Randomized Evaluation of Hypertensive Moms: Interventional Nudge to Drive Transitions of Care
Phase: NA
Conditions: Preeclampsia, Preeclampsia Severe, Gestational Hypertension, Hypertensive Disorder of Pregnancy, Superimposed Pre-Eclampsia
Sponsor: University of Pennsylvania

Page 1 of 19 
Study Title: Randomized Evaluation of hypertensive Moms: Interventional 
Nudge to Drive transitions of care  
NCT number: NCT04660032 
Protocol Date: 7/21/2021 
  
 

Page 2 of 19 
Modification 
Basic Info 
Confirmation Number: 
decfejje 
Protocol Number: 
844269 
Created By: 
TRIEBWASSER, JOURDAN E 
Principal Investigator: 
TRIEBWASSER, JOURDAN E 
Protocol Title: 
Randomized Evaluation of hypertensive Moms: Interventional Nudge to Drive transitions of care 
Short Title: 
REMIND Trial 
Protocol Description: 
Hypertensive disorders of pregnancy are stress tests which identify women at high risk of future 
cardiovascular disease, However, most women do not receive adequate counseling nor do they seek 
preventative care in the months following delivery. We will perform a randomized, controlled trial 
of electronic prompts to obstetric care providers to initiate transitions of care to continuity care 
providers. This will be a hospital-wide initiative using a pre-existing postpartum monitoring system. 
Submission Type: 
Biomedical Research 
Application Type: 
FULL 
PennERA Protocol Status 
Approved (No CR) 
Resubmission* 
No 
Are you submitting a Modification to this protocol?* 
Yes 
Current Status of Study 
Study Status 
Closed to subject enrollment (remains active) 
If study is currently in progress, please enter the following 
Number of subjects enrolled at Penn since the study was initiated 
0 
Actual enrollment at participating centers 
0 

Page 3 of 19 
If study is closed to further enrollment, please enter the following 
Number of subjects in therapy or intervention 
0 
Number of subjects in long-term follow-up only 
222 
IRB Determination 
If the change represents more than minimal risk to subjects, it must be reviewed and approved by the IRB 
at a convened meeting. For a modification to be considered more than minimal risk, the proposed change 
would increase the risk of discomfort or decrease benefit. The IRB must review and approve the proposed 
change at a convened meeting before the change can be implemented unless the change is necessary to 
eliminate an immediate hazard to the research participants. In the case of a change implemented to 
eliminate an immediate hazard to participants, the IRB will review the change to determine that it is 
consistent with ensuring the participant&prime;s continued welfare. Examples: Convened Board Increase 
in target enrollment for investigator initiated research or potential Phase I research Expanding inclusion or 
removing exclusion criteria where the new population may be at increased risk Revised risk information 
with active participants Minor risk revisions that may affect a subject&prime;s willingness to continue to 
participate Expedited Review Increase in target enrollment at Penn where overall enrollment target is not 
exceeded or potentially sponsored research Expanding inclusion or removing exclusion where the new 
population has the same expected risk as the previous, based on similarities of condition Revised risk 
information with subjects in long-term follow-up Minor risk revisions with no subjects enrolled to date 
Expedited Review 
Modification Summary 
Please describe any required modification to the protocol. If you are using this form to submit an exception 
or report a deviation, enter 'N/A' in the box below. 
Adding study staff. Clarice Zhou's CITI training certificates are attached to protocol resubmission. 
Risk / Benefit 
Does this amendment alter the Risk/Benefit profile of the study? 
No 
Change in Consent 
Has there been a change in the consent documents? 
No 
If YES, please choose from the options below regarding re-consenting 
Deviations 
Are you reporting a deviation to this protocol?* 
No 
Exceptions 
Are you reporting an exception to this protocol?* 
No 

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Protocol Details 
Resubmission* 
Yes 
Hospital Sites 
Will any research activities and/or services be conducted at a Penn Medicine affiliated hospital site? Yes 
Active Hospital Sites 
Pennsylvania Hospital (PAH) ***Primary*** 
Study Personnel 
Principal Investigator 
Name: 
TRIEBWASSER, JOURDAN E 
Dept / School / Div: 
4333 - OB-Obstetrics and Gynecology 
Campus Address 
Mail Code 
Address: 
City State Zip: 
Phone: 
215-454-3509 
Fax: 
Pager: 
Email: 
Jourdan.Triebwasser@pennmedicine.upenn.edu 
HS Training Completed: 
Yes 
Training Expiration Date: 
Name of course completed : 
CITI Protection of Human Subjects Research Training - ORA 
Study Contacts 
Name: 
SRINIVAS, SINDHU 
Dept / School / Div: 
4333 - OB-Obstetrics and Gynecology 
Campus Address 
Mail Code 
4283 
Address: 
2 Silverstein 
3400 Spruce Street 
City State Zip: 
Philadelphia PA 19104-4283 
Phone: 
215-662-4789 
Fax: 
215-349-5625 

