Evaluating the Performance of the Shared Decision Making Process Scale in Patients Making Cancer Screening Decisions
Conditions: Breast Cancer Screening, Colon Cancer Screening, Prostate Cancer Screening
Sponsor: Massachusetts General Hospital

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
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Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
PRINCIPAL/OVERALL INVESTIGATOR 
Karen Sepucha Ph.D.  
PROTOCOL TITLE 
Improving Patient Involvement in Decision-Making in Primary Care 
FUNDING 
Massachusetts General Physicians Organization, The Donaghue Foundation 
VERSION DATE 
November 30, 2021 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
1.
Demonstrate the ability to introduce and disseminate shared decision-making (SDM)
programs to patients within the Partners Healthcare System.  We will measure the
volume and type of programs that are “prescribed” to patients.
2.
Assess “prescribing” utilization, trends and patterns by clinician and across practices,
and identify and understand the barriers and problems faced by clinicians in making the
SDM programs an integrated part of the clinical practice of primary and specialty care.
Identification and understanding of the barriers will be gained through clinician
interviews.
3.
Gain feedback from the patients about: their experiences, perceptions and satisfaction
with receiving SDM programs; the effect the program has on their decision preference;
what they think about the available options; and how they feel about making a decision.
This feedback will be obtained through written and online surveys, and telephone
interviews.
4.
Surgery shared decision making survey: Integrate new measures to assess the quality
of elective surgical decisions across the Partners Healthcare network for patients with
knee and hip osteoarthritis, herniated disc and spinal stenosis and test the hypothesis
that routinely measuring shared decision making for these elective surgical decisions,
and reporting that data back to clinicians and administrators, has the potential to make
a positive impact on the value of care provided to patients.
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
Multiple studies assessing the value of decision aids, such as the shared decision-making 
programs produced by the Informed Medical Decisions Foundation, have found that these 
tools reduce uncertainty and decisional conflict, and increase knowledge and patient’s desire 
to participate in decision-making, without increasing anxiety.  Decision aids have been 

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Version Date:  June 1, 2005 
 
  
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shown to increase patient involvement in treatment decisions, and are particularly helpful 
when the clinical evidence supports more than one treatment or testing option. Decision 
aids improve the ability of patients to take into account their own values when making such 
decisions, increase patient satisfaction and improve health outcomes. High quality decision 
aids present the evidence about treatment and testing options in a fashion that most 
patients understand. However, despite the multiple studies investigating the quality and 
value of decision aids and shared decision-making, their integration into the practice setting 
has been slow. Questions remain as to how to successfully and efficiently incorporate 
decision aids into the office visit and how physicians can gain the knowledge, skills, and 
proper attitude to promote this process where appropriate. Additionally, further information 
is needed about the impact of these tools and processes on the care experience from the 
patient and provider perspectives and on the actual care that patients receive.  
 
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
 
The dissemination of the programs will occur as part of routine care and will vary depending 
on the provider group and program. They may be sent in advance of the visit, or prescribed 
after the visit. The programs may also be put online and accessed by patients with a 
password. One common way the programs are distributed is outlined as follows: 
1. Patient has visit with primary care clinician. 
2. Clinician determines patient is clinically eligible for one of the SDM programs and 
discusses it with the patient. 
3. Clinician “prescribes” program through the electronic medical record, and gives patient 
the one-page description of the program that automatically prints when the program is 
ordered.  The “prescription” function in the electronic medical record triggers an email 
message with the order information to be sent to the Blum Patient and Family Learning 
Center.   
4. The program is sent (or given, in the case of the “pick-up” option) to the patient with a 
questionnaire and pre-paid, addressed envelope. The goal of the questionnaire is to 
assess the patient’s intentions with regard to the topic and the patient’s opinion about 
shared decision-making prior to viewing the decision aid. After viewing the decision 
aid, patients will also be asked a series of general knowledge questions about the 
target topic and a few questions evaluating the content and comprehensiveness of the 
decision aid itself.  
5. Some patients will receive a follow-up “post-visit” survey in the mail and a pre-paid 
addressed envelope several months after receiving a decision aid. The purpose of this 
questionnaire is to learn the extent to which viewing decision aids impacts patients’ 
conversations with their providers and ultimately their treatment decisions.   
 
