. Upon DSMB 
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request and approval by NIA, reports could be modified at any time during the study. All meeting 
materials should be sent by email to NIA at least 7 to 10 calendar days prior to the meeting. NIA 
PO will send the reports to the DSMB.  
Part 1 - Open Session Reports (Template for Single Site - Open; Template for Multi Site - 
Open): Open session reports will include administrative reports that describe participants 
screened, enrolled, completed, and discontinued, as well as baseline characteristics of the 
study population. Other general information on study status may also be presented. Listings of 
adverse events and serious adverse events as well as any other information requested by the 
DSMB may also be in the open session report, but none of the data will be presented in an 
unblinded manner.  
Part 2 – Closed Session Report (Template for Single Site - Closed; Template for Multi Site - 
Closed):  Closed session reports will present the same information as presented in the open 
session but by unblinded treatment group.  
 Reports from the DSMB 
A report containing the recommendations for continuation or modification of the study will be 
prepared by the DSMB, NIA Project Officer or NIA contractors. The draft report will be sent to 
the DSMB members for review and approval not later than three weeks after the meeting. Once 
approved by the DSMB members, the Program Official will forward the DSMB recommendations 
to the Principal Investigator indicating NIA’s concurrence with the report or its parts. It is the 
responsibility of the Principal Investigator to distribute the DSMB recommendation to all co-
investigators and to ensure that copies are submitted to the IRB that reviewed and approved the 
study documents. 
As it stated above, each meeting must include a recommendation to continue the study made 
by a formal DSMB majority or unanimous vote. Should the DSMB decide to issue a termination 
recommendation, the full vote of the DSMB is required. In the event of a split vote, majority vote 
will rule and a minority report should be appended. The DSMB Chair provides the tiebreaking 
vote in the event of a 50-50 split vote. 
A recommendation to terminate the study may be made by the DSMB at any time by majority 
vote. If this recommendation was made during the DSMB’s Executive session, the Chair should 
provide notify the NIA immediately by telephone and email. After the NIA Director makes a 
decision about whether to accept or decline the DSMB recommendation to terminate the study, 
NIA PO informs the PI about the decision.  
Confidentiality  
All materials, discussions, and proceedings of the DSMB are completely confidential. Members 
and other participants in DSMB meetings are expected to maintain confidentiality.  
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i
DSMP Template Updated 4 September 2019
DATA & SAFETY MONITORING PLAN 
(DSMP)
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ii
DSMP Template Updated 4 September 2019
Amy Finkelstein
P30 AG064190
MIT Roybal Center for Translational Research to Improve 
Healthcare for the Aging
Project PIs: Mark Clapp, MD, MPH; Jessica Cohen, PhD
Bridging the Gap to Primary Care: A Behavioral Science 
Informed Intervention to Improve Chronic Disease Management 
among Postpartum Women
Brief Description of Intervention: We aim to evaluate the efficacy of a behavioral- 
science inspired intervention bundle (patient-tailored health information, automatic 
scheduling of PCP appointment after delivery, and appointment reminder nudges) to 
increase patient attendance at a routine health care maintenance appointment within 4 
months of delivery for women with obesity, diabetes, hypertension, and/or a mental 
health condition. We will conduct a randomized controlled trial comparing this 
intervention bundle to the receipt of generic information on the importance of primary 
care follow-up after delivery.
Brief Description of Project Design
360 pregnant or recently postpartum patients with pre-existing or newly diagnosed 
health condition (hypertension, diabetes, obesity, mood disorder) will be randomly 
assigned to one of two interventions:
1. Routine care
2. Routine care + a bundle of behavioral-based interventions intended to improve 
a patient’s transition from postpartum to primary care
Stage of Behavioral Intervention Development Stage II (traditional efficacy testing)
NIH Phase III Clinical Trial? No
Note: An NIH-defined Phase III clinical trial is a broadly based prospective clinical 
investigation, usually involving several hundred or more human subjects, for the 
purpose of evaluating an experimental intervention in comparison with a standard or 
control intervention or comparing two or more existing treatments.
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iii
DSMP Template Updated 4 September 2019
Multiple Site Trial? No
List of Specific Aims
1. Test the efficacy of a behavioral science inspired intervention bundle to 
increase patient attendance within 4 months of delivery for women with chronic 
conditions.
2. Test the efficacy of the intervention bundle to improve receipt of tailored health 
screenings.
3. Test the efficacy of the intervention bundle to reduce unscheduled or urgent 
encounters within the health system.
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iv
DSMP Template Updated 4 September 2019
TABLE OF CONTENTS
Page
1.0
PARTICIPANT SAFETY .................................................................................................1
1.1 Potential Risks and Benefits for Participants ...................................................................1
1.2 Adverse Event and Serious Adverse Event Collection and Reporting.............................1
1.3 Protection Against Study Risks........................................................................................1
2.0
INTERIM ANALYSIS.......................................................................................................4
3.0
DATA AND SAFETY MONITORING ..............................................................................4
3.1 Frequency of Data and Safety Monitoring........................................................................4
3.2 Data Analysis and Coordination.......................................................................................4
3.3 Content of Data and Safety Monitoring Report ................................................................4
3.4 DSMB Membership and Affiliation ...................................................................................5
3.5 Conflict of Interest for DSMB’s.........................................................................................5
3.6 Protection of Confidentiality .............................................................................................5
3.7 DSMB Responsibilities.....................................................................................................5
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1
1.0
PARTICIPANT SAFETY
1.1 Potential Risks and Benefits for Participants 
Potential Risks:
There are minimal risks to participants. Those in the intervention arm will receive 
condition-specific information on pregnancy comorbidities and their implications on 
their long-term health. This information may cause anxiety or worry among patients; 
however, this same information is routinely reviewed by obstetrics providers at 
visits. Furthermore, individuals in the intervention group will be scheduled for an 
appointment with a primary care doctor. There is the possibility that this visit may 
result in a charge/cost for the patient. Under the Affordable Care Act, commercial
health plans are required to cover an annual Preventive Health Exam at no cost to the 
patient (no co-payment, co-insurance or deductible). MassHealth also covers these 
visits without cost-sharing. However, if this visit turns into a “sick” or “disease 
management” visit, the patient may be billed for some or all aspects of the services 
provided, depending on their insurer.
Potential Benefits:
Participants in the control group will receive information on the importance of 
postpartum care and transitioning to primary care after their delivery.
Participants in the intervention group will receive a bundle of interventions designed to 
increase attendance at primary care visits and facilitate the transition of care after their 
delivery.
The goal and potential benefits to the subjects in this trial is to increase patient 
engagement and connection with their primary care provider, receive recommended 
health screenings and directed counseling, and reduce unscheduled or urgent visits in 
the postpartum period.
1.2 Adverse Event and Serious Adverse Event Collection and Reporting
This is a minimal-risk study in which the intervention involves default scheduling of 
appointments and patient messaging. Adverse events are not expected, and there is 
no physiologic plausibility for this intervention to cause any NIH-defined serious 
adverse events (e.g., death, prolonged hospitalization, significant disability).
Adverse events will be defined and classified in accordance with NIH guidelines:
1.2.1 Adverse Event (AE)/Serious Adverse Event (SAE) Definitions
Definition of Adverse Events: Any untoward or unfavorable medical 
occurrence in a human subject, including any abnormal sign, symptom, or
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2
disease, temporally associated with the subject’s participation in the research, 
whether considered related to the subject’s participation in the research or not.
Definition of Serious Adverse Events: Any AE that (1) results in death, (2) is 
life-threatening, (3) results in inpatient hospitalization or prolongation of existing 
hospitalization, (4) results in persistent or significant disability/incapacity, (5) 
results in a congenital anomaly/birth defect, and/or (6) may jeopardize the 
subject’s health and may require medical or surgical intervention to prevent one 
of the other five outcomes listed here.
1.2.2 Grading Scale 
Severity
Mild: Awareness of signs or symptoms, but easily tolerated and of minor 
irritation, causing no loss of time from normal activities. Symptoms do not 
require therapy or a medical evaluation; signs and symptoms are transient. 
Moderate: Events introduce a low level of inconvenience or concern to the 
participant and may interfere with daily activities, but are usually improved by 
simple therapeutic measures.
Severe: Events interrupt the participant’s normal daily activities and generally 
require systemic drug therapy or other treatment. They are usually 
incapacitating.
Expectedness
Unexpected: nature or severity of the event is not consistent with information 
about the condition under study or intervention in the protocol or consent form. 
Expected: event is known to be associated with the intervention or condition 
under study. Because the intervention being delivered is informational in 
nature, there are no expected AEs or SAEs for this study.
1.2.3. Study Relatedness
Definitely Related: The adverse event is clearly related to the intervention- i.e. 
an event that follows a reasonable temporal sequence from administration of 
the intervention, follows a known or expected response pattern to the 
suspected intervention, that is confirmed by improvement on stopping and 
reappearance of the event on repeated exposure and that could not be 
reasonably explained by the known characteristics of the subject’s clinical state. 
Possibly Related: An adverse event that follows a reasonable temporal 
sequence from administration of the study intervention, follows a known or 
expected response pattern to the suspected intervention, but that could readily 
have been produced by a number of other factors.
Not Related: The adverse event is clearly not related to the intervention- i.e. 
another cause of the event is most plausible; and/or a plausible temporal 
sequence is inconsistent with the onset of the event and the study intervention 
and/or causal relationships is considered implausible.
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3
1.2.4. Timeline for Reporting
In the unlikely event an AE or SAE occurs, it will be brought to the PI's attention 
and the PI will classify the AE/SAE by severity, expectedness, and relatedness, 
as listed above. All events that are both serious and unexpected will be 
reported to Mass General Brigham's IRB, the NIA PO, and to the DSMB within 
48 hours of the research team's knowledge of the SAE. The summary of all 
other SAEs will be reported to the NIA and to the DSMB quarterly unless 
otherwise specified by the DSMB. Any unanticipated problem, defined as an 
issue related to the research suggesting the research places participants or 
others at greater risk than expected, will be reported to the IRB, the NIA PO, 
and to the DSMB within 48 hours of discovery. If the problem involves death 
then reporting will occur within 24 hours, and this report will include a plan to 
correct the problem and prevent its occurrence. Any breach of PHI will be 
reported to the PI, who will report to the IRB and NIA PO within 24 hours of 
discovery
1.3 Protection Against Study Risks 
Informed Consent Process
Eligible patients who are interested in the study may agree to meet with a study staff 
member, who will describe the study, answer questions, and obtain written informed 
consent from eligible patients who elect to participate. The consent form will include 
information about the purpose of the study, the nature of the subject’s participation, 
the possible risks and discomforts associated with participation, the potential benefits 
of participation, a statement of the voluntary nature of participation, and a description 
of the mechanisms used to ensure confidentiality. All prospective subjects will be 
provided with an informed consent document written at the 8th-grade reading level in 
English and Spanish. The study staff also will provide a scripted oral form of the 
informed consent document and, to ensure comprehension, will ask prospective 
subjects to restate the main purposes and risks of the study, as well as restate that 
their access to ongoing care will not be influenced by their decision about 
participation. Individuals who cannot accurately restate these three elements of 
consent will not be enrolled, regardless of their interest.
Protection Against Risks
Health information collected as part of this study will be stored in REDCap. No 
identifiable data will be stored or downloaded on any personal or unauthorized 
computers. Study staff will access the data on institutionally purchased and managed 
computers that operate behind the health system’s security and firewall protections. 
Only the study MGH study staff will have access to the identifiable data set. Once the 
study is completed, data will be deidentified such that it can be analyzed without risk 
of a breach of privacy or confidentiality. Any data that is shared outside of MGH will 
require a data use authorization.
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4
Although we will make every effort to protect participant privacy and confidentiality, it 
is possible that participants' involvement in the study could become known to others. 
For those in the intervention group, we will be sending messages via text or the 
patient portal (per subject request); there is the possibility that study participation or 
health information could become known to others despite the use of firewalls, 
password protection, and other security measures.
For those in the intervention group, we will provide information about the possibility 
that their scheduled primary care visit may have an associated charge. We will provide 
the standard MGH information sheet on billing and charges for health care 
maintenance and directions for patients to contact their insurers prior to a visit to 
inquire about potential cost-sharing and/or deductibles for their visit.
2.0
INTERIM ANALYSIS
No interim analysis is planned as this study is no more than minimal risk for 
participants.
3.0
DATA SAFETY AND MONITORING
The Principal Investigator (PI), with the assistance of the research study staff, is 
responsible for ensuring participants’ safety and ensuring the study is implemented in 
accordance with the approved IRB protocol and procedures. The study protocol and 
DSMP will be reviewed by the NIA Roybal Center Data Safety Monitoring Board 
(DSMB), who will make recommendations regarding the modification, continuation, or 
conclusion of the trial.
3.6 Frequency of Data and Safety Monitoring
Any AEs or SAEs will be dealt with as described in section above. The frequency of 
additional monitoring, including the submission of safety reports, will be determined by 
the DSMB and safety officer (if applicable).
3.7 Data Analysis and Coordination
The PIs and research assistant will be responsible for data processing and analysis. 
All data will be directly available to the DSMB and Program Officer on request, except 
raw data identifying individual participants. Any data sharing requests of patient 
information outside the research team and the approved IRB protocol will be facilitated 
through the Mass General Brigham Office of Research Management.
3.8 Content of Data and Safety Monitoring Report
We anticipate the content of the data and safety monitoring report will include study 
progress, recruitment and retention status, and safety information.
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5
3.9 DSMB Membership and Affiliation
DSMB oversight is provided by the Standing Roybal DSMB, which includes the 
members listed: Andrea B. Troxel, ScD (chair); Abby King, PhD; Jerry Gurwitz, MD; 
Hae-Ra Han, PhD, RN, FAAN; Hang Lee, PhD; Ezra Golberstein, PhD; David Kim, 
MD PhD; Christopher Celano, MD.
3.10
Conflict of Interest for DSMB/SO
DSMB members will have no direct involvement with the study or conflict of interest 
with the investigators or institutions conducting the study. Each member has signed a 
COI statement which includes current affiliations, if any, with pharmaceutical or 
biotechnology companies (e.g., stockholder, consultant), and any other relationship 
that could be perceived as a conflict of interest related to the study and/or associated 
with commercial interests pertinent to study objectives.
3.6 Protection of Confidentiality
Data presented to the DSMB will be deidentified as to protect individual participant’s 
privacy and health information. Should the identify of a deidentified subject need to be 
revealed, the DSMB request will be reviewed and processed by the Mass General 
Brigham IRB.
3.7 DSMB/SO Responsibilities
Please see the DSMB charter for a description of DSMB responsibilities.
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Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed 
Intervention to Improve Chronic Disease Management among Postpartum Women
Study PIs: Mark Clapp, MD MPH (MGH); Jessica Cohen, PhD (Harvard)
Site PI: Mark Clapp, MD MPH (MGH)
Eligibility Screening Variable List
•
Name
•
Medical Record Number
•
Age
•
Estimated due date
•
Primary OB provider
•
Primary prenatal care clinic location
•
Pregnancy history (gravidity/parity)
•
Pre-pregnancy comorbidities:
o
Obesity (BMI)
o
Hypertension
o
Diabetes
o
Anxiety
o
Depression
•
Pregnancy-related conditions:
o
Hypertension
o
Diabetes
o
Anxiety
o
Depression
•
Risk factors for hypertensive disorders of pregnancy
o
Chronic kidney disease
o
Lupus / autoimmune disease
o
Multifetal gestation
o
History of pre-eclampsia
o
Aspirin 81 mg use (as proxy for provider recognition/designation for elevated risk)
•
Race/ethnicity
•
Primary/preferred language
•
Primary insurer/payer
•
Patient Gateway enrollment status
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1
Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed 
Intervention to Improve Chronic Disease Management among Postpartum Women
Study PIs: Mark Clapp, MD MPH (MGH); Jessica Cohen, PhD (Harvard)
Site PI: Mark Clapp, MD MPH (MGH)
Baseline Survey
SECTION 1. Interview Information
101. RA ID number
102: Enrollment Facility ID number
103: Facility name
104: Date of interview (MM/DD/YY)
105: Start time of interview
106: End time of interview
107: Time of interview in relation to patient’s prenatal/postnatal visit: 
1=Before visit
2=After visit
3=Partly before and partly after visit
SECTION 2. Consent
Instructions: please make sure to complete this section for every individual approached.
201. Respondent First Name
202: Respondent Last Name
203: Respondent Medical Record Number
204: Respondent OBGYN/CNM Last Name: 
205: Respondent Primary OBGYN Practice Location:
206: Respondent EDD
208: Date respondent was sent Patient Gateway Research Letter (MM/DD/YY)
                                                                                                                                        
209: Is interview date at least two weeks after Patient Gateway Research Letter was sent? 
1= Yes
2= No ->STOP, End Survey
210: READ OUT LOUD TO PATIENT: May we have your permission to explain why we are 
here today, and to ask you some questions?
1= Yes
2= No ->STOP, if respondent would not like to participate: End Survey.
211: REVIEW INFORMED CONSENTS and indicate whether consent was granted. 
1 = Consented  Skip to next section 
2 = Did not consent   STOP, End Survey. 
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2
SECTION 3. Verification of Respondent Demographic Information 
Pre-fill this section based on Patient Record and ask patient to verify or update this information. 
301.
 Respondent family name: 
302.
 Respondent first name: 
303.
 Respondent mobile number: 
304.
 If consented to SMS messagint, respondent’s ability to receive SMS messages:
305.
 Respondent home address: 
306.
 Respondent email address:
307.
 Respondent race:  
308.
 Respondent ethnicity: 
309.
 Respondent Preferred Language:  
310.
 Respondent Date of Birth: 
311.
Primary Care Provider Practice:
312.
 Primary Care Provider Name: 
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3
SECTION 4. Demographic Information and Plans for Postpartum Leave
401.  How many children have you had (not including your current pregnancy)? 
Number: ________
Refused -99
402. How many people (not including yourself) currently live in your household?
Number: ___________
Don’t know -88
Refused -99
403. What is your marital status?
1. Married
2. Not married
Refused -99
404. Are you currently cohabitating with a spouse or partner?
1. Yes
2. No
Refused -99
 
405. At any time during your pregnancy did you work for pay in a job located in 
Massachusetts? 
1. Yes
2. No, I worked for pay outside of MA
3. No
Refused -99
406. Which of the below best describes the type of work you had? (Tick all that apply. List 
name of employer)
1.
Federal or State Government
2.
Private or For-Profit Company
3.
Municipality (school department, public works, housing authority, regional school district)
4.
Church or Religious Organization
5.
Self-employed
6.
I don’t know which of these categories by employer falls into. 
Refused -99
407. In the past 12 months, approximately how much did you earn? 
1. $0
2. $1 - $10,000
3. $10,001 – $29,999
4. $30,000-$49,999
5. $50,000 - $74,999
6. $75,000-$100,000
7. > $100,000
8. Don’t know
99. Refused
408. What type of leave(s) do you plan on taking after the birth of your baby? (Tick all that 
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4
apply)
1. Paid leave
2. Unpaid leave
3. I do not plan on taking leave. 
8. Don’t know
99. Refused
 409. Approximately how many weeks or months of leave in total do you plan to take after the 
birth of your baby? 
________Weeks
________ Months
8. Don’t know
99. Refused
410. Have you ever seen, read or heard anything about a state program called the “Paid 
Family and Medical Leave“ (PFML),  which provides eligible workers with paid time off for 
family or medical reasons?
1. Yes
2. No
99. Refused
411. What do you plan to do for childcare after your baby is 3 months old? (Tick all that apply)
1. My partner and/or I will care for the child
2. Child care by a family member or friend for free
3. Child care by a family member or friend you pay
4. Nanny or babysitter
5. Private daycare center
6. Headstart Daycare Center or Other Free Daycare
88. Don’t Know
99. Refused
412. Do you have access to a car? 
1. Yes, always
2. Yes, sometimes
3. No
88. Don’t know
99. Refused
413. What mode of transportation do you usually take to get to medical appointments? 
1. Personal car
2. Taxi, Uber or Lyft
3. Bus
4. Subway (“T”)
5. Train
6. Bicycle
7. On foot
88. Don’t know
99. Refused 
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5
414. Aside from money you may earn yourself, do you expect any of the following people to 
also provide financial support for you and your child/children after the baby is born? (Tick all 
that apply)
1. Baby’s father
2. Partner (if not baby’s father)
3. Family
4. Friends
5. Government Support
6. Other
88. Don’t know
99. Refused
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[Date]
[Patient name
Address
City, State, Zip]
Dear [Ms. Patient],
We are writing to let you know about a research study that might interest you. Mass General 
Brigham is committed to providing excellent care to you and to our community. An important 
part of our mission is to learn new ways to care for our patients by doing research. Our patients 
play an important role in research by joining studies to help discover better treatments or better 
ways to prevent health problems.
Mass General Brigham is a health system that includes hospitals, community health centers, and 
groups of doctors.  We work together to provide the best care possible to our community. 
Patients at Mass General Brigham have access to high-quality care across our entire system. As a 
healthcare system, we also work together to provide access to research studies to all our 
patients. 
The information below tells you about the study that might interest you.  You can learn more 
or speak with the research team to decide if it is a good match for you.
Study Name:
Bridging the Gap from Postpartum to Primary Care
What we are studying:
Methods to improve primary care among postpartum women
Who might qualify:
Pregnant and postpartum people who may particularly benefit 
from primary care in the postpartum period. 
These may or may not apply to you.  
What you are asked 
to do in the study:
Agree to receive occasional messages by the study team via 
Patient Gateway between the time of enrollment through 4 
months postpartum
For more information:
To learn more about THIS study:
Contact the study’s research coordinator, Fowsia Warsame, 
at 617-643-5483. After you learn more, you can decide to 
join or not. We may also find out that you do not qualify for 
the study. Whether you join the study or not, it will not 
change the medical care you receive here at Mass General 
Brigham.
Page 72 of 79
Compiled Summary of Protocol Amendments
Page 73 of 278

If you are definitely NOT interested in THIS study, and don’t want to hear more about it, please 
call study coordinator Fowsia Warsame at 617-643-5483. If 
we do not hear back from you within two weeks, we may 
approach or call you to see if you wish to hear more about 
the study.
To learn more about 
research in general:
Call the Research
Navigator Office: 
857-282-5370 
Go to the Rally website:
rally.partners.org/research
If you do not want to receive notices about any studies at Mass General Brigham:
•
Log in to your Patient Gateway account.
On the Menu scroll down to “Resources” and choose “Research Opportunities”
Read the brief information and chose the appropriate button.
OR
•
Contact the Research Navigator Office:  Call 857-282-5370
Thank you in advance for considering this research study.
Sincerely,
Mark Clapp, MD MPH
Maternal-Fetal Medicine
Massachusetts General Hospital
617-724-4531
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Compiled Summary of Protocol Amendments
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All likely eligible individuals sent "opt-out" research 
notification via Patient Gateway (PG)
Not approached
Approached at in-person 
visit (preferred) or via phone
Does not opt-out 
after 2 weeks
Opts out
Excluded
Baseline screening survey
Declines
Consents to 
enroll
Randomization assignment
Importance of 
postpartum to primary 
care message sent 
Importance of 
postpartum to primary 
care message sent 
Study team makes PCP 
appointment and messages 
patient
PCP appointment reminder 
nudge sent
PCP appointment reminder 
nudge sent
2-4 weeks 
prior to EDD or 
once enrolled if after 
this date
2-3 weeks 
after EDD 
4-8 weeks 
before appt
1-4 weeks 
before appt 
Control Group
Intervention Group
2-4 weeks 
prior to EDD or 
once enrolled if after 
this date
Outcome assessment for primary and secondary 
outcomes via EHR review
4 months from 
delivery date
Page 74 of 79
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Page 75 of 278

Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic 
Disease Management among Postpartum Women
Study PIs: Mark Clapp, MD MPH (MGH); Jessica Cohen, PhD (Harvard)
Site PI: Mark Clapp, MD MPH (MGH)
* EDD, estimated date of delivery; PG, Patient Gateway secure messaging portal.
Patient Message Text
Group
Timing  
Type
Message content if PCP appt scheduled
Message content if PCP appt not scheduled
Control
2-4 
weeks 
prior to 
EDD 
PG
N/A
Dear XXX,
Having a primary care provider (PCP) and seeing 
them at least once a year is important for your 
health. These providers can identify health risks 
and help you improve your health through your 
entire life.
These providers have different roles than your 
obstetrician (pregnancy doctor) or midwife. It is 
recommended that all patients see their PCP after 
your pregnancy ends and your relationship with 
your pregnancy provider has ended (typically 6-12 
weeks after your delivery).
If you have questions about finding or seeing your 
PCP after your delivery, please ask your 
pregnancy provider or call your PCP.
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator XX or email the study team at XX. Do 
not reply directly to this message with questions 
about your health or to arrange follow-up.
Page 75 of 79
Compiled Summary of Protocol Amendments
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Bridging the Gap from Postpartum to Primary Care
Patient Message Text
2
Group
Timing  
Type
Message content if PCP appt scheduled
Message content if PCP appt not scheduled
Intervention
2-4 
weeks 
prior to 
EDD 
PG
N/A
Dear XXX,
Having a primary care provider (PCP) and seeing 
them at least once a year is important for your 
health. These providers can identify health risks 
and help you improve your health through your 
entire life.
These providers have different roles than your 
obstetrician (pregnancy doctor) or midwife. It is 
recommended that all patients see their PCP after 
your pregnancy ends and your relationship with 
your pregnancy provider has ended (typically 6-12 
weeks after your delivery).
We will help you schedule an appointment with 
your PCP! 
If you have preferences for your appointment, 
please fill out this form [REDCap link]. If not, we 
will schedule your appointment with the PCP listed 
in your record within the next few months.
If you have questions about finding or seeing your 
PCP after your delivery, please ask your 
pregnancy provider or call your PCP.
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator XX or email the study team at XX. Do 
not reply directly to this message with questions 
about your health or to arrange follow-up.
Page 76 of 79
Compiled Summary of Protocol Amendments
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Bridging the Gap from Postpartum to Primary Care
Patient Message Text
3
Group
Timing  
Type
Message content if PCP appt scheduled
Message content if PCP appt not scheduled
Intervention
2 weeks 
after 
EDD
PG
An appointment with your primary care provider 
(PCP) has been specially reserved for you:
XXX APPT INFO ##
This appointment is important to transition your 
care from your pregnancy provider back to your 
PCP after your delivery. Your PCP will ensure you 
have the appropriate screening tests and a plan in 
place to keep you healthy in the future. 
Specific issues or risks from your pregnancy that 
you may want to address with your PCP include: 
XXX
Often, this “annual exam” is offered at no cost to 
you, depending on your insurer. For more 
information on costs, please call your PCP’s office 
or visit: 
https://www.massgeneral.org/notices/billing/preve
ntive-health-exams
If you are unable to make this appointment or wish 
to reschedule, please call your PCP’s office at 
XXX or contact XXX with the Bridge Study Team. 
Please note that some clinics may have penalties 
for not showing to a scheduled visit. 
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator XX or email the study team at XX. Do 
not reply directly to this message with questions 
about your health or to arrange follow-up.
We have been unable to reserve a primary care 
provider (PCP) appointment for you with XXX at 
XXX Practice because XXX. Please call your 
PCP’s office to schedule. We will also call you 
within the next week to see if we can help.
The PCP appointment is important to transition 
your care from your pregnancy provider back to 
your PCP after your delivery. 
Specific issues or risks from your pregnancy that 
you may want to address with your provider 
include: XXX
Often, this “annual exam” is offered at no cost to 
you, depending on your insurer. For more 
information on costs, please visit: 
https://www.massgeneral.org/notices/billing/preven
tive-health-exams
Some conditions that you may be at risk for that 
may need continued long-term follow-up with your 
PCP include: XXX. Your PCP will ensure you have 
the appropriate screening tests and a plan in place 
to keep you healthy in the future. 
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator XX or email the study team at XX. Do 
not reply directly to this message with questions 
about your health or to arrange follow-up.
Intervention
2 weeks 
after 
EDD
SMS
An appointment with your PCP has been specially 
reserved for you! Check Patient Gateway for 
details. -The Bridge Study Team
[do not reply to this message]
character count: 154
Oh no! We are having trouble arranging your PCP 
appointment. Check Patient Gateway for details. -
The Bridge Study Team
[do not reply to this message]
character count: 147
Page 77 of 79
Compiled Summary of Protocol Amendments
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Bridging the Gap from Postpartum to Primary Care
Patient Message Text
4
Group
Timing  
Type
Message content if PCP appt scheduled
Message content if PCP appt not scheduled
Intervention
4 weeks 
before 
PCP 
appointm
ent
PG
Dear XXX,
Your primary care provider (PCP) is looking 
forward to caring for you going forward after your 
pregnancy at this upcoming important 
appointment:
XXX APPT INFO ##
This appointment is important to transition your 
care from your pregnancy provider back to your 
PCP after your delivery. 
Often, this “annual exam” is offered at no cost to 
you, depending on your insurer. For more 
information on costs, please visit: 
https://www.massgeneral.org/notices/billing/preve
ntive-health-exams
If you are unable to make this appointment or wish 
to reschedule, please call your PCP’s office at 
XXX or contact XXX with the Bridge Study Team. 
Please note that some clinics may have penalties 
for not showing to a scheduled visit. 
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator XX or email the study team at XX. Do 
not reply directly to this message with questions 
about your health or to arrange follow-up.
Dear XXX,
We do not see that you have a PCP appointment 
scheduled after your pregnancy in the upcoming 1-
2 months. Please call your PCP’s office to 
schedule. We will also call you within the next 
week to see if we can help.
The PCP appointment is important to transition 
your care from your pregnancy provider back to 
your PCP after your delivery. Often, this “annual 
exam” is offered with little to no cost to you, 
depending on your insurer.
Specific issues or risks from your pregnancy that 
you may want to address with your PCP include: 
XXX
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator XX or email the study team at XX. Do 
not reply directly to this message with questions 
about your health or to arrange follow-up.
Intervention
4 weeks 
before 
PCP appt
OR
8 weeks 
pp if no 
PCP appt 
SMS
Your PCP appointment is looking forward to your 
upcoming appointment! Check Patient Gateway 
for details. -The Bridge Study Team 
[do not reply to this message]
character count: 158
Oh no! You do not have a PCP care transition 
appointment scheduled. Check Patient Gateway 
for details. -The Bridge Study Team
[do not reply to this message]
character count: 159
Page 78 of 79
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Bridging the Gap from Postpartum to Primary Care
Patient Message Text
5
Group
Timing  
Type
Message content if PCP appt scheduled
Message content if PCP appt not scheduled
PG
Dear XXX,
Your reserved postpartum-to-primary care 
transition appointment with your PCP is coming 
up!
XXX APPT INFO ##
This appointment is important to keeping you 
healthy in the future. Specific issues or risks from 
your pregnancy that you may want to address with 
your provider include: XXX
Often, this “annual exam” is offered at no cost to 
you, depending on your insurer. For more 
information on costs, please visit: 
https://www.massgeneral.org/notices/billing/preve
ntive-health-exams
If you are unable to make this appointment or wish 
to reschedule, please call your PCP’s office at 
XXX or contact XXX with the Bridge Study Team. 
Please note that some clinics may have penalties 
for not showing to a scheduled visit. 
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator XX or email the study team at XX. Do 
not reply directly to this message with questions 
about your health or to arrange follow-up.
Dear XXX,
We do not see that you have a PCP appointment 
scheduled to transition your care after your 
pregnancy in the upcoming 1-2 months. We will 
call you within the next week to see if we can help.
The PCP appointment is important to transition 
your care from your pregnancy provider back to 
your PCP after your delivery. Often, this “annual 
exam” is offered with little to no cost to you, 
depending on your insurer.
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator XX or email the study team at XX. Do 
not reply directly to this message with questions 
about your health or to arrange follow-up.
Intervention
1 week 
before 
PCP appt
OR
12 weeks 
pp if no 
PCP appt 
SMS
Reminder: Your PCP appointment is within the 
next few days! Check Patient Gateway for details. 
-The Bridge Study Team 
[do not reply to this message]
character count: 148
Reminder! You do not have a PCP care transition 
appointment scheduled. Check Patient Gateway 
for details. -The Bridge Study Team
[do not reply to this message]
character count: 158
Page 79 of 79
Compiled Summary of Protocol Amendments
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Version: V2.5 created on 09/14/22 - 09:51 AM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:37 PM 
 
 
Title: Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to 
Improve Chronic Disease Management among Postpartum Women (the Bridge Study)  
Sponsor Name: 
PI Name: Clapp, Mark A  
Protocol #: 2022P001723 
Type: Amendment (AME2)  
Date Received: September 13, 2022  
Signatures 
PI Name: Clapp, Mark A, MD, MPH 
Authenticated: September 13, 2022 
Amendment  
COVID-19 Amendment 
 
Is this amendment ONLY related to research impacted by COVID-19? 
 
Refer to MGB Policy on Conduct of Human Research Activities during COVID-19 Operations for description 
of Amendments which do require prior IRB review and approval.   
⚪  Yes   
◉  No  
 
 
Central IRB Performance Sites  
 
Is this a protocol where the Mass General Brigham IRB is serving as the single IRB (sIRB) for external 
sites/institutions? 
⚪  Yes   
◉  No  
 
 
Sponsor Amendment 
  
Is there a sponsor amendment number? 
⚪  Yes   
◉  No  
 
 
Change in Protocol Status 
 
Is this a cede protocol or project that was determined to be exempt, not human subjects research or not 
engaged in human subjects research?  
⚪  Yes   
◉  No  
 
 
Do you need to change the overall status of the protocol?  For example, Re-Open to Enrollment or 
indicate that Research Interventions/Assessments Continue after telling the IRB these have ceased. 
⚪  Yes  
 
◉  No  
 
 
  
Briefly describe the proposed changes: 
Page 1 of 29
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Version: V2.5 created on 09/14/22 - 09:51 AM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:37 PM 
 
 
No patients have been enrolled or approached yet. 
The following amendments are being made: 
1) minor adjustments to the enrollment criteria 
2) minor updates to the language in the patient messages  
3) added additional component to intervention arm (study team messages PCP that their patient is 
recently postpartum and an appointment has been scheduled for them) 
4) added explicit language on the possibility of PCP visit cost to study messages and study fact sheet at 
request of project funder 
5) minor sample size adjustments after more accurate estimates on potential eligible patients 
6) study schema changed to reflect accurate outcome assessment time point 
 
  
Provide rationale for the proposed changes: 
Rationale:  
1) minor adjustments to the enrollment criteria  
- requires patient to have a PCP listed in Epic as there is limited to no available of "New" primary care 
appointments at MGH 
- avoids enrollment of a patient with a new diagnosis or being evaluated for a stillbirth given the 
extenuating circumstances associated with this encounter 
2) minor updates to the language in the patient messages  
- updated to be consistent with a 6th grade reading level 
- added information on the possibility of PCP visit cost at the recommendation of the project funder 
3) added additional component to intervention arm (study team messages PCP that their patient is 
recently postpartum and an appointment has been scheduled for them) 
- after discussion with Dr. Ray (PCP on the study team), this element was felt to be important 
4) added explicit language on the possibility of PCP visit cost to study messages and study fact sheet  
- added at the recommendation of the project funder 
5) minor sample size adjustments  
- more accurate estimates on potential eligible patients became available 
6) study schema changed to reflect accurate outcome assessment time point 
- the components of the intervention arm will be timed around the estimated date of delivery for 
consistency (not the actual variable date) 
 
  
Will the proposed change(s) significantly alter the risk to benefit assessment the IRB relied upon to approve 
the protocol? 
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Version: V2.5 created on 09/14/22 - 09:51 AM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:37 PM 
 
 
⚪  Yes   
◉  No  
 
 
  
Will the proposed change(s) significantly affect the integrity of the protocol? 
⚪  Yes   
◉  No  
 
 
Informed Consent 
 
Do the changes require a revision to the consent form? 
⚪  Yes   
◉  No  
 
Attachments 
 
Name 
Mode 
Study Fact Sheet_090122 (Consent Fact/Information Sheet)  
Electronic  
Detailed Protocol_090122_v1-3_clean (Detailed Protocol)  
Electronic  
PCP Study Baseline Survey_9-13-22 (Instrument/Questionnaire) Electronic  
Study Schema (Schema)  
Electronic  
 