Page 5 of 19 
Pager: 
Email: 
ssrinivas@obgyn.upenn.edu 
HS Training Completed: 
Yes 
Training Expiration Date: 
Name of course completed : 
CITI Protection of Human Subjects Research Training - ORA 
Other Investigator 
Name: 
WALHEIM, LAUREN 
Dept / School / Div: 
2100 - Health System 
Campus Address 
Mail Code 
Address: 
Pennsylvania Hospital 
Ob-Gyn Residents 
City State Zip: 
Phone: 
Fax: 
Pager: 
Email: 
Lauren.Walheim@Pennmedicine.upenn.edu 
HS Training Completed: 
Yes 
Training Expiration Date: 
Name of course completed : 
CITI Protection of Human Subjects Research Training - ORA 
Responsible Org (Department/School/Division): 
4333 - OB-Obstetrics and Gynecology 
Key Study Personnel 
Name: 
ZHOU, CLARICE 
Department/School/Division: 
Health System 
HS Training Completed: 
Training Expiration Date: 
Name of course completed: 
No 
Name: 
RIIS, VALERIE 
Department/School/Division: 
WM-Ctr for Res on Reprod and Women's Health 
HS Training Completed: 
Yes 
Training Expiration Date: 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
Name: 
MORLEY, ANDREA M 
Department/School/Division: 
WM-Ctr for Res on Reprod and Women's Health 

Page 6 of 19 
HS Training Completed: 
Yes 
Training Expiration Date: 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
Name: 
SEHDEV, HARISH M 
Department/School/Division: 
OB-Obstetrics and Gynecology 
HS Training Completed: 
Yes 
Training Expiration Date: 
Name of course completed: 
CITI Protection of Human Subjects Research Training - ORA 
Disclosure of Significant Financial Interests* 
Does any person who is responsible for the design, conduct, or reporting of this research protocol have a 
FINANCIAL INTEREST? No 
Penn Intellectual Property* 
To the best of the Principal Investigator's knowledge, does this protocol involve the testing, development 
or evaluation of a drug, device, product, or other type of intellectual property (IP) that is owned by or 
assigned to the University of Pennsylvania? 
No 
Certification 
I have reviewed the Financial Disclosure and Presumptively Prohibited Conflicts for Faculty Participating 
in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored Projects  with all 
persons who are responsible for the design, conduct, or reporting of this research; and all required 
Disclosures have been attached to this application. 
Yes 
Biomedical Research 
Clinical Trial* 
Is this a clinical trial? 
Yes 
If Yes, please be aware that for each clinical trial conducted or supported by a Federal department or 
agency, one IRB-approved informed consent form used to enroll subjects must be posted by the awardee 
or the Federal department or agency component conducting the trial on a publicly available Federal Web 
site that will be established as a repository for such informed consent forms. 
Investigator Initiated Trial* 
Is this an investigator initiated trial? 
No 
Drugs or Devices* 
Does this research study involve Drugs or Devices? 
No 
IND Exemption 
For studies that fall under an IND exemption, please provide the number below 
For studies including IND or IDE's, please provide the number(s) below 

Page 7 of 19 
IDE Review* 
NOTE: For research involving investigational devices, you are required to review the guidance on 
Managing Research Device Inventory. Consult the Penn Manual for Clinical Research: https:// 
www.med.upenn.edu/pennmanual/secure/investigational-product-management-at-sites-not-
usinginvestigational-drug-services-(ids).html Please check the box Yes if you have reviewed the guidance. 
No 
Research Device Management* 
Please indicate how research device(s) will be managed. 
Not Applicable (no investigational devices) 
Drug, Herbal Product or Other Chemical Element Management * 
Please indicate how drugs, herbal products or other chemical entities will be managed. Not 
Applicable (no drugs, herbal products or other chemical entities) 
Radiation Exposure* 
Are research subjects receiving any radiation exposure (e.g. X-rays, CT, Fluoroscopy, DEXA, pQCT, FDG, 
Tc-99m, etc.) that they would not receive if they were not enrolled in this protocol? 
No 
Gene Transfer* 
Does this research involve gene transfer (including all vectors) to human subjects? 
No 
Human Source Material* 
Does this research include collection or use of human source material (i.e., human blood, blood products, 
tissues or body fluids)? 
No 
CACTIS and CT Studies* 
Does the research involve Center for Advanced Computed Tomography Imaging Services (CACTIS) and 
CT studies that research subjects would not receive if they were not part of this protocol? 
No 
CAMRIS and MRI Studies* 
Does the research involve Center for Advanced Magnetic Resonance Imaging and Spectroscopy 
(CAMRIS) and MRI studies that research subjects would not receive if they were not part of this protocol? 
No 
Investigational Agent or Device within the Operating Room* 
Does the research project involve the use of an investigational agent or device within the Operating  
Room? 
No 
Cancer Related research not being conducted by an NCI cooperative group* 
Does this protocol involve cancer-related studies in any of the following categories? 
No 
Processing of Materials* 
Will the research involve processing (such as over encapsulating, or compounding)? 
No 
In-House Manufacturing of Materials* 
Will the research involve processing (such as over encapsulating, or compounding)? 
No 
Medical Information Disclosure* 
Does the research proposal involve the use and disclosure of research subject's medical information for 
research purposes? Yes 