 
It is difficult to anticipate the total number of patients who will receive a SDM program 
because the “prescription” of the program is incorporated into routine clinical care, similar 
to clinicians giving a pamphlet or other written patient education materials to their patients.  
We anticipate the target enrollment of patients to be 80,000. Patients who are eligible are: 
 Adult patients in the Partners Healthcare System primary or specialty care practices.  
 Patients, for whom a SDM program is clinically appropriate, based on the clinical 
judgment of the clinician.  This includes patients with the following health 

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problems/concerns: general healthcare options, low back pain (chronic, acute, spinal 
stenosis, and herniated disc), osteoarthritis of the knee or hip, coronary artery/heart 
disease, benign prostatic hyperplasia, abnormal uterine bleeding, uterine fibroids, 
symptoms of menopause, obesity, depression, ovarian cancer screening, prostate 
cancer screening, colorectal cancer screening, advance directives, heart failure, 
diabetes, breast cancer treatment, prostate cancer treatment, insomnia, carotid artery 
disease, and chronic pain.   
 
Patient decision aids are all available in English and Spanish except for 4 programs that are 
only available in English: Prediabetes: Choices you can make to prevent diabetes, 
Pregnancy: Birth Options if your baby is getting too big, and Pregnancy: Your birth options 
after cesarean, Prostate Cancer: Is radiation or surgery right for you. 
 
The staff maintain a program log as part of their standard operating procedures so they can 
keep track of the programs that are sent to patients.  Routine follow-up with patients who 
received a program is important to ensure proper “close the loop” process. Follow-up may 
include a phone call, post-card or email reminder to patients. Follow-up will occur within 2 
weeks of the initial survey. Reminder survey packets will be mailed within 4 weeks if the 
patient has yet to return the survey. These patients will also receive reminder phone calls 
within 2 weeks of the reminder mailing. It will be mentioned to the patient as a reminder 
that they can return the questionnaire, if they wish, or complete the questionnaire by 
telephone during the phone call. Patients willing to complete the questionnaire and who 
have not yet viewed the decision aid will be asked only pre-viewing questions, and will be 
encouraged to view the decision aid and follow up for administration of the post-viewing 
questions.     
 
Questionnaires will include solely, a coded unique numeric identifier for each patient. 
Therefore, all completed questionnaires will be stripped of any personal identifiers and/or 
HIPAA related information. Only MGH approved study staff for this protocol will have access 
to the information crosswalk needed to link this unique identifier with confidential personal 
information. The completed, coded questionnaires will be returned, where study staff will 
enter the de-indentified data into a secured online data warehouse. The online surveys will 
be entered directly into the data warehouse. The operating processes are as follows: 
 
 Study staff provides questionnaires, which are then assigned a systematic unique 7-
digit study ID.   
 Study staff provides a tracking log for each title that is “prescribed.”  
 Staff will record in a secured, restricted-access tracking log the primary care practice 
name (of the prescribing clinician); patient’s name, address, and phone number; 
program topic; date sent; and date returned.   
 Once questionnaires have been returned, a study staff will enter the coded de-
identified data into a secured online data warehouse separate from the information 
crosswalk with no ability to link the data back to patient’s personal and HIPAA related 
information.  
 
The providers’ perspectives will also be collected, periodically, through questionnaires or 
individual interviews.  An email invitation will be sent to all eligible Partners Healthcare 
System primary care physicians, specialists, nurses and other clinic staff involved in a 
patient’s care to complete either the questionnaire or participate in an interview. The 
providers and staff will be able to choose to complete the questionnaire online or by paper. 
A reminder email will be sent to those who haven’t completed the questionnaire within a 2-
week timeframe. Study staff will work individually with those interested in the interviews, at 
the time of a specific project.  