Page 3 of 29
Compiled Summary of Protocol Amendments
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Research Study Fact Sheet
Bridging the Gap from Postpartum to Primary Care (The Bridge Study)
Principal Investigators
Mark Clapp, MD MPH (Massachusetts General Hospital)
Jessica Cohen, PhD (Harvard T. H. Chan School of Public Health)
Overview
This is a research study being conducted among pregnant and recently postpartum 
individuals who receive care at MGH.
Purpose
Your primary care provider (PCP) is responsible for managing and overseeing your 
current and long-term health. The purpose of this project is to improve primary care in 
the postpartum period. 
Sponsor
This research is being sponsored by the National Institute on Aging, MIT Roybal 
Center for Translational Research to Improve Health Care for the Aging and the 
NBER Roybal Center for Behavior Change in Health.
Contact
We sent you a Patient Gateway message about this study because you are a person 
who may particularly benefit from receiving postpartum primary care. 
Study Details
If you agree to participate, we will ask you a few questions about your health and visit 
history at the time of enrollment, which are all optional.
You will then be randomly assigned (50/50 chance) to be in the “standard care” group 
or the “facilitated transition” group. Regardless of which group you are assigned, you 
will continue to receive standard prenatal and postpartum care from your obstetrical 
care provider. 
In the “standard care” group, you will receive a limited number of messages (less than 
5) from the study team. 
In the “facilitated transition” group, you will receive a limited number of  messages 
(less than 5) from the study team between your enrollment and up to four months 
after your delivery. The study team will also assist in connecting you with your primary 
care provider after your delivery. Specifically, we may call your primary care 
provider’s office on your behalf to help schedule an appointment. You always have 
the option to change or cancel this appointment. We also will message your PCP that 
you have recently delivered and that a follow-up appointment is being arranged.
Messages that we send you via Patient Gateway will also appear in your medical 
record for other members of your care team to see.
For both groups, we will review your medical record after your delivery to see if/when 
you received any care within the Mass General Brigham health system and 
information on your health status for up to two years after your delivery.
We also may contact you once between four and twelve months after your delivery to 
ask you questions about your postpartum care experience. You can decline to 
participate or answer any or all questions.
You may opt out of receiving messages or decline to participate in any survey, and/or 
withdraw from the study at any point without penalty.
Approximately 350 people will participate in this study.
Privacy/Confidentiality
We are required by the Health Insurance Portability and Accountability Act (HIPAA) to 
protect the privacy of health information obtained for research. More details related to 
the privacy of your health information is included on Pages 3-4 of this fact sheet.
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The Bridge Study: Fact Sheet
2
All information collected as a part of this study will be kept confidential and secure. As 
with all studies, there is a very low risk that others may become aware of your 
participation or health information. The study procedures and its protections of your 
information have been approved by the Mass General Brigham Human Subjects 
Research committee. Once the study has completed, all information that could 
identify you, such as your name or medical record number, will be deleted. 
Study Information
We will collect information on your health and pregnancy history, including about visits 
you have with providers within the Mass General Brigham health system. Data 
collected as a part of this study will not affect your clinical care directly. Any 
messages sent from the study team will be visible to you and your care team within 
the electronic medical record. Your de-identified information may be used or shared 
with other researchers without your additional informed consent.
Risks
There are minimal risks to participate. 
Although we will make every effort to protect participant privacy and confidentiality, it 
is possible that your involvement in the study could become known to others. We will 
be sending messages via Patient Gateway, which is a HIPAA-compliant method for 
communicating with you. You have the option to also receive SMS text messages that 
will not have any identifiable or personal health information. There is a rare possibility 
that study participation or health information could become known to others despite 
the use of firewalls, password protection, and other security measures.
Costs
You do not have to pay to take part in this research study. 
By attending a PCP visit, there is a possibility that you will incur a charge, such as a 
co-pay or deductible payment, depending on your individual insurance coverage. If 
you do not have insurance, you may have to pay for the entire cost of the visit. We will 
provide you information on how to check potential costs with your insurer prior to your 
visit.
Participation
Those who participate will receive a $20 gift card after enrollment. 
Participation is voluntary, and you can withdraw or stop the study at any time. 
Deciding not to participate won't affect medical care you receive at Mass General 
Brigham now or in the future, or any benefits they receive now or have a right to 
receive.
Study Contact
Mark Clapp, MD MPH, is the person at MGH who in charge of this research study. 
You can call him at 617-724-4531 (M-F 9a-5p). You can also call the study 
coordinator (Fowsia Warsame) at 617-643-5483 (M-F 9a-5p) with questions about 
this research study. You can also email bridgestudy@mgh.harvard.edu.
If you’d like to speak to someone not involved in this research about your rights as a 
research subject, or any concerns or complaints you may have about the research, 
contact the Mass General Brigham IRB at (857) 282-1900.
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The Bridge Study: Fact Sheet
3
Option to Receive Text (SMS) Messages
Text messages by mobile/cell phones are a common form of communication. Our study team would like to 
send you no more than 3 text (SMS) messages as a part of the study, though this is optional and not 
required to participate in the Bridge Study. Texting over mobile/cell phones carries security risks because 
text messages to mobile/cell phones are not encrypted.  This means that information you send or receive by 
text message could be intercepted or viewed by an unintended recipient, or by your mobile/cell phone provider 
or carrier. 
Below are some important points about texting as a part of a research study:
•
Receiving text messages is optional in this study and not required to participate.
•
Text messages are not encrypted, and therefore carry security risks. This research study and Mass 
General Brigham are not responsible for any interception of messages sent through unencrypted text 
message communications.  
•
You will be responsible for all fees charged by your carrier’s service plan for text messaging.  This 
research study and Mass General Brigham are not responsible for any increased charges, data 
usage against plan limits or changes to data fees from the research texts.
•
Text messaging should not be used in case of an emergency.  If you experience a medical emergency, 
call 911 or go to the nearest hospital emergency department.  
•
You may decide to not send or receive text messages with staff associated with this research study at any 
time. You can do this in person or by sending the research number a text message that says “Stop 
Research Text.” 
•
Your agreement applies to this research study only.  Agreeing to other texts from Mass General Brigham, 
for example appointment reminders, is a separate process.  Opting out of other texts from Mass General 
Brigham is a separate process as well.
•
It is your responsibility to update your mobile/cell phone number with this research study in the event of a 
change.
Information Regarding the Privacy of Your Health Information
Federal law requires Mass General Brigham and its affiliated hospitals to protect the privacy of health 
information and related information that identifies you.  We refer to this information as “protected health 
information.” Your protected health information will be used and shared with others as explained below.  You 
are agreeing to the collection, use, and sharing of your protected health information as described in this 
information sheet. If you have questions, you may ask the researcher who is reviewing this information sheet 
with you or you can contact the researcher listed above. 
In this study, we may collect protected health information about you from:
•
Past, present, and future medical records
•
Research procedures, including but not limited to research visits, tests, interviews, and questionnaires
Why will protected health information about you be used or shared with others?
The main reasons include:
•
to conduct and oversee the research described in this information sheet for this study;
•
to ensure the research meets legal, institutional, and accreditation requirements; and 
•
to conduct public health activities (including reporting of adverse events or situations where you or 
others may be at risk of harm).
Who may see, use, and share your protected health information and why they may need to do so?
•
Mass General Brigham researchers and staff involved in this study
•
The sponsor(s) of the study, and people or groups it hires to help perform this research or to audit the 
research
Page 6 of 29
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The Bridge Study: Fact Sheet
4
•
Other researchers and medical centers that are part of this study
•
The Mass General Brigham ethics board 
•
A group that oversees the data (study information) and safety of this study
•
Non-research staff within Mass General Brigham who need identifiable information to do their jobs, 
such as for treatment, payment (billing), or hospital operations (such as assessing the quality of care or 
research)
•
People or groups that we hire to do certain work for us, such as data storage companies, accreditors, 
insurers, and lawyers
•
Federal agencies (such as the U.S. Department of Health and Human Services (DHHS) and agencies 
within DHHS like the Food and Drug Administration, the National Institutes of Health, and the Office for 
Human Research Protections), state agencies, and foreign government bodies that oversee, evaluate, 
and audit research, which may include inspection of your records
•
Public health and safety authorities, if we learn information that could mean harm to you or others (such 
as to make required reports about communicable diseases or about child or elder abuse)
Some people or groups who get your protected health information might not have to follow the same privacy 
rules that we follow and might use or share your protected health information without your permission in ways 
that are not described in this form.  We share your protected health information only when we must, and we 
ask anyone who receives it from us to take measures to protect your privacy.  However, once your protected 
health information is shared outside Mass General Brigham, we cannot control all the ways that others use or 
share it and cannot promise that it will remain private.
The results of this research study may be published in a medical book or journal or used to teach 
others.  However, your name or other identifiable information will not be used for these purposes without your 
specific permission.
For how long will protected health information about you be used or shared with others?
Because research is an ongoing process, we cannot give you an exact date when we will either destroy or stop 
using or sharing your protected health information.  Your permission to use and share your protected health 
information does not expire.
Your Privacy Rights
You have the right not to agree to our use and sharing of your protected health information for research; 
however, if you don’t agree, you can’t take part in this research study. However, refusing to agree will not affect 
your present or future care and will not cause any penalty or loss of benefits to which you are otherwise 
entitled.
You have the right to withdraw your permission for the further use or sharing of your protected health 
information for this research study. If you want to withdraw your permission, you must notify the person in 
charge of this research study in writing at the name and address listed above.  Once permission is withdrawn, 
you cannot continue to take part in the study.
If you withdraw your permission, then to the extent that we have retained any protected health information that 
can be linked to you, we will stop using and sharing the protected health information further for the 
research.  However, we will not be able to take back information that has already been used or shared with 
others, and such information may continue to be used for certain purposes, such as to comply with the law or 
maintain the reliability of the study.
You have the right to see and get a copy of your protected health information that is used or shared for 
treatment or for payment.  To ask for this information, please contact the person in charge of this research 
study identified above.  You may only get such information after the research is finished.
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Principal Investigator:
Mark Clapp, MD MPH (MGH), Jessica Cohen, PhD (HSPH)
Project Title:
Bridging the Gap from Postpartum to Primary Care: A Behavioral 
Science Informed Intervention to Improve Chronic Disease Management 
among Postpartum Women
Version Date:
09/01/2022
Version Name/Number:
v1.3
1.
 Background and Significance
Burden of Chronic Disease and the Role of Primary Care
Chronic health conditions affect millions of people in the US each year. In 2018, 51.8% of adults 
had at least 1 chronic condition, and 27.2% had multiple conditions.1 The prevalence of chronic 
disease was higher in women compared to men, older adults (87.6% in adults ≥65 years old), 
and people with public insurance.1 Many chronic conditions, by their nature, develop over time 
and have risk factors that can be identified prior to the onset of disease. Strong evidence 
underpins prevention strategies for many conditions, which are advanced by the US 
Preventative Services Taskforce.2 While the long-term health of a patient is the responsibility of 
an entire health system, primary care providers (PCPs) provide an integral role in preventing, 
screening for, and managing disease across the lifespan. Studies have shown the health 
benefits of receiving regular care under a PCP.3–6
Despite the known benefits of having an identifiable usual source of care and the value of health 
care maintenance, the percent of the population with a PCP has been decreasing over time.7 
Consistently, adults who are younger (age 20-40 years) have the lowest rates of primary care 
use. In 2015, 44% and 36% of 20- and 30-year-olds had no identifiable source of primary care.7 
The proportion without primary care were also higher among racial/ethnic minority populations 
and among those who had less education, lower incomes, and no known comorbidities.7 The 
number of adults and the time elapsed without regular primary care follow-up can be considered 
missed opportunities to improve a patient’s current and long-term health. The disproportionate 
lack of primary care among certain subgroups of the population, often groups who already have 
worse health outcomes, only serves to widen the pre-existing disparities.
Pregnancy as a Window to Future Health
In the US, 98.2% of pregnant women receive some form of prenatal care, with the average 
patient having >10 visits during their pregnancy.8 During a pregnancy, women are screened for 
pre-existing and pregnancy-related conditions.9 In adults ages 18-39, the prevalence of obesity, 
hypertension, prediabetes/diabetes, and mental illness are estimated at 39%, 7.5%, 28%, 25%, 
respectively.10–13 Even for those who have no prior identified comorbidities, the most common 
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pregnancy-related conditions—pregnancy-related hypertension and gestational diabetes (8% 
and 10% of pregnancies, respectively)—indicate a predisposition to or confer health risks that 
persist as women age. For example, over 25% of women with gestational diabetes will develop 
Type 2 diabetes mellitus, and women with pre-eclampsia have more than a two-fold risk of 
significant cardiovascular disease later in life.14,15 For these reasons, pregnancy is often 
considered a “window” into a woman’s future health and presents a unique opportunity to 
optimize a woman’s health status early in her life when she otherwise may not have been 
engaged in care.16 
Pregnancy as on Opportunity for Engagement with a Long-term Care Provider
Pregnancy is a period when women are highly engaged and active participants in their health 
care.17 It has been described as a “golden opportunity” to motivate women towards positive 
health behaviors, including prevention and management of chronic disease. However, women 
often fall off a “postpartum cliff” of health system engagement after the early postpartum 
period.18 A range of systemic, financial, and behavioral barriers often prevents patients from 
effectively transitioning to primary care. Postpartum women are often simply told to follow-up 
with their PCP without much information regarding the importance of this follow up care, without 
assistance in scheduling an appointment (or identifying a PCP if they don’t have one), and often 
without a direct transfer of relevant health information or accountability across providers. 
Postpartum women are left largely on their own to navigate this transition to primary care and, in 
particular, to navigate it at a time when they face the high cognitive and physical demands of 
caring for an infant. At this time of limited cognitive bandwidth, the importance of continuity of 
care for chronic conditions and active engagement in one’s longer-term health and wellbeing is 
unlikely to be salient and top-of-mind. These critical moments of unsupported health care 
transition can exacerbate pre-existing disparities in health and health care, with patients who 
are the least able to navigate the US health care system most likely to fall through the cracks.  
Momentum is building in US health and social safety net policy to facilitate healthy transitions 
from pregnancy to parenthood. For example, federal and state initiatives to expand pregnancy-
related Medicaid coverage from 60 days to one year postpartum have been proposed, and 
access to paid family leave is increasing. However, very little evidence exists on effective and 
cost-effective approaches to facilitating transitions to primary care and management of chronic 
diseases in the postpartum year.  
2.
Specific Aims and Objectives 
The objective of the proposed study is to increase patient engagement in primary care after the 
immediate postpartum period for women with pregnancy-associated conditions that convey a 
long-term health risk. Specifically, we aim to evaluate the efficacy of an intervention bundle 
(automatic scheduling of PCP appointment after delivery, salient labeling, and appointment 
reminder nudges) to increase patient attendance at a primary care provider appointment (within 
4 months of delivery for women with or at risk for obesity, diabetes, hypertension, and/or a 
mental health condition. 
Specific Aims:
1) Test the efficacy of an intervention bundle (patient-tailored health information, automatic 
scheduling of PCP appointment after delivery, and appointment reminder nudges) to 
increase patient attendance at a primary care provider appointment within 4 months of 
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delivery for women with obesity, diabetes, hypertension, and/or a mental health 
condition
2) Test the efficacy of the intervention bundle to improve compliance with the condition-
specific, guideline-based health screenings
3) Test the efficacy of the intervention bundle to reduce unscheduled or urgent encounters 
(e.g., emergency department visits) within the health system
3.
General Description of Study Design
We will conduct a randomized controlled trial comparing this intervention bundle to the receipt of 
generic information on the importance of primary care follow-up after delivery.  
Women will be randomized with equal probability into either a treatment or control arm. The 
intervention combines several features designed to target reasons for low take-up of primary 
care among postpartum women (see Logic Model). We leverage the potential value of 
defaults/opt-out, salient labels, and reminders to encourage use of primary care within 4 months 
of delivery. Women in both the intervention and control arms will receive information via MGH’s 
patient portal toward the end of the pregnancy regarding the importance of transitions to primary 
care in the postpartum year. This information will be similar to, but reinforcing, the information 
they would receive from their obstetrician about following up with their primary care physician. In 
addition to this initial message, women in the treatment arm will receive the following 
intervention components, developed based on recent evidence regarding behavioral science 
approaches to activating health behaviors:19–21
➢
Targeted messages about the importance and benefits of primary care. 
➢
Default scheduling into a primary care appointment at approximately 3-4 months after 
delivery. The patient will be scheduled for a primary care visit with their assigned primary 
care provider in the Mass General Brigham system. They will be informed of the option to 
cancel the appointment, change the appointment day/time, or change the care provider 
either through the patient portal). 
➢
Reminders about the appointment and importance of follow up primary care at 2-4 points 
during the postpartum period via the patient portal. 
➢
Tailored language in the reminders based on recent evidence from behavioral science about 
the most effective approaches to increasing take-up. For example, messages will inform the 
patient that an appointment has been reserved for them at their doctor. 
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The Logic Framework that underpins the basis for this study is shown below:
 
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The flow of study activities is shown below: 
4.
Subject Selection
Pregnant patients receiving prenatal care at Massachusetts General Hospital (MGH) will be 
targeted for recruitment. MGH conducts approximately 3500 deliveries per year, with roughly 
one-third of patients identifying as non-white and 35% of pregnancies covered by Medicaid.
Approximately 49% of the clinic population may ultimately be eligible to be approached.
The eligibility criteria include:
•
Estimated date of delivery and the following 4-month postpartum outcome 
assessment window completed prior to study end date
•
Currently pregnant or within 2 weeks of delivery
•
Have one or more of the following conditions: 
o
Chronic hypertension
o
Hypertensive disorders of pregnancy or risk factors for hypertensive disorders 
of pregnancy per the USPTF aspirin prescribing guidelines (e.g., history of 
pre-eclampsia, kidney disease, multiple gestation, autoimmune disease)22
o
Type 1 or 2 diabetes
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o
Gestational diabetes
o
Obesity (body mass index ≥30 kg/m2)
o
Depression or anxiety disorder 
•
Have a primary care provider listed in the patient’s medical record 
•
Receive obstetric care at an MGH-affiliated outpatient prenatal clinic
•
Has access to and be enrolled in the electronic health record patient portal and 
consents to be contacted via these modalities
•
Able to read/speak English or Spanish language
•
Age ≥18 years old
•
Not diagnosed with or undergoing evaluation for stillbirth/fetal demise
All women, regardless of race/ethnicity, who meet the eligibility criteria will be included. In 2019, 
3,789 women gave birth at the study institution, of whom 57% were white, 7% were black, 12% 
were Asian, 18% were Hispanic, and 6% declined to report their race/ethnicity. A similar 
distribution is expected for this study.
The study will distribute materials in English and Spanish languages. This encompasses >95% 
of patients who deliver at the study institution.
5.
Subject Enrollment
This study will rely on recruiting for research through Patient Gateway and follow the IRB 
guidance and DHeC Research Checklist and training for this process.
In the month prior to the start of enrollment, all potentially eligible individuals (based on the 
criteria above) will be identified using RPDR and Epic Reporting search queries. This list (the 
“potentially eligible” list) will be provided to the DHeCare Research Team to build an RSH 
Record in Epic. This list will be updated monthly to identify newly eligible individuals (e.g., new 
diagnosis of gestational diabetes or new patient transferring into the practice) during the 
recruitment months and fed back to the DHeCare team to update “potentially eligible” list.
Once built and each month during recruitment phase, the study’s research coordinator (not 
study investigators) will send the IRB-approved Research Invitation Letter to patients who are 
eligible, not already enrolled, and have not declined to be sent research notifications through the 
portal. The Research Letter will employ an opt-out approach, asking individuals who do not wish 
to be approached in clinic or remotely to respond via PG messaging, email, or phone within 2 
weeks of receipt of the letter. Those who have “read” the letter and not opted out after 2 weeks 
will be moved from the “potentially eligible” list to the “waiting to be approached” list in the study 
workflow.
During recruitment months, the study coordinator will keep a log of patient’s upcoming 
appointments for those on the “waiting to be approached” list. They will then attempt to 
approach individuals for enrollment when they present for an in-person encounters (preferred). 
Patients will ideally be approached between 32-36 weeks of gestation, when feasible; however, 
priority will be given to patients at the latest gestation. For those Spanish-speaking patients, a 
hospital-based interpreter will be used when approaching/consenting patients.
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The study staff will introduce the study and review the purpose of the study, the nature of the 
subject’s participation, the possible risks and discomforts associated with participation, the 
potential benefits of participation, a statement of the voluntary nature of participation, and a 
description of the mechanisms used to ensure confidentiality. 
All patients will receive study-related messages through Patient Gateway. In addition, patients 
will be asked if they would be willing to receive no more than 5 SMS messages to their personal 
cell phone during the first 4 months of the postpartum period. The study staff will review the 
specific concerns and risks about receiving unencrypted text messaging communications, as 
outlined by the MGB IRB. 
A waiver of documentation of informed consent is requested, as the study presents no more 
than minimal risk of harm to subjects and involves no procedures for which written consent is 
normally required outside of the research context. Verbal consent will be obtained for 1) overall 
study participation and 2) optional SMS message participation, separately. Verbal consent will 
be obtained from both in-person and phone recruitment efforts.
A Study Fact Sheet, which summarizes the study details, risks, and benefits, will be provided to 
all subjects who are approached, either in-person, by mail, or electronically. This Study Fact 
Sheet also includes information supplied by the MGB IRB specifically related to the concerns 
and risks of receiving unencrypted SMS/text messages.
For tracking verbal consent, the study staff will keep a detailed log in REDCap documenting:
1) name of study staff performing consent,
2) date of attempted approach,
3) the method of attempted approach (in-person or via phone),
4) use of Spanish interpreter (yes/no),
5) subject agreement to be approached (agree/disagree),
6) attestation to full review of the study procedures/risks/benefits with the subject, as would 
be done during the process of reviewing a written consent form, 
7) attestation to review of supplemental consent to receive unencrypted SMS messages 
with the subject,
8) subject overall study participation status (enrolled, declined, deferred – agrees to be 
recontacted, deferred – wishes not to be recontacted),
9) if enrolled, unencrypted SMS text messaging participation (consents, declines),
10) attestation to Study Fact Sheet provided,
11) method by which Study Fact Sheet was provided (in-person, mail, electronic),
12) date in which Study Fact Sheet was provided (in-person, mail, electronic).
6.
STUDY PROCEDURES
The RA will keep a detailed log of all patients in the practice, if they are eligible, if they have 
been approached, and if they consented.
For those that agree to be enrolled, patients will be asked to complete a baseline survey to 
obtain voluntarily reported information on their demographics, socioeconomic status, health care 
visit history, and primary care provider. Patients will also be asked to consent to being contacted 
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by the research team via Patient Gateway messaging. A $20 gift card will be given at the time of 
enrollment for those that complete the questionnaire and receive the information sheet.
Randomization will occur via a prespecified random allocation sequence within strata. Within 
each stratum, the PIs will generate a random sequence of treatment-control allocation prior the 
enrollment of subjects. Then, as patients within strata are enrolled, they will be assigned to the 
treatment arm associated with that enrollment number. 
Control Group
Approximately 2 weeks before a patient’s estimated due date (EDD) or as soon as enrolled if 
this date has passed, the patient will be sent information via the Patient Gateway on the 
importance of postpartum care and follow-up with their PCP.
Intervention Group
1.
Tailored Information:
Approximately 2-4 weeks prior to the EDD (or later for those who are enrolled beyond 38 
weeks gestation or postnatally), the patient will be sent an information via the Patient 
Gateway on the importance of postpartum care and follow-up with their PCP, which also 
includes the name and phone number of their primary care provider. 
2.
Scheduled PCP Appointment:
Between 2-3 weeks after their delivery, the RA will call the patient’s PCP office and 
make an appointment for them between 3-4 months after delivery based on the 
scheduling preferences obtained in the initial survey.
3.
Targeted Appointment Message with Salient Labeling:
After the PCP appointment has been made, the patient will be sent a Patient Gateway 
message saying that a PCP appointment has been reserved for them with the 
date/time/location information.
For those consenting to receive SMS messages, an unencrypted text message will also 
be sent simultaneously.
4.
Nudge Reminders: 
Patient Gateway messages will be sent at approximately 4-8 weeks (goal: 4 weeks) and 
1-4 week (goal: 1 week) prior to their PCP appointment, reminding a patient of their 
upcoming appointment. 
For those consenting to receive SMS messages, an unencrypted text message will also 
be sent simultaneously.
5.
Facilitated PCP Communication:
A study staff member will send the patient’s PCP an Epic Inbasket message that the 
patient 1) is recently postpartum, 2) has or developed health conditions that need long-
term management, and 3) has been scheduled (or attempted to be scheduled) for a 
follow-up visit.
All messages will be made available in English and Spanish.
The text for these Patient Gateway messages is included in the submission. At the end of each 
patient message, patients will be given the opportunity to stop receiving study-related messages 
by emailing or calling the study staff. “Opt out” requests will be logged and patients removed 
from future planned study-related contact. 
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The text for 3 SMS messages is included in the submission. SMS messages will be sent via 
Google Voice. We will follow standard recommendations from the MGB Research Information 
Security for using this system (included under Privacy and Confidentiality section).
The study team will review the patient’s EHR record for the primary and secondary outcome 
assessments. Patients will be asked to consent to have records reviewed up to 2 years after the 
date of their delivery to allow for long-term effects of the intervention on primary care use and 
health status. 
During the initial consent process, patients will be asked to agree to be potentially contacted at 
the end of the first 4-month follow-up period for a survey. Currently, this endline survey is not 
planned due to funding limitations; however, if funding becomes available, an IRB amendment 
will be submitted for review of the endline survey prior to being administered to any study 
subjects.
Deidentified data from this project may be shared outside of MGB with the study funders (J-
PAL/NBER/NIA) for data sharing and reproducibility requirements and secondary statistical 
analysis. All data will be stripped of patient identifiers, per IRB guidance. No data will be shared 
without a formal Data Use Agreement with MGB.
6.
Risks and Discomforts
There are minimal risks to participants. 
Patients will be reassured that nonparticipation will not affect clinical care. Patients will also be 
informed that the researchers with whom they will interact (e.g., during consent, face-to-face, 
during telephone interviews) are not health care providers. Participants will be consistently 
reminded that responses to any queries deemed sensitive or uncomfortable (e.g., country of 
origin/immigration status, income, previous history of abortion) should be considered optional, 
and they may decline to answer any question(s) and can refuse to continue the study at any 
point. Participants will be reassured that neither their opportunities for continued health care nor 
their relationships with health care providers will be jeopardized by study participation.
Health information collected as part of this study will be stored in REDCap. No identifiable data 
will be stored or downloaded on any personal or unauthorized computers. Study staff will 
access the data on institutionally purchased and managed computers that operate behind the 
health system’s security and firewall protections. Only the MGH study staff will have access to 
the identifiable data set. Once the study is completed, data will be deidentified such that it can 
be analyzed without risk of a breach of privacy or confidentiality. Any data that is shared outside 
of MGH will require a data use authorization.
Although we will make every effort to protect participant privacy and confidentiality, it is possible 
that participants' involvement in the study could become known to others. For those in the 
intervention group, we will be sending personalized messages via the patient portal; for those 
providing additional consent, we will be sending unencrypted SMS messages that will not 
contain any personal protected health information. There is the rare possibility that study 
participation or health information could become known to others despite the use of firewalls, 
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password protection, and other security measures. Standard procedures, as outlined by the 
MGB Research Information Security Office, will be followed to reduce this risk.
Individuals in the intervention group will be scheduled for an appointment with a primary care 
doctor. There is the possibility that this visit may result in a charge/cost for the patient. Under 
the Affordable Care Act, commercial health plans are required to cover an annual Preventive 
Health Exam at no cost to the patient (no co-payment, co-insurance or deductible). MassHealth 
also covers these visits without cost-sharing. However, if this visit turns or scheduled as into a 
“sick” or “disease management” visit, the patient may be billed for some or all aspects of the 
services provided, depending on their insurer. We will provide directions for patients on how to 
to contact their insurers or PCP’s office prior to the visit to inquire about potential cost-sharing 
and/or deductibles. Patients will also be advised that some clinics may penalize individuals for 
not showing to a scheduled appointment (“no show” fee) and be given opportunities to request 
the appointment be canceled or rescheduled with each appointment reminder.
7.
Benefits
Participants in the control group will receive information on the importance of postpartum care 
and transitioning to primary care after their delivery.
Participants in the intervention group will receive a bundle of interventions designed to increase 
attendance at primary care visits and facilitate the transition of care after their delivery.
The goal and potential benefits to the subjects in this trial is to increase patient engagement and 
connection with their primary care provider, receive recommended health screenings and 
directed counseling, and reduce unscheduled or urgent visits in the postpartum period.
8.
Statistical Analysis
Statistical Methods
Analyses will be performed according to the intention-to-treat principle.
Standard independent, two-sided, two-group comparison testing will be used to compare 
baseline characteristics between the two groups (chi squared tests, t tests, Wilcoxon rank sum 
tests, when appropriate).
The primary outcome will be attendance rates at PCP visit within 4 months after estimated date 
of delivery (captured at time of enrollment), which will be compared between the groups using 
chi squared tests. Relative risks and 95% confidence intervals will be reported. 
Secondary outcomes will include measures of long-term health and health care use after the 
postpartum period. 
Subgroup analyses will be performed by a variety of patient characteristics including gestational 
age at enrollment, prenatal risk factors, morbidity types, patient race-ethnicity, payer, and 
enrollment location. 
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P-value of less than 0.05 will be considered to indicate statistical significance.
Power Calculation
Most study calculations were estimated from the MGH 2020 delivery population. The rates of 
PCP follow-up were estimated from a randomly selected cohort of 50 patients who met the 
inclusion criteria. We plan to recruit patients into the study for a period of 4 months and expect 
1200 unique patients to be at the targeted gestational age during this period. Among these, we 
expect 86% to already have an assigned PCP in the network, leaving roughly 1,032 patients. 
Among these, we estimate that 49% have at least one of the targeted health conditions, leaving 
a target study population of 506 over the 4-month period. Based on previous studies conducted 
at MGH, we expect an 70% willingness to participate in the research, leaving an expected 
recruited population of 354 individuals. Based on our record extraction, we estimate that 15% of 
the targeted study population has a primary care visit within 4 months of delivery. Assuming an 
alpha of 0.05 and a baseline mean of 15%, with this expected sample size and power of 80%, 
our study has a minimum detectable effect size of roughly 13 percentage points (from 15% to 
28%). A previous study found that default scheduling into postpartum care appointments (with 
an OBGYN, not a PCP) increased postpartum care take-up by 24 percentage points; since our 
intervention incorporates defaults and other activating interventions, an MDE of 13 percentage 
points is reasonable.
9.
  Monitoring and Quality Assurance
This is a minimal risk study in which the intervention involves default scheduling of 
appointments and patient messaging. Adverse events are not expected, and there is no 
physiologic plausibility for this intervention to cause any NIH-defined serious adverse events 
(e.g., death, prolonged hospitalization, significant disability).
No interim analyses are planned.
Adverse events will be defined and classified in accordance with NIH guidelines:
Definition of Adverse Events (AE): Any untoward or unfavorable medical occurrence 
in a human subject, including any abnormal sign, symptom, or disease, temporally 
associated with the subject’s participation in the research, whether considered 
related to the subject’s participation in the research or not.
Definition of Serious Adverse Events (SAE): Any AE that (1) results in death, (2) is life-
threatening, (3) results in inpatient hospitalization or prolongation of existing 
hospitalization, (4) results in persistent or significant disability/incapacity, (5) results in a 
congenital anomaly/birth defect, and/or (6) may jeopardize the subject’s health and may 
require medical or surgical intervention to prevent one of the other five outcomes listed 
here.
In the unlikely event an AE or SAE occurs, it will be brought to the PI's attention, and the PI 
will classify the AE/SAE by severity, expectedness, and relatedness, as listed above. All events 
that are both serious and unexpected will be reported to Mass General Brigham's IRB, the NIA 
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PO, and to the NIA Roybal DSMB within 48 hours of the research team's knowledge of the 
SAE. The summary of all other SAEs will be reported to the NIA and to the DSMB quarterly 
unless otherwise specified by the DSMB. Any unanticipated problem, defined as an issue 
related to the research suggesting the research places participants or others at greater risk 
than expected, will be reported to the IRB, the NIA PO, and to the Roybal DSMB within 48 
hours of discovery. If the problem involves death then reporting will occur within 24 hours, and 
this report will include a plan to correct the problem and prevent its occurrence. Any breach of 
PHI will be reported to the PI, who will report to the IRB and NIA PO within 24 hours of 
discovery.
The Roybal DSMB oversight is provided by the Standing Roybal DSMB, which includes the 
members listed: Andrea B. Troxel, ScD (chair); Abby King, PhD; Jerry Gurwitz, MD; Hae-Ra 
Han, PhD, RN, FAAN; Hang Lee, PhD; Ezra Golberstein, PhD; David Kim,  MD PhD; 
Christopher Celano, MD.
DSMB members will have no direct involvement with the study or conflict of interest with the 
investigators or institutions conducting the study. Each member has signed a COI statement 
which includes current affiliations, if any, with pharmaceutical or biotechnology companies 
(e.g., stockholder, consultant), and any other relationship that could be perceived as a conflict 
of interest related to the study and/or associated with commercial interests pertinent to study 
objectives.
Data presented to the DSMB will be deidentified as to protect individual participants’ privacy and 
health information. Should the identity of a deidentified subject need to be  revealed, the DSMB 
request will be reviewed and ultimately at the discretion of the Mass General Brigham IRB.
10.   Privacy and Confidentiality
☒Study procedures will be conducted in a private setting
☒Only data and/or specimens necessary for the conduct of the study will be collected
☒Data collected (paper and/or electronic) will be maintained in a secure location with 
appropriate protections such as password protection, encryption, physical security 
measures (locked files/areas)
☐Specimens collected will be maintained in a secure location with appropriate protections 
(e.g. locked storage spaces, laboratory areas)
☒Data and specimens will only be shared with individuals who are members of the IRB-
approved research team or approved for sharing as described in this IRB protocol
☒ Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password 
protection, using chain-of-custody procedures, etc.)
☒   All electronic communication with participants will comply with Mass General Brigham 
secure communication policies
☒Identifiers will be coded or removed as soon as feasible and access to files linking 
identifiers with coded data or specimens will be limited to the minimal necessary 
members of the research team required to conduct the research
☒All staff are trained on and will follow the Mass General Brigham policies and procedures 
for maintaining appropriate confidentiality of research data and specimens
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☒The PI will ensure that all staff implement and follow any Research Information Service 
Office (RISO) requirements for this research
☒Additional privacy and/or confidentiality protections
The following procedures (as provided by MGB RISO) will be used for sending SMS messages 
via Google Voice:
•
Google Account:
o
A separate account should be created just for the purpose of the effort/study (in 
other words, personal Gmail accounts should not be used) 
o
For the Google Voice portal, make sure you are not using the same password as 
your MGB account and ensure the password is strong. (Minimum of 8 characters, 
alphanumeric, uppercase, lowercase, special character).
▪
Two-factor authentication must be enabled
o
Google account will not be shared
o
The Google account used for Google Voice should not be used for emailing or 
using any other Google Service (i.e., YouTube, Calendar, Contacts, etc.)
o
No credit cards should be added to the Google Account
o
The Google account must be deleted at the end of the study / project
•
Participants will be informed not to send personal or health related information via text
•
Siri will not be integrated with Google Voice
•
Text messages will not address participants by their first name
•
Text messages will be sent through the McLean email within the Google account that is 
created
•
Only phone numbers and a unique subject ID will be stored in Google Voice
o
Log records should be deleted manually after 30 days
•
No PHI or sensitive information will be communicated via text message
o
Content will not include anything where a healthcare condition or diagnosis can 
be inferred
•
Text message history should be deleted from Google Voice account when no longer 
needed (within 30 days)
•
Study staff will track opt-out requests and delete phone numbers from Google Voice as 
necessary
•
Study staff must not communicate with participants via a group text message
•
Access to the portal and overall research must be done from systems that meet MRB 
RISO compliance requirements; encryption, MobileIron (if Smartphone/Tablet), up to 
date malware protection, Crowdstrike.
o
https://rc.partners.org/security/secure-your-computer
•
Participants:
o
Participants will be texted only if they consent
o
Participants should be informed to delete text messages when no longer needed 
and hide text push notifications
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Mass General Brigham Institutional Review Board
Intervention/Interaction Detailed Protocol
Version 2022.09.01
Page 14 of 15
12.   References
1.
Boersma P. Prevalence of Multiple Chronic Conditions Among US Adults, 2018. Prev 
Chronic Dis. 2020;17. doi:10.5888/pcd17.200130
2.
Home page | United States Preventive Services Taskforce. Accessed December 15, 2021. 
https://www.uspreventiveservicestaskforce.org/uspstf/
3.
Blewett LA, Johnson PJ, Lee B, Scal PB. When a usual source of care and usual provider 
matter: adult prevention and screening services. J Gen Intern Med. 2008;23(9):1354-1360. 
doi:10.1007/s11606-008-0659-0
4.
O’Malley AS, Mandelblatt J, Gold K, Cagney KA, Kerner J. Continuity of care and the use 
of breast and cervical cancer screening services in a multiethnic community. Arch Intern 
Med. 1997;157(13):1462-1470.
5.
DeVoe JE, Saultz JW, Krois L, Tillotson CJ. A medical home versus temporary housing: 
the importance of a stable usual source of care. Pediatrics. 2009;124(5):1363-1371. 
doi:10.1542/peds.2008-3141
6.
Atlas SJ, Grant RW, Ferris TG, Chang Y, Barry MJ. Patient-physician connectedness and 
quality of primary care. Ann Intern Med. 2009;150(5):325-335. doi:10.7326/0003-4819-
150-5-200903030-00008
7.
Levine DM, Linder JA, Landon BE. Characteristics of Americans With Primary Care and 
Changes Over Time, 2002-2015. JAMA Internal Medicine. 2020;180(3):463-466. 
doi:10.1001/jamainternmed.2019.6282
8.
NVSS - Birth Data. Published June 14, 2021. Accessed September 1, 2021. 
https://www.cdc.gov/nchs/nvss/births.htm
9.
Prenatal care and tests | Office on Women’s Health. Accessed December 15, 2021. 
https://www.womenshealth.gov/pregnancy/youre-pregnant-now-what/prenatal-care-and-
tests
10.
Centers for Disease Control and Prevention (CDC). Adult Obesity Facts. Published August 
29, 2017. Accessed February 14, 2018. https://www.cdc.gov/obesity/data/adult.html
11.
Mental Illness. National Institute of Mental Health (NIMH). Accessed December 17, 2021. 
https://www.nimh.nih.gov/health/statistics/mental-illness
12.
Products - Data Briefs - Number 289 - October 2017. Published June 6, 2019. Accessed 
December 17, 2021. https://www.cdc.gov/nchs/products/databriefs/db289.htm
13.
National Diabetes Statistics Report 2020. Estimates of diabetes and its burden in the 
United States. Published online 2020:32.
14.
Sattar N, Greer IA. Pregnancy complications and maternal cardiovascular risk: 
opportunities for intervention and screening? BMJ. 2002;325(7356):157-160. 
doi:10.1136/bmj.325.7356.157
15.
Kim C, Tabaei BP, Burke R, et al. Missed Opportunities for Type 2 Diabetes Mellitus 
Screening Among Women With a History of Gestational Diabetes Mellitus. Am J Public 
Health. 2006;96(9):1643-1648. doi:10.2105/AJPH.2005.065722
16.
Media BKK. Publications & Guidelines | SMFM.org - The Society for Maternal-Fetal 
Medicine. Accessed October 18, 2021. https://www.smfm.org/publications/225-smfm-
statement-implementation-of-the-use-of-antenatal-corticosteroids-in-the-late-preterm-birth-
period-in-women-at-risk-for-preterm-delivery
17.
Yee LM, Simon MA, Grobman WA, Rajan PV. Pregnancy as a “golden opportunity” for 
patient activation and engagement. American Journal of Obstetrics & Gynecology. 
2021;224(1):116-118. doi:10.1016/j.ajog.2020.09.024
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Intervention/Interaction Detailed Protocol
Version 2022.09.01
Page 15 of 15
18.
Cohen JL, Daw JR. Postpartum Cliffs—Missed Opportunities to Promote Maternal Health 
in the United States. JAMA Health Forum. 2021;2(12):e214164. 
doi:10.1001/jamahealthforum.2021.4164
19.
Milkman KL, Patel MS, Gandhi L, et al. A megastudy of text-based nudges encouraging 
patients to get vaccinated at an upcoming doctor’s appointment. PNAS. 2021;118(20). 
doi:10.1073/pnas.2101165118
20.
Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl 
J Med. 2018;378(3):214-216. doi:10.1056/NEJMp1712984
21.
Thaler RH, Sunstein CR. Nudge: The Final Edition. Revised edition. Penguin Books; 2021.
22.
Henderson JT, Vesco KK, Senger CA, Thomas RG, Redmond N. Aspirin Use to Prevent 
Preeclampsia and Related Morbidity and Mortality: Updated Evidence Report and 
Systematic Review for the US Preventive Services Task Force. JAMA. 2021;326(12):1192. 
doi:10.1001/jama.2021.8551
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1
Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed 
Intervention to Improve Chronic Disease Management among Postpartum Women
Study PIs: Mark Clapp, MD MPH (MGH); Jessica Cohen, PhD (Harvard)
Site PI: Mark Clapp, MD MPH (MGH)
Baseline Survey
SECTION 1. Interview Information
101. RA ID number
102: Enrollment Facility ID number
103: Enrollment Facility name
104: Date of interview (MM/DD/YY)
105: Start time of interview (HH:MM)
        AM_____    PM_______ (Tick one)
106: End time of interview (HH:MM)
        AM_____    PM_______ (Tick one)
107: Time of interview in relation to patient’s prenatal/postnatal visit: 
1. In-person, during prenatal visit
2. In-person, during postpartum visit
3. Phone, before delivery
4. Phone, after delivery
SECTION 2. Eligibility Criteria
●
≥18 years old
●
Able to read/speak English or Spanish language
●
Received research letter > 2 weeks ago and 
●
Did not opt out of study
●
Has PCP listed in Epic
●
Not diagnosed with or being evaluated for fetal demise at time of enrollment
●
Have one or more of the following conditions listed in Epic Problem List: 
□
Chronic hypertension
□
Hypertensive disorders of pregnancy or risk factors for hypertensive disorders of 
pregnancy (e.g., history of preeclampsia, kidney disease, multiple gestation, 
autoimmune disease) 
□
Type 1 or 2 diabetes
□
Gestational diabetes
□
Obesity (body mass index ≥30 kg/m2) prior to pregnancy
□
Depression or anxiety disorder
SECTION 3. Consent
301: READ OUT LOUD TO PATIENT: I am a Research Assistant with the MGH Bridge 
Study. Our research team thinks you might be eligible to participate in a study to improve 
your health after your delivery. 
May we have your permission to tell you more about the study and ask you some questions?
1. Yes -> Review Study Information Sheet
2. No -> STOP, if respondent would not like to participate: End Survey.
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2
302: After Study Information Sheet reviewed, indicate whether consent was granted. 
1. Consented for overall study AND text messaging -> Skip to next section 
2. Consented for overall study but NOT text messaging -> Skip to next section
3. Did not consent 
303. RATIONALE FOR DECLINING CONSENT: Would you like to share why you do not 
want to participate in this study? If so, please tell us in your own words why you did not 
choose to participate.
1. Did not give a reason/no response
2. Rationale for declining: ____________________________________________________
SECTION 4. Pre-Fill & Verification of Respondent Information
Instructions: Pre-fill bolded items based on Patient Record before approaching the respondent. 
Please make sure to ask the patient to verify or update this information. 
401. Respondent First Name:
a. Confirmed? Yes ___ No ____
b. If No, specify correct information:
402. Respondent Last Name:
a. Confirmed? Yes ___ No ____  
b. If No, specify correct information:
403. Respondent Medical Record Number:
404. Respondent Home Address:
 None listed
a. Confirmed? Yes ___ No ____  
b. If No, specify correct information:
405. Respondent Mobile Number: 
 None listed
a. Confirmed? Yes ___ No ____  
b. If No, specify correct information:
406. Respondent Email Address: 
 None listed
a. Confirmed? Yes ___ No ____  
b. If No, specify correct information:
c. How often does the respondent check this email address? Rarely___ Monthly___ 
Weekly___ Daily___
407. Respondent Preferred Language: 
 None listed
a. Confirmed? Yes ___ No ____  
b. If No, specify correct information: 
408. Respondent Race (tick all that apply) 
i.
White ______
ii.
Black or African American ______
iii.
American Indian or Alaska Native ______ 
iv.
Asian ______ 
v.
Native Hawaiian or Other Pacific Islander ______ 
vi.
Other, please specify ______ 
vii.
Declined ______
viii.
Unavailable ______
a. Confirmed? Yes ___ No ____ 
b. If No, specify correct information:
c. No race provided
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3
409. Respondent Ethnicity: 
i.
Hispanic or Latino ______
ii.
Not Hispanic or Latino ______
iii.
Prefer not to say/Decline ______
iv.
Unavailable ______
a. Confirmed? Yes ___ No ____
b. If No, specify correct information:
c. No ethnicity provided
410.  Primary Care Provider Name:
a.  Confirmed? Yes ___ No ____ Patient does not know/unsure__________
b. If No, specify correct information: _______________
         Notes: 
411.  Primary Care Provider Location/Address:
a.  Confirmed? Yes ___ No ____ Patient does not know/unsure__________
b. If No, specify correct information: _______________
         Notes: 
412. Patient Gateway Access 
How easy or difficult is it for you to access the Patient Gateway portal?
o
Very easy to access
o
Somewhat easy to access
o
Neither easy nor difficult
o
Somewhat difficult to access
o
Very difficult to access
SECTION 5. Health and Health Care Use 
501.  Before your pregnancy, would you say that in general your PHYSICAL health was: 
1. Excellent
2. Very good
3. Good
4. Fair
5. Poor
88. Don’t know/not sure
99. Refused
502.  Before your pregnancy, would you say that in general your MENTAL health was: 
1. Excellent
2. Very good
3. Good
4. Fair
5. Poor
88. Don’t know/not sure
99. Refused
503. In the year before your pregnancy, if you had a medical issue or concern, how easy or 
difficult was it for you to see a health care provider in a clinic (not for an emergency)? 
1. Very easy
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4
2. Somewhat easy
3. Neither easy nor difficult
4. Somewhat difficult
5. Very difficult
6. I did not try to receive health care prior to pregnancy
88. Don’t know/not sure
99. Refused
504.  There are many reasons people delay or avoid getting medical care. Please select any 
of the following reasons that have caused you to not get the care you needed before your 
pregnancy. 
1. Didn’t know who to make an appointment with.
2. Couldn’t get an appointment 
3. Didn’t have transportation
4. The clinic or doctor’s office wasn’t open when you could get there
5. Once you got to the appointment, the wait was too long to see the doctor
6. You were worried about the financial cost of care
7. You couldn’t get time off of work to get care
8. You didn’t think that the medical care would help
9. You didn’t have childcare
10. Other, please specify ______ 
88. Don’t know/not sure
99. Refused
505. How do you usually get to medical appointments?  Tick all that apply.
1. Personal car
2. Taxi, Uber, or Lyft
3. Bus
4. Subway (“T”)
5. Train
6. Bicycle
7. On foot/walking
8. Other, please specify ______
99. Refused 
506. In the year before your pregnancy, did you receive care at any clinics (outpatient 
appointments) that were NOT a part of Mass General Hospital or the Mass General Brigham 
health system (including primary care visits, specialty visits, urgent care visits)?
1. Yes
2. No
3. I did not have any appointments in the year before my pregnancy
88. Don’t know/not sure
99. Refused
507-510: Have you ever been told by a doctor, nurse, or other health professional that you have 
or are:
Condition
Yes
No
Not sure
High blood pressure 
⚪
⚪
⚪
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5
or hypertension
Diabetes or high 
blood sugar
⚪
⚪
⚪
Anxiety or a 
depressive disorder 
(including 
depression, major 
depression, 
dysthymia, or minor 
depression) 
⚪
⚪
⚪
Overweight or obese
⚪
⚪
⚪
SECTION 6. Postpartum / Leave 
601. At any time during your pregnancy have you worked for pay in a job located in 
Massachusetts? 
1. Yes
2. No -> Skip to 603
88. Don’t know/not sure  -> Skip to 603
99. Refused  -> Skip to 603
602. Which best describes the type(s) of work you have done during your pregnancy? (Check 
all that apply. List name of employer)
1.
Federal or State Government._____ Name:_________________________
2.
Private or For-Profit Company: ._____ Name:_________________________
3.
Municipality (school dept, public works, housing authority, regional school district):._____ 
Name:_________________________
4.
Church or Religious Organization______ Name: ____________________
5.
Self-employed _____________ Name: _____________________
6.
I don’t know which of these categories my employer falls into
7.
Other: ______________
88. Don’t know/not sure
99. Refused
603. Do you plan to return to work or start a new job within the first year after your baby is 
born?
1. Yes, return to previous job
2, Yes, start a new job
3. No -> Skip to 606
88. Don’t know/not sure -> Skip to 606
99. Refused -> Skip to 606
604. How long after the baby is born do you intend to return to work/start working? 
________Weeks
________ Months
88. Don’t know/not sure
99. Refused
605. Do you intend to take any fully or partially paid leave from your job after your baby is 
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6
born? 
1. Yes
2. No
88. Don’t know/not sure
99. Refused
606. Have you ever seen, read, or heard anything about a Massachusetts state program 
called “Paid Family and Medical Leave“ (PFML)? This program provides eligible workers with 
paid time off for family or medical reasons.
1.Yes, I have seen, read, or heard about the Massachusetts PFML program.
2.No, I have not seen, read, or heard about the Massachusetts PFML program. -> Skip to 
next section
88. Don’t know/not sure -> Skip to next section
99.Refused -> Skip to next section
607. Do you intend to apply for the Massachusetts Paid Family Medical Leave program? 
1. Yes
2. No. State reason why: ____________________________
88. Don’t know/not sure
99. Refused
SECTION 7. Additional Demographic Information 
701. What is your marital status?
1. Married
2. Divorced
3. Widowed
4. Separated
5. Never married
6. Member of an unmarried couple
99. Refused
702. Do you anticipate not having or losing health insurance coverage in the year after your 
baby is born?
1. Yes
2. No
88. Don’t know/not sure
99. Refused
703. Do you expect your primary insurance provider to change after your pregnancy?
1. Yes 
2. No
88. Don’t know/not sure
99. Refused
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Version: V3.5 created on 10/07/22 - 10:56 AM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:38 PM 
 
 
Title: Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to 
Improve Chronic Disease Management among Postpartum Women (the Bridge Study)  
Sponsor Name: 
PI Name: Clapp, Mark A  
Protocol #: 2022P001723 
Type: Amendment (AME3)  
Date Received: October 06, 2022  
Signatures 
PI Name: Clapp, Mark A, MD, MPH 
Authenticated: October 06, 2022 
Amendment  
COVID-19 Amendment 
 
Is this amendment ONLY related to research impacted by COVID-19? 
 