Page 8 of 19 
If the answer is YES, indicate which items is is provided with this submission: 
Request for HIPAA Waiver of Authorization 
CTRC Resources* 
Does the research involve CTRC resources? 
No 
Pathology and Laboratory Medicine Resources* 
Will samples be collected by hospital phlebotomy and/or processed or analyzed by any of the clinical 
laboratories of the University of Pennsylvania Health System? 
No 
Research Involves Apheresis, Cell Collection, and/or Blood Product Collection* 
Does this research involve collection of blood products in the Penn Donor Center and/or the use of 
apheresis for treatment or collection of cells or other blood components? 
No 
Research involving blood transfusion or drug infusions* 
Will your research involve blood transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for 
research purposes? 
No 
Trial in Radiation Oncology 
Is this research a prospective trial being done in Radiation Oncology, and if so, has this protocol been 
approved by the Radiation Oncology Protocol committee? 
N/A 
Study in Radiation Oncology 
Is this research a retrospective study being done in Radiation Oncology, and if so, has this project been 
reviewed by the Radiation Oncology Clinical Research Group? 
N/A 
Use of UPHS services* 
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures*, whether considered routine care or strictly for research purposes? 
No 
Primary Focus* 
Clinical Trial (prospectively assigning subjects to health-related interventions to evaluate outcomes) 
Protocol Interventions 
Sociobehavioral (i.e. cognitive or behavioral therapy) 
Drug 
Device - therapeutic 
Device - diagnostic (assessing a device for sensitivity or specificity in disease diagnosis) 
Surgical 
Diagnostic test/procedure (research-related diagnostic test or procedure) 
Obtaining human tissue for basic research or biospecimen bank x 
Survey instrument 
None of the above 
The following documents are currently attached to this item: 
There are no documents attached for this item. 

Page 9 of 19 
Sponsors 
Business Administrator 
Name: 
HELFRICK, MEGAN 
Dept / School / Div: 
4333 - OB-Obstetrics and Gynecology 
Phone: 
215-573-3390 
Fax: 
- 
Pager: 
Email: 
helfrick@pennmedicine.upenn.edu 
Department budget code 
400 - 400 - 2 - 014001 - xxxx - 2813 - 0940 
Funding Sponsors 
Funding sponsors billing address 
If you have selected a commercial or industry sponsor, please provide the appropriate address and contact 
information for the Sponsor for the purposes of billing for IRB review fees (initial review, continuing 
review and convened modification fees apply here). If the Sponsor is not industry/ commercial, this 
information is not necessary to provide with your application. 
N/A 
Funding sponsors gift 
Is this research being funded by a philanthropic gift? 
No 
Regulatory Sponsor 
IND Sponsor 
none 
400 - 400 - 2 - 014001 - xxxx - 2813 - 0940 
Industry Sponsor 
None 
Project Funding* 
Is this project funded by or associated with a grant or contract? 
No 
Sponsor Funding 
Is this study funded by an industry sponsor? 
Status of contract 
The following documents are currently attached to this item: 
There are no documents attached for this item. 

Page 10 of 19 
Multi-Center Research 
Penn as lead 
1. Is this a multi-center study where Penn is serving as the Lead Site or the Penn PI is serving as the Lead 
Investigator? 
No 
Management of Information for Multi-Center Research 
Penn irb of record 
2. Is this a multi-center study where the Penn IRB will be asked to serve as the IRB of Record for other 
external study sites? 
No 
Other Sites 
No other sites 
Protocol 
Abstract 
Hypertensive disorders of pregnancy (HDP) are stress tests which may identify women at high risk of 
future cardiovascular disease (CVD), the leading cause of death among women. Given the public health 
impact of HDP and CVD, there is a compelling need to identify scalable interventions to improve 
preventative care among women who have risk identified during pregnancy. We will examine the effects 
of delivering electronic prompts to obstetric care providers (nudge) on transitions of care in the postpartum 
period. We will conduct a pilot randomized trial to evaluate whether this nudge intervention will improve 
postpartum counseling and lead to greater follow-up with preventative care providers among women with 
HDP. Objectives 
Overall objectives 
The objective of the study is to evaluate the effect of a hospital-wide initiative using electronic prompts to 
encourage physicians to transition care for women with HDP to continuity care providers in accordance 
with national society guidelines. 
Primary outcome variable(s) 
The primary outcome measure is documentation of counseling about transitioning care to a continuity care 
provider (primary care or cardiology) at the postpartum visit. 
Secondary outcome variable(s) 
Secondary outcomes include 1. Electronic prompts opened by obstetric care providers within 1 week of 
receipt.  2. Documentation of CVD risk at the postpartum visit.  3. Use of scripted dot phrases (available 
in Epic) for counseling on transitions of care and CVD risk in the postpartum note.  4. Attendance at a 
primary care or cardiology visit for preventative care within 6 months of delivery. 
Background 
Women with HDP need ongoing care in the postpartum and inter-pregnancy period. HDP, including PEC 
and gestational hypertension (GHTN), complicate up to 10% of all pregnancies and are associated with 
immediate and long-term cardiovascular morbidity and mortality.1 HDP increase lifelong risk for chronic 
hypertension, diabetes, ischemic heart disease, stroke, and heart failure.2-5 Black women have a higher 
incidence of HDP and have a disproportionately higher morbidity and mortality compared to non-black 
women.6,7 ACOG and the American Heart Association (AHA) emphasize the postpartum period as an 
important opportunity to identify and intervene upon women at high-risk for future cardiovascular disease 
(CVD).8,9 However, current postpartum practices inadequately address transitions of care for women with 