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Patients who have indicated their consent to be contacted in the future for other studies will 
be contacted to see if they would be interested in participating in a pilot study examining 
the effectiveness of mental health decisions aids: sleeping better, depression, and anxiety. 
Patients will be contacted first by telephone and asked if they would be interested in 
participating in a survey study. If they agree to participate they will be asked to review 
some additional patient educational materials either online or on paper. After the patient 
reviews the materials, they will be asked to complete and answer the questions via phone 
with study staff at a scheduled time. Consent will be implied by the completion of the 
questionnaire. If a patient would like to complete the questionnaire via paper, an 
information sheet, questionnaire, and return-envelope will be sent to the patient. The 
project goal is to have approximately 30 eligible patients complete the survey. 
 
Patients who have indicated their consent to be contacted in the future for other studies will 
be contacted to see if they would be interested in participating in a structured interview 
either in-person or via telephone to learn more about decision making for older adults about 
whether to continue colorectal cancer screening. We may also have primary care physicians 
(PCP) identify patients who they believe would good candidates to participate in the 
interviews. The PCP will provide the patient with the information sheet and if the patient is 
interested, the PCP will provide the research staff contact information for the subject to call 
to indicate their interest in participating. Subjects will be contacted first by telephone and 
asked their interest to participate in an interview. If they agree to participate they will be 
asked whether they prefer to conduct the interview in-person or via telephone and study 
staff will schedule a mutually convenient time. Consent will be implied by the completion of 
the interview. A cover letter and an information sheet will be sent by mail or email (if 
subjects provide verbal consent to use personal email) for those interested in an interview. 
The project goal is to have approximately 20 eligible subjects complete the interview.  
 
We will conduct 60 interviews with up to 20 patients and physicians to evaluate how they 
interact with the patient decision aid accessed through Patient Gateway. The interviews will 
be conducted in-person or remotely using a videoconference approved by MGH Brigham 
(such as Healthcare Secure Zoom or Enterprise Zoom). Each interview using the 
videoconference will require a waiting room and secure password for that specific meeting. 
During the interview, the moderator and research subject (physician or patient) will review 
all the steps in the process. We will audiotape the interviews and a research coordinator will 
be present during the interview to take notes on the interaction. The interviews will take 
place at a location on the MGH campus convenient to the participant or via the approved 
videoconference platform. The interviews will follow structured guides. 
 
Patients will be recruited from the database of patients who have received decision aids. For 
patients who have given consent to be re-contacted, study staff will telephone the patient 
and invite them to participate in the interview. For patients who were not asked about being 
recontacted for future studies, we will send the patient an invitation letter letting them know 
about the study opportunity and how to opt-out if they do not want to be contacted. We will 
also include the study information sheet with the mailing. If the person does not opt-out, 
study staff will call the patient and ask if she/he is interested in participating. If they agree 
to participate, study staff will schedule a remote interview using a secure videoconference 
at a mutually convenient time. The patient will be asked to consent to participating in a 
secure videoconference and will be asked permission for the researcher to audiotape the 
call. Consent will be implied by completion of the interview. A letter indicating the date and 
time of the interview will be sent by mail or email (if the subjects provide verbal consent to 
use personal email). We will include English-speaking men and women aged 40-80 years. 
Patients will be asked if they are enrolled in Patient Gateway. If not, they will not be eligible. 

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Version Date:  June 1, 2005 
 
  
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Physicians will be recruited from the database of patients who were prescribed a patient 
decision aid at MGH in the past. We will recruit physicians across a range of practices and 
specialties. 
 
Patients who received a specialty referral where their physician provisionally ordered a 
decision aid will also be contacted for feedback. Their feedback on the referral process will 
be collected through individual interviews or surveys. A cover letter and information sheet 
describing the study will be mailed to the patients so that they may choose to participate or 
not. A reminder phone call will be placed for those who haven’t completed the questionnaire 
within a 2-week timeframe. The patients’ demographic information will be collected through 
an RPDR data collection. 
 