Refer to MGB Policy on Conduct of Human Research Activities during COVID-19 Operations for description 
of Amendments which do require prior IRB review and approval.   
⚪  Yes   
◉  No  
 
 
Central IRB Performance Sites  
 
Is this a protocol where the Mass General Brigham IRB is serving as the single IRB (sIRB) for external 
sites/institutions? 
⚪  Yes   
◉  No  
 
 
Sponsor Amendment 
  
Is there a sponsor amendment number? 
⚪  Yes   
◉  No  
 
 
Change in Protocol Status 
 
Is this a cede protocol or project that was determined to be exempt, not human subjects research or not 
engaged in human subjects research?  
⚪  Yes   
◉  No  
 
 
Do you need to change the overall status of the protocol?  For example, Re-Open to Enrollment or 
indicate that Research Interventions/Assessments Continue after telling the IRB these have ceased. 
⚪  Yes  
 
◉  No  
 
 
  
Briefly describe the proposed changes: 
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Version: V3.5 created on 10/07/22 - 10:56 AM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:38 PM 
 
 
Updated baseline survey after initial piloting 
 
  
Provide rationale for the proposed changes: 
The baseline survey questions ordering and language have been updated after additional piloting with 
non-study subjects. The content and purpose of the baseline survey did not change. Non-patient-facing 
survey questions or tasks (e.g., instructions for survey staff) were removed. 
 
  
Will the proposed change(s) significantly alter the risk to benefit assessment the IRB relied upon to approve 
the protocol? 
⚪  Yes   
◉  No  
 
 
  
Will the proposed change(s) significantly affect the integrity of the protocol? 
⚪  Yes   
◉  No  
 
 
Informed Consent 
 
Do the changes require a revision to the consent form? 
⚪  Yes   
◉  No  
 
Attachments 
 
Name 
Mode 
Baseline_10-5-22_final (Instrument/Questionnaire)  
Electronic  
 
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Bridging the Gap from Postpartum to Primary Care
 
Study PIs: Mark Clapp, MD MPH (MGH); Jessica Cohen, PhD (Harvard)
Site PI: Mark Clapp, MD MPH (MGH)
 
SECTION 5. Patient Survey 
All information will be kept private and will not affect any services you are now getting.
701. What is your marital status? 
1. Married 
2. Divorced 
3. Widowed 
4. Separated 
5. Never married 
6. Member of an unmarried couple 
88. Don’t know/not sure
99. Prefer not to say 
702. What option best describes the highest degree or level of school you have completed? 
1. 8th grade or less 
2. 9th - 12th grade, no diploma 
3. High school graduate or GED completed 
4. Some college credit but no degree 
5. Associate degree (e.g., AA, AS) 
6. Bachelor’s degree (e.g., BA, AB, BS) 
7. Master’s degree (e.g., MA, MS, MEng, MEd, MSW, MBA) 
8. Doctorate (e.g., Ph.D., EdD) or Professional degree 
88. Don’t know/not sure
99. Prefer not to say 
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703. In the past 12 months, approximately how much money have you individually earned? 
1. $0
2. $1 – $6,000
3. $6,001 –  $10,000
3. $10,001 – $30,000 
4. $30,001 –  $50,000
5. $50,001 – $75,000
6. $75,001 –  $100,000
7. > $100,001
88. Don’t know/not sure
99. Prefer not to say
704. Do you anticipate losing or going without health insurance the year after your baby is 
born?
1. Yes
2. No
88. Don’t know/not sure
99. Prefer not to say
705. Do you expect your primary insurance provider to change after your pregnancy?
1. Yes 
2. No
88. Don’t know/not sure
99. Prefer not to say
501.  How easy or difficult is it for you to access the Patient Gateway portal?
1. Very easy
2. Somewhat easy 
3. Neither easy nor difficult
4. Somewhat difficult 
5. Very difficult 
88. Don’t know/not sure
99. Prefer not to answer
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502.  In the year BEFORE your pregnancy, how would describe your PHYSICAL health? 
1. Excellent
2. Very good
3. Good
4. Fair
5. Poor
88. Don’t know/not sure
99. Prefer not to answer
503.  In the year BEFORE your pregnancy, how would describe your MENTAL health? 
1. Excellent
2. Very good
3. Good
4. Fair
5. Poor
88. Don’t know/not sure
99. Prefer not to answer
504. Thinking about the year before your pregnancy, if you needed to see a health care 
provider for a non-emergency medical issue, how easy or difficult was it for you? 
1. Very easy
2. Somewhat easy
3. Neither easy nor difficult
4. Somewhat difficult
5. Very difficult88. Don’t know/not sure
99. Prefer not to answer
505.  There are many reasons people delay or avoid getting medical care. Did any of the 
following issues cause you to not get the medical care you needed before your pregnancy? 
Please read each option aloud. When finished, ask “Anything else?”. 
1. Unsure who to make an appointment with
2. Difficulty getting an appointment 
3. Difficulty arranging transportation
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4. The clinic or doctor’s office wasn’t open when you could get there
6. Concern about the financial cost of care
7. Difficulty obtaining time off work to get care
8. Unsure that the medical care would help
9. Difficulty getting childcare
10. Other, please specify ______ 
88. Don’t know/not sure
99. Prefer not to answer
505. Do you have a personal car?
1. Yes
2. No
88. Don’t know/not sure
99. Prefer not to answer
506. What was your mode of transportation to your appointment today? Select all that apply.
1. Personal car
2. Taxi, Uber, or Lyft
3. Car of a friend or family member
4. Bus
5. Subway/Train (“T”)
6. Bicycle
7. On foot/walking
8. Other, please specify ______
88. Don’t know/not sure
99. Prefer not to answer
505. Do you have a personal car?
1. Yes
2. No
88. Don’t know/not sure
99. Prefer not to answer
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507. In the year before your pregnancy, other than visits to the emergency room, did you see 
a doctor or nurse for any reason? This does not include visits to the emergency room but can 
include visits with your primary care doctor, specialty care doctor, urgent care, etc.
1. Yes, please specify where________
2. No
88. Don’t know/not sure
99. Prefer not to answer
 
508-511: Have you ever been told by a doctor, nurse, or other health professional that you have 
or are:
Condition
Yes
No
 Don’t Know/Not 
sure
Prefer not to 
Answer
High blood 
pressure or 
hypertension
⚪
⚪
⚪
⚪
Diabetes or 
high blood 
sugar
⚪
⚪
⚪
⚪
Anxiety or 
depression
⚪
⚪
⚪
⚪
Overweight 
or obese
⚪
⚪
⚪
⚪
 
SECTION 6. Employment and Postpartum Leave 
601. Are you currently working for pay? 
1. Yes  Skip to 603
2. No 
88. Don’t know/not sure
99. Prefer not to say 
 
602. Have you worked for pay at any time in the past 12 months?
1. Yes
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2. No  Skip to 604
88. Don’t know/not sure
99. Prefer not to say
603. Which best describes the type(s) of work you have done the past 12 months? (Check all 
that apply. List name of employer. For each employer listed, ask “Is this employer in 
Massachusetts?”). 
1.
Federal or State Government:_____ Name:_________________________
In Massachusetts? Yes: _____ No: _______
2.
Private or For-Profit Company: _____ Name:_________________________
In Massachusetts? Yes: _____ No: _______
3.
Municipality (school dept, public works, housing authority, regional school 
district):_____ Name:_________________________
In Massachusetts? Yes: _____ No: _______
4.
Church or Religious Organization______ Name: ____________________
In Massachusetts? Yes: _____ No: _______
5.
Self-employed _____________ Name: _____________________
In Massachusetts? Yes: _____ No: _______
6.
Independent Contractor _____________ Name: _____________________
In Massachusetts? Yes: _____ No: _______
7.
Other: ______________
In Massachusetts? Yes: _____ No: _______
88. Don’t know/not sure
99. Prefer not to say
604. Do you plan to return to work or start a new job within the first year after your baby is 
born?
1. Yes, return to previous job
2, Yes, start a new job
3. No -> Skip to 606
88. Don’t know/not sure 
99. Prefer not to say 
605. How long after the baby is born do you intend to return to work/start working? 
1. Less than one week
2. 1-4 weeks 
3. 5-8 weeks
4. 9-12 weeks
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5. 13-16 weeks
6. 17-20 weeks
7. 21-24 weeks
8. 25 weeks or more
88. Don’t know/not sure
99. Prefer not to say
606. Have you ever seen, read, or heard anything about a Massachusetts state program 
called “Paid Family and Medical Leave“ (PFML)? This program provides eligible workers with 
paid time off for family or medical reasons.
1.Yes, I have seen, read, or heard about the Massachusetts Paid Family and Medical Leave 
program.
2.No, I have not seen, read, or heard about the Massachusetts Paid Family and Medical 
Leave program. 
88. I don't know/am not sure about the Massachusetts Paid Family and Medical Leave 
program.
99. Prefer not to say 
607. Do you intend to apply for the Massachusetts Paid Family Medical Leave program? 
1. Yes
2. No. State reason why: ____________________________
88. Don’t know/not sure
99. Prefer not to say
 
 
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Version: V4.12 created on 10/14/22 - 03:50 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:38 PM 
 
 
Title: Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to 
Improve Chronic Disease Management among Postpartum Women (the Bridge Study)  
Sponsor Name: 
PI Name: Clapp, Mark A  
Protocol #: 2022P001723 
Type: Amendment (AME4)  
Date Received: October 12, 2022  
Signatures 
PI Name: Clapp, Mark A, MD, MPH 
Authenticated: October 12, 2022 
Amendment  
COVID-19 Amendment 
 
Is this amendment ONLY related to research impacted by COVID-19? 
 
Refer to MGB Policy on Conduct of Human Research Activities during COVID-19 Operations for description 
of Amendments which do require prior IRB review and approval.   
⚪  Yes   
◉  No  
 
 
Central IRB Performance Sites  
 
Is this a protocol where the Mass General Brigham IRB is serving as the single IRB (sIRB) for external 
sites/institutions? 
⚪  Yes   
◉  No  
 
 
Sponsor Amendment 
  
Is there a sponsor amendment number? 
⚪  Yes   
◉  No  
 
 
Change in Protocol Status 
 
Is this a cede protocol or project that was determined to be exempt, not human subjects research or not 
engaged in human subjects research?  
⚪  Yes   
◉  No  
 
 
Do you need to change the overall status of the protocol?  For example, Re-Open to Enrollment or 
indicate that Research Interventions/Assessments Continue after telling the IRB these have ceased. 
⚪  Yes  
 
⚪  No  
 
 
  
Briefly describe the proposed changes: 
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Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:38 PM 
 
 
1) Adding Spanish versions of the IRB-approved documents (study invitation letter, patient messages, 
study fact sheet) 
2) Added clinicaltrials.gov registration number 
 
  
Provide rationale for the proposed changes: 
To be able to send materials in individuals' preferred language 
 
  
Will the proposed change(s) significantly alter the risk to benefit assessment the IRB relied upon to approve 
the protocol? 
⚪  Yes   
◉  No  
 
 
  
Will the proposed change(s) significantly affect the integrity of the protocol? 
⚪  Yes   
◉  No  
 
 
Informed Consent 
 
Do the changes require a revision to the consent form? 
⚪  Yes   
◉  No  
 
Clinical Trials Registration  
 
Clinical Trials Registration and Results Reporting 
 
Investigator–initiated clinical trials must be registered on ClinicalTrials.gov to comply with federal FDA 
requirements in FDA 42 CFR 11 (Final Rule) and/or NIH Policy. Studies that falls under both FDA and NIH 
requirements only need to be registered once. The information posted on ClinicalTrials.gov (CT.gov) must be 
updated and verified at least every 12 months. 
 
The following information is used to identify studies that require clinical trials registration and results 
reporting, and to inform Principal Investigators (PI) of their responsibilities for registration and results 
reporting. 
 
IMPORTANT NOTE: Even if your investigator-initiated clinical trial does not meet the NIH or FDA 
clinical trials registration requirements, you are strongly advised to read and consider registering 
your trial to comply with the following additional requirements: 
• A non-federal sponsor may require registration as part of the award's terms and conditions 
• International Committee of Medical Journal Editors (ICMJE) for publication purposes  
• Center for Medicare & Medicaid for research billing claims for qualifying clinical trials (Mass 
General Brigham Clinical Trials Office will notify you if applicable)  
• Research funders now requiring registration and results reporting: May 18, 2017 Joint 
Statement 
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Version: V4.12 created on 10/14/22 - 03:50 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:38 PM 
 
 
 
For additional information, please see the Human Research Affairs Compliance and Education Office 
website for Clinical Trials Registration. 
  
 
  
Is this a Mass General Brigham investigator – initiated research study? 
 
⚪  No  
 
◉  Yes  
 
 
 
Is this research funded in whole or in part by NIH AND does this research meet the NIH's definition of 
clinical trial? 
 
NIH defines a clinical trial as any research study that meets all of the following criteria: 
• The study involves human participants;  
• The participants are prospectively assigned to an intervention;  
• The study is designed to evaluate the effect of the intervention on participants; AND 
• The effect being evaluated is a health-related, biomedical or behavioral outcome. 
 
⚪  No  
 
◉  Yes  
 
  
The responses to the questions above indicate this study meets the NIH Policy 
requirements for clinical trials registration and results reporting. Mass General Brigham 
Institutions have delegated responsibility for clinical trials registration, periodic updates, 
and results and adverse event reporting to the Principal Investigator ("Responsible Party"). 
This study must be registered on ClinicalTrials.gov prior to the first subject being enrolled 
into the study. 
 
Additional information is available from the NIH: 
• NIH's Definition of a Clinical Trial | grants.nih.gov 
• NIH Definition of Clinical Trial Case Studies | 
grants.nih.gov 
 
  
Responsible Party 
 
Enter Name of MGB investigator who will be the Responsible Party, for example Jane Doe, MD: 
  
Mark Clapp, MD 
 
Enter the full name of the MGB Institution of the MGB investigator, for example, Massachusetts 
General Hospital: 
  
Massachusetts General Hospital 
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Version: V4.12 created on 10/14/22 - 03:50 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:38 PM 
 
 
 
 
Documentation of ClinicalTrials.gov Registration 
 
Have you submitted registration information to ClinicalTrials.gov? 
 
⚪  No   
◉  Yes   
 
Indicate if a National Clinical Trial (NCT) registration number has been assigned: 
 
◉  Assigned  
 
⚪  Pending  
 
 
Enter the NCT number; for example NCT12345678: 
 
NCT05543265 
 
Results Reporting 
 
ClinicalTrials.gov results reporting is required within 12 months of the primary endpoint 
completion date defined as the date that the final subject was examined or received the 
intervention for the purposes of collection of primary outcome. Early consultation is 
strongly advised. Please contact the HRA Compliance and Education Office for assistance: 
  
Mass General Brigham Human Research Affairs Compliance and Education Office: 
QIProgramCTgovTeam@partners.org  
  
 
Additional information can be found at: 
HRA Compliance and Education Office website for Clinical Trials Registration 
www.ClinicalTrials.gov 
Attachments 
 
Name 
Mode 
Study Fact Sheet_090122_Spanish (Consent Fact/Information 
Sheet)  
Electronic  
Letter of Certification_P-2022-3783 (Other)  
Electronic  
Patient Gateway Research Invitation Letter_Spanish 
(Recruitment Letter)  
Electronic  
Patient Messages_final_Spanish (Document for review)  
Electronic  
 
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Documento informativo del estudio de investigación
Cerrando la brecha entre el posparto y la atención primaria (Bridge Study)
Investigadores 
principales
Mark Clapp, MD MPH (Massachusetts General Hospital)
Jessica Cohen, PhD (Harvard T. H. Chan School of Public Health)
Descripción general
Este es un estudio de investigación que se realiza entre mujeres embarazadas y que 
han dado a luz recientemente y que reciben atención en MGH.
Objetivo
Su proveedor de atención primaria (PCP) es responsable de manejar y supervisar su 
salud actual y a largo plazo. El objetivo de este proyecto es mejorar la atención 
primaria en el período de posparto. 
Patrocinador
Esta investigación está patrocinada por el Instituto Nacional del Envejecimiento 
(National Institute of Aging, NIA), el Centro Roybal del MIT para la Investigación 
Traslacional para Mejorar la Atención Médica de los Adultos Mayores (MIT Roybal 
Center for Translational Research to Improve Health Care for the Aging) y el Centro 
Roybal del NBER para el Cambio de Comportamiento en la Salud (NBER Roybal 
Center for Behavior Change in Health).
Contacto
Le hemos enviado un mensaje de Patient Gateway sobre este estudio porque usted 
es una persona que puede beneficiarse especialmente de recibir atención primaria de 
posparto. 
Detalles del estudio
Si acepta participar, le haremos algunas preguntas sobre su salud y su historial de 
visitas en el momento de la inscripción, todas ellas opcionales.
Entonces se la asignará aleatoriamente (50/50 de probabilidades) para participar en 
el grupo de “atención estándar” o en el grupo de “transición asistida”. 
Independientemente del grupo al que se la asigne, seguirá recibiendo atención 
prenatal y posparto estándar por parte de su proveedor de atención obstétrica. 
En el grupo de “atención estándar”, recibirá una cantidad limitada de mensajes 
(menos de 5) del equipo del estudio. 
En el grupo de “transición asistida”, recibirá una cantidad limitada de mensajes 
(menos de 5) del equipo del estudio entre el momento de la inscripción y hasta cuatro 
meses después del parto. El equipo del estudio también la ayudará a comunicarse 
con su proveedor de atención primaria después del parto. Específicamente, podemos 
llamar al consultorio de su proveedor de atención primaria de su parte para ayudar a 
programar una cita. Usted siempre tiene la opción de cambiar o cancelar esta cita. 
También le enviaremos un mensaje a su PCP para informarle que ha dado a luz 
recientemente y que se está programando una cita de seguimiento.
Los mensajes que le enviemos a través de Patient Gateway también figurarán en su 
historia clínica para que los demás miembros de su equipo de atención los vean.
Para ambos grupos, revisaremos su historia clínica después de su parto para ver si 
recibió y cuándo recibió algún tipo de atención dentro del sistema de salud de Mass 
General Brigham e información sobre su estado de salud hasta dos años después de 
su parto.
También es posible que nos comuniquemos con usted una vez entre cuatro y doce 
meses después de su parto para hacerle preguntas sobre su experiencia de atención 
posparto. Puede negarse a participar o a responder a alguna o a todas las preguntas.
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Bridge Study: Documento informativo
2
Puede optar por no recibir mensajes o negarse a participar en cualquier encuesta, y/o 
retirarse del estudio en cualquier momento sin recibir ninguna sanción.
En este estudio, participarán aproximadamente 350 personas.
Privacidad/
Confidencialidad
La Ley de Portabilidad y Responsabilidad de Seguros Médicos (Health Insurance 
Portability and Accountability Act, HIPAA) nos exige que protejamos la privacidad de 
la información de salud obtenida para la investigación. En las páginas 3 y 4 de este 
documento informativo se incluyen más detalles relacionados con la privacidad de su 
información de salud.
Se mantendrá la confidencialidad y la seguridad de toda la información recopilada 
como parte de este estudio. Como en todos los estudios, existe un riesgo muy bajo 
de que otras personas puedan conocer su participación o su información de salud. El 
Comité de Investigación en Seres Humanos de Mass General Brigham ha aprobado 
los procedimientos del estudio y la protección de su información. Una vez finalizado 
el estudio, se eliminará toda la información que pudiera identificarla, como por 
ejemplo su nombre o número de historia clínica. 
Información del estudio Recopilaremos información sobre sus antecedentes de salud y embarazo, incluso 
sobre las visitas que realice a los proveedores del sistema de salud de Mass General 
Brigham. Los datos recopilados como parte de este estudio no afectarán de manera 
directa su atención clínica. Usted y su equipo de atención podrán ver todos los 
mensajes enviados por el equipo del estudio en la historia clínica electrónica. La 
información sobre usted sin identificación se puede usar o compartir con otros 
investigadores sin su consentimiento informado adicional.
Riesgos
Los riesgos de participar son mínimos. 
Aunque haremos todo lo posible para proteger la privacidad y confidencialidad de los 
participantes, es posible que otras personas conozcan su participación en el estudio. 
Para comunicarnos con usted, le enviaremos mensajes a través de Patient Gateway, 
que es un método que cumple con la HIPAA. Usted tiene la opción de recibir también 
mensajes de texto SMS que no incluirán ninguna información de salud personal o 
que permita identificarla. Existe una posibilidad poco frecuente de que otras personas 
conozcan su participación en el estudio o la información sobre su salud, a pesar del 
uso de cortafuegos, protección con contraseña y otras medidas de seguridad.
Costos
No está obligada a pagar para participar en este estudio de investigación. 
Puede haber un costo para que usted asista a una visita con un PCP, como por 
ejemplo el pago de un copago o un deducible. Sus costos se basan en la cobertura 
de su seguro individual. Si no tiene seguro, es posible que se le facture de manera 
directa la totalidad del costo de esta visita. Le proporcionaremos información sobre 
cómo comprobar los posibles costos con su aseguradora o con el consultorio de su 
PCP antes de su visita. 
Algunas clínicas pueden sancionar a las personas que no se presenten a una cita 
programada (tarifa por “no presentarse”). Se le dará la oportunidad de optar por no 
ser citada y se le recordará varias veces que debe cancelar o reprogramar la cita si 
no puede asistir.
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Bridge Study: Documento informativo
3
Participación
Aquellas personas que participen recibirán una tarjeta de regalo de $20 después de 
la inscripción. 
La participación es voluntaria, y puede retirarse o suspender el estudio en cualquier 
momento. 
Su decisión de no participar no afectará la atención médica que reciba en Mass 
General Brigham ahora o en el futuro ni ningún beneficio que reciba ahora o que 
tenga derecho a recibir.
Contacto del estudio
Mark Clapp, MD MPH, es la persona de MGH a cargo de este estudio de 
investigación. Puede llamarle al 617-724-4531 (de lunes a viernes de 9 a. m. a 
5 p. m.). También puede llamar a la coordinadora del estudio (Fowsia Warsame) al 
617-643-5483 (de lunes a viernes, de 9 a. m. a 5 p. m.), si tiene preguntas sobre este 
estudio de investigación. También puede enviar un correo electrónico a 
bridgestudy@mgh.harvard.edu.
Si desea hablar con alguien que no participe en esta investigación acerca de sus 
derechos como sujeto de una investigación o sobre cualquier preocupación o queja 
que pueda tener respecto a la investigación, comuníquese con el IRB de Mass 
General Brigham IRB al (857) 282-1900.
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Opción de recibir mensajes de texto (SMS)
Los mensajes de texto por teléfonos móviles/celulares son una forma común de comunicación. A nuestro 
equipo del estudio le gustaría enviarle no más de 3 mensajes de texto (SMS) como parte del estudio, aunque 
esto es opcional y no se requiere para participar en Bridge Study. El envío de mensajes de texto por 
teléfonos móviles/celulares implica riesgos de seguridad debido a que tales mensajes de texto no están 
cifrados.  Esto significa que la información que usted envíe o reciba por mensajes de texto podría ser 
interceptada o vista por un destinatario no deseado, o bien por su proveedor o compañía de servicios de 
telefonía móvil/celular. 
A continuación se presentan algunos puntos importantes sobre el envío de mensajes de texto como parte de 
un estudio de investigación:
•
Recibir mensajes de texto en este estudio es opcional y no es obligatorio para participar.
•
Los mensajes de texto no están cifrados y, por lo tanto, presentan riesgos de seguridad. Ni este estudio 
de investigación ni Mass General Brigham son responsables de la interceptación de los mensajes 
enviados mediante comunicaciones por mensajes de texto no cifrados.  
•
Usted será responsable de todas las tarifas que se le cobren según el plan de servicios de mensajes de 
texto de su compañía de servicios de telefonía.  Ni este estudio de investigación ni Mass General 
Brigham son responsables de los aumentos de los cargos, del uso de los datos en función de los límites 
del plan ni de los cambios en las tarifas de datos de los mensajes de texto de la investigación.
•
No se debe enviar mensajes de texto en caso de emergencia.  Si tiene una emergencia médica, llame al 
911 o vaya al departamento de emergencias del hospital más cercano.  
•
En cualquier momento, puede decidir no comunicarse con el personal asociado a este estudio de 
investigación mediante el envío o la recepción de mensajes de texto. Puede hacerlo personalmente o 
enviar un mensaje de texto que diga “Stop Research Text” (Detener mensajes de texto de la 
investigación). 
•
Su aceptación se aplica a este estudio de investigación solamente.  La aceptación de otros mensajes de 
texto de Mass General Brigham, como por ejemplo los recordatorios de citas, corresponde a un proceso 
independiente.  La opción de no recibir otros mensajes de texto de Mass General Brigham también 
representa un proceso independiente.
•
Es su responsabilidad actualizar su número de teléfono móvil/celular en este estudio de investigación si 
se produce algún cambio.
Información sobre la privacidad de su información de salud
Las leyes federales exigen que Mass General Brigham y sus hospitales afiliados protejan la privacidad de la 
información de salud y la información relacionada que la identifica.  Nos referimos a esa información como 
“información de salud protegida”. Se usará y compartirá la información de salud protegida sobre usted con 
otras personas como se explica a continuación.  Usted acepta que se recopile, utilice y comparta la 
información de salud protegida sobre usted tal y como se describe en esta hoja informativa. Si tiene 
preguntas, puede preguntarle al investigador que está revisando este documento informativo con usted o 
puede comunicarse con el investigador indicado arriba. 
En este estudio, podemos recopilar información de salud protegida sobre usted proveniente de:
•
Historia clínica pasada, presente y futura
•
Procedimientos de investigación, que incluyen, entre otros, visitas para la investigación, pruebas, 
entrevistas y cuestionarios
¿Por qué se utilizará o compartirá con terceros la información de salud protegida sobre usted?
Las principales razones incluyen:
•
llevar a cabo y supervisar la investigación descrita en este documento informativo para este estudio;
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5
•
garantizar que la investigación cumpla con los requisitos legales, institucionales y de acreditación; y 
•
llevar a cabo actividades de salud pública (incluida la notificación de acontecimientos adversos o 
situaciones en las que usted u otras personas puedan correr riesgo de sufrir daños).
¿Quiénes pueden ver, usar y compartir la información de salud protegida sobre usted y por qué es necesario 
que lo hagan?
•
Los investigadores y el personal de Mass General Brigham que participan en este estudio
•
El o los patrocinadores del estudio y las personas o los grupos que ellos contraten para ayudar a 
realizar o auditar la investigación
•
Otros investigadores e instituciones médicas que participen en este estudio
•
La junta de ética de Mass General Brigham 
•
Un grupo que supervise los datos (la información del estudio) y la seguridad de este estudio
•
El personal de Mass General Brigham que no se dedica a la investigación y que necesita información 
que permite la identificación para realizar su trabajo, por ejemplo para el tratamiento, el pago 
(facturación) o las operaciones del hospital (como la evaluación de la calidad de la atención o la 
investigación)
•
Personas o grupos que contratemos para hacer ciertos trabajos para nosotros, tales como empresas 
de almacenamiento de datos, agentes autorizados, aseguradoras y abogados
•
Agencias federales como el Departamento de Salud y Servicios Sociales (Department of Health and 
Human Services, DHHS) y organismos dentro de DHHS como la Administración de Alimentos y 
Medicamentos (Food and Drug Administration, FDA), los Institutos Nacionales de Salud (National 
Institutes of Health, NIH) y la Oficina para la Protección de Seres Humanos que Participan en 
Investigaciones (Office for Human Research Protections), entidades gubernamentales extranjeras que 
supervisan, evalúan y auditan la investigación, lo que puede incluir la inspección de los registros.
•
Autoridades de salud y seguridad públicas, si obtenemos información que podría significar un daño 
para usted o para otras personas (como realizar los informes obligatorios sobre enfermedades 
contagiosas o sobre abuso infantil o de adultos mayores).
Es posible que algunas personas o grupos que obtengan la información de salud protegida sobre usted no 
tengan que cumplir con las mismas normas de privacidad que cumplimos nosotros y podrían usar o compartir 
la información de salud protegida sobre usted sin su permiso de maneras que no se detallan en este 
formulario.  Compartimos la información de salud protegida sobre usted solamente cuando debemos hacerlo, 
y solicitamos que quienes la reciban tomen medidas para proteger su privacidad.  Sin embargo, una vez que 
la información de salud protegida sobre usted se comparta fuera de Mass General Brigham, no podremos 
controlar todas las maneras en las que otras personas o entidades la usen o la compartan, y no podemos 
prometer que se mantendrá en privado.
Los resultados de este estudio de investigación pueden publicarse en un libro o una revista médica, o usarse 
para enseñar a otros.  Sin embargo, no se usará su nombre ni otra información que permita identificarla con 
este fin sin su permiso específico.
¿Durante cuánto tiempo se utilizará o compartirá con terceros la información de salud protegida sobre usted?
Debido a que la investigación es un proceso continuo, no podemos darle una fecha exacta en la que 
destruiremos o dejaremos de usar o de compartir la información de salud protegida sobre usted.  El permiso 
que usted nos ha dado para usar y compartir la información de salud protegida sobre usted no vence.
Sus derechos de privacidad
Tiene derecho a no aceptar que utilicemos y compartamos la información de salud protegida sobre usted para 
investigaciones. Sin embargo, si no está de acuerdo, no podrá participar en este estudio de investigación. Sin 
embargo, negarse a aceptar no afectará su atención presente o futura y no le ocasionará ninguna sanción o 
pérdida de beneficios a los que de otro modo tiene derecho.
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6
Tiene derecho a retirar su permiso para que se siga utilizando o compartiendo la información de salud 
protegida sobre usted para este estudio de investigación. Si desea retirar su permiso, debe comunicárselo por 
escrito a la persona a cargo de este estudio de investigación según el nombre y la dirección indicados 
arriba.  Una vez retirado el permiso, no podrá seguir participando en el estudio.
Si retira su permiso, en la medida en que hayamos conservado cualquier información de salud protegida que 
pueda relacionarse con usted, dejaremos de utilizar y compartir la información de salud protegida para la 
investigación.  Sin embargo, no podremos recuperar la información que ya se haya usado o compartido con 
otras personas o entidades, y tal información se puede seguir utilizando para determinados fines, como por 
ejemplo cumplir con la ley o mantener la confiabilidad del estudio.
Usted tiene derecho a ver y obtener una copia de la información de salud protegida sobre usted que se usa o 
se comparte para el tratamiento o para el pago.  Para pedir esta información, comuníquese con la persona a 
cargo de este estudio de investigación identificada arriba.  Podrá obtener dicha información únicamente 
después de que la investigación haya finalizado.
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460 W Irving Park Rd 
Suite C 
Bensenville, IL 60106  
800 959 2874 
www.burgtranslations.com 
 
 
 
 
September 27, 2022 
 
 
I, the undersigned, having been duly sworn, depose and say that the following documents: 
 
• Patient Gateway Research Invitation Letter_Spanish.docx 
• Patient Messages_final_Spanish.docx 
• Study Fact Sheet_090122_Spanish.docx 
 
have been translated from English into Spanish by BURG Translations, Inc. and, to the best of 
my knowledge and belief, they are true and accurate renderings of the original documents.  
 
 
 
 
 
 
STATE OF ILLINOIS 
COUNTY OF COOK 
Chicago, Illinois, September 27, 2022 
 
Signed and attested before me on this 27th day of 
September, 2022 by Michelle Delana 
 
 
 
BURG TRANSLATIONS, INC. 
460 W Irving Park Rd,  
Suite C 
Bensenville, Illinois 60106 
(800) 959-2874 
 
 
 
Michelle Delana 
Project Manager 
 
 
 
 
 
 
 
 
 
 
 
 
 
   Angelo Passalacqua, Notary Public 
 
    Cook County, State of Illinois 
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[Fecha]
[Nombre del paciente
Dirección
Ciudad, Estado, Código postal]
Estimada [Sra. paciente]:
Le estamos escribiendo para informarle sobre un estudio de investigación que podría 
interesarle. Mass General Brigham se compromete a proporcionar una excelente atención para 
usted y nuestra comunidad. Una parte importante de nuestra misión es aprender nuevas formas 
de cuidar a nuestros pacientes realizando investigaciones. Nuestros pacientes tienen un papel 
importante en la investigación al participar en estudios para ayudar a descubrir mejores 
tratamientos o mejores formas de prevenir los problemas de salud.
Mass General Brigham es un sistema de salud que incluye hospitales, centros de salud 
comunitarios y grupos de médicos.  Trabajamos juntos para proporcionar la mejor atención 
posible a nuestra comunidad. Los pacientes de Mass General Brigham tienen acceso a una 
atención de alta calidad en todo nuestro sistema. Como sistema de atención médica, también 
trabajamos juntos para proporcionar acceso a los estudios de investigación a todos nuestros 
pacientes. 
La información que se incluye a continuación es sobre el estudio que podría interesarle.  Para 
decidir si es una buena opción para usted, puede obtener más información o hablar con el 
equipo de investigación.
Nombre del estudio:
Cerrando la brecha entre el posparto y la atención primaria
Qué estamos estudiando:
Métodos para mejorar la atención primaria entre las mujeres 
puérperas
Quiénes podrían calificar:
Embarazadas y puérperas que podrían beneficiarse 
especialmente de la atención primaria en el período de 
posparto. 
Tal vez esto se aplica a usted o tal vez no.  
Qué se le solicita 
que haga en el estudio:
Aceptar recibir mensajes esporádicos del equipo del estudio a 
través de Patient Gateway desde el momento de la inscripción 
hasta 4 meses de posparto
Para obtener más información:
Para obtener más información 
sobre ESTE estudio:
Comuníquese con la coordinadora de investigación del 
estudio, Fowsia Warsame, al 617-643-5483. Después de 
Page 12 of 20
Compiled Summary of Protocol Amendments
Page 130 of 278

obtener más información, puede decidir participar o no. Es 
posible que también descubra que no califica para el 
estudio. Independientemente de si participa o no en el 
estudio, la atención médica que recibe aquí en Mass 
General Brigham no cambiará.
Si definitivamente NO tiene interés en ESTE estudio, y no quiere saber nada más al respecto, 
comuníquese con la coordinadora del estudio, Fowsia 
Warsame, al 617-643-5483. Si no recibimos su respuesta en 
dos semanas, es posible que nos dirijamos a usted o le 
llamemos para ver si desea obtener más información sobre 
el estudio.
Para obtener más información sobre 
la investigación en general:
Llame a la Oficina
del Orientador de Investigación: 
857-282-5370 
Visite el sitio web de Rally:rally.partners.org/research
Si no desea recibir notificaciones sobre ninguno de los estudios de Mass General Brigham:
•
Inicie sesión en su cuenta de Patient Gateway.
Busque “Resources” (Recursos) en el menú y seleccione “Research 
Opportunities” (Oportunidades de investigaciones)
Lea la información del resumen y seleccione el botón correcto.
O
•
Comuníquese con la Oficina del Orientador de Investigaciones:  
Llame al 857-282-5370
Desde ya le agradecemos por considerar este estudio de investigación.
Atentamente,
Mark Clapp, MD MPH
Medicina materno-fetal
Massachusetts General Hospital
617-724-4531
Page 13 of 20
Compiled Summary of Protocol Amendments
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Cerrando la brecha entre el posparto y la atención primaria: Una intervención basada en la ciencia del comportamiento 
para mejorar el manejo de enfermedades crónicas entre las mujeres puérperas
Investigadores principales del estudio: Mark Clapp, MD MPH (MGH); Jessica Cohen, PhD (Harvard)
Investigador principal de la institución: Mark Clapp, MD MPH (MGH)
* EDD, fecha estimada de parto; PG, portal de mensajería segura de Patient Gateway.
Mensaje de texto para el paciente
Grupo
Moment
o  
Tipo
Contenido del mensaje si se programó una 
cita con un PCP
Contenido del mensaje si no se programó una 
cita con un PCP
Control
Entre 2 y 
4 seman
as antes 
de la 
EDD 
PG
N/C
Estimada XXX:
Disponer de un proveedor de atención primaria 
(primary care provider, PCP) y visitarle al menos 
una vez al año es importante para su salud y 
bienestar actuales y futuros.
Estos proveedores tienen funciones diferentes a 
las de su obstetra (médico del embarazo) o 
partera. Se recomienda que vea a su PCP en los 
meses posteriores al parto, ya que dejará de ver a 
su proveedor de atención del embarazo.
Si tiene preguntas sobre cómo encontrar o ver a 
su PCP después del parto, pregunte a su 
proveedor de atención del embarazo o llame a su 
PCP.
--
El equipo de Bridge Study ha enviado este 
mensaje. Si desea dejar de recibir mensajes de 
este equipo, llame al coordinador del estudio al 
617-643-5483 o envíe un correo electrónico al 
equipo del estudio a 
bridgestudy@mgh.harvard.edu. No responda de 
manera directa a este mensaje con preguntas 
sobre su salud o para programar el seguimiento.
Page 14 of 20
Compiled Summary of Protocol Amendments
Page 132 of 278