Page 11 of 19 
HDP. A significant proportion of women with HDP do not see a preventative care provider (primary care, 
cardiology) in the months after delivery.10-12 Black women are particularly vulnerable to being lost to 
follow-up after complicated pregnancy.10,11 The HSM program is an innovative, patient-centered 
program that monitors postpartum blood pressure remotely using a text-based interface. It is supported by 
the Way to Health platform. HSM improves blood pressure management in the two weeks after delivery 
and eliminates racial disparities in blood pressure ascertainment during that time.13,14 However, 
enrollment in HSM did not improve follow-up in the year after delivery, with less than 1/3 of women 
having a preventative care visit.15 Poor follow-up is likely multifactorial, but may be driven by inadequate 
patient counseling in the postpartum period. Among women enrolled in HSM, only 21% of women were 
counseled on follow-up with primary care and only 4% were counseled on CVD risk at their postpartum 
visits based on chart review.16  Nudges are effective for changing medical decision-making and improving 
clinical outcomes. Nudges utilize concepts from behavioral economics to subtly change the decision-
making environment to facilitate evidence-based care and can be delivered to patients, providers, or 
both.17 Examples of nudges include electronic prompts to order cancer screening and electronic defaults 
that guide ordering practices.18 Nudges are low cost, scalable using Electronic Medical Record (EMR) 
systems, and improve rates of preventative services including influenza vaccination, referral to 
mammography, and statin prescription for CVD prevention.19-22 References: 1. American College of 
Obstetricians and Gynecologists; Task Force on Hypertension in Pregnancy. Executive summary: 
hypertension in pregnancy. Obstet Gynecol 2013;122:1122-31. 2. Timpka S, Stuart JJ, Tanz LJ, Rimm EB, 
Franks PW, Rich-Edwards JW. Lifestyle in progression from hypertensive disorders of pregnancy to 
chronic hypertension in Nurses Health Study II: observational cohort study. BMJ 2017 Jul 12;358:j3024. 
3. Cirillo PM, Cohn BA. Pregnancy complications and cardiovascular disease death: 50-year follow-up of 
the Child Health and Development Studies Pregnancy Cohort. Circulation 2015;132:123442. 4. Theilen 
LH, Fraser A, Hollingshaus MS, Shliep KC, et al. All-cause and cause specific mortality after hypertensive 
disease of pregnancy. Obstet Gynecol 2016;128:238-44. 5. Wu P, Haththotuwa R, Kwok CS, et al. 
Preeclampsia and future cardiovascular health: a systematic review and meta-analysis. Circ Cardiovasc 
Qual Outcomes 2017;10:e003497. 6. Gyamfi-Bannerman C, Pandita A, Miller EC, Boehme AK, Wright 
JD, Siddiq Z, et al. Preeclampsia outcomes at delivery and race. J Matern Fetal Neonatal Med 2019:18. 7. 
Miranda ML, Swamy GK, Edwards S, Maxson P, Gelfand A, James S. Disparities in maternal hypertension 
and pregnancy outcomes: evidence from North Carolina, 1994-2003. Public Health Rep 2010;125:57987 
8. American College of Obstetricians and Gyenecologists. Optimizing postpartum care. ACOG Committee 
Opinion No. 736. Obstet Gynecol 2018;131:e140-50. 9. Brown HL, Warner JJ, Gianos E, et al. Promoting 
risk identification and reduction of cardiovascular disease in women through collaboration with 
obstetricians and gynecologists: a presidential advisory from the American Heart Association and the 
American College of Obstetricians and Gynecologists. Circulation 2018;137:e843-52. 10. Bennett WL, 
Chang H-Y, Levine DM, Wang L, Neale D, Werner EF, et al. Utilization of primary and obstetric care after 
medically complicated pregnancies: an analysis of medical claims data. J Gen Intern Med 2014;29:63645. 
11. Levine LD, Nkonde-Price C, Limaye M, Srinivas SK. Factors associated with postpartum follow-up 
and persistent hypertension among women with severe preeclampsia. J Perinatol 2016;36:1079. 12. Lewey 
J, Levine L, Yang L, Groeneveld P. Abstract 21105: The Impact of Gestational Hypertension and 
Preeclampsia on Postpartum Rates of Follow-Up With Continuity Providers. Circulation 2017. 13. 
Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-based remote 
monitoring in the management of postpartum hypertension: a randomised clinical trial. BMJ Qual Saf 
2018;27:8717. 14. Hirshberg A, Sammel MD, Srinivas SK. Text message remote monitoring reduced racial 
disparities in postpartum blood pressure ascertainment. Am J Obstet Gynecol 2019;221:2835. 15. 
Triebwasser JE, Srinivas SK. 1077: Effect of a text-based blood pressure monitoring program on continuity 
care after hypertensive pregnancy. Am J Obstet Gynecol 2020;222:S664-5. 16. Janssen MK, Sehdev HM, 
Triebwasser JE. 779: Measuring quality: counseling after hypertensive disorders of pregnancy. Am J 
Obstet Gynecol 2020;222:S494. 17. Patel MS. Nudges for influenza vaccination. Nat Hum Behav 
2018;2:720-1. 18. Patel MS, Navathe AS, Liao JM. Using Nudges to Improve Value by Increasing 
Imaging-Based Cancer  
Screening. J Am Coll Radiol 2020;17:3841. 19. Patel MS, Volpp KG, Small DS, Wynne C, Zhu J, Yang L, 
et al. Using active choice within the electronic health record to increase influenza vaccination rates. J Gen 
Intern Med 2017:32;790-5 20. Yokum D, Lauffenburger JC, Ghazinouri R, Choudhry NK. Letters designed 
with behavioural science increase influenza vaccination in Medicare beneficiaries. Nat Hum Behav. 2018 
Oct;2(10) 743-749. doi:10.1038/s41562-018-0432-2. PMID: 31406294. 21. Hsiang EY,  
Mehta SJ, Small DS, Rareshide CAL, Snider CK, Day SC, et al. Association of an Active Choice 
Intervention in the Electronic Health Record Directed to Medical Assistants With Clinician Ordering and 