The patients’ feedback will also be collected, periodically, through individual or group 
interviews.  An email or mailed invitation to participate in interviews will be sent to a sample 
of patients who indicated their consent to be re-contacted. The patients will be able to 
choose to participate in an individual or group interview. Participants will receive $20 for 
participation in the 45-minute individual interview, $40 for the 90-minute individual 
interview, and $60 for participation in the group interview.  
 
A medical chart abstraction will be conducted looking at patients who have both received a 
decision aid and who have not. For patients who have not received a decision aid, the 
patients’ medical records will be pulled based on the relevant ICD-9, ICD-10, or procedure 
(CPT) codes associated with a visit within the study timeframe.  
 
In collaboration with Partners Center for Population Health, patients across PHS who have a 
surgical procedure for one of the 4 identified clinical diagnoses: hip osteoarthritis, knee 
osteoarthritis, lumbar herniated disc and lumbar spinal stenosis, will be surveyed about 
shared decision making. The shared decision making surveys will be integrated into the 
routine patient reported outcomes measurement (PROMS) assessments that are in current 
clinical practice at these sites for these clinical situations. The PROMs platform does not 
capture or include the shared decision making survey for all surgeons and all patients and; 
as a result, study staff will track all potentially eligible patients and will mail the survey to a 
randomly selected sample of patients who are eligible, but who did not complete the 
questions as part of the PROMs platform. Patients who complete the mailed survey will be 
asked if they are interested in participating in a short phone interview to discuss their 
survey responses. The patient can indicate their interest in the interview on the survey. For 
patients who completed the shared decision making items via the PROMS system, an 
invitation letter will be sent to the patient who completed the PROMs questionnaire to invite 
them to participate in a phone interview.  
 
A report of surgical patients will be created by the eCare team to support identification of 
eligible patients. The report will identify adults across the four hospitals who are scheduled 
for, or who have recently had, one of the surgical procedures for the targeted diagnoses., 
We will supplement the eCare report with a query from the Research Patient Data Registry 
(RPDR) to identify and confirm eligible patients using their MRNs (from eCare report) or 
using relevant ICD-10 and CPT codes to identify patients and get required data. The RPDR 
query will pull information from the medical record about surgeon visits, diagnoses and 
treatments related to the index diagnosis (hip or knee osteoarthritis, spinal stenosis or 
herniated disc), imaging reports (X-Ray and MRI), pathology reports (post-surgical bone 
pathology), clinical and patient features (e.g. BMI, disease severity), patient demographics 
and contact information (to support mailing survey as needed). Specific diagnoses that may 
indicate that the procedure is not elective, or it’s for a different diagnosis, will also be 

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included in the eCare report and RPDR queries to help identify patients who should be 
excluded (e.g. to identify patients who had a hip replacement to treat a hip fracture as 
opposed to hip osteoarthritis) as outlined in Table 1. The list of patients generated by the 
eCare report will be compared to the list from the RPDR query in order to identify any 
potentially eligible patients missing from either list. For patients who are not captured by 
the RPDR query or for whom RPDR is missing data (e.g., patient-reported outcomes data), a 
limited review of that patient’s electronic medical record will be conducted, only covering 
the information listed above. These data will help study staff identify a cohort of surgical 
patients who are potentially eligible for the shared decision making survey. Table 1 has the 
specific eligibility criteria.     
 
To ensure that the RPDR and eCare reports are providing a complete, accurate list of eligible 
patients, a limited review of the surgical schedules for the participating surgeons will also be 
conducted. We estimate that staff will need to review about 2 months for hip and knee 
surgeons and up to 6 months for spine surgeons to ensure a minimum number of about 300 
procedures for each of the four conditions.  When the review of surgical schedules identifies 
a patient that is not included in the RPDR query or eCare report, a review of the visit and 
imaging notes from their surgical consults and surgical report in their EHR chart will be 
conducted to determine eligibility and reasons why the patient was not identified by the 
eCare or RPDR reports. This limited review will be used to establish validity of the approach 
(i.e., eCare report and RPDR query) that we are using to identify elective surgical patients 
for these four clinical areas. 
 