Cerrando la brecha entre el posparto y la atención primaria
Mensaje de texto para el paciente
2
Grupo
Moment
o  
Tipo
Contenido del mensaje si se programó una 
cita con un PCP
Contenido del mensaje si no se programó una 
cita con un PCP
Intervención
Entre 2 y 
4 seman
as antes 
de la 
EDD 
PG
N/C
Estimada XXX:
Disponer de un proveedor de atención primaria 
(primary care provider, PCP) y visitarle al menos 
una vez al año es importante para su salud y 
bienestar actuales y futuros.
Estos proveedores tienen funciones diferentes a 
las de su obstetra (médico del embarazo) o 
partera. Se recomienda que vea a su PCP en los 
meses posteriores al parto, ya que dejará de ver a 
su proveedor de atención del embarazo.
Para ayudarla en la transición a la atención 
primaria después del parto, programaremos su cita 
de “Transición del embarazo a la atención 
primaria” con su PCP en los próximos meses. Le 
enviaremos un mensaje una vez que se haya 
programado la cita. Si tiene preferencias en cuanto 
a la fecha y el horario para esta cita O no desea 
que le programemos esta cita, llame al 
coordinador del estudio (617-643-5483) o envíe un 
correo electrónico al equipo del estudio a 
bridgestudy@mgh.harvard.edu en las 2 semanas 
siguientes.
Si tiene preguntas sobre su atención o sobre cómo 
consultar a su PCP después del parto, pregúntele 
a su proveedor de atención del embarazo o llame 
a su PCP.
--
El equipo de Bridge Study ha enviado este 
mensaje. Si desea dejar de recibir mensajes de 
Page 15 of 20
Compiled Summary of Protocol Amendments
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Cerrando la brecha entre el posparto y la atención primaria
Mensaje de texto para el paciente
3
Grupo
Moment
o  
Tipo
Contenido del mensaje si se programó una 
cita con un PCP
Contenido del mensaje si no se programó una 
cita con un PCP
este equipo, llame al coordinador del estudio al 
617-643-5483 o envíe un correo electrónico al 
equipo del estudio a 
bridgestudy@mgh.harvard.edu. No responda de 
manera directa a este mensaje con preguntas 
específicas sobre su salud o plan de seguimiento.
Intervención
Entre 2 y 
4 seman
as antes 
de la 
EDD
SMS
Ha recibido un mensaje importante a través de 
Patient Gateway. Consulte el portal para obtener 
más información. -Bridge Study de MGH
[no responda]
cantidad de caracteres: 141
Ha recibido un mensaje importante a través de 
Patient Gateway. Consulte el portal para obtener 
más información. -Bridge Study de MGH
cantidad de caracteres: 147
Intervención
2 seman
as 
después 
de la 
EDD
PG
Estimada XXX: 
Se ha reservado especialmente para usted su cita 
de “Transición del embarazo a la atención 
primaria”:
XXX INFORMACIÓN DE LA CITA ##
Esta cita se programó para ayudarla en la 
transición de su proveedor de atención del 
embarazo a su proveedor de atención primaria 
(PCP) después de su parto. Su PCP se asegurará 
de que tenga un plan para mantenerse saludable 
y puede responder a cualquier pregunta o 
inquietud que tenga sobre su salud. 
Las citas pueden tener un costo dependiendo de 
su plan de seguro (como por ejemplo, un copago 
o un deducible). Si tiene preguntas sobre la 
cobertura de su seguro o los posibles costos 
asociados con una visita, llame al consultorio de 
su PCP, al proveedor de seguros o a la Oficina de 
Facturación de Pacientes de Mass General 
Brigham al 617-726-3884.  
Si no puede acudir a esta cita o desea cancelarla 
o reprogramarla, llame al consultorio de su PCP al 
Estimada XXX: 
No hemos podido reservar su cita de "Transición 
del embarazo a la atención primaria" con XXX 
en la consulta de XXX. Llame al consultorio de su 
PCP para programarla. El número de teléfono del 
consultorio es: XXX
Estamos intentando programar esta cita para 
usted con el fin de ayudarla en la transición de su 
proveedor de atención del embarazo a su 
proveedor de atención primaria (PCP) después de 
su parto. Su PCP se asegurará de que tenga un 
plan para mantenerse saludable y puede 
responder a cualquier pregunta o inquietud que 
tenga sobre su salud. 
Las citas pueden tener un costo dependiendo de 
su seguro (como por ejemplo, un copago o 
deducible). Si tiene preguntas sobre la cobertura 
de su seguro o los posibles costos asociados con 
una visita, llame al consultorio de su PCP, al 
proveedor de seguros o a la Oficina de 
Facturación de Pacientes de Mass General 
Brigham al 617-726-3884.  
Page 16 of 20
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Cerrando la brecha entre el posparto y la atención primaria
Mensaje de texto para el paciente
4
Grupo
Moment
o  
Tipo
Contenido del mensaje si se programó una 
cita con un PCP
Contenido del mensaje si no se programó una 
cita con un PCP
XXX o comuníquese con el equipo de Bridge 
Study (617-643-5483). Tenga en cuenta que 
algunas clínicas pueden cobrar una tarifa por no 
presentarse a una visita programada. 
--
El equipo de Bridge Study ha enviado este 
mensaje. Si desea dejar de recibir mensajes de 
este equipo, llame al coordinador del estudio al 
617-643-5483 o envíe un correo electrónico al 
equipo del estudio a 
bridgestudy@mgh.harvard.edu. No responda de 
manera directa a este mensaje con preguntas 
específicas sobre su salud o plan de seguimiento.
--
El equipo de Bridge Study ha enviado este 
mensaje. Si desea dejar de recibir mensajes de 
este equipo, llame al coordinador del estudio al 
617-643-5483 o envíe un correo electrónico al 
equipo del estudio a 
bridgestudy@mgh.harvard.edu. No responda de 
manera directa a este mensaje con preguntas 
específicas sobre su salud o plan de seguimiento.
Intervención
2 seman
as 
después 
de la 
EDD
SMS
¡Se ha reservado para usted una cita con el PCP! 
Consulte Patient Gateway para obtener más 
detalles. -Bridge Study de MGH
[no responda]
cantidad de caracteres: 115
¡Oh, no! Estamos teniendo problemas para 
programar su cita con el PCP. Consulte Patient 
Gateway para obtener más detalles. -Bridge Study 
de MGH
[no responda]
cantidad de caracteres: 158
Intervención
4 seman
as antes 
de la cita 
con el 
PCP
PG
Estimada XXX:
Su proveedor de atención primaria (PCP) espera 
atenderla después de su embarazo. 
Se ha reservado para usted su cita de 
“Transición del embarazo a la atención 
primaria”:
XXX INFORMACIÓN DE LA CITA ##
Esta cita se programó para ayudarla en la 
transición de su proveedor de atención en el 
embarazo a su proveedor de atención primaria 
(PCP) después de su parto. Su PCP se asegurará 
de que tenga un plan para mantenerse saludable 
y puede responder a cualquier pregunta o 
inquietud que tenga sobre su salud.
Estimada XXX:
No vemos que haya programado su cita de 
“Transición del embarazo a la atención 
primaria”. Llame al consultorio de su proveedor de 
atención primaria (PCP) para programarla.  El 
número de teléfono del consultorio es: XXX
Estamos intentando programar esta cita para 
usted con el fin de ayudar a la transición de su 
proveedor de atención del embarazo a su PCP 
después de su parto. Su PCP se asegurará de que 
tenga un plan para mantenerse saludable y puede 
responder a cualquier pregunta o inquietud que 
tenga sobre su salud. 
Page 17 of 20
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Cerrando la brecha entre el posparto y la atención primaria
Mensaje de texto para el paciente
5
Grupo
Moment
o  
Tipo
Contenido del mensaje si se programó una 
cita con un PCP
Contenido del mensaje si no se programó una 
cita con un PCP
Las citas pueden tener un costo dependiendo de 
su seguro (como por ejemplo, un copago o 
deducible). Si tiene preguntas sobre la cobertura 
de su seguro o los posibles costos asociados con 
una visita, llame al consultorio de su PCP, al 
proveedor de seguros o a la Oficina de 
Facturación de Pacientes de Mass General 
Brigham al 617-726-3884.  
Si no puede acudir a esta cita o desea cancelarla 
o reprogramarla, llame al consultorio de su PCP al 
XXX o comuníquese con el equipo de Bridge 
Study (617-643-5483). Tenga en cuenta que 
algunas clínicas pueden cobrar una tarifa por no 
presentarse a una visita programada. 
--
El equipo de Bridge Study ha enviado este 
mensaje. Si desea dejar de recibir mensajes de 
este equipo, llame al coordinador del estudio al 
617-643-5483 o envíe un correo electrónico al 
equipo del estudio a 
bridgestudy@mgh.harvard.edu. No responda de 
manera directa a este mensaje con preguntas 
específicas sobre su salud o plan de seguimiento.
Las citas pueden tener un costo dependiendo de 
su seguro (como por ejemplo, un copago o 
deducible). Si tiene preguntas sobre la cobertura 
de su seguro o los posibles costos asociados con 
una visita, llame al consultorio de su PCP, al 
proveedor de seguros o a la Oficina de 
Facturación de Pacientes de Mass General 
Brigham al 617-726-3884.  
--
El equipo de Bridge Study ha enviado este 
mensaje. Si desea dejar de recibir mensajes de 
este equipo, llame al coordinador del estudio al 
617-643-5483 o envíe un correo electrónico al 
equipo del estudio a 
bridgestudy@mgh.harvard.edu. No responda de 
manera directa a este mensaje con preguntas 
específicas sobre su salud o plan de seguimiento.
Intervención
4 
semanas 
antes de 
la cita 
con el 
PCP
O BIEN
8 
semanas 
después 
del parto 
si no 
SMS
¡Su PCP está esperando su próxima cita! 
Consulte Patient Gateway para obtener más 
detalles. -Bridge Study de MGH
[no responda]
cantidad de caracteres: 128
¡Oh, no! No tiene programada una cita de 
transición de atención con el PCP. Consulte 
Patient Gateway para obtener más detalles. -
Bridge Study de MGH 
[no responda]
cantidad de caracteres: 139
Page 18 of 20
Compiled Summary of Protocol Amendments
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Cerrando la brecha entre el posparto y la atención primaria
Mensaje de texto para el paciente
6
Grupo
Moment
o  
Tipo
Contenido del mensaje si se programó una 
cita con un PCP
Contenido del mensaje si no se programó una 
cita con un PCP
programó 
una cita 
con el 
PCP 
Intervención
1 
semana 
antes de 
la cita 
con el 
PCP
O BIEN
12 
semanas 
después 
del parto 
si no 
programó 
una cita 
con el 
PCP 
PG
Estimada XXX:
¡Se aproxima su cita reservada de “Transición 
del embarazo a la atención primaria”!
XXX INFORMACIÓN DE LA CITA ##
Esta cita se programó para ayudarla en la 
transición de su proveedor de atención en el 
embarazo a su proveedor de atención primaria 
(PCP) después de su parto. Su PCP se asegurará 
de que tenga un plan para mantenerse saludable 
y puede responder a cualquier pregunta o 
inquietud que tenga sobre su salud.
Las citas pueden tener un costo dependiendo de 
su seguro (como por ejemplo, un copago o 
deducible). Si tiene preguntas sobre la cobertura 
de su seguro o los posibles costos asociados con 
una visita, llame al consultorio de su PCP, al 
proveedor de seguros o a la Oficina de 
Facturación de Pacientes de Mass General 
Brigham al 617-726-3884.  
Si no puede acudir a esta cita o desea cancelarla 
o reprogramarla, llame al consultorio de su PCP al 
XXX o comuníquese con el equipo de Bridge 
Study (617-643-5483). Tenga en cuenta que 
algunas clínicas pueden cobrar una tarifa por no 
presentarse a una visita programada. 
--
El equipo de Bridge Study ha enviado este 
mensaje. Si desea dejar de recibir mensajes de 
este equipo, llame al coordinador del estudio al 
Estimada XXX:
No vemos que haya programado su cita de 
“Transición del embarazo a la atención 
primaria”. Llame al consultorio de su proveedor de 
atención primaria (PCP) para programarla.  El 
número de teléfono del consultorio es: XXX
Estamos intentando programar esta cita para 
usted con el fin de ayudar a la transición de su 
proveedor de atención en el embarazo a su PCP 
después de su parto. Su PCP se asegurará de que 
tenga un plan para mantenerse saludable y puede 
responder a cualquier pregunta o inquietud que 
tenga sobre su salud. 
Las citas pueden tener un costo dependiendo de 
su seguro (como por ejemplo, un copago o 
deducible). Si tiene preguntas sobre la cobertura 
de su seguro o los posibles costos asociados con 
una visita, llame al consultorio de su PCP, al 
proveedor de seguros o a la Oficina de 
Facturación de Pacientes de Mass General 
Brigham al 617-726-3884.  
--
El equipo de Bridge Study ha enviado este 
mensaje. Si desea dejar de recibir mensajes de 
este equipo, llame al coordinador del estudio al 
617-643-5483 o envíe un correo electrónico al 
equipo del estudio a 
bridgestudy@mgh.harvard.edu. No responda de 
manera directa a este mensaje con preguntas 
específicas sobre su salud o plan de seguimiento.
Page 19 of 20
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Cerrando la brecha entre el posparto y la atención primaria
Mensaje de texto para el paciente
7
Grupo
Moment
o  
Tipo
Contenido del mensaje si se programó una 
cita con un PCP
Contenido del mensaje si no se programó una 
cita con un PCP
617-643-5483 o envíe un correo electrónico al 
equipo del estudio a 
bridgestudy@mgh.harvard.edu. No responda de 
manera directa a este mensaje con preguntas 
específicas sobre su salud o plan de seguimiento.
SMS
Recordatorio: ¡Su cita con el PCP es dentro de los 
próximos días! Consulte Patient Gateway para 
obtener más detalles. -Bridge Study de MGH 
[no responda]
cantidad de caracteres: 131
¡Recordatorio! No tiene programada una cita de 
transición de atención con el PCP. Consulte 
Patient Gateway para obtener más detalles. -
Bridge Study de MGH 
[no responda]
cantidad de caracteres: 142
Page 20 of 20
Compiled Summary of Protocol Amendments
Page 138 of 278

Version: V6.10 created on 10/28/22 - 02:12 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:39 PM 
 
 
Title: Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to 
Improve Chronic Disease Management among Postpartum Women (the Bridge Study)  
Sponsor Name: 
PI Name: Clapp, Mark A  
Protocol #: 2022P001723 
Type: Amendment (AME6)  
Date Received: October 26, 2022  
Signatures 
PI Name: Clapp, Mark A, MD, MPH 
Authenticated: October 26, 2022 
Amendment  
COVID-19 Amendment 
 
Is this amendment ONLY related to research impacted by COVID-19? 
 
Refer to MGB Policy on Conduct of Human Research Activities during COVID-19 Operations for description 
of Amendments which do require prior IRB review and approval.   
⚪  Yes   
◉  No  
 
 
Central IRB Performance Sites  
 
Is this a protocol where the Mass General Brigham IRB is serving as the single IRB (sIRB) for external 
sites/institutions? 
◉  Yes  
 
⚪  No  
 
Would you like to 'Add' a Site? 
⚪  Yes  
 
◉  No  
 
Would you like to 'Remove' a Site? 
⚪  Yes  
 
◉  No  
 
 
Sponsor Amendment 
  
Is there a sponsor amendment number? 
⚪  Yes   
◉  No  
 
 
Change in Protocol Status 
 
Is this a cede protocol or project that was determined to be exempt, not human subjects research or not 
engaged in human subjects research?  
⚪  Yes   
◉  No  
 
 
Page 1 of 16
Compiled Summary of Protocol Amendments
Page 139 of 278

Version: V6.10 created on 10/28/22 - 02:12 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:39 PM 
 
 
Do you need to change the overall status of the protocol?  For example, Re-Open to Enrollment or 
indicate that Research Interventions/Assessments Continue after telling the IRB these have ceased. 
⚪  Yes  
 
◉  No  
 
 
  
Briefly describe the proposed changes: 
1) Adding Spanish translation of baseline survey 
2) Updating patient messages  
 
  
Provide rationale for the proposed changes: 
1) Spanish version of the survey 
2) Old version of patient message file was uploaded in the original submission; updated/correct patient 
message attachment added. The content, frequency, and purpose of the messages have not changed 
from the originally approved versions. 
*no patients have been enrolled yet 
 
  
Will the proposed change(s) significantly alter the risk to benefit assessment the IRB relied upon to approve 
the protocol? 
⚪  Yes   
◉  No  
 
 
  
Will the proposed change(s) significantly affect the integrity of the protocol? 
⚪  Yes   
◉  No  
 
 
Informed Consent 
 
Do the changes require a revision to the consent form? 
⚪  Yes   
◉  No  
 
Attachments 
 
Name 
Mode 
Baseline_10-5-22_final_Spanish (Instrument/Questionnaire)  
Electronic  
Letter of Certification_P-2022-4226[81] (Other)  
Electronic  
Patient Messages_final (Document for review)  
Electronic  
 
Page 2 of 16
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Cerrando la brecha entre el posparto y la atención primaria
 
Investigadores principales del estudio: Mark Clapp, MD MPH (MGH); Jessica Cohen, PhD 
(Harvard)
Investigador principal de la institución: Mark Clapp, MD MPH (MGH)
 
SECCIÓN 5. Encuesta para pacientes 
Se mantendrá la privacidad de toda la información y los servicios que está recibiendo 
actualmente no se verán afectados.
701. ¿Cuál es su estado civil? 
1. Casada 
2. Divorciada 
3. Viuda 
4. Separada 
5. Nunca se casó 
6. Integra una pareja no casada 
88. No sabe/no está segura
99. Prefiere no decirlo 
702. ¿Qué opción describe mejor el grado o nivel más alto de escolaridad que ha 
completado? 
1. 8.º grado o menos 
2. 9.º - 12.º grado, sin diploma 
3. Escuela secundaria completa o GED aprobado 
4. Algunos créditos universitarios, pero sin título 
5. Técnico superior (p. ej. AA, AS) 
6. Licenciatura (p. ej. BA, AB, BS) 
7. Maestría (p. ej. MA, MS, MEng, MEd, MSW, MBA) 
8. Doctorado (p. ej. Ph.D., EdD) o título profesional 
88. No sabe/no está segura
99. Prefiere no decirlo 
Page 3 of 16
Compiled Summary of Protocol Amendments
Page 141 of 278

703. ¿Aproximadamente cuánto dinero ha ganado usted personalmente en los últimos 12 
meses? 
1. $0
2. $1 – $6,000
3. $6,001 – $10,000
3. $10,001 – $30,000 
4. $30,001 – $50,000
5. $50,001 – $75,000
6. $75,001 – $100,000
7. Más de $100,001
88. No sabe/no está segura
99. Prefiere no decirlo
704. ¿Prevé perder el seguro de salud o estar sin seguro durante el año posterior al 
nacimiento de su bebé?
1. Sí
2. No
88. No sabe/no está segura
99. Prefiere no decirlo
705. ¿Prevé que cambie su proveedor de seguros principal después de su embarazo?
1. Sí 
2. No
88. No sabe/no está segura
99. Prefiere no decirlo
501.  ¿Qué tan fácil o difícil le resulta acceder al portal para pacientes Patient Gateway?
1. Muy fácil
2. Algo fácil 
3. Ni fácil ni difícil
4. Algo difícil 
5. Muy difícil 
88. No sabe/no está segura
Page 4 of 16
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99. Prefiere no responder
502.  Durante el año ANTERIOR a su embarazo, ¿cómo describiría que fue su salud 
FÍSICA? 
1. Excelente
2. Muy buena
3. Buena
4. Aceptable
5. Mala
88. No sabe/no está segura
99. Prefiere no responder
503.  Durante el año ANTERIOR a su embarazo, ¿cómo describiría que fue su salud 
MENTAL? 
1. Excelente
2. Muy buena
3. Buena
4. Aceptable
5. Mala
88. No sabe/no está segura
99. Prefiere no responder
504. Piense en el año anterior a su embarazo; si necesitó consultar a un profesional de la 
salud por un problema que no era de emergencia, ¿qué tan fácil o difícil le resultó? 
1. Muy fácil
2. Algo fácil
3. Ni fácil ni difícil
4. Algo difícil
5. Muy difícil88. No sabe/no está segura
99. Prefiere no responder
505.  Hay muchos motivos por los que la gente retrasa o evita buscar atención médica. 
¿Alguno de los siguientes problemas hizo que no obtuviera la atención médica que 
necesitaba antes de su embarazo? Lea cada opción en voz alta. Cuando termine, pregunte: 
“¿Algo más?”. 
Page 5 of 16
Compiled Summary of Protocol Amendments
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1. No estaba segura de con quién debía coordinar una cita
2. Le resultó difícil conseguir una cita 
3. Tuvo dificultades de transporte
4. La clínica o el consultorio del médico no estaba abierto cuando usted pudo llegar
6. Le preocupaba el costo financiero de la atención
7. Dificultad para conseguir tiempo libre en el trabajo para obtener atención
8. No estaba segura de que la atención médica le ayudaría
9. Dificultad para conseguir cuidado para los niños
10. Otro, especifique ______ 
88. No sabe/no está segura
99. Prefiere no responder
505. ¿Tiene un auto para su uso personal?
1. Sí
2. No
88. No sabe/no está segura
99. Prefiere no responder
506. ¿Cuál fue su medio de transporte a la cita de hoy? Seleccione todo lo que corresponda.
1. Auto personal
2. Taxi, Uber o Lyft
3. Auto de un amigo o un familiar
4. Autobús
5. Metro/tren ("T")
6. Bicicleta
7. A pie/caminando
8. Otro, especifique ______
88. No sabe/no está segura
99. Prefiere no responder
505. ¿Tiene un auto para su uso personal?
1. Sí
Page 6 of 16
Compiled Summary of Protocol Amendments
Page 144 of 278

2. No
88. No sabe/no está segura
99. Prefiere no responder
507. En el año anterior a su embarazo, aparte de las visitas a la sala de emergencias, 
¿consultó a un médico o a un enfermero por algún motivo? Esto no incluye visitas a la sala 
de emergencias pero puede incluir consultas con su médico de cabecera, un médico 
especialista, atención urgente, etc.
1. Sí, especifique dónde________
2. No
88. No sabe/no está segura
99. Prefiere no responder
 
508-511: ¿Alguna vez un médico, un enfermero u otro personal de la salud le dijo que tiene 
algo de lo siguiente?
Afección
Sí
No
 No sabe/no está 
segura
Prefiere no 
responder
Presión 
arterial alta o 
hipertensión
⚪
⚪
⚪
⚪
Diabetes o 
nivel alto de 
azúcar en 
sangre
⚪
⚪
⚪
⚪
Ansiedad o 
depresión
⚪
⚪
⚪
⚪
Sobrepeso u 
obesidad
⚪
⚪
⚪
⚪
 
SECCIÓN 6. Trabajo y licencia posparto 
601. ¿Tiene actualmente un trabajo remunerado? 
1. Sí  Pase a la 603
2. No 
Page 7 of 16
Compiled Summary of Protocol Amendments
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88. No sabe/no está segura
99. Prefiere no decirlo 
 
602. ¿Ha tenido un trabajo remunerado en algún momento de los últimos 12 meses?
1. Sí
2. No  Pase a la 604
88. No sabe/no está segura
99. Prefiere no decirlo
603. ¿Qué describe mejor el tipo o tipos de trabajo que tuvo en los últimos 12 meses? 
(Marque todo lo que corresponda. Mencione el nombre del empleador. Por cada empleador 
mencionado, pregunte: "¿Este empleador está en Massachusetts?"). 
1.
Gobierno federal o estatal:_____ Nombre:_________________________
¿En Massachusetts? Sí: _____ No: _______
2.
Empresa privada o con fines de lucro: _____ Nombre:_________________________
¿En Massachusetts? Sí: _____ No: _______
3.
Municipalidad (depto. escolar, obras públicas, autoridad de vivienda, distrito escolar 
regional):_____ Nombre:_________________________
¿En Massachusetts? Sí: _____ No: _______
4.
Iglesia u organización religiosa______ Nombre: ____________________
¿En Massachusetts? Sí: _____ No: _______
5.
Trabajador independiente_____________ Nombre: _____________________
¿En Massachusetts? Sí: _____ No: _______
6.
Contratista independiente _____________ Nombre: _____________________
¿En Massachusetts? Sí: _____ No: _______
7.
Otro: ______________
¿En Massachusetts? Sí: _____ No: _______
88. No sabe/no está segura
99. Prefiere no decirlo
604. ¿Tiene planeado reintegrarse a trabajar o empezar un trabajo nuevo dentro del primer 
año después del nacimiento de su bebé?
1. Sí, me reintegraré a mi trabajo anterior
2. Sí, empezaré un trabajo nuevo
3. No -> Pase a la 606
88. No sabe/no está segura 
99. Prefiere no decirlo 
Page 8 of 16
Compiled Summary of Protocol Amendments
Page 146 of 278

605. ¿Cuánto tiempo después del nacimiento del bebé pretende reintegrarse a trabajar o 
empezar a trabajar? 
1. Menos de una semana
2. 1 a 4 semanas 
3. 5 a 8 semanas
4. 9 a 12 semanas
5. 13 a 16 semanas
6. 17 a 20 semanas
7. 21 a 24 semanas
8. 25 semanas o más
88. No sabe/no está segura
99. Prefiere no decirlo
606. ¿Alguna vez vio, leyó o escuchó algo sobre un programa estatal de Massachussetts 
llamado "Licencia paga por razones médicas y familiares" (Paid Family and Medical Leave, 
PFML)? Este programa ofrece a los trabajadores elegibles tiempo libre pago por razones 
familiares o médicas.
1. Sí, he visto, leído o escuchado acerca del programa de Licencia paga por razones 
médicas y familiares de Massachusetts.
2. No, no he visto, leído ni escuchado acerca del programa de Licencia paga por razones 
médicas y familiares de Massachusetts. 
88. No conozco/no estoy segura acerca el programa de Licencia paga por razones médicas y 
familiares de Massachusetts.
99. Prefiere no decirlo 
607. ¿Tiene intención de aplicar para el programa de Licencia paga por razones médicas y 
familiares de Massachusetts? 
1. Sí
2. No. Diga el motivo: ____________________________
88. No sabe/no está segura
99. Prefiere no decirlo
 
 
Page 9 of 16
Compiled Summary of Protocol Amendments
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460 W Irving Park Rd 
Suite C 
Bensenville, IL 60106  
800 959 2874 
www.burgtranslations.com 
 
 
 
 
October 24, 2022 
 
 
I, the undersigned, having been duly sworn, depose and say that the following document: 
 
• Baseline_10-5-22_final_Spanish.docx 
 
has been translated from English into Spanish by BURG Translations, Inc. and, to the best of my 
knowledge and belief, it is a true and accurate rendering of the original document.  
 
 
 
 
 
 
STATE OF ILLINOIS 
COUNTY OF COOK 
Chicago, Illinois, October 24, 2022 
 
Signed and attested before me on this 24th day of 
October, 2022 by Michelle Delana 
 
 
 
BURG TRANSLATIONS, INC. 
460 W Irving Park Rd,  
Suite C 
Bensenville, Illinois 60106 
(800) 959-2874 
 
 
 
Michelle Delana 
Sr. Project Manager 
 
 
 
 
 
 
 
 
 
 
 
 
 
   Angelo Passalacqua, Notary Public 
 
    Cook County, State of Illinois 
Page 10 of 16
Compiled Summary of Protocol Amendments
Page 148 of 278

Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to Improve Chronic 
Disease Management among Postpartum Women
Study PIs: Mark Clapp, MD MPH (MGH); Jessica Cohen, PhD (Harvard)
Site PI: Mark Clapp, MD MPH (MGH)
* EDD, estimated date of delivery; PG, Patient Gateway secure messaging portal.
Patient Message Text
Group
Timing  
Type
Message content if PCP appt scheduled
Message content if PCP appt not scheduled
Control
2-4 
weeks 
prior to 
EDD 
PG
N/A
Dear XXX,
Having a primary care provider (PCP) and seeing 
them at least once a year is important for your 
current and future health and wellbeing.
These providers have different roles than your 
obstetrician (pregnancy doctor) or midwife. It is 
recommended that you see your PCP in the 
months after your delivery since you will stop 
seeing your pregnancy provider.
If you have questions about finding or seeing your 
PCP after your delivery, please ask your 
pregnancy provider or call your PCP.
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator 617-643-5483 or email the study team 
at bridgestudy@mgh.harvard.edu. Do not reply 
directly to this message with questions about your 
health or to arrange follow-up.
Page 11 of 16
Compiled Summary of Protocol Amendments
Page 149 of 278

Bridging the Gap from Postpartum to Primary Care
Patient Message Text
2
Group
Timing  
Type
Message content if PCP appt scheduled
Message content if PCP appt not scheduled
Intervention
2-4 
weeks 
prior to 
EDD 
PG
N/A
Dear XXX,
Having a primary care provider (PCP) and seeing 
them at least once a year is important for your 
current and future health and wellbeing.
These providers have different roles than your 
obstetrician (pregnancy doctor) or midwife. It is 
recommended that you see your PCP in the 
months after your delivery since you will stop 
seeing your pregnancy provider.
To help support you in transitioning to primary care 
after your delivery, we will schedule your 
“Pregnancy-to-Primary Care Transition” 
appointment with your PCP within the next few 
months. We will message you once the 
appointment has been scheduled. If you have 
date/time preferences for this appointment OR do 
not want us to schedule this appointment for you, 
please call the study coordinator (617-643-5483) or 
email the study team at 
bridgestudy@mgh.harvard.edu within 2 weeks.
If you have questions about your care or seeing 
your PCP after your delivery, please ask your 
pregnancy provider or call your PCP.
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator 617-643-5483 or email the study team 
at bridgestudy@mgh.harvard.edu. Do not reply 
directly to this message with specific questions 
about your health or follow-up plan.
Page 12 of 16
Compiled Summary of Protocol Amendments
Page 150 of 278

Bridging the Gap from Postpartum to Primary Care
Patient Message Text
3
Group
Timing  
Type
Message content if PCP appt scheduled
Message content if PCP appt not scheduled
Intervention
2-4 
weeks 
prior to 
EDD
SMS
You have received an important message through 
Patient Gateway. Please check the portal for more 
information. -The MGH Bridge Study
[do not reply]
character count: 141
You have received an important message through 
Patient Gateway. Please check the portal for more 
information. -The MGH Bridge Study
character count: 147
Intervention
2 weeks 
after 
EDD
PG
Dear XXX, 
Your “Pregnancy-to-Primary Care Transition” 
Appointment has been specially reserved for you:
XXX APPT INFO ##
This appointment was made to help support your 
transition from your pregnancy provider to your 
primary care provider (PCP) after your delivery. 
Your PCP will make sure you have a plan in place 
to keep you healthy and can answer any 
questions or concerns you have about your 
health. 
Appointments may have a cost depending on your 
insurance plan (such as a co-pay or deductible). If 
you have questions about your insurance 
coverage or possible costs associated with a visit, 
please call your PCP’s office, insurance provider, 
or Mass General Brigham Patient Billing office at 
617-726-3884.  
If you are unable to make this appointment or wish 
to cancel or reschedule, please call your PCP’s 
office at XXX or contact the Bridge Study Team 
(617-643-5483). Please note that some clinics 
may charge a fee for not showing to a scheduled 
visit. 
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator 617-643-5483 or email the study team 
Dear XXX, 
We have been unable to reserve your 
“Pregnancy-to-Primary Care Transition” 
Appointment for you with XXX at XXX practice. 
Please call your PCP’s office to schedule. The 
office phone number is: XXX
We are trying to make this appointment for you to 
help support your transition from your pregnancy 
provider to your primary care provider (PCP) after 
your delivery. Your PCP will make sure you have a 
plan in place to keep you healthy and can answer 
any questions or concerns you have about your 
health. 
Appointments may have a cost depending on your 
insurance (such as a copay or deductible). If you 
have questions about your insurance coverage or 
possible costs associated with a visit, please call 
your PCP’s office, insurance provider, or Mass 
General Brigham Patient Billing office at 617-726-
3884.  
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator 617-643-5483 or email the study team 
at bridgestudy@mgh.harvard.edu. Do not reply 
directly to this message with specific questions 
about your health or follow-up plan.
Page 13 of 16
Compiled Summary of Protocol Amendments
Page 151 of 278

Bridging the Gap from Postpartum to Primary Care
Patient Message Text
4
Group
Timing  
Type
Message content if PCP appt scheduled
Message content if PCP appt not scheduled
at bridgestudy@mgh.harvard.edu. Do not reply 
directly to this message with specific questions 
about your health or follow-up plan.
Intervention
2 weeks 
after 
EDD
SMS
A PCP appointment has been reserved for you! 
Check Patient Gateway for details. -The MGH 
Bridge Study
[do not reply]
character count: 115
Oh no! We are having trouble arranging your PCP 
appointment. Check Patient Gateway for details. -
The MGH Bridge Study
[do not reply]
character count: 158
Intervention
4 weeks 
before 
PCP 
appointm
ent
PG
Dear XXX,
Your primary care provider (PCP) is looking 
forward to caring for you after your pregnancy. 
Your “Pregnancy-to-Primary Care Transition” 
appointment has been reserved for you:
XXX APPT INFO ##
This appointment was made to help support your 
transition from your pregnancy provider to your 
primary care provider (PCP) after your delivery. 
Your PCP will make sure you have a plan in place 
to keep you healthy and can answer any 
questions or concerns you have about your 
health.
Appointments may have a cost depending on your 
insurance (such as a copay or deductible). If you 
have questions about your insurance coverage or 
possible costs associated with a visit, please call 
your PCP’s office, insurance provider, or Mass 
General Brigham Patient Billing office at 617-726-
3884.  
If you are unable to make this appointment or wish 
to cancel or reschedule, please call your PCP’s 
office at XXX or contact the Bridge Study Team 
(617-643-5483). Please note that some clinics 
may charge a fee for not showing to a scheduled 
visit. 
Dear XXX,
We do not see that you have your “Pregnancy-to-
Primary Care Transition” appointment scheduled. 
Please call your primary care provider (PCP) office 
to schedule.  The office phone number is: XXX
We are attempting to make this appointment for 
you in order to help support your transition from 
your pregnancy provider to your PCP after your 
delivery. Your PCP will make sure you have a plan 
in place to keep you healthy and can answer any 
questions or concerns you have about your health. 
Appointments may have a cost depending on your 
insurance (such as a copay or deductible). If you 
have questions about your insurance coverage or 
possible costs associated with a visit, please call 
your PCP’s office, insurance provider, or Mass 
General Brigham Patient Billing office at 617-726-
3884.  
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator 617-643-5483 or email the study team 
at bridgestudy@mgh.harvard.edu. Do not reply 
directly to this message with specific questions 
about your health or follow-up plan.
Page 14 of 16
Compiled Summary of Protocol Amendments
Page 152 of 278

Bridging the Gap from Postpartum to Primary Care
Patient Message Text
5
Group
Timing  
Type
Message content if PCP appt scheduled
Message content if PCP appt not scheduled
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator 617-643-5483 or email the study team 
at bridgestudy@mgh.harvard.edu. Do not reply 
directly to this message with specific questions 
about your health or follow-up plan.
Intervention
4 weeks 
before 
PCP appt
OR
8 weeks 
pp if no 
PCP appt 
SMS
Your PCP is looking forward to your upcoming 
appointment! Check Patient Gateway for details. -
The MGH Bridge Study
[do not reply]
character count: 128
Oh no! You do not have a PCP care transition 
appointment scheduled. Check Patient Gateway 
for details. -The MGH Bridge Study 
[do not reply]
character count: 139
Intervention
1 week 
before 
PCP appt
OR
12 weeks 
pp if no 
PCP appt 
PG
Dear XXX,
Your reserved “Pregnancy-to-Primary Care 
Transition” Appointment is coming up!
XXX APPT INFO ##
This appointment was made to help support your 
transition from your pregnancy provider to your 
primary care provider (PCP) after your delivery. 
Your PCP will make sure you have a plan in place 
to keep you healthy and can answer any 
questions or concerns you have about your 
health.
Appointments may have a cost depending on your 
insurance (such as a copay or deductible). If you 
have questions about your insurance coverage or 
possible costs associated with a visit, please call 
your PCP’s office, insurance provider, or Mass 
General Brigham Patient Billing office at 617-726-
3884.  
Dear XXX,
We do not see that you have your “Pregnancy-to-
Primary Care Transition” appointment scheduled. 
Please call your primary care provider (PCP) office 
to schedule.  The office phone number is: XXX
We are attempting to make this appointment for 
you in order to help support your transition from 
your pregnancy provider to your PCP after your 
delivery. Your PCP will make sure you have a plan 
in place to keep you healthy and can answer any 
questions or concerns you have about your health. 
Appointments may have a cost depending on your 
insurance (such as a copay or deductible). If you 
have questions about your insurance coverage or 
possible costs associated with a visit, please call 
your PCP’s office, insurance provider, or Mass 
General Brigham Patient Billing office at 617-726-
3884.  
Page 15 of 16
Compiled Summary of Protocol Amendments
Page 153 of 278

Bridging the Gap from Postpartum to Primary Care
Patient Message Text
6
Group
Timing  
Type
Message content if PCP appt scheduled
Message content if PCP appt not scheduled
If you are unable to make this appointment or wish 
to cancel or reschedule, please call your PCP’s 
office at XXX or contact the Bridge Study Team 
(617-643-5483). Please note that some clinics 
may charge a fee for not showing to a scheduled 
visit. 
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator 617-643-5483 or email the study team 
at bridgestudy@mgh.harvard.edu. Do not reply 
directly to this message with specific questions 
about your health or follow-up plan.
--
This message has been sent from The Bridge 
Study team. If you wish to no longer receive any 
messages from this team, please call the study 
coordinator 617-643-5483 or email the study team 
at bridgestudy@mgh.harvard.edu. Do not reply 
directly to this message with specific questions 
about your health or follow-up plan.
SMS
Reminder: Your PCP appointment is within the 
next few days! Check Patient Gateway for details. 
-The MGH Bridge Study 
[do not reply]
character count: 131
Reminder! You do not have a PCP care transition 
appointment scheduled. Check Patient Gateway 
for details. -The MGH Bridge Study 
[do not reply]
character count: 142
Page 16 of 16
Compiled Summary of Protocol Amendments
Page 154 of 278

Version: V8.5 created on 12/02/22 - 04:41 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:40 PM 
 
 
Title: Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to 
Improve Chronic Disease Management among Postpartum Women (the Bridge Study)  
Sponsor Name: 
PI Name: Clapp, Mark A  
Protocol #: 2022P001723 
Type: Amendment (AME8)  
Date Received: December 01, 2022  
Signatures 
PI Name: Clapp, Mark A, MD, MPH 
Authenticated: December 01, 2022 
Amendment  
COVID-19 Amendment 
 
Is this amendment ONLY related to research impacted by COVID-19? 
 
Refer to MGB Policy on Conduct of Human Research Activities during COVID-19 Operations for description 
of Amendments which do require prior IRB review and approval.   
⚪  Yes   
◉  No  
 
 
Central IRB Performance Sites  
 
Is this a protocol where the Mass General Brigham IRB is serving as the single IRB (sIRB) for external 
sites/institutions? 
◉  Yes  
 
⚪  No  
 
Would you like to 'Add' a Site? 
⚪  Yes  
 
◉  No  
 
Would you like to 'Remove' a Site? 
⚪  Yes  
 
◉  No  
 
 
Sponsor Amendment 
  
Is there a sponsor amendment number? 
⚪  Yes   
◉  No  
 
 
Change in Protocol Status 
 
Is this a cede protocol or project that was determined to be exempt, not human subjects research or not 
engaged in human subjects research?  
⚪  Yes   
◉  No  
 
 
Page 1 of 17
Compiled Summary of Protocol Amendments
Page 155 of 278

Version: V8.5 created on 12/02/22 - 04:41 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:40 PM 
 
 
Do you need to change the overall status of the protocol?  For example, Re-Open to Enrollment or 
indicate that Research Interventions/Assessments Continue after telling the IRB these have ceased. 
⚪  Yes  
 
◉  No  
 
 
  
Briefly describe the proposed changes: 
Amending the study protocol to add clarity to one component of the eligibility criteria 
 
  
Provide rationale for the proposed changes: 
Study approach and intervention timings were designed (and are currently operating) based on the 
established date of delivery.  
However, the current detailed protocol eligibility criteria has the condition "Currently pregnant or within 2 
weeks of delivery," which does not exactly match the language in the rest of the protocol. To add clarity 
and to match the language used throughout the rest of the protocol and the schema, this has been 
updated to "Currently pregnant or within 2 weeks of estimated date of delivery." 
This change does not affect any patients that have been previously enrolled as the study has been 
operating based on the clarified language since its start. 
No other forms or study documents contain language that need to be updated as a result of this change, 
including the study fact sheet. 
 