Page 12 of 19 
Patient Completion of Breast and Colorectal Cancer Screening Tests. JAMA Netw Open 2019;2:e1915619. 
22. Patel MS, Kurtzman GW, Kannan S, Small DS, Morris A, Honeywell S Jr, et al. Effect of an Automated 
Patient Dashboard Using Active Choice and Peer Comparison Performance Feedback to Physicians on 
Statin Prescribing: The PRESCRIBE Cluster Randomized Clinical Trial. JAMA Netw Open 
2018;1:e180818. 
Study Design 
Phase* 
Not applicable 
Design 
This study will be a randomized, controlled superiority trial to evaluate a hospital-wide initiative to 
improve counseling for postpartum women who experienced HDP during their pregnancy or in the 
immediate postpartum period.  Hypotheses: 1. We hypothesize that the prompt will increase the proportion 
of women counseled on transitioning care to a primary care provider or cardiologist after pregnancy 
(primary outcome). 2. We hypothesize that the provider nudge will increase the proportion of women 
attending a preventative care visit within 6 months of delivery as assessed by chart review and patient 
surveys.  The HSM daily log generated through the Way to Health platform will be used to generate lists 
of patients who eligible for the study. For each eligible woman, the date of and obstetric care provider for 
her postpartum visit will be recorded within 3 weeks of delivery. Patients will then be randomly assigned 
to a control group with no intervention (usual care through HSM) or the intervention group (physician 
nudge) using simple 1:1 randomization through the Way to Health Platform. If a woman is randomized to 
the intervention arm, her obstetric care provider for her postpartum visit will receive a staff message in 
Epic (Penn Chart) that his/her patient has an upcoming postpartum visit. The message will be sent 1 week 
before the scheduled visit. The message will have patient-specific information including hypertensive 
diagnosis, blood pressure medication(s), gestational diabetes diagnosis, and primary care provider as listed 
in the Epic banner. The message will also have dot phrases for recommended counseling and contact 
information for UPHS primary care and cardiology providers. There will be a dot phrase recommending 
follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin 
in a future pregnancy.  A web-based survey will be distributed to all women in the study 6 months after 
delivery through the Way to Health platform. The survey will assess attendance at a preventative care visit, 
social determinants of health, health status, and insurance status after delivery. Demographic 
characteristics, medical and obstetric history, hypertensive disorder, laboratory test results (platelet count, 
creatinine, liver function tests, urine protein, total cholesterol, triglycerides, LDL-C, HDL-C, glucose, 
hemoglobin A1c), blood pressure measurements, height, weight, and office visits within 6 months of 
delivery will be abstracted from the EMR. We will perform detailed abstraction of counseling at the 
postpartum visit and additional office visits within 6 months of delivery focusing on 1) health maintenance 
2) hypertension, or 3) cardiovascular risk reduction. Two reviewers will assess counseling at each visit. 
We will obtain data on obstetric care providers including level (resident physician, attending physician, 
nurse practitioner, physician assistant, or certified nurse midwife), gender, and years in practice from 
publicly available databases or websites online. 
Study duration 
Estimated length of time is 12 months. We believe it will take no more than 4 months to enroll all patients 
with follow-up survey at 6 months, and allow two months for data analysis. This is based on number of 
women clinically enrolled over the 1st year of Heart Safe Motherhood at Pennsylvania Hospital. We hope 
to initiate the proposed study on November 1, 2020. 
Resources necessary for human research protection 
Describe research staff and justify that the staff are adequate in number and qualifications to conduct the 
research. Describe how you will ensure that all staff assisting with the research are adequately informed 
about the protocol and their research related duties. Please allow adequate time for the researchers to 
conduct and complete the research. Please confirm that there are adequate facilities for the research. 
The research staff will include Maternal Fetal Medicine attendings, residents in obstetrics & gynecology, 
and the Maternal and Child Health Research (MCHRC) clinical research team. The MCHRC provides an 
established infrastructure for clinical and translational research. The Way To Health platform has multiple 
features to implement this trial and capture data including two-way texting, integrated survey options, 
integration with the EMR, and automated schedules for patient messages. Patients will be clinically 