  
Will the proposed change(s) significantly alter the risk to benefit assessment the IRB relied upon to approve 
the protocol? 
⚪  Yes   
◉  No  
 
 
  
Will the proposed change(s) significantly affect the integrity of the protocol? 
⚪  Yes   
◉  No  
 
 
Informed Consent 
 
Do the changes require a revision to the consent form? 
⚪  Yes   
◉  No  
 
Attachments 
 
Name 
Mode 
Detailed Protocol_120122_v1-4_clean (Detailed Protocol)  
Electronic  
 
Page 2 of 17
Compiled Summary of Protocol Amendments
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Version 2021.06.10
Page 1 of 15
Institutional Review Board
Intervention/Interaction Detailed Protocol
Principal Investigator:
Mark Clapp, MD MPH (MGH), Jessica Cohen, PhD (HSPH)
Project Title:
Bridging the Gap from Postpartum to Primary Care: A Behavioral 
Science Informed Intervention to Improve Chronic Disease Management 
among Postpartum Women
Version Date:
12/01/2022
Version Name/Number:
v1.4
1.
 Background and Significance
Burden of Chronic Disease and the Role of Primary Care
Chronic health conditions affect millions of people in the US each year. In 2018, 51.8% of adults 
had at least 1 chronic condition, and 27.2% had multiple conditions.1 The prevalence of chronic 
disease was higher in women compared to men, older adults (87.6% in adults ≥65 years old), 
and people with public insurance.1 Many chronic conditions, by their nature, develop over time 
and have risk factors that can be identified prior to the onset of disease. Strong evidence 
underpins prevention strategies for many conditions, which are advanced by the US 
Preventative Services Taskforce.2 While the long-term health of a patient is the responsibility of 
an entire health system, primary care providers (PCPs) provide an integral role in preventing, 
screening for, and managing disease across the lifespan. Studies have shown the health 
benefits of receiving regular care under a PCP.3–6
Despite the known benefits of having an identifiable usual source of care and the value of health 
care maintenance, the percent of the population with a PCP has been decreasing over time.7 
Consistently, adults who are younger (age 20-40 years) have the lowest rates of primary care 
use. In 2015, 44% and 36% of 20- and 30-year-olds had no identifiable source of primary care.7 
The proportion without primary care were also higher among racial/ethnic minority populations 
and among those who had less education, lower incomes, and no known comorbidities.7 The 
number of adults and the time elapsed without regular primary care follow-up can be considered 
missed opportunities to improve a patient’s current and long-term health. The disproportionate 
lack of primary care among certain subgroups of the population, often groups who already have 
worse health outcomes, only serves to widen the pre-existing disparities.
Pregnancy as a Window to Future Health
In the US, 98.2% of pregnant women receive some form of prenatal care, with the average 
patient having >10 visits during their pregnancy.8 During a pregnancy, women are screened for 
pre-existing and pregnancy-related conditions.9 In adults ages 18-39, the prevalence of obesity, 
hypertension, prediabetes/diabetes, and mental illness are estimated at 39%, 7.5%, 28%, 25%, 
respectively.10–13 Even for those who have no prior identified comorbidities, the most common 
Page 3 of 17
Compiled Summary of Protocol Amendments
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Mass General Brigham Institutional Review Board
Intervention/Interaction Detailed Protocol
Version 2022.09.01
Page 2 of 15
pregnancy-related conditions—pregnancy-related hypertension and gestational diabetes (8% 
and 10% of pregnancies, respectively)—indicate a predisposition to or confer health risks that 
persist as women age. For example, over 25% of women with gestational diabetes will develop 
Type 2 diabetes mellitus, and women with pre-eclampsia have more than a two-fold risk of 
significant cardiovascular disease later in life.14,15 For these reasons, pregnancy is often 
considered a “window” into a woman’s future health and presents a unique opportunity to 
optimize a woman’s health status early in her life when she otherwise may not have been 
engaged in care.16 
Pregnancy as on Opportunity for Engagement with a Long-term Care Provider
Pregnancy is a period when women are highly engaged and active participants in their health 
care.17 It has been described as a “golden opportunity” to motivate women towards positive 
health behaviors, including prevention and management of chronic disease. However, women 
often fall off a “postpartum cliff” of health system engagement after the early postpartum 
period.18 A range of systemic, financial, and behavioral barriers often prevents patients from 
effectively transitioning to primary care. Postpartum women are often simply told to follow-up 
with their PCP without much information regarding the importance of this follow up care, without 
assistance in scheduling an appointment (or identifying a PCP if they don’t have one), and often 
without a direct transfer of relevant health information or accountability across providers. 
Postpartum women are left largely on their own to navigate this transition to primary care and, in 
particular, to navigate it at a time when they face the high cognitive and physical demands of 
caring for an infant. At this time of limited cognitive bandwidth, the importance of continuity of 
care for chronic conditions and active engagement in one’s longer-term health and wellbeing is 
unlikely to be salient and top-of-mind. These critical moments of unsupported health care 
transition can exacerbate pre-existing disparities in health and health care, with patients who 
are the least able to navigate the US health care system most likely to fall through the cracks.  
Momentum is building in US health and social safety net policy to facilitate healthy transitions 
from pregnancy to parenthood. For example, federal and state initiatives to expand pregnancy-
related Medicaid coverage from 60 days to one year postpartum have been proposed, and 
access to paid family leave is increasing. However, very little evidence exists on effective and 
cost-effective approaches to facilitating transitions to primary care and management of chronic 
diseases in the postpartum year.  
2.
Specific Aims and Objectives 
The objective of the proposed study is to increase patient engagement in primary care after the 
immediate postpartum period for women with pregnancy-associated conditions that convey a 
long-term health risk. Specifically, we aim to evaluate the efficacy of an intervention bundle 
(automatic scheduling of PCP appointment after delivery, salient labeling, and appointment 
reminder nudges) to increase patient attendance at a primary care provider appointment (within 
4 months of delivery for women with or at risk for obesity, diabetes, hypertension, and/or a 
mental health condition. 
Specific Aims:
1) Test the efficacy of an intervention bundle (patient-tailored health information, automatic 
scheduling of PCP appointment after delivery, and appointment reminder nudges) to 
increase patient attendance at a primary care provider appointment within 4 months of 
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delivery for women with obesity, diabetes, hypertension, and/or a mental health 
condition
2) Test the efficacy of the intervention bundle to improve compliance with the condition-
specific, guideline-based health screenings
3) Test the efficacy of the intervention bundle to reduce unscheduled or urgent encounters 
(e.g., emergency department visits) within the health system
3.
General Description of Study Design
We will conduct a randomized controlled trial comparing this intervention bundle to the receipt of 
generic information on the importance of primary care follow-up after delivery.  
Women will be randomized with equal probability into either a treatment or control arm. The 
intervention combines several features designed to target reasons for low take-up of primary 
care among postpartum women (see Logic Model). We leverage the potential value of 
defaults/opt-out, salient labels, and reminders to encourage use of primary care within 4 months 
of delivery. Women in both the intervention and control arms will receive information via MGH’s 
patient portal toward the end of the pregnancy regarding the importance of transitions to primary 
care in the postpartum year. This information will be similar to, but reinforcing, the information 
they would receive from their obstetrician about following up with their primary care physician. In 
addition to this initial message, women in the treatment arm will receive the following 
intervention components, developed based on recent evidence regarding behavioral science 
approaches to activating health behaviors:19–21
➢
Targeted messages about the importance and benefits of primary care. 
➢
Default scheduling into a primary care appointment at approximately 3-4 months after 
delivery. The patient will be scheduled for a primary care visit with their assigned primary 
care provider in the Mass General Brigham system. They will be informed of the option to 
cancel the appointment, change the appointment day/time, or change the care provider 
either through the patient portal). 
➢
Reminders about the appointment and importance of follow up primary care at 2-4 points 
during the postpartum period via the patient portal. 
➢
Tailored language in the reminders based on recent evidence from behavioral science about 
the most effective approaches to increasing take-up. For example, messages will inform the 
patient that an appointment has been reserved for them at their doctor. 
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The Logic Framework that underpins the basis for this study is shown below:
 
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The flow of study activities is shown below: 
4.
Subject Selection
Pregnant patients receiving prenatal care at Massachusetts General Hospital (MGH) will be 
targeted for recruitment. MGH conducts approximately 3500 deliveries per year, with roughly 
one-third of patients identifying as non-white and 35% of pregnancies covered by Medicaid.
Approximately 49% of the clinic population may ultimately be eligible to be approached.
The eligibility criteria include:
•
Estimated date of delivery and the following 4-month postpartum outcome 
assessment window completed prior to study end date
•
Currently pregnant or within 2 weeks of estimated date of delivery
•
Have one or more of the following conditions: 
o
Chronic hypertension
o
Hypertensive disorders of pregnancy or risk factors for hypertensive disorders 
of pregnancy per the USPTF aspirin prescribing guidelines (e.g., history of 
pre-eclampsia, kidney disease, multiple gestation, autoimmune disease)22
o
Type 1 or 2 diabetes
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o
Gestational diabetes
o
Obesity (body mass index ≥30 kg/m2)
o
Depression or anxiety disorder 
•
Have a primary care provider listed in the patient’s medical record 
•
Receive obstetric care at an MGH-affiliated outpatient prenatal clinic
•
Has access to and be enrolled in the electronic health record patient portal and 
consents to be contacted via these modalities
•
Able to read/speak English or Spanish language
•
Age ≥18 years old
•
Not diagnosed with or undergoing evaluation for stillbirth/fetal demise
All women, regardless of race/ethnicity, who meet the eligibility criteria will be included. In 2019, 
3,789 women gave birth at the study institution, of whom 57% were white, 7% were black, 12% 
were Asian, 18% were Hispanic, and 6% declined to report their race/ethnicity. A similar 
distribution is expected for this study.
The study will distribute materials in English and Spanish languages. This encompasses >95% 
of patients who deliver at the study institution.
5.
Subject Enrollment
This study will rely on recruiting for research through Patient Gateway and follow the IRB 
guidance and DHeC Research Checklist and training for this process.
In the month prior to the start of enrollment, all potentially eligible individuals (based on the 
criteria above) will be identified using RPDR and Epic Reporting search queries. This list (the 
“potentially eligible” list) will be provided to the DHeCare Research Team to build an RSH 
Record in Epic. This list will be updated monthly to identify newly eligible individuals (e.g., new 
diagnosis of gestational diabetes or new patient transferring into the practice) during the 
recruitment months and fed back to the DHeCare team to update “potentially eligible” list.
Once built and each month during recruitment phase, the study’s research coordinator (not 
study investigators) will send the IRB-approved Research Invitation Letter to patients who are 
eligible, not already enrolled, and have not declined to be sent research notifications through the 
portal. The Research Letter will employ an opt-out approach, asking individuals who do not wish 
to be approached in clinic or remotely to respond via PG messaging, email, or phone within 2 
weeks of receipt of the letter. Those who have “read” the letter and not opted out after 2 weeks 
will be moved from the “potentially eligible” list to the “waiting to be approached” list in the study 
workflow.
During recruitment months, the study coordinator will keep a log of patient’s upcoming 
appointments for those on the “waiting to be approached” list. They will then attempt to 
approach individuals for enrollment when they present for an in-person encounters (preferred). 
Patients will ideally be approached between 32-36 weeks of gestation, when feasible; however, 
priority will be given to patients at the latest gestation. For those Spanish-speaking patients, a 
hospital-based interpreter will be used when approaching/consenting patients.
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The study staff will introduce the study and review the purpose of the study, the nature of the 
subject’s participation, the possible risks and discomforts associated with participation, the 
potential benefits of participation, a statement of the voluntary nature of participation, and a 
description of the mechanisms used to ensure confidentiality. 
All patients will receive study-related messages through Patient Gateway. In addition, patients 
will be asked if they would be willing to receive no more than 5 SMS messages to their personal 
cell phone during the first 4 months of the postpartum period. The study staff will review the 
specific concerns and risks about receiving unencrypted text messaging communications, as 
outlined by the MGB IRB. 
A waiver of documentation of informed consent is requested, as the study presents no more 
than minimal risk of harm to subjects and involves no procedures for which written consent is 
normally required outside of the research context. Verbal consent will be obtained for 1) overall 
study participation and 2) optional SMS message participation, separately. Verbal consent will 
be obtained from both in-person and phone recruitment efforts.
A Study Fact Sheet, which summarizes the study details, risks, and benefits, will be provided to 
all subjects who are approached, either in-person, by mail, or electronically. This Study Fact 
Sheet also includes information supplied by the MGB IRB specifically related to the concerns 
and risks of receiving unencrypted SMS/text messages.
For tracking verbal consent, the study staff will keep a detailed log in REDCap documenting:
1) name of study staff performing consent,
2) date of attempted approach,
3) the method of attempted approach (in-person or via phone),
4) use of Spanish interpreter (yes/no),
5) subject agreement to be approached (agree/disagree),
6) attestation to full review of the study procedures/risks/benefits with the subject, as would 
be done during the process of reviewing a written consent form, 
7) attestation to review of supplemental consent to receive unencrypted SMS messages 
with the subject,
8) subject overall study participation status (enrolled, declined, deferred – agrees to be 
recontacted, deferred – wishes not to be recontacted),
9) if enrolled, unencrypted SMS text messaging participation (consents, declines),
10) attestation to Study Fact Sheet provided,
11) method by which Study Fact Sheet was provided (in-person, mail, electronic),
12) date in which Study Fact Sheet was provided (in-person, mail, electronic).
6.
STUDY PROCEDURES
The RA will keep a detailed log of all patients in the practice, if they are eligible, if they have 
been approached, and if they consented.
For those that agree to be enrolled, patients will be asked to complete a baseline survey to 
obtain voluntarily reported information on their demographics, socioeconomic status, health care 
visit history, and primary care provider. Patients will also be asked to consent to being contacted 
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by the research team via Patient Gateway messaging. A $20 gift card will be given at the time of 
enrollment for those that complete the questionnaire and receive the information sheet.
Randomization will occur via a prespecified random allocation sequence within strata. Within 
each stratum, the PIs will generate a random sequence of treatment-control allocation prior the 
enrollment of subjects. Then, as patients within strata are enrolled, they will be assigned to the 
treatment arm associated with that enrollment number. 
Control Group
Approximately 2 weeks before a patient’s estimated due date (EDD) or as soon as enrolled if 
this date has passed, the patient will be sent information via the Patient Gateway on the 
importance of postpartum care and follow-up with their PCP.
Intervention Group
1.
Tailored Information:
Approximately 2-4 weeks prior to the EDD (or later for those who are enrolled beyond 38 
weeks gestation or postnatally), the patient will be sent an information via the Patient 
Gateway on the importance of postpartum care and follow-up with their PCP, which also 
includes the name and phone number of their primary care provider. 
2.
Scheduled PCP Appointment:
Between 2-3 weeks after their delivery, the RA will call the patient’s PCP office and 
make an appointment for them between 3-4 months after delivery based on the 
scheduling preferences obtained in the initial survey.
3.
Targeted Appointment Message with Salient Labeling:
After the PCP appointment has been made, the patient will be sent a Patient Gateway 
message saying that a PCP appointment has been reserved for them with the 
date/time/location information.
For those consenting to receive SMS messages, an unencrypted text message will also 
be sent simultaneously.
4.
Nudge Reminders: 
Patient Gateway messages will be sent at approximately 4-8 weeks (goal: 4 weeks) and 
1-4 week (goal: 1 week) prior to their PCP appointment, reminding a patient of their 
upcoming appointment. 
For those consenting to receive SMS messages, an unencrypted text message will also 
be sent simultaneously.
5.
Facilitated PCP Communication:
A study staff member will send the patient’s PCP an Epic Inbasket message that the 
patient 1) is recently postpartum, 2) has or developed health conditions that need long-
term management, and 3) has been scheduled (or attempted to be scheduled) for a 
follow-up visit.
All messages will be made available in English and Spanish.
The text for these Patient Gateway messages is included in the submission. At the end of each 
patient message, patients will be given the opportunity to stop receiving study-related messages 
by emailing or calling the study staff. “Opt out” requests will be logged and patients removed 
from future planned study-related contact. 
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The text for 3 SMS messages is included in the submission. SMS messages will be sent via 
Google Voice. We will follow standard recommendations from the MGB Research Information 
Security for using this system (included under Privacy and Confidentiality section).
The study team will review the patient’s EHR record for the primary and secondary outcome 
assessments. Patients will be asked to consent to have records reviewed up to 2 years after the 
date of their delivery to allow for long-term effects of the intervention on primary care use and 
health status. 
During the initial consent process, patients will be asked to agree to be potentially contacted at 
the end of the first 4-month follow-up period for a survey. Currently, this endline survey is not 
planned due to funding limitations; however, if funding becomes available, an IRB amendment 
will be submitted for review of the endline survey prior to being administered to any study 
subjects.
Deidentified data from this project may be shared outside of MGB with the study funders (J-
PAL/NBER/NIA) for data sharing and reproducibility requirements and secondary statistical 
analysis. All data will be stripped of patient identifiers, per IRB guidance. No data will be shared 
without a formal Data Use Agreement with MGB.
6.
Risks and Discomforts
There are minimal risks to participants. 
Patients will be reassured that nonparticipation will not affect clinical care. Patients will also be 
informed that the researchers with whom they will interact (e.g., during consent, face-to-face, 
during telephone interviews) are not health care providers. Participants will be consistently 
reminded that responses to any queries deemed sensitive or uncomfortable (e.g., country of 
origin/immigration status, income, previous history of abortion) should be considered optional, 
and they may decline to answer any question(s) and can refuse to continue the study at any 
point. Participants will be reassured that neither their opportunities for continued health care nor 
their relationships with health care providers will be jeopardized by study participation.
Health information collected as part of this study will be stored in REDCap. No identifiable data 
will be stored or downloaded on any personal or unauthorized computers. Study staff will 
access the data on institutionally purchased and managed computers that operate behind the 
health system’s security and firewall protections. Only the MGH study staff will have access to 
the identifiable data set. Once the study is completed, data will be deidentified such that it can 
be analyzed without risk of a breach of privacy or confidentiality. Any data that is shared outside 
of MGH will require a data use authorization.
Although we will make every effort to protect participant privacy and confidentiality, it is possible 
that participants' involvement in the study could become known to others. For those in the 
intervention group, we will be sending personalized messages via the patient portal; for those 
providing additional consent, we will be sending unencrypted SMS messages that will not 
contain any personal protected health information. There is the rare possibility that study 
participation or health information could become known to others despite the use of firewalls, 
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password protection, and other security measures. Standard procedures, as outlined by the 
MGB Research Information Security Office, will be followed to reduce this risk.
Individuals in the intervention group will be scheduled for an appointment with a primary care 
doctor. There is the possibility that this visit may result in a charge/cost for the patient. Under 
the Affordable Care Act, commercial health plans are required to cover an annual Preventive 
Health Exam at no cost to the patient (no co-payment, co-insurance or deductible). MassHealth 
also covers these visits without cost-sharing. However, if this visit turns or scheduled as into a 
“sick” or “disease management” visit, the patient may be billed for some or all aspects of the 
services provided, depending on their insurer. We will provide directions for patients on how to 
to contact their insurers or PCP’s office prior to the visit to inquire about potential cost-sharing 
and/or deductibles. Patients will also be advised that some clinics may penalize individuals for 
not showing to a scheduled appointment (“no show” fee) and be given opportunities to request 
the appointment be canceled or rescheduled with each appointment reminder.
7.
Benefits
Participants in the control group will receive information on the importance of postpartum care 
and transitioning to primary care after their delivery.
Participants in the intervention group will receive a bundle of interventions designed to increase 
attendance at primary care visits and facilitate the transition of care after their delivery.
The goal and potential benefits to the subjects in this trial is to increase patient engagement and 
connection with their primary care provider, receive recommended health screenings and 
directed counseling, and reduce unscheduled or urgent visits in the postpartum period.
8.
Statistical Analysis
Statistical Methods
Analyses will be performed according to the intention-to-treat principle.
Standard independent, two-sided, two-group comparison testing will be used to compare 
baseline characteristics between the two groups (chi squared tests, t tests, Wilcoxon rank sum 
tests, when appropriate).
The primary outcome will be attendance rates at PCP visit within 4 months after estimated date 
of delivery (captured at time of enrollment), which will be compared between the groups using 
chi squared tests. Relative risks and 95% confidence intervals will be reported. 
Secondary outcomes will include measures of long-term health and health care use after the 
postpartum period. 
Subgroup analyses will be performed by a variety of patient characteristics including gestational 
age at enrollment, prenatal risk factors, morbidity types, patient race-ethnicity, payer, and 
enrollment location. 
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P-value of less than 0.05 will be considered to indicate statistical significance.
Power Calculation
Most study calculations were estimated from the MGH 2020 delivery population. The rates of 
PCP follow-up were estimated from a randomly selected cohort of 50 patients who met the 
inclusion criteria. We plan to recruit patients into the study for a period of 4 months and expect 
1200 unique patients to be at the targeted gestational age during this period. Among these, we 
expect 86% to already have an assigned PCP in the network, leaving roughly 1,032 patients. 
Among these, we estimate that 49% have at least one of the targeted health conditions, leaving 
a target study population of 506 over the 4-month period. Based on previous studies conducted 
at MGH, we expect an 70% willingness to participate in the research, leaving an expected 
recruited population of 354 individuals. Based on our record extraction, we estimate that 15% of 
the targeted study population has a primary care visit within 4 months of delivery. Assuming an 
alpha of 0.05 and a baseline mean of 15%, with this expected sample size and power of 80%, 
our study has a minimum detectable effect size of roughly 13 percentage points (from 15% to 
28%). A previous study found that default scheduling into postpartum care appointments (with 
an OBGYN, not a PCP) increased postpartum care take-up by 24 percentage points; since our 
intervention incorporates defaults and other activating interventions, an MDE of 13 percentage 
points is reasonable.
9.
  Monitoring and Quality Assurance
This is a minimal risk study in which the intervention involves default scheduling of 
appointments and patient messaging. Adverse events are not expected, and there is no 
physiologic plausibility for this intervention to cause any NIH-defined serious adverse events 
(e.g., death, prolonged hospitalization, significant disability).
No interim analyses are planned.
Adverse events will be defined and classified in accordance with NIH guidelines:
Definition of Adverse Events (AE): Any untoward or unfavorable medical occurrence 
in a human subject, including any abnormal sign, symptom, or disease, temporally 
associated with the subject’s participation in the research, whether considered 
related to the subject’s participation in the research or not.
Definition of Serious Adverse Events (SAE): Any AE that (1) results in death, (2) is life-
threatening, (3) results in inpatient hospitalization or prolongation of existing 
hospitalization, (4) results in persistent or significant disability/incapacity, (5) results in a 
congenital anomaly/birth defect, and/or (6) may jeopardize the subject’s health and may 
require medical or surgical intervention to prevent one of the other five outcomes listed 
here.
In the unlikely event an AE or SAE occurs, it will be brought to the PI's attention, and the PI 
will classify the AE/SAE by severity, expectedness, and relatedness, as listed above. All events 
that are both serious and unexpected will be reported to Mass General Brigham's IRB, the NIA 
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PO, and to the NIA Roybal DSMB within 48 hours of the research team's knowledge of the 
SAE. The summary of all other SAEs will be reported to the NIA and to the DSMB quarterly 
unless otherwise specified by the DSMB. Any unanticipated problem, defined as an issue 
related to the research suggesting the research places participants or others at greater risk 
than expected, will be reported to the IRB, the NIA PO, and to the Roybal DSMB within 48 
hours of discovery. If the problem involves death then reporting will occur within 24 hours, and 
this report will include a plan to correct the problem and prevent its occurrence. Any breach of 
PHI will be reported to the PI, who will report to the IRB and NIA PO within 24 hours of 
discovery.
The Roybal DSMB oversight is provided by the Standing Roybal DSMB, which includes the 
members listed: Andrea B. Troxel, ScD (chair); Abby King, PhD; Jerry Gurwitz, MD; Hae-Ra 
Han, PhD, RN, FAAN; Hang Lee, PhD; Ezra Golberstein, PhD; David Kim,  MD PhD; 
Christopher Celano, MD.
DSMB members will have no direct involvement with the study or conflict of interest with the 
investigators or institutions conducting the study. Each member has signed a COI statement 
which includes current affiliations, if any, with pharmaceutical or biotechnology companies 
(e.g., stockholder, consultant), and any other relationship that could be perceived as a conflict 
of interest related to the study and/or associated with commercial interests pertinent to study 
objectives.
Data presented to the DSMB will be deidentified as to protect individual participants’ privacy and 
health information. Should the identity of a deidentified subject need to be  revealed, the DSMB 
request will be reviewed and ultimately at the discretion of the Mass General Brigham IRB.
10.   Privacy and Confidentiality
☒Study procedures will be conducted in a private setting
☒Only data and/or specimens necessary for the conduct of the study will be collected
☒Data collected (paper and/or electronic) will be maintained in a secure location with 
appropriate protections such as password protection, encryption, physical security 
measures (locked files/areas)
☐Specimens collected will be maintained in a secure location with appropriate protections 
(e.g. locked storage spaces, laboratory areas)
☒Data and specimens will only be shared with individuals who are members of the IRB-
approved research team or approved for sharing as described in this IRB protocol
☒ Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password 
protection, using chain-of-custody procedures, etc.)
☒   All electronic communication with participants will comply with Mass General Brigham 
secure communication policies
☒Identifiers will be coded or removed as soon as feasible and access to files linking 
identifiers with coded data or specimens will be limited to the minimal necessary 
members of the research team required to conduct the research
☒All staff are trained on and will follow the Mass General Brigham policies and procedures 
for maintaining appropriate confidentiality of research data and specimens
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☒The PI will ensure that all staff implement and follow any Research Information Service 
Office (RISO) requirements for this research
☒Additional privacy and/or confidentiality protections
The following procedures (as provided by MGB RISO) will be used for sending SMS messages 
via Google Voice:
•
Google Account:
o
A separate account should be created just for the purpose of the effort/study (in 
other words, personal Gmail accounts should not be used) 
o
For the Google Voice portal, make sure you are not using the same password as 
your MGB account and ensure the password is strong. (Minimum of 8 characters, 
alphanumeric, uppercase, lowercase, special character).
▪
Two-factor authentication must be enabled
o
Google account will not be shared
o
The Google account used for Google Voice should not be used for emailing or 
using any other Google Service (i.e., YouTube, Calendar, Contacts, etc.)
o
No credit cards should be added to the Google Account
o
The Google account must be deleted at the end of the study / project
•
Participants will be informed not to send personal or health related information via text
•
Siri will not be integrated with Google Voice
•
Text messages will not address participants by their first name
•
Text messages will be sent through the McLean email within the Google account that is 
created
•
Only phone numbers and a unique subject ID will be stored in Google Voice
o
Log records should be deleted manually after 30 days
•
No PHI or sensitive information will be communicated via text message
o
Content will not include anything where a healthcare condition or diagnosis can 
be inferred
•
Text message history should be deleted from Google Voice account when no longer 
needed (within 30 days)
•
Study staff will track opt-out requests and delete phone numbers from Google Voice as 
necessary
•
Study staff must not communicate with participants via a group text message
•
Access to the portal and overall research must be done from systems that meet MRB 
RISO compliance requirements; encryption, MobileIron (if Smartphone/Tablet), up to 
date malware protection, Crowdstrike.
o
https://rc.partners.org/security/secure-your-computer
•
Participants:
o
Participants will be texted only if they consent
o
Participants should be informed to delete text messages when no longer needed 
and hide text push notifications
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Boersma P. Prevalence of Multiple Chronic Conditions Among US Adults, 2018. Prev 
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2.
Home page | United States Preventive Services Taskforce. Accessed December 15, 2021. 
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3.
Blewett LA, Johnson PJ, Lee B, Scal PB. When a usual source of care and usual provider 
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doi:10.1007/s11606-008-0659-0
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of breast and cervical cancer screening services in a multiethnic community. Arch Intern 
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DeVoe JE, Saultz JW, Krois L, Tillotson CJ. A medical home versus temporary housing: 
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doi:10.1542/peds.2008-3141
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Atlas SJ, Grant RW, Ferris TG, Chang Y, Barry MJ. Patient-physician connectedness and 
quality of primary care. Ann Intern Med. 2009;150(5):325-335. doi:10.7326/0003-4819-
150-5-200903030-00008
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Levine DM, Linder JA, Landon BE. Characteristics of Americans With Primary Care and 
Changes Over Time, 2002-2015. JAMA Internal Medicine. 2020;180(3):463-466. 
doi:10.1001/jamainternmed.2019.6282
8.
NVSS - Birth Data. Published June 14, 2021. Accessed September 1, 2021. 
https://www.cdc.gov/nchs/nvss/births.htm
9.
Prenatal care and tests | Office on Women’s Health. Accessed December 15, 2021. 
https://www.womenshealth.gov/pregnancy/youre-pregnant-now-what/prenatal-care-and-
tests
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Centers for Disease Control and Prevention (CDC). Adult Obesity Facts. Published August 
29, 2017. Accessed February 14, 2018. https://www.cdc.gov/obesity/data/adult.html
11.
Mental Illness. National Institute of Mental Health (NIMH). Accessed December 17, 2021. 
https://www.nimh.nih.gov/health/statistics/mental-illness
12.
Products - Data Briefs - Number 289 - October 2017. Published June 6, 2019. Accessed 
December 17, 2021. https://www.cdc.gov/nchs/products/databriefs/db289.htm
13.
National Diabetes Statistics Report 2020. Estimates of diabetes and its burden in the 
United States. Published online 2020:32.
14.
Sattar N, Greer IA. Pregnancy complications and maternal cardiovascular risk: 
opportunities for intervention and screening? BMJ. 2002;325(7356):157-160. 
doi:10.1136/bmj.325.7356.157
15.
Kim C, Tabaei BP, Burke R, et al. Missed Opportunities for Type 2 Diabetes Mellitus 
Screening Among Women With a History of Gestational Diabetes Mellitus. Am J Public 
Health. 2006;96(9):1643-1648. doi:10.2105/AJPH.2005.065722
16.
Media BKK. Publications & Guidelines | SMFM.org - The Society for Maternal-Fetal 
Medicine. Accessed October 18, 2021. https://www.smfm.org/publications/225-smfm-
statement-implementation-of-the-use-of-antenatal-corticosteroids-in-the-late-preterm-birth-
period-in-women-at-risk-for-preterm-delivery
17.
Yee LM, Simon MA, Grobman WA, Rajan PV. Pregnancy as a “golden opportunity” for 
patient activation and engagement. American Journal of Obstetrics & Gynecology. 
2021;224(1):116-118. doi:10.1016/j.ajog.2020.09.024
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18.
Cohen JL, Daw JR. Postpartum Cliffs—Missed Opportunities to Promote Maternal Health 
in the United States. JAMA Health Forum. 2021;2(12):e214164. 
doi:10.1001/jamahealthforum.2021.4164
19.
Milkman KL, Patel MS, Gandhi L, et al. A megastudy of text-based nudges encouraging 
patients to get vaccinated at an upcoming doctor’s appointment. PNAS. 2021;118(20). 
doi:10.1073/pnas.2101165118
20.
Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl 
J Med. 2018;378(3):214-216. doi:10.1056/NEJMp1712984
21.
Thaler RH, Sunstein CR. Nudge: The Final Edition. Revised edition. Penguin Books; 2021.
22.
Henderson JT, Vesco KK, Senger CA, Thomas RG, Redmond N. Aspirin Use to Prevent 
Preeclampsia and Related Morbidity and Mortality: Updated Evidence Report and 
Systematic Review for the US Preventive Services Task Force. JAMA. 2021;326(12):1192. 
doi:10.1001/jama.2021.8551
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Version: V9.9 created on 02/02/23 - 05:24 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:40 PM 
 
 
Title: Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to 
Improve Chronic Disease Management among Postpartum Women (the Bridge Study)  
Sponsor Name: 
PI Name: Clapp, Mark A  
Protocol #: 2022P001723 
Type: Amendment (AME9)  
Date Received: January 26, 2023  
Signatures 
PI Name: Clapp, Mark A, MD, MPH 
Authenticated: January 26, 2023 
Amendment  
COVID-19 Amendment 
 
Is this amendment ONLY related to research impacted by COVID-19? 
 
Refer to MGB Policy on Conduct of Human Research Activities during COVID-19 Operations for description 
of Amendments which do require prior IRB review and approval.   
⚪  Yes   
◉  No  
 
 
Central IRB Performance Sites  
 
Is this a protocol where the Mass General Brigham IRB is serving as the single IRB (sIRB) for external 
sites/institutions? 
◉  Yes  
 
⚪  No  
 
Would you like to 'Add' a Site? 
⚪  Yes  
 
◉  No  
 
Would you like to 'Remove' a Site? 
⚪  Yes  
 
◉  No  
 
 
Sponsor Amendment 
  
Is there a sponsor amendment number? 
⚪  Yes   
◉  No  
 
 
Change in Protocol Status 
 
Is this a cede protocol or project that was determined to be exempt, not human subjects research or not 
engaged in human subjects research?  
⚪  Yes   
◉  No  
 
 
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Version: V9.9 created on 02/02/23 - 05:24 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:40 PM 
 
 
Do you need to change the overall status of the protocol?  For example, Re-Open to Enrollment or 
indicate that Research Interventions/Assessments Continue after telling the IRB these have ceased. 
⚪  Yes  
 
◉  No  
 
 
  
Briefly describe the proposed changes: 
The protocol is being amended to include a endline survey among participants enrolled in the study. 
Consent to contact patients for the survey was approved as part of the initial IRB approval. This 
amendment adds the survey tool, the administration procedure, and the text of the mail and SMS 
messages that will be used. The study schema was updated to add "and patient survey" in the bottom 
outcomes assessment box. 
There are no changes to the Study Fact Sheet or consent process as this endline survey was already 
included. 
 
  
Provide rationale for the proposed changes: 
An endline survey was planned during the conception of this project, but the final tool was developed 
after the initial study protocol was approved. No individuals that have been enrolled have yet to reach 
the "4 months after due date" follow-up window yet -- the starting time point for the outcomes 
assessment.  
 
  
Will the proposed change(s) significantly alter the risk to benefit assessment the IRB relied upon to approve 
the protocol? 
⚪  Yes   
◉  No  
 
 
  
Will the proposed change(s) significantly affect the integrity of the protocol? 
⚪  Yes   
◉  No  
 
 
Informed Consent 
 
Do the changes require a revision to the consent form? 
⚪  Yes   
◉  No  
 
Protocol Key Areas  
Choose up to 3 key areas below that describes this research protocol. Once you select a key area, you may 
be able to select additional specialty areas. 
☐ Anesthesiology 
 
☐ Colon and Rectal surgery 
 
☐ Dermatology 
 
☐ Emergency Medicine 
 
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☑ 
Family Medicine 
Choose all that apply: 
☐ Adolescent Medicine 
☐ Geriatric Medicine 
☐ Hospice & Palliative Medicine 
☐ Pain Medicine 
☐ Sleep Medicine 
☐ Sports Medicine 
☐ Not Applicable 
 
☑ 
Internal Medicine 
Choose all that apply: 
☐ Adolescent Medicine  
☐ Adult Congenital Heart Disease  
☐ Advanced Heart Failure & Transplant 
☐ Cardiology 
☐ Cardiovascular Disease 
☐ Clinical Cardiac Electrophysiology 
☐ Critical Care Medicine 
☐ Endocrinology, Diabetes & Metabolism 
☐ Gastroenterology  
☐ Geriatric Medicine 
☐ Hematology 
☐ Hospice & Palliative Medicine 
☐ Infectious Disease 
☐ Interventional Cardiology 
☐ Medical Oncology 
☐ Nephrology 
☐ Neurocritical Care 
☐ Pulmonary Disease 
☐ Rheumatology 
☐ Sleep Medicine 
☐ Sports Medicine 
☐ Transplant Hepatology 
☐ Not Applicable 
 
☐ Medical Genetics and Genomics 
 
☐ Neurological Surgery 
 
☐ Nuclear Medicine 
 
☑ 
Obstetrics and Gynecology 
Choose all that apply: 
☐ 
Complex Family Planning 
☐ 
Critical Care Medicine 
☐ 
Female Pelvic Medicine & Reconstructive Surgery 
☐ 
Gynecologic Oncology 
☐ 
Hospice & Palliative Medicine 
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Downloaded date: 04/16/24 - 03:40 PM 
 
 
☑ Maternal-Fetal Medicine 
☐ 
Reproductive Endocrinology & Infertility 
☐ 
Not Applicable 
 
☐ Ophthalmology 
 
☐ Orthopedic Surgery 
 
☐ Otolaryngology: Head & Neck Surgery 
 
☐ Pathology 
 
☐ Pediatrics 
 
☐ Physical Medicine and Rehabilitation 
 
☐ Plastic Surgery 
 
☐ Preventive Medicine 
 
☐ Psychiatry and Neurology 
 
☐ Radiology 
 
☐ Surgery 
 
☐ Thoracic Surgery 
 
☐ Urology 
Remuneration  
 
Will subjects be paid or receive any type of remuneration / compensation for their time and expenses? 
◉  Yes  
 
⚪  No  
 
 
Payment for Participation in Research 
  
Indicate the type and total amount of compensation for completion of the study. 
☐ Cash 
 
☐ Check 
 
☑ 
Gift Certificate 
Amount e.g., $50, enter 50.00 
20 
 
☑ 
Other 
 
Amount e.g., $200, enter 200.00 
25 
Explain: 
An additional $25 gift card is being provided to individuals who opt to complete the end line 
survey. 
  
NOTE: Payments to subjects must be made by check if payment involves a one-time payment of 
greater than $50 OR multiple payments of any amount.  See policies Payments to Human 
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Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:40 PM 
 
 
Subjects for Participation in Research and Cash Control and Accountability for Payments to 
Human Subjects for Participation in Research. 
 
Reimbursement for Expenses Related to Participation in Research 
 
If there is not a set amount for meals, parking, and transportation, then estimate or enter the maximum 
amount budgeted per subject.  
☐ Meals 
 
☐ Parking 
 
☐ Transportation 
 
☐ Other 
Instruments / Questionnaires  
 
  
Will the research involve the development of instruments, questionnaires, surveys, interviews, and/or focus 
group topics? 
⚪  Yes   
◉  No  
 
 
Will the research involve the use of instruments, questionnaires, surveys, interviews, and/or focus group 
topics? 
◉  Yes  
 
⚪  No  
 
 
  
List of Instruments / Questionnaires / Surveys / Interviews / Focus Group Topics 
 
 
Enter the name of each of the instruments, questionnaires, surveys, interviews and/or focus 
group topics. Upload each of the instruments, questionnaires, surveys, interviews and/or focus group 
topics to the Attachments page.  Do not list any that are under development. 
Baseline Survey  
 
 
Enter the name of each of the instruments, questionnaires, surveys, interviews and/or focus 
group topics. Upload each of the instruments, questionnaires, surveys, interviews and/or focus group 
topics to the Attachments page.  Do not list any that are under development. 
Endline Survey  
Attachments 
 
Name 
Mode 
Detailed Protocol_012623_v1-5_clean (Detailed Protocol)  
Electronic  
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Version: V9.9 created on 02/02/23 - 05:24 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:40 PM 
 
 
Name 
Mode 
Bridge Survey Endline _ 012623 (Instrument/Questionnaire)  
Electronic  
Study Schema_012623 (Schema)  
Electronic  
Survey Email Text (Document for review)  
Electronic  
Survey Remider SMS Text (Document for review)  
Electronic  
 
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Version 2021.06.10
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Institutional Review Board
Intervention/Interaction Detailed Protocol
Principal Investigator:
Mark Clapp, MD MPH (MGH), Jessica Cohen, PhD (HSPH)
Project Title:
Bridging the Gap from Postpartum to Primary Care: A Behavioral 
Science Informed Intervention to Improve Chronic Disease Management 
among Postpartum Women
Version Date:
01/26/2023
Version Name/Number:
v1.5
1.
 Background and Significance
Burden of Chronic Disease and the Role of Primary Care
Chronic health conditions affect millions of people in the US each year. In 2018, 51.8% of adults 
had at least 1 chronic condition, and 27.2% had multiple conditions.1 The prevalence of chronic 
disease was higher in women compared to men, older adults (87.6% in adults ≥65 years old), 
and people with public insurance.1 Many chronic conditions, by their nature, develop over time 
and have risk factors that can be identified prior to the onset of disease. Strong evidence 
underpins prevention strategies for many conditions, which are advanced by the US 
Preventative Services Taskforce.2 While the long-term health of a patient is the responsibility of 
an entire health system, primary care providers (PCPs) provide an integral role in preventing, 
screening for, and managing disease across the lifespan. Studies have shown the health 
benefits of receiving regular care under a PCP.3–6
Despite the known benefits of having an identifiable usual source of care and the value of health 
care maintenance, the percent of the population with a PCP has been decreasing over time.7 
Consistently, adults who are younger (age 20-40 years) have the lowest rates of primary care 
use. In 2015, 44% and 36% of 20- and 30-year-olds had no identifiable source of primary care.7 
The proportion without primary care were also higher among racial/ethnic minority populations 
and among those who had less education, lower incomes, and no known comorbidities.7 The 
number of adults and the time elapsed without regular primary care follow-up can be considered 
missed opportunities to improve a patient’s current and long-term health. The disproportionate 
lack of primary care among certain subgroups of the population, often groups who already have 
worse health outcomes, only serves to widen the pre-existing disparities.
Pregnancy as a Window to Future Health
In the US, 98.2% of pregnant women receive some form of prenatal care, with the average 
patient having >10 visits during their pregnancy.8 During a pregnancy, women are screened for 
pre-existing and pregnancy-related conditions.9 In adults ages 18-39, the prevalence of obesity, 
hypertension, prediabetes/diabetes, and mental illness are estimated at 39%, 7.5%, 28%, 25%, 
respectively.10–13 Even for those who have no prior identified comorbidities, the most common 
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pregnancy-related conditions—pregnancy-related hypertension and gestational diabetes (8% 
and 10% of pregnancies, respectively)—indicate a predisposition to or confer health risks that 
persist as women age. For example, over 25% of women with gestational diabetes will develop 
Type 2 diabetes mellitus, and women with pre-eclampsia have more than a two-fold risk of 
significant cardiovascular disease later in life.14,15 For these reasons, pregnancy is often 
considered a “window” into a woman’s future health and presents a unique opportunity to 
optimize a woman’s health status early in her life when she otherwise may not have been 
engaged in care.16 
Pregnancy as on Opportunity for Engagement with a Long-term Care Provider
Pregnancy is a period when women are highly engaged and active participants in their health 
care.17 It has been described as a “golden opportunity” to motivate women towards positive 
health behaviors, including prevention and management of chronic disease. However, women 
often fall off a “postpartum cliff” of health system engagement after the early postpartum 
period.18 A range of systemic, financial, and behavioral barriers often prevents patients from 
effectively transitioning to primary care. Postpartum women are often simply told to follow-up 
with their PCP without much information regarding the importance of this follow up care, without 
assistance in scheduling an appointment (or identifying a PCP if they don’t have one), and often 
without a direct transfer of relevant health information or accountability across providers. 
Postpartum women are left largely on their own to navigate this transition to primary care and, in 
particular, to navigate it at a time when they face the high cognitive and physical demands of 
caring for an infant. At this time of limited cognitive bandwidth, the importance of continuity of 
care for chronic conditions and active engagement in one’s longer-term health and wellbeing is 
unlikely to be salient and top-of-mind. These critical moments of unsupported health care 
transition can exacerbate pre-existing disparities in health and health care, with patients who 
are the least able to navigate the US health care system most likely to fall through the cracks.  
Momentum is building in US health and social safety net policy to facilitate healthy transitions 
from pregnancy to parenthood. For example, federal and state initiatives to expand pregnancy-
related Medicaid coverage from 60 days to one year postpartum have been proposed, and 
access to paid family leave is increasing. However, very little evidence exists on effective and 
cost-effective approaches to facilitating transitions to primary care and management of chronic 
diseases in the postpartum year.  
2.
Specific Aims and Objectives 
The objective of the proposed study is to increase patient engagement in primary care after the 
immediate postpartum period for women with pregnancy-associated conditions that convey a 
long-term health risk. Specifically, we aim to evaluate the efficacy of an intervention bundle 
(automatic scheduling of PCP appointment after delivery, salient labeling, and appointment 
reminder nudges) to increase patient attendance at a primary care provider appointment (within 
4 months of delivery for women with or at risk for obesity, diabetes, hypertension, and/or a 
mental health condition. 
Specific Aims:
1) Test the efficacy of an intervention bundle (patient-tailored health information, automatic 
scheduling of PCP appointment after delivery, and appointment reminder nudges) to 
increase patient attendance at a primary care provider appointment within 4 months of 
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delivery for women with obesity, diabetes, hypertension, and/or a mental health 
condition
2) Test the efficacy of the intervention bundle to improve compliance with the condition-
specific, guideline-based health screenings
3) Test the efficacy of the intervention bundle to reduce unscheduled or urgent encounters 
(e.g., emergency department visits) within the health system
3.
General Description of Study Design
We will conduct a randomized controlled trial comparing this intervention bundle to the receipt of 
generic information on the importance of primary care follow-up after delivery.  
Women will be randomized with equal probability into either a treatment or control arm. The 
intervention combines several features designed to target reasons for low take-up of primary 
care among postpartum women (see Logic Model). We leverage the potential value of 
defaults/opt-out, salient labels, and reminders to encourage use of primary care within 4 months 
of delivery. Women in both the intervention and control arms will receive information via MGH’s 
patient portal toward the end of the pregnancy regarding the importance of transitions to primary 
care in the postpartum year. This information will be similar to, but reinforcing, the information 
they would receive from their obstetrician about following up with their primary care physician. In 
addition to this initial message, women in the treatment arm will receive the following 
intervention components, developed based on recent evidence regarding behavioral science 
approaches to activating health behaviors:19–21
➢
Targeted messages about the importance and benefits of primary care. 
➢
Default scheduling into a primary care appointment at approximately 3-4 months after 
delivery. The patient will be scheduled for a primary care visit with their assigned primary 
care provider in the Mass General Brigham system. They will be informed of the option to 
cancel the appointment, change the appointment day/time, or change the care provider 
either through the patient portal). 
➢
Reminders about the appointment and importance of follow up primary care at 2-4 points 
during the postpartum period via the patient portal. 
➢
Tailored language in the reminders based on recent evidence from behavioral science about 
the most effective approaches to increasing take-up. For example, messages will inform the 
patient that an appointment has been reserved for them at their doctor. 
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The Logic Framework that underpins the basis for this study is shown below:
 
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The flow of study activities is shown below: 
4.
Subject Selection
Pregnant patients receiving prenatal care at Massachusetts General Hospital (MGH) will be 
targeted for recruitment. MGH conducts approximately 3500 deliveries per year, with roughly 
one-third of patients identifying as non-white and 35% of pregnancies covered by Medicaid.
Approximately 49% of the clinic population may ultimately be eligible to be approached.
The eligibility criteria include:
•
Estimated date of delivery and the following 4-month postpartum outcome 
assessment window completed prior to study end date
•
Currently pregnant or within 2 weeks of estimated date of delivery
•
Have one or more of the following conditions: 
o
Chronic hypertension
o
Hypertensive disorders of pregnancy or risk factors for hypertensive disorders 
of pregnancy per the USPTF aspirin prescribing guidelines (e.g., history of 
pre-eclampsia, kidney disease, multiple gestation, autoimmune disease)22
o
Type 1 or 2 diabetes
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o
Gestational diabetes
o
Obesity (body mass index ≥30 kg/m2)
o
Depression or anxiety disorder 
•
Have a primary care provider listed in the patient’s medical record 
•
Receive obstetric care at an MGH-affiliated outpatient prenatal clinic
•
Has access to and be enrolled in the electronic health record patient portal and 
consents to be contacted via these modalities
•
Able to read/speak English or Spanish language
•
Age ≥18 years old
•
Not diagnosed with or undergoing evaluation for stillbirth/fetal demise
All women, regardless of race/ethnicity, who meet the eligibility criteria will be included. In 2019, 
3,789 women gave birth at the study institution, of whom 57% were white, 7% were black, 12% 
were Asian, 18% were Hispanic, and 6% declined to report their race/ethnicity. A similar 
distribution is expected for this study.
The study will distribute materials in English and Spanish languages. This encompasses >95% 
of patients who deliver at the study institution.
5.
Subject Enrollment
This study will rely on recruiting for research through Patient Gateway and follow the IRB 
guidance and DHeC Research Checklist and training for this process.
In the month prior to the start of enrollment, all potentially eligible individuals (based on the 
criteria above) will be identified using RPDR and Epic Reporting search queries. This list (the 
“potentially eligible” list) will be provided to the DHeCare Research Team to build an RSH 
Record in Epic. This list will be updated monthly to identify newly eligible individuals (e.g., new 
diagnosis of gestational diabetes or new patient transferring into the practice) during the 
recruitment months and fed back to the DHeCare team to update “potentially eligible” list.
Once built and each month during recruitment phase, the study’s research coordinator (not 
study investigators) will send the IRB-approved Research Invitation Letter to patients who are 
eligible, not already enrolled, and have not declined to be sent research notifications through the 
portal. The Research Letter will employ an opt-out approach, asking individuals who do not wish 
to be approached in clinic or remotely to respond via PG messaging, email, or phone within 2 
weeks of receipt of the letter. Those who have “read” the letter and not opted out after 2 weeks 
will be moved from the “potentially eligible” list to the “waiting to be approached” list in the study 
workflow.
During recruitment months, the study coordinator will keep a log of patient’s upcoming 
appointments for those on the “waiting to be approached” list. They will then attempt to 
approach individuals for enrollment when they present for an in-person encounters (preferred). 
Patients will ideally be approached between 32-36 weeks of gestation, when feasible; however, 
priority will be given to patients at the latest gestation. For those Spanish-speaking patients, a 
hospital-based interpreter will be used when approaching/consenting patients.
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The study staff will introduce the study and review the purpose of the study, the nature of the 
subject’s participation, the possible risks and discomforts associated with participation, the 
potential benefits of participation, a statement of the voluntary nature of participation, and a 
description of the mechanisms used to ensure confidentiality. 
All patients will receive study-related messages through Patient Gateway. In addition, patients 
will be asked if they would be willing to receive no more than 5 SMS messages to their personal 
cell phone during the first 4 months of the postpartum period. The study staff will review the 
specific concerns and risks about receiving unencrypted text messaging communications, as 
outlined by the MGB IRB. 
A waiver of documentation of informed consent is requested, as the study presents no more 
than minimal risk of harm to subjects and involves no procedures for which written consent is 
normally required outside of the research context. Verbal consent will be obtained for 1) overall 
study participation and 2) optional SMS message participation, separately. Verbal consent will 
be obtained from both in-person and phone recruitment efforts.
A Study Fact Sheet, which summarizes the study details, risks, and benefits, will be provided to 
all subjects who are approached, either in-person, by mail, or electronically. This Study Fact 
Sheet also includes information supplied by the MGB IRB specifically related to the concerns 
and risks of receiving unencrypted SMS/text messages.
For tracking verbal consent, the study staff will keep a detailed log in REDCap documenting:
1) name of study staff performing consent,
2) date of attempted approach,
3) the method of attempted approach (in-person or via phone),
4) use of Spanish interpreter (yes/no),
5) subject agreement to be approached (agree/disagree),
6) attestation to full review of the study procedures/risks/benefits with the subject, as would 
be done during the process of reviewing a written consent form, 
7) attestation to review of supplemental consent to receive unencrypted SMS messages 
with the subject,
8) subject overall study participation status (enrolled, declined, deferred – agrees to be 
recontacted, deferred – wishes not to be recontacted),
9) if enrolled, unencrypted SMS text messaging participation (consents, declines),
10) attestation to Study Fact Sheet provided,
11) method by which Study Fact Sheet was provided (in-person, mail, electronic),
12) date in which Study Fact Sheet was provided (in-person, mail, electronic).
6.
STUDY PROCEDURES
The RA will keep a detailed log of all patients in the practice, if they are eligible, if they have 
been approached, and if they consented.
For those that agree to be enrolled, patients will be asked to complete a baseline survey to 
obtain voluntarily reported information on their demographics, socioeconomic status, health care 
visit history, and primary care provider. Patients will also be asked to consent to being contacted 
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by the research team via Patient Gateway messaging. A $20 gift card will be given at the time of 
enrollment for those that complete the questionnaire and receive the information sheet.
Randomization will occur via a prespecified random allocation sequence within strata. Within 
each stratum, the PIs will generate a random sequence of treatment-control allocation prior the 
enrollment of subjects. Then, as patients within strata are enrolled, they will be assigned to the 
treatment arm associated with that enrollment number. 
Control Group
Approximately 2 weeks before a patient’s estimated due date (EDD) or as soon as enrolled if 
this date has passed, the patient will be sent information via the Patient Gateway on the 
importance of postpartum care and follow-up with their PCP.
Intervention Group
1.
Tailored Information:
Approximately 2-4 weeks prior to the EDD (or later for those who are enrolled beyond 38 
weeks gestation or postnatally), the patient will be sent an information via the Patient 
Gateway on the importance of postpartum care and follow-up with their PCP, which also 
includes the name and phone number of their primary care provider. 
2.
Scheduled PCP Appointment:
Between 2-3 weeks after their delivery, the RA will call the patient’s PCP office and 
make an appointment for them between 3-4 months after delivery based on the 
scheduling preferences obtained in the initial survey.
3.
Targeted Appointment Message with Salient Labeling:
After the PCP appointment has been made, the patient will be sent a Patient Gateway 
message saying that a PCP appointment has been reserved for them with the 
date/time/location information.
For those consenting to receive SMS messages, an unencrypted text message will also 
be sent simultaneously.
4.
Nudge Reminders: 
Patient Gateway messages will be sent at approximately 4-8 weeks (goal: 4 weeks) and 
1-4 week (goal: 1 week) prior to their PCP appointment, reminding a patient of their 
upcoming appointment. 
For those consenting to receive SMS messages, an unencrypted text message will also 
be sent simultaneously.
5.
Facilitated PCP Communication:
A study staff member will send the patient’s PCP an Epic Inbasket message that the 
patient 1) is recently postpartum, 2) has or developed health conditions that need long-
term management, and 3) has been scheduled (or attempted to be scheduled) for a 
follow-up visit.
All messages will be made available in English and Spanish.
The text for these Patient Gateway messages is included in the submission. At the end of each 
patient message, patients will be given the opportunity to stop receiving study-related messages 
by emailing or calling the study staff. “Opt out” requests will be logged and patients removed 
from future planned study-related contact. 
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The text for 3 SMS messages is included in the submission. SMS messages will be sent via 
Google Voice. We will follow standard recommendations from the MGB Research Information 
Security for using this system (included under Privacy and Confidentiality section).
Outcome Assessment
1. EHR Review
The study team will review the patient’s EHR record for the primary and secondary outcome 
assessments. Patients will be asked to consent to have records reviewed up to 2 years after the 
date of their delivery to allow for long-term effects of the intervention on primary care use and 
health status. 
2. Endline Survey
After 4 months from their established due date (EDD), a patient will be eligible to participate the 
endline survey. The goal timing for the survey completion is 4-6 months after the EDD, but 
patients will remain eligible for up to one year. 
The survey will be administered through REDCap. Study participants will be emailed a unique 
link to complete the survey. Consent to be contacted for this survey will be obtained at the time 
of the subject’s enrollment in the trial. The patient’s email address for contact is verified at the 
time of study enrollment. 
Subjects will be asked to complete a 15-20-minute survey on their care after their delivery. They 
will be reminded that all questions are optional and that responses will be linked to their study 
record; however, no responses will be entered into the electronic health record or become part 
of their permanent medical record. Participants who complete the survey will be offered a $25 
gift card for their participation, which they will be informed of prior to starting the survey. There is 
no penalty for not completing the survey.
If there is no response within approximately 1-2 weeks, the subject will be emailed the link again 
with a reminder to complete the survey. If there is no response within approximately 2-4 weeks 
from the initial email OR the patient does not have a working email address, the subject will be 
called and asked if they would like to complete the survey over the phone. For those that agree, 
the survey text and questions will be read verbatim by a research assistant not affiliated with the 
patient’s clinical care. Individuals who decline to participate in the survey over the phone or 
cannot be reached will be marked as non-respondents.
Patients that consented to receive SMS messages as a part of the study will be sent a text 
message reminder to complete the survey at the same time that emails are sent. No more than 
2 SMS message reminders will be sent to each subject.
Deidentified data from this project may be shared outside of MGB with the study funders (J-
PAL/NBER/NIA) for data sharing and reproducibility requirements and secondary statistical 
analysis. All data will be stripped of patient identifiers, per IRB guidance. No data will be shared 
without a formal Data Use Agreement with MGB.
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6.
Risks and Discomforts
There are minimal risks to participants. 
Patients will be reassured that nonparticipation will not affect clinical care. Patients will also be 
informed that the researchers with whom they will interact (e.g., during consent, face-to-face, 
during telephone interviews) are not health care providers. Participants will be consistently 
reminded that responses to any queries deemed sensitive or uncomfortable (e.g., country of 
origin/immigration status, income, previous history of abortion) should be considered optional, 
and they may decline to answer any question(s) and can refuse to continue the study at any 
point. Participants will be reassured that neither their opportunities for continued health care nor 
their relationships with health care providers will be jeopardized by study participation.
Health information collected as part of this study will be stored in REDCap. No identifiable data 
will be stored or downloaded on any personal or unauthorized computers. Study staff will 
access the data on institutionally purchased and managed computers that operate behind the 
health system’s security and firewall protections. Only the MGH study staff will have access to 
the identifiable data set. Once the study is completed, data will be deidentified such that it can 
be analyzed without risk of a breach of privacy or confidentiality. Any data that is shared outside 
of MGH will require a data use authorization.
Although we will make every effort to protect participant privacy and confidentiality, it is possible 
that participants' involvement in the study could become known to others. For those in the 
intervention group, we will be sending personalized messages via the patient portal; for those 
providing additional consent, we will be sending unencrypted SMS messages that will not 
contain any personal protected health information. There is the rare possibility that study 
participation or health information could become known to others despite the use of firewalls, 
password protection, and other security measures. Standard procedures, as outlined by the 
MGB Research Information Security Office, will be followed to reduce this risk.
Individuals in the intervention group will be scheduled for an appointment with a primary care 
doctor. There is the possibility that this visit may result in a charge/cost for the patient. Under 
the Affordable Care Act, commercial health plans are required to cover an annual Preventive 
Health Exam at no cost to the patient (no co-payment, co-insurance or deductible). MassHealth 
also covers these visits without cost-sharing. However, if this visit turns or scheduled as into a 
“sick” or “disease management” visit, the patient may be billed for some or all aspects of the 
services provided, depending on their insurer. We will provide directions for patients on how to 
to contact their insurers or PCP’s office prior to the visit to inquire about potential cost-sharing 
and/or deductibles. Patients will also be advised that some clinics may penalize individuals for 
not showing to a scheduled appointment (“no show” fee) and be given opportunities to request 
the appointment be canceled or rescheduled with each appointment reminder.
7.
Benefits
Participants in the control group will receive information on the importance of postpartum care 
and transitioning to primary care after their delivery.
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Participants in the intervention group will receive a bundle of interventions designed to increase 
attendance at primary care visits and facilitate the transition of care after their delivery.
The goal and potential benefits to the subjects in this trial is to increase patient engagement and 
connection with their primary care provider, receive recommended health screenings and 
directed counseling, and reduce unscheduled or urgent visits in the postpartum period.
8.
Statistical Analysis
Statistical Methods
Analyses will be performed according to the intention-to-treat principle.
Standard independent, two-sided, two-group comparison testing will be used to compare 
baseline characteristics between the two groups (chi squared tests, t tests, Wilcoxon rank sum 
tests, when appropriate).
The primary outcome will be attendance rates at PCP visit within 4 months after estimated date 
of delivery (captured at time of enrollment), which will be compared between the groups using 
chi squared tests. Relative risks and 95% confidence intervals will be reported. 
Secondary outcomes will include measures of long-term health and health care use after the 
postpartum period. 
Subgroup analyses will be performed by a variety of patient characteristics including gestational 
age at enrollment, prenatal risk factors, morbidity types, patient race-ethnicity, payer, and 
enrollment location. 
P-value of less than 0.05 will be considered to indicate statistical significance.
Power Calculation
Most study calculations were estimated from the MGH 2020 delivery population. The rates of 
PCP follow-up were estimated from a randomly selected cohort of 50 patients who met the 
inclusion criteria. We plan to recruit patients into the study for a period of 4 months and expect 
1200 unique patients to be at the targeted gestational age during this period. Among these, we 
expect 86% to already have an assigned PCP in the network, leaving roughly 1,032 patients. 
Among these, we estimate that 49% have at least one of the targeted health conditions, leaving 
a target study population of 506 over the 4-month period. Based on previous studies conducted 
at MGH, we expect an 70% willingness to participate in the research, leaving an expected 
recruited population of 354 individuals. Based on our record extraction, we estimate that 15% of 
the targeted study population has a primary care visit within 4 months of delivery. Assuming an 
alpha of 0.05 and a baseline mean of 15%, with this expected sample size and power of 80%, 
our study has a minimum detectable effect size of roughly 13 percentage points (from 15% to 
28%). A previous study found that default scheduling into postpartum care appointments (with 
an OBGYN, not a PCP) increased postpartum care take-up by 24 percentage points; since our 
intervention incorporates defaults and other activating interventions, an MDE of 13 percentage 
points is reasonable.
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9.
  Monitoring and Quality Assurance
This is a minimal risk study in which the intervention involves default scheduling of 
appointments and patient messaging. Adverse events are not expected, and there is no 
physiologic plausibility for this intervention to cause any NIH-defined serious adverse events 
(e.g., death, prolonged hospitalization, significant disability).
No interim analyses are planned.
Adverse events will be defined and classified in accordance with NIH guidelines:
Definition of Adverse Events (AE): Any untoward or unfavorable medical occurrence 
in a human subject, including any abnormal sign, symptom, or disease, temporally 
associated with the subject’s participation in the research, whether considered 
related to the subject’s participation in the research or not.
Definition of Serious Adverse Events (SAE): Any AE that (1) results in death, (2) is life-
threatening, (3) results in inpatient hospitalization or prolongation of existing 
hospitalization, (4) results in persistent or significant disability/incapacity, (5) results in a 
congenital anomaly/birth defect, and/or (6) may jeopardize the subject’s health and may 
require medical or surgical intervention to prevent one of the other five outcomes listed 
here.
In the unlikely event an AE or SAE occurs, it will be brought to the PI's attention, and the PI 
will classify the AE/SAE by severity, expectedness, and relatedness, as listed above. All events 
that are both serious and unexpected will be reported to Mass General Brigham's IRB, the NIA 
PO, and to the NIA Roybal DSMB within 48 hours of the research team's knowledge of the 
SAE. The summary of all other SAEs will be reported to the NIA and to the DSMB quarterly 
unless otherwise specified by the DSMB. Any unanticipated problem, defined as an issue 
related to the research suggesting the research places participants or others at greater risk 
than expected, will be reported to the IRB, the NIA PO, and to the Roybal DSMB within 48 
hours of discovery. If the problem involves death then reporting will occur within 24 hours, and 
this report will include a plan to correct the problem and prevent its occurrence. Any breach of 
PHI will be reported to the PI, who will report to the IRB and NIA PO within 24 hours of 
discovery.
The Roybal DSMB oversight is provided by the Standing Roybal DSMB, which includes the 
members listed: Andrea B. Troxel, ScD (chair); Abby King, PhD; Jerry Gurwitz, MD; Hae-Ra 
Han, PhD, RN, FAAN; Hang Lee, PhD; Ezra Golberstein, PhD; David Kim,  MD PhD; 
Christopher Celano, MD.
DSMB members will have no direct involvement with the study or conflict of interest with the 
investigators or institutions conducting the study. Each member has signed a COI statement 
which includes current affiliations, if any, with pharmaceutical or biotechnology companies 
(e.g., stockholder, consultant), and any other relationship that could be perceived as a conflict 
of interest related to the study and/or associated with commercial interests pertinent to study 
objectives.
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Data presented to the DSMB will be deidentified as to protect individual participants’ privacy and 
health information. Should the identity of a deidentified subject need to be  revealed, the DSMB 
request will be reviewed and ultimately at the discretion of the Mass General Brigham IRB.
10.   Privacy and Confidentiality
☒Study procedures will be conducted in a private setting
☒Only data and/or specimens necessary for the conduct of the study will be collected
☒Data collected (paper and/or electronic) will be maintained in a secure location with 
appropriate protections such as password protection, encryption, physical security 
measures (locked files/areas)
☐Specimens collected will be maintained in a secure location with appropriate protections 
(e.g. locked storage spaces, laboratory areas)
☒Data and specimens will only be shared with individuals who are members of the IRB-
approved research team or approved for sharing as described in this IRB protocol
☒ Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password 
protection, using chain-of-custody procedures, etc.)
☒   All electronic communication with participants will comply with Mass General Brigham 
secure communication policies
☒Identifiers will be coded or removed as soon as feasible and access to files linking 
identifiers with coded data or specimens will be limited to the minimal necessary 
members of the research team required to conduct the research
☒All staff are trained on and will follow the Mass General Brigham policies and procedures 
for maintaining appropriate confidentiality of research data and specimens
☒The PI will ensure that all staff implement and follow any Research Information Service 
Office (RISO) requirements for this research
☒Additional privacy and/or confidentiality protections
The following procedures (as provided by MGB RISO) will be used for sending SMS messages 
via Google Voice:
•
Google Account:
o
A separate account should be created just for the purpose of the effort/study (in 
other words, personal Gmail accounts should not be used) 
o
For the Google Voice portal, make sure you are not using the same password as 
your MGB account and ensure the password is strong. (Minimum of 8 characters, 
alphanumeric, uppercase, lowercase, special character).
▪
Two-factor authentication must be enabled
o
Google account will not be shared
o
The Google account used for Google Voice should not be used for emailing or 
using any other Google Service (i.e., YouTube, Calendar, Contacts, etc.)
o
No credit cards should be added to the Google Account
o
The Google account must be deleted at the end of the study / project
•
Participants will be informed not to send personal or health related information via text
•
Siri will not be integrated with Google Voice
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•
Text messages will not address participants by their first name
•
Text messages will be sent through the McLean email within the Google account that is 
created
•
Only phone numbers and a unique subject ID will be stored in Google Voice
o
Log records should be deleted manually after 30 days
•
No PHI or sensitive information will be communicated via text message
o
Content will not include anything where a healthcare condition or diagnosis can 
be inferred
•
Text message history should be deleted from Google Voice account when no longer 
needed (within 30 days)
•
Study staff will track opt-out requests and delete phone numbers from Google Voice as 
necessary
•
Study staff must not communicate with participants via a group text message
•
Access to the portal and overall research must be done from systems that meet MRB 
RISO compliance requirements; encryption, MobileIron (if Smartphone/Tablet), up to 
date malware protection, Crowdstrike.
o
https://rc.partners.org/security/secure-your-computer
•
Participants:
o
Participants will be texted only if they consent
o
Participants should be informed to delete text messages when no longer needed 
and hide text push notifications
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12.   References
1.
Boersma P. Prevalence of Multiple Chronic Conditions Among US Adults, 2018. Prev 
Chronic Dis. 2020;17. doi:10.5888/pcd17.200130
2.
Home page | United States Preventive Services Taskforce. Accessed December 15, 2021. 
https://www.uspreventiveservicestaskforce.org/uspstf/
3.
Blewett LA, Johnson PJ, Lee B, Scal PB. When a usual source of care and usual provider 
matter: adult prevention and screening services. J Gen Intern Med. 2008;23(9):1354-1360. 
doi:10.1007/s11606-008-0659-0
4.
O’Malley AS, Mandelblatt J, Gold K, Cagney KA, Kerner J. Continuity of care and the use 
of breast and cervical cancer screening services in a multiethnic community. Arch Intern 
Med. 1997;157(13):1462-1470.
5.
DeVoe JE, Saultz JW, Krois L, Tillotson CJ. A medical home versus temporary housing: 
the importance of a stable usual source of care. Pediatrics. 2009;124(5):1363-1371. 
doi:10.1542/peds.2008-3141
6.
Atlas SJ, Grant RW, Ferris TG, Chang Y, Barry MJ. Patient-physician connectedness and 
quality of primary care. Ann Intern Med. 2009;150(5):325-335. doi:10.7326/0003-4819-
150-5-200903030-00008
7.
Levine DM, Linder JA, Landon BE. Characteristics of Americans With Primary Care and 
Changes Over Time, 2002-2015. JAMA Internal Medicine. 2020;180(3):463-466. 
doi:10.1001/jamainternmed.2019.6282
8.
NVSS - Birth Data. Published June 14, 2021. Accessed September 1, 2021. 
https://www.cdc.gov/nchs/nvss/births.htm
9.
Prenatal care and tests | Office on Women’s Health. Accessed December 15, 2021. 
https://www.womenshealth.gov/pregnancy/youre-pregnant-now-what/prenatal-care-and-
tests
10.
Centers for Disease Control and Prevention (CDC). Adult Obesity Facts. Published August 
29, 2017. Accessed February 14, 2018. https://www.cdc.gov/obesity/data/adult.html
11.
Mental Illness. National Institute of Mental Health (NIMH). Accessed December 17, 2021. 
https://www.nimh.nih.gov/health/statistics/mental-illness
12.
Products - Data Briefs - Number 289 - October 2017. Published June 6, 2019. Accessed 
December 17, 2021. https://www.cdc.gov/nchs/products/databriefs/db289.htm
13.
National Diabetes Statistics Report 2020. Estimates of diabetes and its burden in the 
United States. Published online 2020:32.
14.
Sattar N, Greer IA. Pregnancy complications and maternal cardiovascular risk: 
opportunities for intervention and screening? BMJ. 2002;325(7356):157-160. 
doi:10.1136/bmj.325.7356.157
15.
Kim C, Tabaei BP, Burke R, et al. Missed Opportunities for Type 2 Diabetes Mellitus 
Screening Among Women With a History of Gestational Diabetes Mellitus. Am J Public 
Health. 2006;96(9):1643-1648. doi:10.2105/AJPH.2005.065722
16.
Media BKK. Publications & Guidelines | SMFM.org - The Society for Maternal-Fetal 
Medicine. Accessed October 18, 2021. https://www.smfm.org/publications/225-smfm-
statement-implementation-of-the-use-of-antenatal-corticosteroids-in-the-late-preterm-birth-
period-in-women-at-risk-for-preterm-delivery
17.
Yee LM, Simon MA, Grobman WA, Rajan PV. Pregnancy as a “golden opportunity” for 
patient activation and engagement. American Journal of Obstetrics & Gynecology. 
2021;224(1):116-118. doi:10.1016/j.ajog.2020.09.024
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18.
Cohen JL, Daw JR. Postpartum Cliffs—Missed Opportunities to Promote Maternal Health 
in the United States. JAMA Health Forum. 2021;2(12):e214164. 
doi:10.1001/jamahealthforum.2021.4164
19.
Milkman KL, Patel MS, Gandhi L, et al. A megastudy of text-based nudges encouraging 
patients to get vaccinated at an upcoming doctor’s appointment. PNAS. 2021;118(20). 
doi:10.1073/pnas.2101165118
20.
Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl 
J Med. 2018;378(3):214-216. doi:10.1056/NEJMp1712984
21.
Thaler RH, Sunstein CR. Nudge: The Final Edition. Revised edition. Penguin Books; 2021.
22.
Henderson JT, Vesco KK, Senger CA, Thomas RG, Redmond N. Aspirin Use to Prevent 
Preeclampsia and Related Morbidity and Mortality: Updated Evidence Report and 
Systematic Review for the US Preventive Services Task Force. JAMA. 2021;326(12):1192. 
doi:10.1001/jama.2021.8551
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Bridging the Gap from Postpartum to Primary Care
Endline Survey 
Study PIs: Mark Clapp, MD MPH (MGH); Jessica Cohen, PhD (Harvard) 
Site PI: Mark Clapp, MD MPH (MGH)
Section 0: Survey Text Introduction
This survey is being administered as part of the MGH Bridge Study, which you agreed to 
participate in during or shortly after your pregnancy.
The survey will take approximately 10-20 minutes to complete. Participants who finish the survey 
will receive a $25 Amazon gift card.
Your responses will not be shared with anyone outside of the research team, including your 
doctors or other care team members. They will not be part of your medical record or affect your 
ability to receive care or services at MGH.
Thank you for your help and contribution to this study. Please feel free to contact me with 
questions or concerns about this study.
Mark Clapp, MD MPH
Maternal-Fetal Medicine
Massachusetts General Hospital
bridgestudy@mgh.harvard.edu 
617-724-4531
By clicking PROCEED, I AGREE TO PARTICIPATE IN THIS SURVEY.
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Section 1: Health Insurance
101. Do you currently have health insurance? [Select ONE.]
1. Yes
2. No
88. Don’t know/not sure
99. Prefer not to say
102. What kind of health insurance do you have now? [Check ALL that apply.] 
1.
Health insurance from my job, school, or the job of my spouse or partner
2.
Health insurance from my parents
3.
Health insurance from the state Marketplace, Massachusetts Health Connector, or 
HealthCare.gov
4.
Medicaid or MassHealth
5.
Other government plan or program such as SCHIP/CHIP
6.
Other government plan or program not listed above such as MCH program, indigent 
program or family planning program
7.
TRICARE or other military/veteran health care
8.
Other health insurance, please specify: _______________________
88. Don’t know/not sure
99. Prefer not to say
Section 2: Health
201. In general, how would you describe your current PHYSICAL health? [Select ONE.]
1. Excellent
2. Very good
3. Good
4. Fair
5. Poor
88. Don’t know/not sure
99. Prefer not to answer
202. In general, how would you describe your current PHYSICAL health? [Select ONE.]
1. Excellent
2. Very good
3. Good
4. Fair
5. Poor
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88. Don’t know/not sure
99. Prefer not to answer
203. Have you ever been told by a doctor, nurse, or other health professional that you 
have any of the following conditions? [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. High blood pressure or hypertension
2. Diabetes or high blood sugar
3. Anxiety or depression
4. Overweight or obesity
204. Since giving birth, have you received any of the following treatments or support for your 
emotional or mental health? [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. Counseling or therapy
2. Medication (e.g., 
antidepressants or antianxiety 
medications)
3. Treatment at a hospital or 
emergency department
4. Support group or care from an 
in-home visiting health professional 
(e.g., nurse, midwife, doula)
5. Support from a social worker
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205. Are you currently using any form of birth control to prevent pregnancy? [Select ONE.]
1. Yes
2. No  Go to Next Section
88. Don’t know/not sure
99. Prefer not to answer
206. What kind of birth control are you or your spouse/partner currently using? [Select an 
answer for EACH option.]
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. Have had a hysterectomy or tubes 
tied/blocked
2. Partner has vasectomy
3. IUD (Mirena, ParaGuard, Liletta, 
Kyleena, etc.)
4. Contraceptive implant in the arm 
(Norplant, Implanon, Nexplanon, etc.)
5. Birth control pills, shots/injections, 
patch or vaginal ring
6. Condoms
7. Withdrawal (pulling out) or calendar 
rhythm/cycle-based method
8. Not having sex (abstinence)
9. I cannot get pregnant due to the sex 
of my partner
10. Other method, please specify: 
     Section 3: Primary Health Care 
301. Do you currently have a primary care provider? This is a person who you would see for 
an “annual visit” or “physical” or for care when you are feeling ill. This does NOT refer to an 
urgent care or emergency department. [Select ONE.]
1.
Yes (Go Question to 303)
2.
No 
3.
88. Don’t know/not sure 
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4.
99. Prefer not to say
  
302. Please indicate ALL of the reasons why you do not currently have a primary care 
provider. 
[Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not sure
Prefer 
not to 
say
1. I don’t feel I need one
2. I don’t know how to find one
3. I want to find one but never have time
4. I am worried about the cost
5. I can’t find one that is accepting new patients 
or has appointments available
6. I can’t find one that accepts my insurance
7. I can’t find one that speaks my preferred 
language
8. I can’t find one I can trust
9. Other reason, please specify: 
303. Currently, if you needed to see your primary care provider to help you if you are sick or 
for an annual physical exam, how difficult would it be for you to do the following? 
[Select an answer for EACH option.]
Very 
Difficu
lt
Somewhat 
Difficult
Not 
Difficult 
at All
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. Get an appointment 
soon enough  
2. Find transportation to 
the appointment
3. Afford the cost of the 
visit 
4. Get time off work or 
school to get to the 
appointment
5. Get childcare in order 
to go to the appointment
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304. Since giving birth, how many times have you had an appointment with a primary care 
provider for a routine checkup, “annual” or “physical exam”, or sick care (either an in-person 
visit or a telemedicine visit by phone/video)? This does not include visits to your pregnancy 
care provider (OB/GYN or midwife), an emergency department, or urgent care center. 
[Select ONE]
1.
No appointments with a primary care provider
2.
1 appointment   (Go to Question 307) 
3.
2 or more appointments  (Go to Question 307)
88. Don’t know/not sure
 
99. Prefer not to answer
305.  Please indicate ALL of the reasons you have not had an appointment with a primary 
care provider since delivery. [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. I have already seen a primary care provider 
within the year before my delivery
2. I have an appointment scheduled in the 
future
3. I had no need or reason to see them
4. I was concerned about the cost
5. I don’t know who to make an appointment 
with
6. I couldn’t get an appointment quickly enough
7. I couldn’t get an appointment at a convenient 
time 
8. I was unable to miss work
9. I couldn’t get childcare so I could go to the 
appointment
10. I didn’t have transportation to the 
appointment
11. I didn’t have the energy or feel well enough.
12. I don’t have a primary care doctor
13. Other reason, please specify: 
306. When was the last time you saw a primary care provider for any reason? You can use 
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either months or years in your answer. Your best estimate is fine. 
______ months ago
______ years ago
88. Don’t know/not sure
99. Prefer not to answer
*************************************SKIP TO NEXT SECTION*******************************************
307. How long after giving birth did you see a primary care provider for any reason (either in-
person or virtual)? [Select ONE.]
1. Within the first month after delivery
2. 1 – 2 months after delivery
3. 3 – 4  months after delivery
4. 5 – 6 months after delivery
88. Don’t know/not sure
99. Prefer not to answer
308. Since giving birth, what were the reasons for your visit(s) with the primary care provider? 
This does not include visits to your pregnancy-care provider (OB/GYN or midwife) OR to an 
emergency department or urgent care center [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not sure
Prefer 
not to say
1. Regular checkup (e.g., 
annual visit)
2. Sick care (e.g., for an 
illness, injury, infection, etc.)
3. To talk about a specific 
medical problem (examples: 
high blood pressure or 
diabetes)
4. To discuss a mental 
health concern
5. To discuss and/or get 
birth control
6. To get a prescription
7. To get a vaccine
8. Other reason, please specify: 
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309. Since giving birth, in any of your primary care visits or phone calls, did the doctor or nurse 
ever do any of the following? [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not sure
Prefer 
not to say
1. Asked me questions 
about my mental health and 
wellbeing
2. Prescribed me medication 
or referred me to a 
therapist/psychiatrist for my 
mental health
3. Checked my weight and 
height
4. Talked to me about ways 
to manage my weight
5. Asked me questions or 
talked to me about my blood 
sugar or diabetes
6. Perform a blood test for 
diabetes
7. Checked my blood 
pressure
8. Talked to me about ways 
to manage my blood 
pressure
Section 4: Urgent or Emergency Care
401. Since giving birth, have you been to an emergency department or urgent care center to 
get care for yourself? [Select ONE]
1.
Yes
2.
No  (Go to Question 403)
88. Don’t know/not sure  (Go to Question 403)
99. Prefer not to answer  (Go to Question 403)
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402. Since giving birth, which emergency department(s) or urgent care center(s) did you go to 
get care for yourself? 
List the names of all hospital emergency rooms or urgent care centers you visited.
Name 1: ______________________________
Name 2: ______________________________
Name 3: ______________________________
Name 4: ______________________________
88. Don’t know/not sure
99. Prefer not to answer
403. The LAST TIME you went to the emergency department or urgent care center for yourself, 
what was the reason you went there? [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. I needed emergency care
2. My doctor instructed me to go to an 
urgent care or emergency department
3. My doctors’ offices were closed
4. I couldn’t get an appointment to my 
doctor soon enough
5. I didn’t have a doctor or primary care 
provider
6. I couldn’t afford the cost to see a 
doctor
7. I needed a prescription drug
8. I didn’t know where else to go
9. Some other reason, please specify: 
     Section 5: Postpartum Obstetric Care
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501. Since giving birth, has your OBGYN or midwife discussed any of the following with you 
in your appointments (either in person or by phone or video)? [Select an answer for EACH 
option.]
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. My mental health and wellbeing
2. How to manage my blood pressure 
or hypertension
3. How to manage my weight
4. How to manage my blood sugar or 
diabetes
5. My plan for birth control or future 
pregnancies
6. A recommendation to see a primary 
care doctor
7. A recommendation to see or talk 
with a social worker
8. Any follow up with a social worker
Section 6: Postpartum Leave, Work and Childcare
601. How many children (under age 18) live in your household? Only include children who live 
with you at least 50% of the time.
  _____ children 
 88. Don’t know/not sure
99. Prefer not to answer
602. How many adults (over age 18), including yourself, live in your household? Only include 
adults who live with you at least 50% of the time.
  _____ adults 
 88. Don’t know/not sure
99. Prefer not to answer
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603. Since giving birth, did anyone in your household receive assistance from any of the 
following sources? [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. Unemployment compensation or 
worker’s compensation
2. Cash assistance from a state or 
county welfare program
3. The Supplemental Nutrition 
Assistance Program (SNAP)
4. Woman, Infants and Children 
Nutrition Program (WIC)
5. Help paying for childcare from a 
government agency
6. A federal, state or local government 
housing program that lowers your rent 
or provides a housing voucher
7. Income from SSI (Supplemental 
Security Income), a federal program to 
help older adults, blind, and disabled 
people
8. Other government program(s) not listed here, please specify: 
604. What is your yearly total household income now, before taxes? Include income from all 
family members living in your household (your income, your spouse’s or partner’s income, and 
any other income you may have received). All information will be kept private and will not 
affect any services you are now getting. [Select ONE]
1. $ 0 - $ 9,999
2. $10,000-$19,999
3. $ 20,000 – $ 29,999
4. $30,000 – $ 39,999
5. $40,000 - $59,999
6. $60,000 - $79,999
7. $80,000 - $99,999
8. $100,000 - $119,999
9. $120,000 - $149,999
10. $150,000 - $174,999
11. $175,000 - $199,999
12. $200,000 or above
88. Don’t know/not sure
99. Prefer not to answer
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605. Since delivery, how many weeks of parental leave/time-off did your spouse, partner, or the 
baby’s father take from work? 
_________ weeks [0-100 NUMBER]
87. Not Applicable 
88. Don’t know/not sure
99. Prefer not to answer
606. Are you currently working for pay?  [Select ONE.]
1. Yes, I am working part time
2. Yes, I am working full time
3. No. - Skip to Question 612
88. Don’t know/not sure
99. Prefer not to answer
607. How many weeks after your delivery did you begin working? 
_________ weeks [0-100 NUMBER]
88. Don’t know/not sure
99. Prefer not to answer
608. Since giving birth, did you receive any paid or unpaid parental leave/time-off from your 
job? [Select ALL THAT APPLY]
1.
Yes, I took paid leave
2.
Yes, I took unpaid leave
3.
No, I did not take any paid or unpaid leave, skip to NEXT SECTION 
88. Don’t know/not sure
99. Prefer not to answer
609. Since giving birth, which types of parental leave have you used? [Select ALL THAT 
APPLY]
1.
Paid parental leave provided by my employer
2.
Unpaid parental leave provided by my employer 
3.
Massachusetts Paid Family and Medical Leave (MA PFML)
4.
Temporary Disability Insurance or Short-Term Disability Insurance
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5.
Paid Time Off / Paid Vacation Days (Sometimes called PTO)
6.
Sick Leave
7.
Unpaid Time Off
8.
Other, please specify_________________
88. Don’t know/not sure
99. Prefer not to answer
610. Since giving birth, how many weeks of parental leave have you taken in total? Please 
answer separately for paid leave and unpaid leave. Your best estimate is fine. 
1.
Number of weeks of paid leave _________ [0-100, NUMBER]
2.
Number of weeks of unpaid leave _________ [0-100, NUMBER]
88. Don’t know/not sure
99. Prefer not to answer
611. How well did you understand the maternity leave benefits that were available to you? 
[Select ONE.]
1.
Extremely well 
2.
Very well 
3.
Moderately well 
4.
Somewhat well 
5.
Not well at all
88. Don’t know/not sure
99. Prefer not to answer
****************************SKIP TO NEXT SECTION***********************************
612. Do you plan on either returning to work or starting a new job in the next year? [Select 
ONE.]
1.
I don’t plan to return to work or start a new job in the next year
2.
Yes, I plan to start working within the next 1 month
3.
Yes, I plan to start working within the next 1 – 3 months
4.
Yes, I plan to start working More than 3 months from now
88. Don’t know/not sure
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99. Prefer not to answer
613. Since giving birth, did you receive any paid or unpaid parental leave/time-off from your 
job? [Select ALL THAT APPLY]
1.
Yes, I took paid leave/time-off
2.
Yes, I took unpaid leave/time-off
3.
No, I did not take any paid or unpaid leave, skip to NEXT SECTION
88. Don’t know/not sure
99. Prefer not to answer
614. Since giving birth, which types of parental leave have you used? [Select ALL THAT 
APPLY]
1. Paid parental leave provided by my employer
2. Unpaid parental leave provided by my employer 
3. Massachusetts Paid Family and Medical Leave (MA PFML)
4. Temporary Disability Insurance or Short-Term Disability Insurance
5. Paid Time Off / Paid Vacation Days (Sometimes called PTO)
6. Sick Leave
7. Unpaid Time Off
8. Other, please specify_________________
88. Don’t know/not sure
99. Prefer not to answer
615. Since giving birth, how many weeks of parental leave have you taken in total? Please 
answer separately for paid leave and unpaid leave. Your best estimate is fine. 
1. Number of weeks of paid leave _________ [0-100, NUMBER]
2. Number of weeks of unpaid leave _________ [0-100, NUMBER]
88. Don’t know/not sure
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99. Prefer not to answer
616. How well did you understand the maternity leave benefits that were available to you? 
[Select ONE.]
1.
Extremely well 
2.
Very well 
3.
Moderately well 
4.
Somewhat well 
5.
Not well at all
88. Don’t know/not sure
99. Prefer not to answer
Section 7: Experiences with Intervention (Treatment Group Only)
701. The study you have participated in aimed to help you to transition to primary care after 
childbirth. How important was seeing your primary care provider after birth for you? 
[Select ONE.]
1. Extremely important
2. Somewhat important
3. Not very important
4. Not important at all
88. Don’t know/not sure
99. Prefer not to say
702. How helpful did you find each aspect of the study? [Select an answer for EACH 
option.]
Extreme
ly 
helpful
So
me
wha
t 
help
ful
Not 
very 
helpf
ul
Not 
helpf
ul at 
all 
Don’t 
know
/ Not 
sure
Prefe
r not 
to 
say
1. Information about the 
role of primary care after 
your delivery
2. Scheduling of your 
primary care appointment 
for you
3. Text messaging to 
remind you about your 
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appointment
4. Reconnecting you to 
your primary care doctor
88. Don’t know/not sure
99. Prefer not to say
703. In your own words, what assistance would you find or have found helpful in 
reconnecting with your primary care provider after delivery? 
88. Don’t know/not sure
99. Prefer not to say
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Email Text for REDCap Survey
Subject Line: “MGH Obstetrics Bridge Study: Follow-up Survey Link”
Body Text:
“Dear Bridge Study Participant,
Thank you for participating in the Bridge Study in the MGH Department of Obstetrics and 
Gynecology!
Please complete the following survey about the care you received after your delivery: <<link>>
Participants who complete the survey will receive a $25 Amazon gift card.
Your responses will not be shared with anyone outside of the research team, including your 
doctors or other care team members. 
Thank you for your help and contribution to this important research. Please feel free to contact 
us with questions or concerns.
MGH Bridge Study
bridgestudy@mgh.harvard.edu
617-643-5483”
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SMS Text Message
For individuals who consented to receive SMS messages
“MGH Bridge Study Message: Please check your email to complete a short survey. 
Respondents will receive a $25 gift card. Thank you!”
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Version: V13.8 created on 03/23/23 - 05:01 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:40 PM 
 
 
Title: Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to 
Improve Chronic Disease Management among Postpartum Women (the Bridge Study)  
Sponsor Name: 
PI Name: Clapp, Mark A  
Protocol #: 2022P001723 
Type: Amendment (AME12)  
Date Received: March 17, 2023  
Signatures 
PI Name: Clapp, Mark A, MD, MPH 
Authenticated: March 17, 2023 
Amendment  
COVID-19 Amendment 
 
Is this amendment ONLY related to research impacted by COVID-19? 
 
Refer to MGB Policy on Conduct of Human Research Activities during COVID-19 Operations for description 
of Amendments which do require prior IRB review and approval.   
⚪  Yes   
◉  No  
 
 
Central IRB Performance Sites  
 
Is this a protocol where the Mass General Brigham IRB is serving as the single IRB (sIRB) for external 
sites/institutions? 
◉  Yes  
 
⚪  No  
 
Would you like to 'Add' a Site? 
⚪  Yes  
 
◉  No  
 
Would you like to 'Remove' a Site? 
⚪  Yes  
 
◉  No  
 
 
Sponsor Amendment 
  
Is there a sponsor amendment number? 
⚪  Yes   
◉  No  
 
 
Change in Protocol Status 
 
Is this a cede protocol or project that was determined to be exempt, not human subjects research or not 
engaged in human subjects research?  
⚪  Yes   
◉  No  
 
 
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Version: V13.8 created on 03/23/23 - 05:01 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:40 PM 
 
 
Do you need to change the overall status of the protocol?  For example, Re-Open to Enrollment or 
indicate that Research Interventions/Assessments Continue after telling the IRB these have ceased. 
⚪  Yes  
 
◉  No  
 
 
  
Briefly describe the proposed changes: 
After piloting, the endline survey questions were modified slightly. The renumeration was decreased 
from $25 to $20 after finding the survey could be completed in 5-10 minutes rather than 10-20 minutes, 
which was originally expected. 
Changes to the renumeration amount required an update to patient messages/communication, which 
are uploaded as attachments. 
 