Page 13 of 19 
enrolled into the WaytoHealth Texting Platform per usual clinical care. Data collection will be performed 
by Drs. Triebwasser and Walheim, and by a study coordinator through the MCHRC. Patient logs for Heart 
Safe Motherhood (Way to Health) will be reviewed daily. Randomization will take place through Way to 
Health after ensuring all eligibility criteria is met. Electronic prompts will be sent to obstetric care 
providers by Dr. Triebwasser or the study coordinator. Survey invitations will be sent through the Heart 
Safe Moterhood interface in Way to Health. All research staff will receive education regarding the protocol 
and their duties prior to the start of the study. 
Characteristics of the Study Population 
Target population 
Postpartum women followed by obstetric care providers at the University of Pennsylvania Health System 
(UPHS) who are diagnosed with HDP and are clinically enrolled in Heart Safe Motherhood (HSM) are 
eligible. 
Subjects enrolled by Penn Researchers 222 
Subjects enrolled by Collaborating Researchers 
0 
Accrual 
Sample size calculations were based on the assumption that 21% of patients in usual care and 40% of 
patients receiving a provider nudge would have documentation about transitioning care. A sample size of 
222 patients (randomized 1:1) would provide 80% power to detect this difference assuming 20% of patients 
will not attend their postpartum visit. Approximately 100 women are enrolled in HSM each month at 
Pennsylvania Hospital. We anticipate that over 90% of those women receive prenatal care at a UPHS 
practice (n=90 per month), and at least 80% will attend a postpartum visit (n=72). We thus anticipate that 
222 women could be enrolled in 3-4 months, allowing for 6-month follow-up during the grant period. 
Key inclusion criteria 
1. At least 18 years old. 2. Have a diagnosis of HDP during delivery admission or have a diagnosis made 
at time of evaluation in the Perinatal Evaluation and Treatment Unit after discharge from the delivery 
admission. HDP diagnoses are based on criteria from the American College of Obstetricians and 
Gynecologists (ACOG). 3. Enrolled in HSM at Pennsylvania Hospital. 4. Have a postpartum visit with a 
UPHS provider scheduled 4-12 weeks after delivery. 
Key exclusion criteria 
1. Women diagnosed with chronic hypertension (CHTN) without superimposed pre-eclampsia (PEC). 
Vulnerable Populations 
Children Form 
Pregnant women (if the study procedures may affect the condition of the pregnant woman or fetus) 
Form 
Fetuses and/or Neonates Form 
Prisoners Form 
Other x None of the above populations are included in the 
research study 
The following documents are currently attached to this item: 
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Populations vulnerable to undue influence or coercion 
This is a hospital-wide initiative which will equally include all postpartum women in HSM who do not 
meet exclusion criteria. 

Page 14 of 19 
Subject recruitment 
The HSM daily log generated through the Way to Health platform will be used to generate lists of patients 
who eligible for the study. For each eligible woman, the date of and obstetric care provider for her 
postpartum visit will be recorded within 3 weeks of delivery. 
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research? 
No 
The following documents are currently attached to this item: 
There are no documents attached for this item. 
Subject compensation* 
Will subjects be financially compensated for their participation? 
Yes 
The following documents are currently attached to this item: 
There are no documents attached for this item. 
If there is subject compensation, provide the schedule for compensation per study visit or session and 
total amount for entire participation, either as text or separate document 
Subjects who complete a web-based survey 6 months postpartum will be compensated with a $5 giftcard. 
Study Procedures 
Suicidal Ideation and Behavior 
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)? 
No 
Procedures 
A flowsheet of patient participation is attached. Subjects will be identified through the HSM daily log.  A 
waiver of informed consent is requested for the intervention portion of this study.  At 30 days after 
discharge, all participants, regardless of study arm will receive the following message "Hello from Heart 
Safe Motherhood! We hope you are doing well. Dont forget to follow-up with your primary or heart doctor 
in the next 2-4 weeks. If you were given an appointment, make sure to keep it. If you want to make an 
appointment with a heart doctor focused on women's health, call 215-662-7700. Have a great day!" At 6 
months postpartum, women will receive a secure text message through the Way To Health platform.  "We 
are trying to understand how women with high blood pressure or preeclampsia stay healthy after delivery. 
Respond yes if you are willing to complete a survey. You will receive $5 for participating." If she responds 
yes, she will receive a survey link integrated with Way To Health.  Patient information will be obtained 
from the electronic medical record including demographic characteristics, medical and obstetric history, 
hypertensive disorder, laboratory test results (platelet count, creatinine, liver function tests, urine protein, 
total cholesterol, triglycerides, LDL-C, HDL-C, glucose, hemoglobin A1c), blood pressure measurements, 
height, weight, and office visits within 6 months of delivery. We will perform detailed abstraction of 
counseling at the postpartum visit and additional office visits within 6 months of delivery focusing on 1) 
health maintenance 2) hypertension, or 3) cardiovascular risk reduction. Two reviewers will assess 
counseling at each visit (from the discharge summary and after visit summary). We will obtain data on 
obstetric care providers including level (resident physician, attending physician, nurse practitioner, 
physician assistant, or certified nurse midwife), gender, and years in practice from publicly available 
databases or websites online. 