  
Provide rationale for the proposed changes: 
Improved survey question language 
More appropriate renumeration based on the study's ask of the participant 
 
  
Will the proposed change(s) significantly alter the risk to benefit assessment the IRB relied upon to approve 
the protocol? 
⚪  Yes   
◉  No  
 
 
  
Will the proposed change(s) significantly affect the integrity of the protocol? 
⚪  Yes   
◉  No  
 
 
Informed Consent 
 
Do the changes require a revision to the consent form? 
⚪  Yes   
◉  No  
 
Remuneration  
 
Will subjects be paid or receive any type of remuneration / compensation for their time and expenses? 
◉  Yes  
 
⚪  No  
 
 
Payment for Participation in Research 
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Version: V13.8 created on 03/23/23 - 05:01 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:40 PM 
 
 
  
Indicate the type and total amount of compensation for completion of the study. 
☐ Cash 
 
☐ Check 
 
☑ 
Gift Certificate 
Amount e.g., $50, enter 50.00 
20 
 
☑ 
Other 
 
Amount e.g., $200, enter 200.00 
20 
Explain: 
An additional $20 gift card is being provided to individuals who opt to complete the end line 
survey. 
  
NOTE: Payments to subjects must be made by check if payment involves a one-time payment of 
greater than $50 OR multiple payments of any amount.  See policies Payments to Human 
Subjects for Participation in Research and Cash Control and Accountability for Payments to 
Human Subjects for Participation in Research. 
 
Reimbursement for Expenses Related to Participation in Research 
 
If there is not a set amount for meals, parking, and transportation, then estimate or enter the maximum 
amount budgeted per subject.  
☐ Meals 
 
☐ Parking 
 
☐ Transportation 
 
☐ Other 
 
Attachments 
 
Name 
Mode 
Detailed Protocol_031723_v1-6_clean (Detailed Protocol)  
Electronic  
Bridge Survey Endline _ final (Instrument/Questionnaire)  
Electronic  
Survey Email Text_031223 (Document for review)  
Electronic  
Survey Remider SMS Text_031723 (Document for review)  
Electronic  
 
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Version 2021.06.10
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Institutional Review Board
Intervention/Interaction Detailed Protocol
Principal Investigator:
Mark Clapp, MD MPH (MGH), Jessica Cohen, PhD (HSPH)
Project Title:
Bridging the Gap from Postpartum to Primary Care: A Behavioral 
Science Informed Intervention to Improve Chronic Disease Management 
among Postpartum Women
Version Date:
03/17/2023
Version Name/Number:
v1.6
1.
 Background and Significance
Burden of Chronic Disease and the Role of Primary Care
Chronic health conditions affect millions of people in the US each year. In 2018, 51.8% of adults 
had at least 1 chronic condition, and 27.2% had multiple conditions.1 The prevalence of chronic 
disease was higher in women compared to men, older adults (87.6% in adults ≥65 years old), 
and people with public insurance.1 Many chronic conditions, by their nature, develop over time 
and have risk factors that can be identified prior to the onset of disease. Strong evidence 
underpins prevention strategies for many conditions, which are advanced by the US 
Preventative Services Taskforce.2 While the long-term health of a patient is the responsibility of 
an entire health system, primary care providers (PCPs) provide an integral role in preventing, 
screening for, and managing disease across the lifespan. Studies have shown the health 
benefits of receiving regular care under a PCP.3–6
Despite the known benefits of having an identifiable usual source of care and the value of health 
care maintenance, the percent of the population with a PCP has been decreasing over time.7 
Consistently, adults who are younger (age 20-40 years) have the lowest rates of primary care 
use. In 2015, 44% and 36% of 20- and 30-year-olds had no identifiable source of primary care.7 
The proportion without primary care were also higher among racial/ethnic minority populations 
and among those who had less education, lower incomes, and no known comorbidities.7 The 
number of adults and the time elapsed without regular primary care follow-up can be considered 
missed opportunities to improve a patient’s current and long-term health. The disproportionate 
lack of primary care among certain subgroups of the population, often groups who already have 
worse health outcomes, only serves to widen the pre-existing disparities.
Pregnancy as a Window to Future Health
In the US, 98.2% of pregnant women receive some form of prenatal care, with the average 
patient having >10 visits during their pregnancy.8 During a pregnancy, women are screened for 
pre-existing and pregnancy-related conditions.9 In adults ages 18-39, the prevalence of obesity, 
hypertension, prediabetes/diabetes, and mental illness are estimated at 39%, 7.5%, 28%, 25%, 
respectively.10–13 Even for those who have no prior identified comorbidities, the most common 
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pregnancy-related conditions—pregnancy-related hypertension and gestational diabetes (8% 
and 10% of pregnancies, respectively)—indicate a predisposition to or confer health risks that 
persist as women age. For example, over 25% of women with gestational diabetes will develop 
Type 2 diabetes mellitus, and women with pre-eclampsia have more than a two-fold risk of 
significant cardiovascular disease later in life.14,15 For these reasons, pregnancy is often 
considered a “window” into a woman’s future health and presents a unique opportunity to 
optimize a woman’s health status early in her life when she otherwise may not have been 
engaged in care.16 
Pregnancy as on Opportunity for Engagement with a Long-term Care Provider
Pregnancy is a period when women are highly engaged and active participants in their health 
care.17 It has been described as a “golden opportunity” to motivate women towards positive 
health behaviors, including prevention and management of chronic disease. However, women 
often fall off a “postpartum cliff” of health system engagement after the early postpartum 
period.18 A range of systemic, financial, and behavioral barriers often prevents patients from 
effectively transitioning to primary care. Postpartum women are often simply told to follow-up 
with their PCP without much information regarding the importance of this follow up care, without 
assistance in scheduling an appointment (or identifying a PCP if they don’t have one), and often 
without a direct transfer of relevant health information or accountability across providers. 
Postpartum women are left largely on their own to navigate this transition to primary care and, in 
particular, to navigate it at a time when they face the high cognitive and physical demands of 
caring for an infant. At this time of limited cognitive bandwidth, the importance of continuity of 
care for chronic conditions and active engagement in one’s longer-term health and wellbeing is 
unlikely to be salient and top-of-mind. These critical moments of unsupported health care 
transition can exacerbate pre-existing disparities in health and health care, with patients who 
are the least able to navigate the US health care system most likely to fall through the cracks.  
Momentum is building in US health and social safety net policy to facilitate healthy transitions 
from pregnancy to parenthood. For example, federal and state initiatives to expand pregnancy-
related Medicaid coverage from 60 days to one year postpartum have been proposed, and 
access to paid family leave is increasing. However, very little evidence exists on effective and 
cost-effective approaches to facilitating transitions to primary care and management of chronic 
diseases in the postpartum year.  
2.
Specific Aims and Objectives 
The objective of the proposed study is to increase patient engagement in primary care after the 
immediate postpartum period for women with pregnancy-associated conditions that convey a 
long-term health risk. Specifically, we aim to evaluate the efficacy of an intervention bundle 
(automatic scheduling of PCP appointment after delivery, salient labeling, and appointment 
reminder nudges) to increase patient attendance at a primary care provider appointment (within 
4 months of delivery for women with or at risk for obesity, diabetes, hypertension, and/or a 
mental health condition. 
Specific Aims:
1) Test the efficacy of an intervention bundle (patient-tailored health information, automatic 
scheduling of PCP appointment after delivery, and appointment reminder nudges) to 
increase patient attendance at a primary care provider appointment within 4 months of 
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delivery for women with obesity, diabetes, hypertension, and/or a mental health 
condition
2) Test the efficacy of the intervention bundle to improve compliance with the condition-
specific, guideline-based health screenings
3) Test the efficacy of the intervention bundle to reduce unscheduled or urgent encounters 
(e.g., emergency department visits) within the health system
3.
General Description of Study Design
We will conduct a randomized controlled trial comparing this intervention bundle to the receipt of 
generic information on the importance of primary care follow-up after delivery.  
Women will be randomized with equal probability into either a treatment or control arm. The 
intervention combines several features designed to target reasons for low take-up of primary 
care among postpartum women (see Logic Model). We leverage the potential value of 
defaults/opt-out, salient labels, and reminders to encourage use of primary care within 4 months 
of delivery. Women in both the intervention and control arms will receive information via MGH’s 
patient portal toward the end of the pregnancy regarding the importance of transitions to primary 
care in the postpartum year. This information will be similar to, but reinforcing, the information 
they would receive from their obstetrician about following up with their primary care physician. In 
addition to this initial message, women in the treatment arm will receive the following 
intervention components, developed based on recent evidence regarding behavioral science 
approaches to activating health behaviors:19–21
➢
Targeted messages about the importance and benefits of primary care. 
➢
Default scheduling into a primary care appointment at approximately 3-4 months after 
delivery. The patient will be scheduled for a primary care visit with their assigned primary 
care provider in the Mass General Brigham system. They will be informed of the option to 
cancel the appointment, change the appointment day/time, or change the care provider 
either through the patient portal). 
➢
Reminders about the appointment and importance of follow up primary care at 2-4 points 
during the postpartum period via the patient portal. 
➢
Tailored language in the reminders based on recent evidence from behavioral science about 
the most effective approaches to increasing take-up. For example, messages will inform the 
patient that an appointment has been reserved for them at their doctor. 
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The Logic Framework that underpins the basis for this study is shown below:
 
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The flow of study activities is shown below: 
4.
Subject Selection
Pregnant patients receiving prenatal care at Massachusetts General Hospital (MGH) will be 
targeted for recruitment. MGH conducts approximately 3500 deliveries per year, with roughly 
one-third of patients identifying as non-white and 35% of pregnancies covered by Medicaid.
Approximately 49% of the clinic population may ultimately be eligible to be approached.
The eligibility criteria include:
•
Estimated date of delivery and the following 4-month postpartum outcome 
assessment window completed prior to study end date
•
Currently pregnant or within 2 weeks of estimated date of delivery
•
Have one or more of the following conditions: 
o
Chronic hypertension
o
Hypertensive disorders of pregnancy or risk factors for hypertensive disorders 
of pregnancy per the USPTF aspirin prescribing guidelines (e.g., history of 
pre-eclampsia, kidney disease, multiple gestation, autoimmune disease)22
o
Type 1 or 2 diabetes
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o
Gestational diabetes
o
Obesity (body mass index ≥30 kg/m2)
o
Depression or anxiety disorder 
•
Have a primary care provider listed in the patient’s medical record 
•
Receive obstetric care at an MGH-affiliated outpatient prenatal clinic
•
Has access to and be enrolled in the electronic health record patient portal and 
consents to be contacted via these modalities
•
Able to read/speak English or Spanish language
•
Age ≥18 years old
•
Not diagnosed with or undergoing evaluation for stillbirth/fetal demise
All women, regardless of race/ethnicity, who meet the eligibility criteria will be included. In 2019, 
3,789 women gave birth at the study institution, of whom 57% were white, 7% were black, 12% 
were Asian, 18% were Hispanic, and 6% declined to report their race/ethnicity. A similar 
distribution is expected for this study.
The study will distribute materials in English and Spanish languages. This encompasses >95% 
of patients who deliver at the study institution.
5.
Subject Enrollment
This study will rely on recruiting for research through Patient Gateway and follow the IRB 
guidance and DHeC Research Checklist and training for this process.
In the month prior to the start of enrollment, all potentially eligible individuals (based on the 
criteria above) will be identified using RPDR and Epic Reporting search queries. This list (the 
“potentially eligible” list) will be provided to the DHeCare Research Team to build an RSH 
Record in Epic. This list will be updated monthly to identify newly eligible individuals (e.g., new 
diagnosis of gestational diabetes or new patient transferring into the practice) during the 
recruitment months and fed back to the DHeCare team to update “potentially eligible” list.
Once built and each month during recruitment phase, the study’s research coordinator (not 
study investigators) will send the IRB-approved Research Invitation Letter to patients who are 
eligible, not already enrolled, and have not declined to be sent research notifications through the 
portal. The Research Letter will employ an opt-out approach, asking individuals who do not wish 
to be approached in clinic or remotely to respond via PG messaging, email, or phone within 2 
weeks of receipt of the letter. Those who have “read” the letter and not opted out after 2 weeks 
will be moved from the “potentially eligible” list to the “waiting to be approached” list in the study 
workflow.
During recruitment months, the study coordinator will keep a log of patient’s upcoming 
appointments for those on the “waiting to be approached” list. They will then attempt to 
approach individuals for enrollment when they present for an in-person encounters (preferred). 
Patients will ideally be approached between 32-36 weeks of gestation, when feasible; however, 
priority will be given to patients at the latest gestation. For those Spanish-speaking patients, a 
hospital-based interpreter will be used when approaching/consenting patients.
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The study staff will introduce the study and review the purpose of the study, the nature of the 
subject’s participation, the possible risks and discomforts associated with participation, the 
potential benefits of participation, a statement of the voluntary nature of participation, and a 
description of the mechanisms used to ensure confidentiality. 
All patients will receive study-related messages through Patient Gateway. In addition, patients 
will be asked if they would be willing to receive no more than 5 SMS messages to their personal 
cell phone during the first 4 months of the postpartum period. The study staff will review the 
specific concerns and risks about receiving unencrypted text messaging communications, as 
outlined by the MGB IRB. 
A waiver of documentation of informed consent is requested, as the study presents no more 
than minimal risk of harm to subjects and involves no procedures for which written consent is 
normally required outside of the research context. Verbal consent will be obtained for 1) overall 
study participation and 2) optional SMS message participation, separately. Verbal consent will 
be obtained from both in-person and phone recruitment efforts.
A Study Fact Sheet, which summarizes the study details, risks, and benefits, will be provided to 
all subjects who are approached, either in-person, by mail, or electronically. This Study Fact 
Sheet also includes information supplied by the MGB IRB specifically related to the concerns 
and risks of receiving unencrypted SMS/text messages.
For tracking verbal consent, the study staff will keep a detailed log in REDCap documenting:
1) name of study staff performing consent,
2) date of attempted approach,
3) the method of attempted approach (in-person or via phone),
4) use of Spanish interpreter (yes/no),
5) subject agreement to be approached (agree/disagree),
6) attestation to full review of the study procedures/risks/benefits with the subject, as would 
be done during the process of reviewing a written consent form, 
7) attestation to review of supplemental consent to receive unencrypted SMS messages 
with the subject,
8) subject overall study participation status (enrolled, declined, deferred – agrees to be 
recontacted, deferred – wishes not to be recontacted),
9) if enrolled, unencrypted SMS text messaging participation (consents, declines),
10) attestation to Study Fact Sheet provided,
11) method by which Study Fact Sheet was provided (in-person, mail, electronic),
12) date in which Study Fact Sheet was provided (in-person, mail, electronic).
6.
STUDY PROCEDURES
The RA will keep a detailed log of all patients in the practice, if they are eligible, if they have 
been approached, and if they consented.
For those that agree to be enrolled, patients will be asked to complete a baseline survey to 
obtain voluntarily reported information on their demographics, socioeconomic status, health care 
visit history, and primary care provider. Patients will also be asked to consent to being contacted 
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by the research team via Patient Gateway messaging. A $20 gift card will be given at the time of 
enrollment for those that complete the questionnaire and receive the information sheet.
Randomization will occur via a prespecified random allocation sequence within strata. Within 
each stratum, the PIs will generate a random sequence of treatment-control allocation prior the 
enrollment of subjects. Then, as patients within strata are enrolled, they will be assigned to the 
treatment arm associated with that enrollment number. 
Control Group
Approximately 2 weeks before a patient’s estimated due date (EDD) or as soon as enrolled if 
this date has passed, the patient will be sent information via the Patient Gateway on the 
importance of postpartum care and follow-up with their PCP.
Intervention Group
1.
Tailored Information:
Approximately 2-4 weeks prior to the EDD (or later for those who are enrolled beyond 38 
weeks gestation or postnatally), the patient will be sent an information via the Patient 
Gateway on the importance of postpartum care and follow-up with their PCP, which also 
includes the name and phone number of their primary care provider. 
2.
Scheduled PCP Appointment:
Between 2-3 weeks after their delivery, the RA will call the patient’s PCP office and 
make an appointment for them between 3-4 months after delivery based on the 
scheduling preferences obtained in the initial survey.
3.
Targeted Appointment Message with Salient Labeling:
After the PCP appointment has been made, the patient will be sent a Patient Gateway 
message saying that a PCP appointment has been reserved for them with the 
date/time/location information.
For those consenting to receive SMS messages, an unencrypted text message will also 
be sent simultaneously.
4.
Nudge Reminders: 
Patient Gateway messages will be sent at approximately 4-8 weeks (goal: 4 weeks) and 
1-4 week (goal: 1 week) prior to their PCP appointment, reminding a patient of their 
upcoming appointment. 
For those consenting to receive SMS messages, an unencrypted text message will also 
be sent simultaneously.
5.
Facilitated PCP Communication:
A study staff member will send the patient’s PCP an Epic Inbasket message that the 
patient 1) is recently postpartum, 2) has or developed health conditions that need long-
term management, and 3) has been scheduled (or attempted to be scheduled) for a 
follow-up visit.
All messages will be made available in English and Spanish.
The text for these Patient Gateway messages is included in the submission. At the end of each 
patient message, patients will be given the opportunity to stop receiving study-related messages 
by emailing or calling the study staff. “Opt out” requests will be logged and patients removed 
from future planned study-related contact. 
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The text for 3 SMS messages is included in the submission. SMS messages will be sent via 
Google Voice. We will follow standard recommendations from the MGB Research Information 
Security for using this system (included under Privacy and Confidentiality section).
Outcome Assessment
1. EHR Review
The study team will review the patient’s EHR record for the primary and secondary outcome 
assessments. Patients will be asked to consent to have records reviewed up to 2 years after the 
date of their delivery to allow for long-term effects of the intervention on primary care use and 
health status. 
2. Endline Survey
After 4 months from their established due date (EDD), a patient will be eligible to participate the 
endline survey. The goal timing for the survey completion is 4-6 months after the EDD, but 
patients will remain eligible for up to one year. 
The survey will be administered through REDCap. Study participants will be emailed a unique 
link to complete the survey. Consent to be contacted for this survey will be obtained at the time 
of the subject’s enrollment in the trial. The patient’s email address for contact is verified at the 
time of study enrollment. 
Subjects will be asked to complete a 15-20-minute survey on their care after their delivery. They 
will be reminded that all questions are optional and that responses will be linked to their study 
record; however, no responses will be entered into the electronic health record or become part 
of their permanent medical record. Participants who complete the survey will be offered a $20 
gift card for their participation, which they will be informed of prior to starting the survey. There is 
no penalty for not completing the survey.
If there is no response within approximately 1-2 weeks, the subject will be emailed the link again 
with a reminder to complete the survey. If there is no response within approximately 2-4 weeks 
from the initial email OR the patient does not have a working email address, the subject will be 
called and asked if they would like to complete the survey over the phone. For those that agree, 
the survey text and questions will be read verbatim by a research assistant not affiliated with the 
patient’s clinical care. Individuals who decline to participate in the survey over the phone or 
cannot be reached will be marked as non-respondents.
Patients that consented to receive SMS messages as a part of the study will be sent a text 
message reminder to complete the survey at the same time that emails are sent. No more than 
2 SMS message reminders will be sent to each subject.
Deidentified data from this project may be shared outside of MGB with the study funders (J-
PAL/NBER/NIA) for data sharing and reproducibility requirements and secondary statistical 
analysis. All data will be stripped of patient identifiers, per IRB guidance. No data will be shared 
without a formal Data Use Agreement with MGB.
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6.
Risks and Discomforts
There are minimal risks to participants. 
Patients will be reassured that nonparticipation will not affect clinical care. Patients will also be 
informed that the researchers with whom they will interact (e.g., during consent, face-to-face, 
during telephone interviews) are not health care providers. Participants will be consistently 
reminded that responses to any queries deemed sensitive or uncomfortable (e.g., country of 
origin/immigration status, income, previous history of abortion) should be considered optional, 
and they may decline to answer any question(s) and can refuse to continue the study at any 
point. Participants will be reassured that neither their opportunities for continued health care nor 
their relationships with health care providers will be jeopardized by study participation.
Health information collected as part of this study will be stored in REDCap. No identifiable data 
will be stored or downloaded on any personal or unauthorized computers. Study staff will 
access the data on institutionally purchased and managed computers that operate behind the 
health system’s security and firewall protections. Only the MGH study staff will have access to 
the identifiable data set. Once the study is completed, data will be deidentified such that it can 
be analyzed without risk of a breach of privacy or confidentiality. Any data that is shared outside 
of MGH will require a data use authorization.
Although we will make every effort to protect participant privacy and confidentiality, it is possible 
that participants' involvement in the study could become known to others. For those in the 
intervention group, we will be sending personalized messages via the patient portal; for those 
providing additional consent, we will be sending unencrypted SMS messages that will not 
contain any personal protected health information. There is the rare possibility that study 
participation or health information could become known to others despite the use of firewalls, 
password protection, and other security measures. Standard procedures, as outlined by the 
MGB Research Information Security Office, will be followed to reduce this risk.
Individuals in the intervention group will be scheduled for an appointment with a primary care 
doctor. There is the possibility that this visit may result in a charge/cost for the patient. Under 
the Affordable Care Act, commercial health plans are required to cover an annual Preventive 
Health Exam at no cost to the patient (no co-payment, co-insurance or deductible). MassHealth 
also covers these visits without cost-sharing. However, if this visit turns or scheduled as into a 
“sick” or “disease management” visit, the patient may be billed for some or all aspects of the 
services provided, depending on their insurer. We will provide directions for patients on how to 
to contact their insurers or PCP’s office prior to the visit to inquire about potential cost-sharing 
and/or deductibles. Patients will also be advised that some clinics may penalize individuals for 
not showing to a scheduled appointment (“no show” fee) and be given opportunities to request 
the appointment be canceled or rescheduled with each appointment reminder.
7.
Benefits
Participants in the control group will receive information on the importance of postpartum care 
and transitioning to primary care after their delivery.
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Participants in the intervention group will receive a bundle of interventions designed to increase 
attendance at primary care visits and facilitate the transition of care after their delivery.
The goal and potential benefits to the subjects in this trial is to increase patient engagement and 
connection with their primary care provider, receive recommended health screenings and 
directed counseling, and reduce unscheduled or urgent visits in the postpartum period.
8.
Statistical Analysis
Statistical Methods
Analyses will be performed according to the intention-to-treat principle.
Standard independent, two-sided, two-group comparison testing will be used to compare 
baseline characteristics between the two groups (chi squared tests, t tests, Wilcoxon rank sum 
tests, when appropriate).
The primary outcome will be attendance rates at PCP visit within 4 months after estimated date 
of delivery (captured at time of enrollment), which will be compared between the groups using 
chi squared tests. Relative risks and 95% confidence intervals will be reported. 
Secondary outcomes will include measures of long-term health and health care use after the 
postpartum period. 
Subgroup analyses will be performed by a variety of patient characteristics including gestational 
age at enrollment, prenatal risk factors, morbidity types, patient race-ethnicity, payer, and 
enrollment location. 
P-value of less than 0.05 will be considered to indicate statistical significance.
Power Calculation
Most study calculations were estimated from the MGH 2020 delivery population. The rates of 
PCP follow-up were estimated from a randomly selected cohort of 50 patients who met the 
inclusion criteria. We plan to recruit patients into the study for a period of 4 months and expect 
1200 unique patients to be at the targeted gestational age during this period. Among these, we 
expect 86% to already have an assigned PCP in the network, leaving roughly 1,032 patients. 
Among these, we estimate that 49% have at least one of the targeted health conditions, leaving 
a target study population of 506 over the 4-month period. Based on previous studies conducted 
at MGH, we expect an 70% willingness to participate in the research, leaving an expected 
recruited population of 354 individuals. Based on our record extraction, we estimate that 15% of 
the targeted study population has a primary care visit within 4 months of delivery. Assuming an 
alpha of 0.05 and a baseline mean of 15%, with this expected sample size and power of 80%, 
our study has a minimum detectable effect size of roughly 13 percentage points (from 15% to 
28%). A previous study found that default scheduling into postpartum care appointments (with 
an OBGYN, not a PCP) increased postpartum care take-up by 24 percentage points; since our 
intervention incorporates defaults and other activating interventions, an MDE of 13 percentage 
points is reasonable.
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9.
  Monitoring and Quality Assurance
This is a minimal risk study in which the intervention involves default scheduling of 
appointments and patient messaging. Adverse events are not expected, and there is no 
physiologic plausibility for this intervention to cause any NIH-defined serious adverse events 
(e.g., death, prolonged hospitalization, significant disability).
No interim analyses are planned.
Adverse events will be defined and classified in accordance with NIH guidelines:
Definition of Adverse Events (AE): Any untoward or unfavorable medical occurrence 
in a human subject, including any abnormal sign, symptom, or disease, temporally 
associated with the subject’s participation in the research, whether considered 
related to the subject’s participation in the research or not.
Definition of Serious Adverse Events (SAE): Any AE that (1) results in death, (2) is life-
threatening, (3) results in inpatient hospitalization or prolongation of existing 
hospitalization, (4) results in persistent or significant disability/incapacity, (5) results in a 
congenital anomaly/birth defect, and/or (6) may jeopardize the subject’s health and may 
require medical or surgical intervention to prevent one of the other five outcomes listed 
here.
In the unlikely event an AE or SAE occurs, it will be brought to the PI's attention, and the PI 
will classify the AE/SAE by severity, expectedness, and relatedness, as listed above. All events 
that are both serious and unexpected will be reported to Mass General Brigham's IRB, the NIA 
PO, and to the NIA Roybal DSMB within 48 hours of the research team's knowledge of the 
SAE. The summary of all other SAEs will be reported to the NIA and to the DSMB quarterly 
unless otherwise specified by the DSMB. Any unanticipated problem, defined as an issue 
related to the research suggesting the research places participants or others at greater risk 
than expected, will be reported to the IRB, the NIA PO, and to the Roybal DSMB within 48 
hours of discovery. If the problem involves death then reporting will occur within 24 hours, and 
this report will include a plan to correct the problem and prevent its occurrence. Any breach of 
PHI will be reported to the PI, who will report to the IRB and NIA PO within 24 hours of 
discovery.
The Roybal DSMB oversight is provided by the Standing Roybal DSMB, which includes the 
members listed: Andrea B. Troxel, ScD (chair); Abby King, PhD; Jerry Gurwitz, MD; Hae-Ra 
Han, PhD, RN, FAAN; Hang Lee, PhD; Ezra Golberstein, PhD; David Kim,  MD PhD; 
Christopher Celano, MD.
DSMB members will have no direct involvement with the study or conflict of interest with the 
investigators or institutions conducting the study. Each member has signed a COI statement 
which includes current affiliations, if any, with pharmaceutical or biotechnology companies 
(e.g., stockholder, consultant), and any other relationship that could be perceived as a conflict 
of interest related to the study and/or associated with commercial interests pertinent to study 
objectives.
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Data presented to the DSMB will be deidentified as to protect individual participants’ privacy and 
health information. Should the identity of a deidentified subject need to be  revealed, the DSMB 
request will be reviewed and ultimately at the discretion of the Mass General Brigham IRB.
10.   Privacy and Confidentiality
☒Study procedures will be conducted in a private setting
☒Only data and/or specimens necessary for the conduct of the study will be collected
☒Data collected (paper and/or electronic) will be maintained in a secure location with 
appropriate protections such as password protection, encryption, physical security 
measures (locked files/areas)
☐Specimens collected will be maintained in a secure location with appropriate protections 
(e.g. locked storage spaces, laboratory areas)
☒Data and specimens will only be shared with individuals who are members of the IRB-
approved research team or approved for sharing as described in this IRB protocol
☒ Data and/or specimens requiring transportation from one location or electronic space to 
another will be transported only in a secure manner (e.g. encrypted files, password 
protection, using chain-of-custody procedures, etc.)
☒   All electronic communication with participants will comply with Mass General Brigham 
secure communication policies
☒Identifiers will be coded or removed as soon as feasible and access to files linking 
identifiers with coded data or specimens will be limited to the minimal necessary 
members of the research team required to conduct the research
☒All staff are trained on and will follow the Mass General Brigham policies and procedures 
for maintaining appropriate confidentiality of research data and specimens
☒The PI will ensure that all staff implement and follow any Research Information Service 
Office (RISO) requirements for this research
☒Additional privacy and/or confidentiality protections
The following procedures (as provided by MGB RISO) will be used for sending SMS messages 
via Google Voice:
•
Google Account:
o
A separate account should be created just for the purpose of the effort/study (in 
other words, personal Gmail accounts should not be used) 
o
For the Google Voice portal, make sure you are not using the same password as 
your MGB account and ensure the password is strong. (Minimum of 8 characters, 
alphanumeric, uppercase, lowercase, special character).
▪
Two-factor authentication must be enabled
o
Google account will not be shared
o
The Google account used for Google Voice should not be used for emailing or 
using any other Google Service (i.e., YouTube, Calendar, Contacts, etc.)
o
No credit cards should be added to the Google Account
o
The Google account must be deleted at the end of the study / project
•
Participants will be informed not to send personal or health related information via text
•
Siri will not be integrated with Google Voice
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•
Text messages will not address participants by their first name
•
Text messages will be sent through the McLean email within the Google account that is 
created
•
Only phone numbers and a unique subject ID will be stored in Google Voice
o
Log records should be deleted manually after 30 days
•
No PHI or sensitive information will be communicated via text message
o
Content will not include anything where a healthcare condition or diagnosis can 
be inferred
•
Text message history should be deleted from Google Voice account when no longer 
needed (within 30 days)
•
Study staff will track opt-out requests and delete phone numbers from Google Voice as 
necessary
•
Study staff must not communicate with participants via a group text message
•
Access to the portal and overall research must be done from systems that meet MRB 
RISO compliance requirements; encryption, MobileIron (if Smartphone/Tablet), up to 
date malware protection, Crowdstrike.
o
https://rc.partners.org/security/secure-your-computer
•
Participants:
o
Participants will be texted only if they consent
o
Participants should be informed to delete text messages when no longer needed 
and hide text push notifications
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12.   References
1.
Boersma P. Prevalence of Multiple Chronic Conditions Among US Adults, 2018. Prev 
Chronic Dis. 2020;17. doi:10.5888/pcd17.200130
2.
Home page | United States Preventive Services Taskforce. Accessed December 15, 2021. 
https://www.uspreventiveservicestaskforce.org/uspstf/
3.
Blewett LA, Johnson PJ, Lee B, Scal PB. When a usual source of care and usual provider 
matter: adult prevention and screening services. J Gen Intern Med. 2008;23(9):1354-1360. 
doi:10.1007/s11606-008-0659-0
4.
O’Malley AS, Mandelblatt J, Gold K, Cagney KA, Kerner J. Continuity of care and the use 
of breast and cervical cancer screening services in a multiethnic community. Arch Intern 
Med. 1997;157(13):1462-1470.
5.
DeVoe JE, Saultz JW, Krois L, Tillotson CJ. A medical home versus temporary housing: 
the importance of a stable usual source of care. Pediatrics. 2009;124(5):1363-1371. 
doi:10.1542/peds.2008-3141
6.
Atlas SJ, Grant RW, Ferris TG, Chang Y, Barry MJ. Patient-physician connectedness and 
quality of primary care. Ann Intern Med. 2009;150(5):325-335. doi:10.7326/0003-4819-
150-5-200903030-00008
7.
Levine DM, Linder JA, Landon BE. Characteristics of Americans With Primary Care and 
Changes Over Time, 2002-2015. JAMA Internal Medicine. 2020;180(3):463-466. 
doi:10.1001/jamainternmed.2019.6282
8.
NVSS - Birth Data. Published June 14, 2021. Accessed September 1, 2021. 
https://www.cdc.gov/nchs/nvss/births.htm
9.
Prenatal care and tests | Office on Women’s Health. Accessed December 15, 2021. 
https://www.womenshealth.gov/pregnancy/youre-pregnant-now-what/prenatal-care-and-
tests
10.
Centers for Disease Control and Prevention (CDC). Adult Obesity Facts. Published August 
29, 2017. Accessed February 14, 2018. https://www.cdc.gov/obesity/data/adult.html
11.
Mental Illness. National Institute of Mental Health (NIMH). Accessed December 17, 2021. 
https://www.nimh.nih.gov/health/statistics/mental-illness
12.
Products - Data Briefs - Number 289 - October 2017. Published June 6, 2019. Accessed 
December 17, 2021. https://www.cdc.gov/nchs/products/databriefs/db289.htm
13.
National Diabetes Statistics Report 2020. Estimates of diabetes and its burden in the 
United States. Published online 2020:32.
14.
Sattar N, Greer IA. Pregnancy complications and maternal cardiovascular risk: 
opportunities for intervention and screening? BMJ. 2002;325(7356):157-160. 
doi:10.1136/bmj.325.7356.157
15.
Kim C, Tabaei BP, Burke R, et al. Missed Opportunities for Type 2 Diabetes Mellitus 
Screening Among Women With a History of Gestational Diabetes Mellitus. Am J Public 
Health. 2006;96(9):1643-1648. doi:10.2105/AJPH.2005.065722
16.
Media BKK. Publications & Guidelines | SMFM.org - The Society for Maternal-Fetal 
Medicine. Accessed October 18, 2021. https://www.smfm.org/publications/225-smfm-
statement-implementation-of-the-use-of-antenatal-corticosteroids-in-the-late-preterm-birth-
period-in-women-at-risk-for-preterm-delivery
17.
Yee LM, Simon MA, Grobman WA, Rajan PV. Pregnancy as a “golden opportunity” for 
patient activation and engagement. American Journal of Obstetrics & Gynecology. 
2021;224(1):116-118. doi:10.1016/j.ajog.2020.09.024
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18.
Cohen JL, Daw JR. Postpartum Cliffs—Missed Opportunities to Promote Maternal Health 
in the United States. JAMA Health Forum. 2021;2(12):e214164. 
doi:10.1001/jamahealthforum.2021.4164
19.
Milkman KL, Patel MS, Gandhi L, et al. A megastudy of text-based nudges encouraging 
patients to get vaccinated at an upcoming doctor’s appointment. PNAS. 2021;118(20). 
doi:10.1073/pnas.2101165118
20.
Patel MS, Volpp KG, Asch DA. Nudge Units to Improve the Delivery of Health Care. N Engl 
J Med. 2018;378(3):214-216. doi:10.1056/NEJMp1712984
21.
Thaler RH, Sunstein CR. Nudge: The Final Edition. Revised edition. Penguin Books; 2021.
22.
Henderson JT, Vesco KK, Senger CA, Thomas RG, Redmond N. Aspirin Use to Prevent 
Preeclampsia and Related Morbidity and Mortality: Updated Evidence Report and 
Systematic Review for the US Preventive Services Task Force. JAMA. 2021;326(12):1192. 
doi:10.1001/jama.2021.8551
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Survey Form Logic
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Bridging the Gap from Postpartum to Primary Care
Endline Survey 
Study PIs: Mark Clapp, MD MPH (MGH); Jessica Cohen, PhD (Harvard) 
Site PI: Mark Clapp, MD MPH (MGH)
Section 0: Survey Text Introduction
This survey is being administered as part of the MGH Bridge Study, which you agreed to 
participate in during or shortly after your pregnancy.
The survey will take approximately 5-10 minutes to complete. Participants who finish the survey 
will receive a $20 Amazon gift card.
Your responses will not be shared with anyone outside of the research team, including your 
doctors or other care team members. They will not be part of your medical record or affect your 
ability to receive care or services at MGH.
Thank you for your help and contribution to this study. Please feel free to contact me with 
questions or concerns about this study.
Mark Clapp, MD MPH
Maternal-Fetal Medicine
Massachusetts General Hospital
bridgestudy@mgh.harvard.edu 
617-724-4531
By clicking PROCEED, I AGREE TO PARTICIPATE IN THIS SURVEY.
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Section 1: Health Care Access
100. Did your pregnancy care provider (OB/GYN or midwife) encourage you to see your 
primary care provider after giving birth?
1.
Yes
2.
No
88. Don’t know/not sure
99. Prefer not to say
101. Do you currently have a primary care provider? This is a person who you would see for 
an “annual visit” or “physical” or for care when you are feeling ill. This does NOT refer to an 
urgent care or emergency department. [Select ONE.]
1.
Yes 
2.
No 
88. Don’t know/not sure 
99. Prefer not to say
102. When was the last time you saw a primary care provider for any reason? This does not 
include visits to your pregnancy care provider (OB/GYN or midwife), an emergency 
department, or urgent care center.  You can use either months or years in your answer. Your 
best estimate is fine. *REQUIRED
1, More than 5 months after giving birth
2, 3-4 months after giving birth
3, 0-2 months after giving birth
4, During pregnancy
5, 0-1 years before my last pregnancy
6, 2-3 years before my last pregnancy
7, More than 3 years before my last pregnancy
88, Don't know/not sure
99, Prefer not to say
103. Currently, if you needed to see a primary care provider to help you if you are sick or for 
an annual physical exam, how hard would it be for you to do the following? 
[Select an answer for EACH option.]
Very 
Hard
Somewhat 
Hard
Not Hard 
at All
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. Get an appointment 
soon enough  
2. Find transportation to 
the appointment
3. Afford the cost of the 
visit 
4. Get time off work or 
school to get to the 
appointment
5. Get childcare in order 
to go to the appointment
6. Find a provider with 
availability 
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104. Since giving birth, did you have an appointment with your pregnancy doctor or midwife? 
This often is called a postpartum visit. 
1, Yes, in-person visits only
2, Yes, telemedicine / phone visits only
3, Yes, both in-person and telemedicine/phone visits
4, No
5, Don't know/not sure
6, Prefer not to say
105. Since giving birth, have you been to an emergency department or urgent care center to 
get care for yourself?
1, Yes
2, No
88, Don't know/not sure
99, Prefer not to say
106. Do you currently have health insurance? [Select ONE.]
1. Yes
2. No
88. Don’t know/not sure
99. Prefer not to say
107. What kind of health insurance do you have now? [Check ALL that apply.] (If 106=1)
1.
Health insurance from my job, school, or the job of my spouse or partner
2.
Health insurance from my parents
3.
Health insurance from the state Marketplace, Massachusetts Health Connector, or 
HealthCare.gov
4.
Medicaid or MassHealth
5.
Other government plan or program such as SCHIP/CHIP
6.
Other government plan or program not listed above such as MCH program, indigent 
program or family planning program
7.
TRICARE or other military/veteran health care
8.
Other health insurance, please specify: _______________________
88. Don’t know/not sure
99. Prefer not to say
108. Since giving birth, how much money have you spent out of pocket on all other health 
care for yourself? Do not include costs of childbirth. Your best estimate is fine. [Select ONE]
1, I did not spend any money out of pocket
2, $0-$500
3, $501 - $1,000
4, $1,001 - $3,000
5, $3,001 - $5,000
6, $5,001 - $7,000
7, $7,001 - $9,000
8, Greater than $9,001
88, Don’t know/not sure
99, Prefer not to say
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109. In general, how worried are you about paying your health care bills? [Select ONE.]
1.
Not at all worried
2.
Somewhat worried
3.
Very worried
88. Don’t know/not sure
99. Prefer not to say
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Section 2: Health
201. In general, how would you describe your current PHYSICAL health? [Select ONE.]
1. Excellent
2. Very good
3. Good
4. Fair
5. Poor
88. Don’t know/not sure
99. Prefer not to say
202. In general, how would you describe your current MENTAL health? [Select ONE.]
1. Excellent
2. Very good
3. Good
4. Fair
5. Poor
88. Don’t know/not sure
99. Prefer not to say
203. Have you ever been told by a doctor, nurse, or other health professional that you have any 
of the following conditions? [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. High blood pressure or hypertension
2. Diabetes or high blood sugar
3. Anxiety or depression
4. Overweight or obesity
204. Since giving birth, have you received any of the following treatments or support for your 
emotional or mental health? [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not sure
Prefer 
not to 
say
1. Counseling or therapy
2. Medication for mood, anxiety, or 
depression
3. Treatment at a hospital or emergency 
department
4. Support group or care from an in-home 
visiting health professional (examples: 
nurse, midwife, doula)
5. Support from a social worker
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205. What kind of birth control are you or your spouse/partner currently using? [Select all that 
apply.]
1, Not using any birth control
2, Birth control pills, shots/injections, patch or vaginal ring
3, Intrauterine device or IUD (Mirena, ParaGuard, Liletta, Kyleena, etc.)
4, Contraceptive implant in the arm (Norplant, Implanon, Nexplanon, etc.)
5, Condoms
6, Withdrawal (pulling out) or calendar rhythm/cycle-based method
7, Not having sex (abstinence)
8, Have had a hysterectomy or tubes tied/blocked
9, Partner has vasectomy
10, I cannot get pregnant due to the sex of my partner
88, Don't know/not sure
99, Prefer not to say
206. Since giving birth, have you gotten health care from any of the following types of specialty 
health care providers? SELECT ALL THAT APPLY
1, Cardiology (heart and blood specialist)
2, Endocrinology (diabetes, thyroid, and hormones specialist)
3, Allergy or Immunology (immune system, allergies specialist)
4, Gynecology
5, Nephrology (kidney specialist)
6, Oncology (cancer specialist)
7, Psychiatry (mental health specialist)
8, Psychology / Therapy
9, Pulmonology (lung specialist)
10, Surgery
11, Urology or urogynecology (urinary tract specialist)
12, Other specialist not mentioned above (please list)  ____
88, Don't know/ not sure
99, Prefer not to say
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Section 3A: No Primary Care 
3A01. Please indicate ALL of the reasons why you do not currently have a primary care 
provider. 
[Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not sure
Prefer 
not to 
say
1. I don’t feel I need one
2. I don’t know how to find one
3. I want to find one but never have time
4. I am worried about the cost
5. I can’t find one that is accepting new patients 
or has appointments available
6. I can’t find one that accepts my insurance
7. I can’t find one that speaks my preferred 
language
8. I can’t find one I can trust
9. Other reason, please specify: 
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Section 3B. For individuals with Primary Care Provider and Appointment
3B01. Since giving birth, how important do you feel your primary care visits (either in-person or 
telemedicine) were for you in helping to manage your overall health? 
1, Extremely important
2, Somewhat important
3, Neither important nor unimportant
4, Somewhat unimportant
5, Extremely unimportant
88, Don't know/not sure
99, Prefer not to say
3B02. Since giving birth, what were the reasons for your visit(s) with the primary care provider? 
This does not include visits to your pregnancy-care provider (OB/GYN or midwife) OR to an 
emergency department or urgent care center [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not sure
Prefer 
not to say
1. Regular checkup (annual 
visit)
2. Sick care (examples: an 
illness, injury, infection)
3. To talk about a specific 
medical problem (examples: 
high blood pressure or 
diabetes)
4. To discuss a mental 
health or mood concern
5. To discuss and/or get 
birth control
6. To get a prescription
7. To get a vaccine
8. Other reason, please specify: 
3B03. Since giving birth, in any of your primary care visits or phone calls, did the doctor or nurse 
ever do any of the following? [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not sure
Prefer 
not to say
1. Asked me questions 
about my mental health and 
wellbeing
2. Prescribed me medication 
or referred me to a 
therapist/psychiatrist for my 
mental health
3. Checked my weight and 
height
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4. Talked to me about ways 
to manage my weight
5. Asked me questions or 
talked to me about my blood 
sugar or diabetes
6. Perform a blood test for 
diabetes
7. Checked my blood 
pressure
8. Talked to me about ways 
to manage my blood 
pressure
3B04. The last time you saw your primary care provider, did you have to pay for the visit?
1.
I had to pay a fee at the time of the visit only.
2.
I received a bill after the visit only.
3.
I had to pay a fee at the time of the visit AND also received a bill after the visit.
4.
I did not have to pay at the time of the visit and did not receive a bill.
88. Don’t know/ not sure
99. Prefer not to say
3B05. The last time you saw your primary care provider, did you receive a reminder about your 
appointment through Patient Gateway?
1, Yes, from my provider's office
2, Yes, from the Bridge Study team
3, Yes, from my provider's office and the Bridge Study team
4, No
88, Don't know / not sure
99, Prefer not to say
3B06. The last time you saw your primary care provider, did you receive a text message 
reminder to your phone about your appointment?
1, Yes, from my provider's office
2, Yes, from the Bridge Study team
3, Yes, from my provider's office and the Bridge Study team
4, No
88, Don't know / not sure
99, Prefer not to say
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Section 3C: Primary Care (No visit)
3C01.  Please indicate ALL of the reasons you have NOT had an appointment with a primary 
care provider since giving birth.
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. I have an appointment scheduled in the 
future
2. I had no need or reason to see them
3. I was concerned about the cost
4. I don’t know who to make an appointment 
with
5. I couldn’t get an appointment quickly enough
6. I was unable to miss work
7. I couldn’t get childcare so I could go to the 
appointment
8. I didn’t have transportation to the appointment
9. I didn’t have the energy or feel well enough.
10. I don’t have a primary care doctor
11. Other reason, please specify: 
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Section 4: Urgent or Emergency Care
401. Since giving birth, which emergency department(s) or urgent care center(s) did you go to 
get care for yourself? (Show if 105=1)
List the names of all hospital emergency rooms or urgent care centers you visited.
Name 1: ______________________________
Name 2: ______________________________
Name 3: ______________________________
Name 4: ______________________________
88. Don’t know/not sure
99. Prefer not to say
402. The LAST TIME you went to the emergency department or urgent care center for yourself, 
what was the reason you went there? [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. I needed emergency care
2. My doctor instructed me to go to an 
urgent care or emergency department
3. My doctors’ offices were closed
4. I couldn’t get an appointment to my 
doctor soon enough
5. I didn’t have a doctor or primary care 
provider
6. I couldn’t afford the cost to see a 
doctor
7. I needed a prescription drug
8. I didn’t know where else to go
9. Some other reason, please specify: 
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Section 5: Postpartum Obstetric Care (Only shown if did not say No PP Visit)
501. Since giving birth, has your OBGYN or midwife discussed any of the following with you 
in your appointments (either in person or by phone or video)? [Select an answer for EACH 
option.]
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. My mental health and wellbeing
2. How to manage my blood pressure 
or hypertension
3. How to manage my weight
4. How to manage my blood sugar or 
diabetes
5. My plan for birth control or future 
pregnancies
6. Recommendation to see a primary 
care doctor
7. Recommendation to see or talk with 
a social worker
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Section 6: Postpartum Leave, Work and Childcare
601. How many children (under age 18) live in your household? Only include children who live 
with you at least 50% of the time.
1, 1
2, 2
3, 3
4, 4
5, 5
6, 6
7, 7
8, 8 or more
88, Don't know/not sure
99, Prefer not to say
602. How many adults (age 18 or older), including yourself, live in your household? Only 
include adults who live with you at least 50% of the time.
1, 1
2, 2
3, 3
4, 4
5, 5
6, 6
7, 7
8, 8 or more
88, Don't know/not sure
99, Prefer not to say
603. Since giving birth, did anyone in your household receive assistance from any of the 
following sources? [Select an answer for EACH option.]
YES
NO
Don’t 
know/ 
Not 
sure
Prefer 
not to 
say
1. Unemployment compensation or 
worker’s compensation
2. Cash assistance from a state or 
county welfare program
3. Supplemental Nutrition Assistance 
Program (SNAP)
4. Woman, Infants and Children 
Nutrition Program (WIC)
5. Help paying for childcare from a 
government agency
6. Federal, state or local government 
housing program that lowers your rent 
or provides a housing voucher
7. Income from SSI (Supplemental 
Security Income), a federal program to 
help older adults, blind, and disabled 
people
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8. Other government program(s) not listed here, please specify: 
604. What is your yearly total household income now, before taxes? Include income from all 
family members living in your household (your income, your spouse’s or partner’s income, and 
any other income you may have received). All information will be kept private and will not 
affect any services you are now getting. [Select ONE]
1. $ 0 - $ 9,999
2. $10,000-$19,999
3. $ 20,000 – $ 29,999
4. $30,000 – $ 39,999
5. $40,000 - $59,999
6. $60,000 - $79,999
7. $80,000 - $99,999
8. $100,000 - $119,999
9. $120,000 - $149,999
10. $150,000 - $174,999
11. $175,000 - $199,999
12. $200,000 or above
88. Don’t know/not sure
99. Prefer not to say
606. Are you currently working for pay?  [Select ONE.]
1. Yes, I am working part time
2. Yes, I am working full time
3. No. - Skip to Question 612
88. Don’t know/not sure
99. Prefer not to say
607. How many weeks after your delivery did you begin working? 
_________ weeks [0-100 NUMBER]
608. Do you plan on either returning to work or starting a new job in the next year? [Select 
ONE.]
1.
I don’t plan to return to work or start a new job in the next year
2.
Yes, I plan to start working within the next 1 month
3.
Yes, I plan to start working within the next 2 – 3 months
4.
Yes, I plan to start working ore than 3 months from now
88. Don’t know/not sure
99. Prefer not to say
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605. How well did you understand the maternity leave benefits that were available to you? 
1.
Extremely well 
2.
Very well 
3.
Moderately well 
4.
Somewhat well 
5.
Not well at all
6.
I was not working for pay prior to giving birth and therefore did not have any leave benefits
88. Don’t know/not sure
99. Prefer not to say
609. Since giving birth, which types of parental leave have you used? [Select ALL THAT 
APPLY] (SHOW ONLY IF 605==1-5)
1. Paid parental leave provided by my employer
2. Unpaid parental leave provided by my employer 
3. Massachusetts Paid Family and Medical Leave (MA PFML)
4. Temporary Disability Insurance or Short-Term Disability Insurance
5. Paid Time Off / Paid Vacation Days (Sometimes called PTO)
6. Sick Leave
7. Unpaid Time Off
8. Other, please specify_________________
88. Don’t know/not sure
99. Prefer not to say
610. Since giving birth, how many weeks of PAID parental leave have you taken in total? Your 
best estimate is fine.  [SHOW ONLY IF 608= (1 OR 2 OR 3)]
_________ [0-100, NUMBER]
611. Since giving birth, how many weeks of UNPAID parental leave have you taken in total? 
Your best estimate is fine.  [SHOW ONLY IF 608= (1 OR 2 OR 3)]
_________ [0-100, NUMBER]
612. Since delivery, how many weeks of parental leave/time-off did your spouse, partner, or the 
baby’s father take from work? 
0, None
1, 1-2 weeks
2, 3-4 weeks
3, 5-6 weeks
4, 7-8 weeks
5, 9-10 weeks
6, 11-12 weeks
7, 13-16 weeks
8, 17+ weeks
77, Not applicable
88, Don't know/not sure
99, Prefer not to say
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613. In the last 30 days, who was your usual childcare provider? [Select ONE.]
1. Me
2. Spouse or partner
3. Baby’s grandparent
4. Other close family members or relatives
5. Friend or neighbor
6. Babysitter, nanny, or other childcare provider
7. Staff at home-based or day care center
8. Other, please specify:______________________
88. Don’t know/not sure
99. Prefer not to say
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Section 7: Experiences with Intervention 
701. The study you have participated in aimed to help you to transition to primary care after 
childbirth. How important was seeing your primary care provider after birth for you? 
[Select ONE.]
1. Extremely important
2. Somewhat important
3. Not very important
4. Not important at all
88. Don’t know/not sure
99. Prefer not to say
703. How helpful would or did you find each of the following actions in reconnecting you to 
your primary care provider? [Select an answer for EACH option.] 
Extreme
ly 
helpful
So
me
wha
t 
help
ful
Not 
very 
helpf
ul
Not 
helpf
ul at 
all 
Don’t 
know
/ Not 
sure
Prefe
r not 
to 
say
1. Information about the 
role of primary care after 
your delivery
2. Scheduling of your 
primary care appointment 
for you
3. Text messaging to 
remind you about your 
appointment
88. Don’t know/not sure
99. Prefer not to say
704. In your own words, what assistance would you find or have found helpful in 
reconnecting with your primary care provider after delivery? 
[ Free text ]
88. Don’t know/not sure
99. Prefer not to say
705. If given the opportunity, would you participate in this study again?
1, Yes
2, No
88, Don't know / not sure
99, Prefer not to say
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Email Text for REDCap Survey
Subject Line: “MGH OB Bridge Study Follow-up Survey”
Body Text:
Dear Bridge Study Participant,
THANK YOU for participating in the Bridge Study in the MGH Department of Obstetrics and 
Gynecology!
Please complete this short survey about the care you received after your delivery: [survey-link]
Participants who complete the survey will receive a $20 Amazon gift card. Your responses will 
not be shared with anyone outside of the research team, including your doctors or other care 
team members.
Thank you for your help and contribution to this research study. Please feel free to contact us 
with questions or concerns.
MGH Bridge Study
bridgestudy@mgh.harvard.edu
617-643-5483
--
If the link above does not work, try copying the link below into your web browser:
[survey-url]
This link is unique to you and should not be forwarded to others.
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SMS Text Message
For individuals who consented to receive SMS messages
“MGH Bridge Study Message: Please check your email to complete a short survey. 
Respondents will receive a $20 gift card. Thank you!”
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Version: V15.5 created on 04/03/23 - 01:56 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:41 PM 
 
 
Title: Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to 
Improve Chronic Disease Management among Postpartum Women (the Bridge Study)  
Sponsor Name: 
PI Name: Clapp, Mark A  
Protocol #: 2022P001723 
Type: Amendment (AME14)  
Date Received: April 02, 2023  
Signatures 
PI Name: Clapp, Mark A, MD, MPH 
Authenticated: April 02, 2023 
Amendment  
COVID-19 Amendment 
 
Is this amendment ONLY related to research impacted by COVID-19? 
 
Refer to MGB Policy on Conduct of Human Research Activities during COVID-19 Operations for description 
of Amendments which do require prior IRB review and approval.   
⚪  Yes   
◉  No  
 
 
Central IRB Performance Sites  
 
Is this a protocol where the Mass General Brigham IRB is serving as the single IRB (sIRB) for external 
sites/institutions? 
◉  Yes  
 
⚪  No  
 
Would you like to 'Add' a Site? 
⚪  Yes  
 
◉  No  
 
Would you like to 'Remove' a Site? 
⚪  Yes  
 
◉  No  
 
 
Sponsor Amendment 
  
Is there a sponsor amendment number? 
⚪  Yes   
◉  No  
 
 
Change in Protocol Status 
 
Is this a cede protocol or project that was determined to be exempt, not human subjects research or not 
engaged in human subjects research?  
⚪  Yes   
◉  No  
 
 
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Version: V15.5 created on 04/03/23 - 01:56 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:41 PM 
 
 
Do you need to change the overall status of the protocol?  For example, Re-Open to Enrollment or 
indicate that Research Interventions/Assessments Continue after telling the IRB these have ceased. 
⚪  Yes  
 
◉  No  
 
 
  
Briefly describe the proposed changes: 
Addition of the Endline Survey Materials translated into Spanish with certification of translation 
 
  
Provide rationale for the proposed changes: 
To allow the endline survey to be sent to Spanish Speakers 
 
  
Will the proposed change(s) significantly alter the risk to benefit assessment the IRB relied upon to approve 
the protocol? 
⚪  Yes   
◉  No  
 
 
  
Will the proposed change(s) significantly affect the integrity of the protocol? 
⚪  Yes   
◉  No  
 
 
Informed Consent 
 
Do the changes require a revision to the consent form? 
⚪  Yes   
◉  No  
 
Attachments 
 
Name 
Mode 
Endline_TranslationCertification (Other)  
Electronic  
Survey-Email-Text_031223-Es (Document for review)  
Electronic  
Survey-Remider-SMS-Text_031723-Es (Document for review)  
Electronic  
Bridge-Survey-Endline-_-final-Es (Document for review)  
Electronic  
 
Page 2 of 23
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The Spanish Group LLC 
1 Park Plaza, Suite 600 
Irvine, CA 92614 
Estados Unidos de América 
https://www.thespanishgroup.org 
Traducción Certificada 
Proporcionado el  27 de marzo de 2023 
Yo, Alexander Largaespada (                                       ), por medio de la presente certifico 
que traduje los presentes documentos de español a inglés o de inglés a español y que es una 
traducción correcta y fiel. Además, certifico que soy competente en la traducción tanto de español 
como de inglés, y que soy capaz de producir y certificar la validez de dicha traducción. Estos 
documentos no se han traducido para un familiar, amigo o socio comercial.
Yo, Salvador G. Ordorica, como Agente de Control de Calidad de The Spanish Group LLC, 
doy fe de que la persona mencionada es un traductor o traductora competente de español a inglés 
y de inglés a español. Por lo tanto, como representante autorizado de The Spanish Group, verifico 
que estos documentos han sido corregidos y que los siguientes documentos son  traducciones 
correctas y fieles de sus originales.
Respetuosamente, 
Salvador G. Ordorica  
The Spanish Group LLC 
(ATA #267262) 
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Texto de Email para Encuesta REDCap 
Asunto: “Encuesta de Seguimiento del Estudio MGH OB Bridge”
Cuerpo del Texto:
Estimado Participante del Estudio Bridge,
!GRACIAS por participar en el Estudio Bridge del Departamento de Obstetricia y Ginecología 
de MGH!
Le rogamos complete esta breve encuesta sobre la atención recibida tras su parto: [link de la 
encuesta] 
Quienes completen la encuesta recibirán una tarjeta regalo de Amazon por valor de 20USD. 
Sus respuestas no serán compartidas con nadie ajeno al equipo de investigación, incluyendo a sus 
médicos y otros miembros del equipo de atención sanitaria. 
Gracias por su ayuda y contribución a este estudio. Si tiene alguna duda o inquietud no dude en 
contactarnos.
MGH Bridge Study
bridgestudy@mgh.harvard.edu
617-643-5483
--
Si el link de arriba no funciona pruebe copiando el siguiente link en su navegador:
[link de la encuesta]
Este link es personal y no debe ser reenviado a otros.
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Mensaje de Texto SMS
Para personas que aceptaron recibir mensajes SMS
“Mensaje del Estudio MGH Bridge: Vea su email para completar una breve encuesta. Los 
participantes recibirán una tarjeta regalo por valor de 20 USD. ¡Gracias!”
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Esquema Lógico de la Encuesta
Sección 0: Introducción
Sección 1: Acceso a Atención Médica
Sección 2: Información de Salud
Sección 3: Tiene PCP pero NO 
tiene cita
Sección 3B: Tiene PCP y cita
Sección 4: Atención de Urgencias
Sección 5: Atención Postparto
Sección 6: Baja de Maternidad
Sección 7: Intervención de Bridge Study
SÍ
SÍ
(Q101 = No sabe, no 
contesta) O
(Q102 = No sabe, no 
contesta si Q101=SÍ)
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Acortando Distancias entre Atención Postparto y Atención Primaria
Encuesta Final
Autores del Estudio: Mark Clapp, MD MPH (MGH); Jessica Cohen, PhD 
(Harvard) 
PI: Mark Clapp, MD MPH (MGH)
Sección 0: Texto Introductorio
Esta encuesta se administra como parte del Estudio MGH Bridge, en el que usted aceptó 
participar durante o poco después de su embarazo.
Completar la encuesta le tomará aproximadamente unos 5-10 minutos. Los participantes que 
completen la encuesta recibirán una tarjeta regalo de Amazon por valor de 20 USD. 
Sus respuestas no serán compartidas con nadie ajeno al equipo de investigación, incluyendo sus 
médicos u otros proveedores de salud. Tampoco serán parte de su historial médico ni afectarán a 
su derecho a recibir atención o servicios en MGH.
Gracias por su contribución a este estudio. Si tiene alguna pregunta sobre el estudio no dude en 
contactarme.
Mark Clapp, MD MPH
Maternal-Fetal Medicine
Massachusetts General Hospital
bridgestudy@mgh.harvard.edu 
617-724-4531
Al marcar SEGUIR, ACEPTO PARTICIPAR EN ESTA ENCUESTA.
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Sección 1: Acceso a la Atención Sanitaria 
100. ¿Su proveedor de asistencia durante el embarazo (obstetra, ginecólogo o partera) le 
alentó a visitar a su médico de cabecera después de dar a luz?
1.
Sí
2.
No
88. No lo sé/no estoy segura
99. Prefiero no contestar
101. ¿Tiene médico de cabecera actualmente? Entendido como alguien a quien uno ve para 
una revisión anual o un examen físico, o a quien consulta cuando se encuentra mal. ESTO 
NO ALUDE A UN DEPARTAMENTO DE URGENCIAS [Marcar UNO.]
1.
Sí
2.
No 
88. No lo sé/no estoy segura
99. Prefiero no contestar
102. ¿Cuándo fue la última vez que vio a su médico de cabecera por cualquier motivo? Esto no 
incluye las visitas a su proveedor de asistencia durante el embarazo (obstetra, ginecólogo 
o partera) ni las visitas a urgencias. Puede usar meses o años en su respuesta. Conteste en la 
medida de sus conocimientos. *OBLIGATORIO
1, Más de 5 meses después de dar a luz
2, 3-4 meses después de dar a luz
3, 0-2 meses después de dar a luz
4, Durante el embarazo
5, 0-1 año antes de mi último embarazo
6, 2-3 años antes de mi último embarazo
7, Más de 3 años antes de mi último embarazo
88, No lo sé/no estoy segura
99, Prefiero no contestar
103. Al día de hoy, si necesita ver a su médico de cabecera para recibir asistencia si se 
encuentra enferma o para un examen físico anual, ¿cuánto le costaría hacer lo siguiente? 
[Seleccionar una respuesta por CADA opción]
Muy 
Difícil
Algo 
Difícil
Nada 
Difícil
No lo 
sé
Prefiero no 
contestar
1. Conseguir una cita a 
corto plazo  
2. Conseguir transporte 
para la cita
3. Pagar el coste de la 
visita
4. Tomarme tiempo libre 
en el trabajo o la escuela 
para acudir a la cita
5. Conseguir niñera para 
acudir a la cita
6. Encontrar un médico 
disponible 
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104. Desde que dio a luz, ¿tuvo cita con su ginecólogo u obstetra, o partera? 
Esto es lo que suele llamarse una visita postparto. 
1, Sí, sólo de forma presencial
2, Sí, sólo por vía telemática o telefónica
3, Sí, tanto visitas presenciales como por vía telemática/telefónica
4, No
5, No lo sé/no estoy segura
6, Prefiero no contestar
105. Desde que dio a luz, ¿visitó algún centro de emergencias para recibir atención para 
usted?
1, Sí
2, No
88, No lo sé/no estoy segura
99, Prefiero no responder
106. ¿Cuenta con seguro médico actualmente? [Marcar UNO.]
1. Sí
2. No
88. No lo sé/no estoy segura
99. Prefiero no responder
107. ¿Qué tipo de seguro médico tiene ahora? [Marcar TODAS las que apliquen] (Si 106=1)
1.
Seguro médico de mi trabajo, escuela o del trabajo de mi cónyuge o pareja
2.
Seguro médico de mis padres
3.
Seguro médico estatal del Marketplace, Massachusetts Health Connector, o 
HealthCare.gov
4.
Medicaid o MassHealth
5.
Otro plan o programa gubernamental como SCHIP/CHIP
6.
Otro plan o programa gubernamental no listado arriba como el programa MCH, el 
programa de indigencia o el programa de planificación familiar
7.
TRICARE u otro plan de asistencia para militares/veteranos
8.
Otro seguro médico, especificar: _______________________
88. No lo sé/no estoy segura
99. Prefiero no responder
108. Desde que dio a luz, ¿cuánto dinero ha gastado en atención sanitaria para usted? No 
incluir los gastos del parto. Responda en la medida de sus conocimientos. [Marcar UNO]
1, No gasté nada de dinero
2, $0-$500
3, $501 - $1,000
4, $1,001 - $3,000
5, $3,001 - $5,000
6, $5,001 - $7,000
7, $7,001 - $9,000
8, Más de $9,001
88, No lo sé/no estoy segura
99, Prefiero no responder
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109. En general, ¿cuánto le preocupa tener que pagar sus facturas de atención sanitaria? 
[Marcar UNO]
1.
No me preocupa nada
2.
Me preocupa un poco
3.
Me preocupa mucho
88. No lo sé/no estoy segura
99. Prefiero no responder
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Sección 2: Salud
201. En general, ¿cómo describiría su salud FÍSICA actualmente? [Marcar UNO]
1. Excelente 
2. Muy buena
3. Buena
4. Normal
5. Mala
88. No lo sé/no estoy segura
99. Prefiero no responder
202. En general, ¿cómo describiría su salud MENTAL actualmente? [Marcar UNO]
1. Excelente
2. Muy buena
3. Buena
4. Normal
5. Mala 
88. No lo sé/no estoy segura
99. Prefiero no responder
203. ¿Alguna vez un médico, enfermera u otro profesional de la salud le dijo que tiene alguna 
de las siguientes condiciones? [Marcar una respuesta por CADA opción]
SÍ
NO
No lo 
sé/no 
estoy 
segura
Prefiero 
no 
respond
er
1. Presión alta o hipertensión
2. Diabetes o azúcar alto en sangre
3. Ansiedad o depresión
4. Sobrepeso u obesidad
204. Desde que dio a luz, ¿recibió alguno de los siguientes tratamientos para su salud mental 
o emocional? [Marcar una respuesta por CADA opción]
´SÍ
NO
No lo 
sé/no 
estoy 
segura
Prefiero 
no 
respond
er
1. Asesoría o terapia
2. Medicación para el humor, ansiedad o 
depresión
3. Tratamiento en hospital o 
departamento de urgencias
4. Grupo de apoyo o asistencia de un 
profesional sanitario a domicilio 
(ejemplos: enfermera, partera, doula)
5. Asistencia de un trabajador social
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205. ¿Qué tipo de anticonceptivo usa con su cónyuge actualmente? [Marcar todos los que 
apliquen]
1, No usamos anticonceptivos
2, Píldora anticonceptiva, inyecciones, parche o anillo vaginal
3, Dispositivo intrauterino o DIU (Mirena, ParaGuard, Liletta, Kyleena, etc.)
4, Implante anticonceptivo en el brazo (Norplant, Implanon, Nexplanon, etc.)
5, Preservativos
6, Retirada (antes de la eyaculación) o método de calendario/ciclos
7, No tener sexo (abstinencia)
8, Tengo hecha la histerectomía o ligadura de trompas
9, Mi cónyuge tiene la vasectomía
10, No puedo quedar embarazada debido al sexo de mi pareja
88. No lo sé/no estoy segura
99. Prefiero no responder
206. Desde que dio a luz, ¿ha recibido asistencia de alguno de los siguientes especialistas 
sanitarios? MARCAR TODOS LOS QUE APLIQUEN
1, Cardiólogo (especialista en corazón y flujo sanguíneo)
2, Endocrinólogo (especialista en diabetes, tiroides y hormonas)
3, Alergólogo o Inmunólogo (especialista en sistema inmunitario y alergias)
4, Ginecólogo
5, Nefrólogo (especialista en riñones)
6, Oncólogo (especialista en cáncer)
7, Psiquiatra (especialista en salud mental)
8, Psicólogo
9, Neumólogo (especialista en pulmones)
10, Cirujano
11, Urólogo o uroginecólogo (especialista en el tracto urinario)
12, Otro especialista (especificar)  ____
88. No lo sé/no estoy segura
99. Prefiero no responder
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Sección 3A: Sin Atención Primaria
3A01. Marque TODAS las razones por las que actualmente no cuenta con proveedor de 
atención primaria/médico de cabecera. [Marcar una respuesta para CADA opción]
SÍ
NO
No lo sé/no 
estoy 
segura
Prefiero 
no 
responder
1. No siento que lo necesite
2. No sé cómo encontrar uno
3. Quiero encontrar uno pero nunca tengo tiempo
4. Me preocupa el gasto
5. No encuentro uno que acepte nuevos 
pacientes o tenga turnos disponibles
6. No encuentro uno que acepte mi seguro
7. No encuentro uno que hable mi idioma
8. No encuentro uno en quien confíe
9. Otro motivo, especificar: 
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Sección 3B. Para personas con Proveedor de Atención Primaria y Turnos
3B01. Desde que dio a luz, ¿qué importancia le da a sus visitas al médico de cabecera (ya sea 
en persona o por vía telemática) en la gestión de su salud general? 
1, Mucha importancia
2, Algo de importancia
3, No demasiada importancia
4, Poca importancia
5, Nada de importancia
88. No lo sé/no estoy segura
99. Prefiero no responder
3B02. Desde que dio a luz, ¿qué motivo su(s) visita(s) a su médico de cabecera? Esto no 
incluye las visitas a su obstetra, ginecólogo o partera NI al departamento o centro de 
urgencias. [Marcara una respuesta por CADA opción]
SÍ
NO
No lo sé/no 
estoy 
segura
Prefiero no 
responder 
1. Examen de rutina (visita 
anual)
2. Visita por enfermedad, 
lesión, infección, etc.
3. Para hablar sobre un 
problema médico específico 
(ejemplos: presión alta o 
diabetes)
4. Para hacer una consulta 
relacionada con su salud 
mental
5. Para hablar sobre/pedir 
anticonceptivos
6. Para pedir una receta
7. Para recibir una vacuna
8. Otro motivo, especificar
3B03. Desde que dio a luz, en alguna de sus visitas o llamadas a atención primaria, ¿el médico 
o enfermera hizo lo siguiente? [Marcar una respuesta por CADA opción]
SÍ
NO
No lo sé/no 
estoy 
segura
Prefiero no 
responder
1. Preguntó por mi salud 
mental y bienestar
2. Me recetó algo o me 
derivó a un 
terapeuta/psiquiatra por mi 
salud mental
3. Comprobó mi peso y 
altura
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4. Me habló sobre formas de 
controlar mi peso
5. Me hizo preguntas o 
habló sobre mi azúcar en 
sangre o diabetes
6. Me hizo un análisis de 
sangre para controlar la 
diabetes
7. Me tomó la presión
8. Me habló sobre formas de 
controlar la presión 
sanguínea
3B04. La última vez que visitó a su médico de cabecera, ¿tuvo que pagar por la visita?
1.
Tuve que pagar una cuota sólo al momento de la visita.
2.
Recibí una factura después de la visita.
3.
Tuve que pagar una cuota al momento de la visita Y también recibí una factura tras la 
visita.
4.
No tuve que pagar al momento de la visita ni recibí una factura.
88. No lo sé/no estoy segura
99. Prefiero no responder
3B05. La última vez que visitó a su médico de cabecera, ¿le llegó un recordatorio de su cita a 
través de Patient Gateway?
1, Sí, de la oficina de mi médico
2, Sí, del equipo de Bridge Study
3, Sí, de la oficina de mi médico y del equipo de Bridge Study
4, No
88, No lo sé/no estoy segura
99, Prefiero no responder
3B06. La última vez que visitó a su médico de cabecera, ¿recibió un mensaje de texto en su 
teléfono recordándole su cita?
1, Sí, de la oficina de mi médico
2, Sí, del equipo de Bridge Study
3, Sí, de la oficina de mi médico y del equipo de Bridge Study
4, No
88, No lo sé/no estoy segura
99, Prefiero no responder
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Sección 3C: Atención Primaria (Sin visitas)
3C01.  Por favor, indique TODOS los motivos por los que NO reservó una cita con su médico 
de cabecera desde que dio a luz.
SÍ
NO
No lo sé/no 
estoy 
segura
Prefiero no 
responder
1. Tengo una cita programado en el futuro
2. No tenía necesidad ni motivo para verlo
3. Me preocupaba el coste
4. No sé cómo reservar una cita
5. No pude reservar una cita a tiempo
6. No podía faltar al trabajo
7. No tenía quien cuidase a mis hijos mientras 
iba al médico
8. No tenía transporte para ir a la cita
9. No tenía energía ni me sentía con fuerzas
10. No tengo médico de cabecera
11. Otro motivo, especificar
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Sección 4: Atención de Urgencias
401. Desde que dio a luz, ¿qué departamento(s) o centro(s) de urgencias visitó para recibir 
asistencia? (Mostrar si 105=1)
Indicar los nombres de todas las salas o centros de urgencias que visitó.
Nombre 1: ______________________________
Nombre 2: ______________________________
Nombre 3: ______________________________
Nombre 4: ______________________________
88. No lo sé/no estoy segura
99. Prefiero no responder
402. La ÚLTIMA VEZ que acudió a un departamento o centro de urgencias para recibir 
asistencia para usted, ¿cuál fue el motivo de su visita? [Marcar una respuesta por CADA 
opción]
SÍ
NO
No lo 
sé/no 
estoy 
segura
Prefiero 
no 
responder
1. Necesitaba atención urgente
2. Mi médico me indicó que fuera a un 
departamento o centro de urgencias
3. El consultorio de mi médico estaba 
cerrado
4. No puede reservar una cita a tiempo 
con mi médico
5. No tenía médico de cabecera
6. No podía pagar la visita al médico
7. Necesitaba una receta
8. No sabía dónde más ir
9. Otro motivo, especificar:
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Sección 5: Atención Obstétrica Postparto (Sólo aparece si no se marcó como No PP Visit)
501. Desde que dio a luz, ¿Su gineco-obstetra o partera habló con usted de alguno de los 
siguientes temas en sus citas (ya sea en persona o por teléfono/videollamada)? [Seleccionar 
una respuesta por CADA opción]
SÍ
NO
No lo 
sé/no 
estoy 
segura
Prefiero 
no 
responder
1. Mi salud mental y bienestar
2. Control de mi presión sanguínea o 
hipertensión
3. Cómo controlar mi peso
4. Cómo controlar mi azúcar en 
sangre o diabetes
5. Mi plan anticonceptivo o de 
embarazos futuros
6. Derivación a un médico de atención 
primaria
7. Recomendación de ver a hablar 
con un trabajador social
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Sección 6: Licencia de Maternidad, Trabajo y Cuidado de Niños
601. ¿Cuántos niños (menores de 18 años) viven en su casa? Incluir sólo a los niños que 
vivan con usted al menos el 50% del tiempo.
1, 1
2, 2
3, 3
4, 4
5, 5
6, 6
7, 7
8, 8 o más
88, No lo sé/no estoy segura
99, Prefiero no responder
602. ¿Cuántos adultos (mayores de 18 años), incluyéndola a usted, viven en su casa? Incluir 
sólo a los adultos que vivan con usted al menos el 50% del tiempo.
1, 1
2, 2
3, 3
4, 4
5, 5
6, 6
7, 7
8, 8 o más
88, No lo sé/no estoy segura
99, Prefiero no responder
603. Desde que dio a luz, ¿alguien en su casa recibió asistencia de alguno de los siguientes? 
[Marcar una respuesta por CADA opción]
SÍ
NO
No lo 
sé/no 
estoy 
segura
Prefiero 
no 
responder
1. Prestación por desempleo o 
compensación por accidente
2. Ayuda en efectivo de un programa 
benéfico estatal o del condado
3. Programa de Asistencia de 
Nutrición Complementaria (SNAP)
4. Programa de Nutrición de Mujeres, 
Infantes y Niños (WIC)
5. Ayuda de una agencia 
gubernamental para pagar el cuidado 
de niños
6. Programa de vivienda federal, 
estatal o local que disminuya su 
alquiler o le dé un vale de vivienda
7. Ingresos del SSI (Supplemental 
Security Income), un programa federal 
de asistencia a adultos mayores, 
personas ciegas y discapacitadas
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8. Otro/s programa/s gubernamental/es no indicados aquí, especificar: 
604. ¿Cuáles son sus ingresos familiares anuales actuales antes de impuestos? Incluir 
ingresos de todos los familiares que vivan en su residencia (sus ingresos, los ingresos de su 
cónyuge o pareja y cualquier otro ingreso recibido). Esta información es privada y no 
afectará a los servicios que recibe actualmente. [Marcar UNO]
1. $ 0 - $ 9,999
2. $10,000-$19,999
3. $ 20,000 – $ 29,999
4. $30,000 – $ 39,999
5. $40,000 - $59,999
6. $60,000 - $79,999
7. $80,000 - $99,999
8. $100,000 - $119,999
9. $120,000 - $149,999
10. $150,000 - $174,999
11. $175,000 - $199,999
12. $200,000 o más
88. No lo sé/no estoy segura
99. Prefiero no responder
606. ¿Trabaja a cambio de un sueldo actualmente?  [Marcar UNO]
1. Sí, trabajo a tiempo parcial
2. Sí, trabajo a tiempo completo
3. No. - Pasar a la Pregunta 612
88. No lo sé/no estoy segura
99. Prefiero no responder
607. ¿Cuántas semanas después del parto empezó a trabajar? 
_________ semanas [NÚMERO DEL 0-100]
608. ¿Planea volver a trabajar o comenzar en un nuevo trabajo durante el próximo año? 
[Marcar UNO]
1.
No planeo volver a trabajar ni comenzar en un nuevo trabajo durante el próximo año
2.
Sí, planeo empezar a trabajar durante el próximo mes
3.
Sí, planeo volver a trabajar durante los próximos 2-3 meses
4.
Sí, planeo volver a trabajar dentro de más de 3 meses
88. No lo sé/no estoy segura
99. Prefiero no responder
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605. ¿Qué tal comprendió las prestaciones de baja por maternidad que tiene a su disposición? 
1.
Perfectamente
2.
Muy bien
3.
Moderadamente bien
4.
Más o menos bien
5.
Nada bien
6.
No trabajaba antes de dar a luz y por lo tanto no tuve prestaciones de maternidad
88. No lo sé/no estoy segura
99. Prefiero no responder
609. Desde que dio a luz, ¿qué tipos de licencia por maternidad ha usado? [Marcar TODOS 
LOS QUE APLIQUEN] (MOSTRAR SÓLO SI 605==1-5)
1. Licencia remunerada proporcionada por mi empleador
2. Licencia no remunerada proporcionada por mi empleador
3. Licencia Familiar Pagada de Massachusetts y Licencia Médica (MA PFML)
4. Seguro Temporal por Discapacidad o Seguro por Discapacidad a Corto Plazo
5. Licencia Remunerada / Días de Vacaciones Remuneradas
6. Licencia por Enfermedad
7. Licencia No Remunerada
8. Otro, especificar_________________
88. No lo sé/no estoy segura
99. Prefiero no responder
610. Desde que dio a luz, ¿cuántas semanas de licencia por maternidad REMUNERADA se ha 
tomado en total? Responda en la medida de sus conocimientos. [MOSTRAR SÓLO SI 608= (1 
O 2 O 3)]
_________ [NÚMERO DE 0-100]
611. Desde que dio a luz, ¿cuántas semanas de licencia por maternidad NO REMUNERADA 
se ha tomado en total? Responda en la medida de sus conocimientos. [MOSTRAR SÓLO SI 
608= (1 O 2 O 3)]
_________ [NÚMERO DE 0-100]
612. Desde que dio a luz, cuántas semanas de licencia por paternidad/días libres se tomó su 
cónyuge/pareja/padre del bebé? 
0, Ninguna
1, 1-2 semanas
2, 3-4 semanas
3, 5-6 semanas
4, 7-8 semanas
5, 9-10 semanas
6, 11-12 semanas
7, 13-16 semanas
8, 17+ semanas
77, No aplica
88, No lo sé/no estoy segura
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99, Prefiero no responder
613. Durante los últimos 30 días, ¿quién fue su proveedor de cuidado infantil? [Marcar UNO]
1. Yo
2. Cónyuge o pareja
3. Abuelo/a del bebé
4. Otros parientes cercanos
5. Amigo/a o vecino/a
6. Niñera u otro proveedor de cuidados
7. Personal de guardería o centro de día
8. Otro, especificar: ______________________
88. No lo sé/no estoy segura
99. Prefiero no responder
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Sección 7: Experiencias con Intervenciones
701. El estudio en el que ha participado tiene como meta asistirle en su transición a atención 
primaria después de dar a luz. ¿Qué importancia tuvo para usted ver a su médico de 
cabecera después del parto? [Marcar UNO]
1. Muy importante
2. Algo importante
3. Poco importante
4. Nada importante
88. No lo sé/no estoy segura
99. Prefiero no responder
703. ¿Qué importancia le da/daría a cada una de las siguientes acciones a la hora de 
reconectarla con su proveedor de atención primaria [Seleccionar una respuesta por CADA 
opción] 
Muy 
importante
Algo 
importa
nte
Poco 
importa
nte
Nada 
importa
nte
No lo 
sé/no 
estoy 
segura
Prefiero 
no 
respond
er
1. Información sobre el rol 
de la atención primaria 
después del parto
2. Programación de sus 
turnos de atención primaria
3. Mensajes de texto para 
recordar sus turnos
88. No lo sé/no estoy segura
99. Prefiero no responder
704. En sus propias palabras, ¿qué asistencia le ayudó o le ayudaría a reconectar con su 
médico de cabecera después del parto? 
[Texto libre]
88. No lo sé/no estoy segura
99. Prefiero no responder
705. Si tuviera la ocasión, ¿volvería a participar en este estudio?
1, Sí
2, No
88, No lo sé/no estoy segura
99, Prefiero no responder
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Version: V16.5 created on 05/04/23 - 12:18 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:42 PM 
 
 
Title: Bridging the Gap from Postpartum to Primary Care: A Behavioral Science Informed Intervention to 
Improve Chronic Disease Management among Postpartum Women (the Bridge Study)  
Sponsor Name: 
PI Name: Clapp, Mark A  
Protocol #: 2022P001723 
Type: Amendment (AME15)  
Date Received: April 25, 2023  
Signatures 
PI Name: Clapp, Mark A, MD, MPH 
Authenticated: April 25, 2023 
Amendment  
COVID-19 Amendment 
 
Is this amendment ONLY related to research impacted by COVID-19? 
 
Refer to MGB Policy on Conduct of Human Research Activities during COVID-19 Operations for description 
of Amendments which do require prior IRB review and approval.   
⚪  Yes   
◉  No  
 
 
Central IRB Performance Sites  
 
Is this a protocol where the Mass General Brigham IRB is serving as the single IRB (sIRB) for external 
sites/institutions? 
◉  Yes  
 
⚪  No  
 
Would you like to 'Add' a Site? 
⚪  Yes  
 
◉  No  
 
Would you like to 'Remove' a Site? 
⚪  Yes  
 
◉  No  
 
 
Sponsor Amendment 
  
Is there a sponsor amendment number? 
⚪  Yes   
◉  No  
 
 
Change in Protocol Status 
 
Is this a cede protocol or project that was determined to be exempt, not human subjects research or not 
engaged in human subjects research?  
⚪  Yes   
◉  No  
 
 
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Version: V16.5 created on 05/04/23 - 12:18 PM 
Electronic IRB Submission Generated On April 16, 2024 
Downloaded date: 04/16/24 - 03:42 PM 
 
 
Do you need to change the overall status of the protocol?  For example, Re-Open to Enrollment or 
indicate that Research Interventions/Assessments Continue after telling the IRB these have ceased. 
◉  Yes  
 
⚪  No  
 
 
Indicate new status:  
⚪  Active, Open to Enrollment/Collection  
 
◉  Active, Closed to Enrollment/Collection  
 
⚪  Active, Long Term Follow-Up  
 
⚪  Active, Data Analysis Only   
 
  
Briefly describe the proposed changes: 
1) The study has achieved it's target sample size and enrollment is now closed. Follow-up is ongoing. 
2) The SMS endline survey messages have been edited to include the link to the REDCap survey link, 
which is also being sent via email. 
 
  
Provide rationale for the proposed changes: 
We have poor response rates from emailing the survey. We expect response rates to increase when 
sent via SMS message.  
 
  
Will the proposed change(s) significantly alter the risk to benefit assessment the IRB relied upon to approve 
the protocol? 
⚪  Yes   
◉  No  
 
 
  
Will the proposed change(s) significantly affect the integrity of the protocol? 
⚪  Yes   
◉  No  
 
 
Informed Consent 
 
Do the changes require a revision to the consent form? 
⚪  Yes   
◉  No  
 
Attachments 
 
Name 
Mode 
Survey Remider SMS Text_042523 (Document for review)  
Electronic  
Survey-Remider-SMS-Text_042523-Es (Document for review)  
Electronic  
 
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SMS Text Message
For individuals who consented to receive SMS messages
“MGH Bridge Study Message: Please check your email to complete a short survey. 
Respondents will receive a $20 gift card. Thank you! [redcap-survey-link]”
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Compiled Summary of Protocol Amendments
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Mensaje de Texto SMS
Para personas que aceptaron recibir mensajes SMS
“Mensaje del Estudio MGH Bridge: Vea su email para completar una breve encuesta. Los 
participantes recibirán una tarjeta regalo por valor de 20 USD. ¡Gracias! [redcap-survey-link]"
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Compiled Summary of Protocol Amendments
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