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Deception 
Does your project use deception? 
No 
International Research 
Are you conducting research outside of the United States? 
No 
Analysis Plan 
We hypothesize that a provider nudge will increase the proportion of women who are counseled about 1) 
transitioning care and 2) CVD risk after pregnancy complicated by HDP. This is designed as a superiority 
trial. We hypothesize that the provider nudge will lead to improved follow-up with continuity care 
providers.  Primary efficacy endpoint:  1. Documentation of counseling about transitioning care to a 
continuity care provider (primary care or cardiology) at the postpartum visit.  Secondary efficacy 
endpoints:  1. Documentation of CVD risk at the postpartum visit.  2. Attendance at a primary care or 
cardiology visit for preventative care within 6 months of delivery. Chi square or Fishers exact test will be 
used to compare categorical data. T-test will be used to compare parametric data. Mann-Whitney U test 
will be used to compare non-parametric data. Univariate comparisons will be made between exposure 
(intervention) and outcome. Proportion and relative risk (95% CI) will be presented for primary and 
secondary outcomes. Multivariable logistic regression models will be created to control for potential 
confounders. Outcomes will be analyzed by the intention to treat principle. Our threshold for statistical 
significance will be two-side with alpha 0.05. Exploratory analyses: Primary and secondary outcomes will 
be analyzed by race (Black vs. Non-Black) based on data that HSM reduced racial disparities in blood 
pressure ascertainment outcomes. We will explore whether there is an interaction of race with regards to 
counseling and follow-up. We will also assess time trends in counseling over the study period. 
The following documents are currently attached to this item: 
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Data confidentiality 
x Paper-based records will be kept in a secure location and only be accessible to personnel involved in 
the study. 
x Computer-based files will only be made available to personnel involved in the study through the use 
of access privileges and passwords. 
Prior to access to any study-related information, personnel will be required to sign statements agreeing 
to protect the security and confidentiality of identifiable information. 
x Wherever feasible, identifiers will be removed from study-related information. 
A Certificate of Confidentiality will be obtained, because the research could place the subject at risk 
of criminal or civil liability or cause damage to the subject's financial standing, employability, or 
liability. 
x A waiver of documentation of consent is being requested, because the only link between the subject 
and the study would be the consent document and the primary risk is a breach of confidentiality. 
(This is not an option for FDA-regulated research.) 
x Precautions are in place to ensure the data is secure by using passwords and encryption, because the 
research involves web-based surveys. 
Audio and/or video recordings will be transcribed and then destroyed to eliminate audible 
identification of subjects. 
Subject Confidentiality 
Computer-based files will only be made available to personnel involved in the study through the use of 
access privileges and passwords. Wherever feasible, identifiers will be removed from study-related 

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information. Precautions are already in place to ensure the data are secure by using passwords and HIPAA-
compliant encryption. Data on patients will be obtained from Epic and patient-completed surveys. Any 
information that is obtained will be used for research purposes only. Information on patients will only be 
disclosed within the study team and to the patients obstetric care provider. All study staff will be reminded 
of the confidential nature of the data collected and contained in these databases. All members that access 
data must complete HIPAA training including secure data transfer, passwords, computer security habits 
and knowledge of what constitutes misuse or inappropriate use of the server. Only trained study staff will 
have access to the code that links the unique identifier to the subjects identity. Electronic data will be stored 
on secure, password-protected firewalled servers at the University of Pennsylvania. Data collected for this 
study will be stored in REDCap and the WayToHealth platform. Linkage to PHI will be stored until study 
analysis and publication completion, and then will be destroyed. 
Sensitive Research Information* 
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record? 
No 
Subject Privacy 
Privacy refers to the person's desire to control access of others to themselves. Privacy concerns people, 
whereas confidentiality concerns data. Describe the strategies to protect privacy giving consideration to 
the following: The degree to which privacy can be expected in the proposed research and the safeguards 
that will be put into place to respect those boundaries. The methods used to identify and contact potential 
participants. The settings in which an individual will be interacting with an investigator. The privacy 
guidelines developed by relevant professions, professional associations and scholarly disciplines (e.g., 
psychiatry, genetic counseling, oral history, anthropology, psychology).  
All efforts will be made by study staff to ensure subject privacy. Data will be evaluated in a deidentified 
manner whenever possible. 
Data Disclosure 
Will the data be disclosed to anyone who is not listed under Personnel? 
No 
Data Protection* 
x Name 
x Street address, city, county, precinct, zip code, and equivalent geocodes 
x All elements of dates (except year) for dates directly related to an individual and all ages over 89 
x Telephone and fax number x Electronic mail addresses 
Social security numbers 
x Medical record numbers 
Health plan ID numbers 
Account numbers 
Certificate/license numbers 
Vehicle identifiers and serial numbers, including license plate numbers 
Device identifiers/serial numbers 
Web addresses (URLs) 
Internet IP addresses 
Biometric identifiers, incl. finger and voice prints 
Full face photographic images and any comparable images 
Any other unique identifying number, characteristic, or code 
None 

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Does your research request both a waiver of HIPAA authorization for collection of patient information and 
involve providing Protected Health Information ("PHI") that is classified as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a recipient 
outside of the University of Pennsylvania covered entity? 
No 
Tissue Specimens Obtained as Part of Research* Are 
Tissue Specimens being obtained for research? 
No 
Tissue Specimens - Collected during regular care* 
Will tissue specimens be collected during regulator clinical care (for treatment or diagnosis)? 
No 
Tissue Specimens - otherwise discarded* Would 
specimens otherwise be discarded? 
No 
Tissue Specimens - publicly available* Will 
tissue specimens be publicly available? 
No 
Tissue Specimens - Collected as part of research protocol* Will 
tissue specimens be collected as part of the research protocol? 
No 
Tissue Specimens - Banking of blood, tissue etc. for future use* Does 
research involve banking of blood, tissue, etc. for future use? 
No 
Genetic testing 
If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or 
exploratory in nature.  If predictive, please describe plan for disclosing results to subjects and provision of 
genetic counseling. Describe how subject confidentiality will be protected Note: If no genetic testing is to 
be obtained, write: "Not applicable." Not applicable. 
Consent 
1. Consent Process 
Overview 
A waiver of informed consent is requested for the intervention portion of this study. This is a hospitalwide 
initiative that will be implemented. The study is to evaluate that initiative. Therefore, physicians and their 
patients will not be consented as this will be the standard practice for women in Heart Safe Motherhood at 
Pennsylvania Hospital. Without a waiver of the consent, the initiative would still be implemented at 
Pennsylvania Hospital, but the study would be infeasible. There are several additional reasons why we feel 
a waiver of consent should be granted. First, it is not feasible to consent every patient and physician. 
Second, if members of the control group were consented, they would know they were being studied and 
this could change their behavior. This could potential disrupt the design of the study and making 
interpretation of the findings challenging. Third, physicians are not being forced to use the information 
from the prompt or suggested counseling with their patients. Instead, they are being reminded of evidence-
based practice and offered an opportunity to review pertinent information prior to the postpartum visit. 
This is no different than standard of care in which a physician would review the same information and 
decide on postpartum counseling. The initiative is simply a reminder for the physician and makes their 
standard of care process easier to conduct. 
Children and Adolescents 

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Children and adolescents will not be enrolled. 
Adult Subjects Not Competent to Give Consent 
All adult subjects with be competent to give informed consent. 
2. Waiver of Consent 
Waiver or Alteration of Informed Consent* 
Waiver of written documentation of informed consent: the research 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 
Minimal Risk* 
Impact on Subject Rights and Welfare* 
Waiver Essential to Research* 
Additional Information to Subjects 
Written Statement of Research* 
Yes 
If no written statement will be provided, please provide justificiation 
The subjects will receive a written statement of research for the web-based survey, but will not receive a 
statement on research for the intervention as knowledge of the intervention may change behavior and make 
interpretation of the study difficult. 
The following documents are currently attached to this item: 
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Risk / Benefit 
Potential Study Risks 
The potential risks associated with this study are minimal. Breach of data is a potential risk that will be 
mitigated by using HIPAA compliant and secure data platforms for patient identification, randomization, and 
web-based surveys (Way to Health) and data storage (REDCap). 
Potential Study Benefits 
An intervention that prompts obstetric care providers to actively think about postpartum care guidelines 
could contribute positively to patient care and outcomes. However, it is possible that patients will receive 
no benefit from this study. 
Alternatives to Participation (optional) 
Women will be receive postpartum counseling per the usual practice of their obstetric care provider. 
Data and Safety Monitoring 
Principal investigator. 
The following documents are currently attached to this item: 
There are no documents attached for this item. 
Risk / Benefit Assessment 
There is minimal risk to participation in this study with potential for improved counseling and transitions 
of care. 

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General Attachments 
The following documents are currently attached to this item: 
Additional forms (citi-clarice.pdf) Additional forms (citi2-clarice.pdf) Additional forms 
(citi3-clarice.pdf)