Based on estimates from RPDR and from analysts at Center for Population Health, we 
anticipate that 5,880 patients have one of the procedures for the targeted diagnoses each 
year and will be included in the eCare reports and RPDR queries. About 40% will have 
completed a PROMs assessment pre-operatively and 38% will have completed a PROMs 
assessment post-operatively. Our target is to receive 1,200 completed shared decision 
making surveys across the hospitals and four conditions over the three-year project. 
Ideally, we will have about 300 surveys per diagnosis and about 300 per hospital. If the 
shared decision making survey completions from the PROMs system are not balanced across 
sites or across diagnoses, we will purposively select a sample of eligible patients to receive 
a mailed survey in order to meet the minimum targets.  
 
Cancer Screening Study 2020:  
A subset of patients who received decision aids on: breast cancer screening, colorectal 
cancer screening, prostate cancer screening, or lung cancer screening will be eligible for this 
study. The goal of the study is to understand the decision making process between patients 
and providers related to cancer screening tests. The research study will be a one-time 
survey asking patients to reflect on conversations with their providers regarding the 
decision to screen for breast cancer, colorectal cancer, prostate cancer, or lung cancer in 
the last 2 years. Our target is to receive 400 completed surveys across all 4 clinical 
contexts. Eligible patients (see Table 2) will be identified and study staff will use RPDR 
queries to capture contact information for the study invitation packet and information on 
relevant cancer screening tests that the patient had completed. A chart review will be 
conducted to collect information related to cancer screening tests and visit notes related to 
cancer screening tests. This project is funded by the Agency for Healthcare Research and 
Quality (AHRQ).  
 
Path to Lifestyle Change: Patients who are eligible for the research study will be participants in 
the Path to Lifestyle Change program offered through the MGH Diabetes Center. As part of the 
Path to Lifestyle Change program, the Healthwise® Decision Aid entitled “Pre-Diabetes:  Which 
Treatment Should I Use to Prevent Type 2 Diabetes?” will be sent to participants at enrollment 
in the clinical program. The goal of this research study is to survey patients using a secure 

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REDCap link at 5 time points over 2 years (one-week post-baseline visit, 6 months, 12 months, 
18 months and 24 months) to collect patient-reported outcomes related to treatment 
decisions. The Path to Lifestyle Change program is planning to recruit up to 200 participants. 
Once a patient has been enrolled in the Path to Lifestyle Change clinical program, he/she will be 
asked permission to use their email to send them a fact sheet and recruitment letter about a 
research project. The clinician from the MGH Diabetes Center who enrolls the patient in the 
Path to Lifestyle Change program will obtain permission to send the information by email. For 
patients who do not provide their email, they will not be sent information about the study.  
 
 
Table 1: Eligibility Criteria  
             Eligible 
         Ineligible 
 • 
Adults 21 and older 
• 
Able to read and speak English  
• 
Scheduled for an elective primary total 
hip or knee replacement, spinal fusion, 
laminectomy, or discectomy or had 
procedure in past 4 weeks.  
• 
Primary or secondary diagnosis of hip or 
knee osteoarthritis, lumbar spinal 
stenosis or herniated disc for the 
procedure 
 
• Patients with severe cognitive impairment 
who cannot consent for themselves 
• Hip and knee patients who had a hip or 
knee fracture within the last 12 months 
• Hip and knee patients with or aseptic 
necrosis in the past 12 months Spine 
patients with severe weakness in leg/ 
foot, or bladder or bowel changes 
• Spine patients who had a spine fracture 
within the last 12 months 
• Any patients who had a possible or 
confirmed tumor at the surgery site within 
the last 12 months 
• Unable to confirm primarily language is 
English  
 
 
Surgeons who see patients with these conditions across the participating sites will be 
eligible for a survey. Study staff will give the paper survey to surgeons in person or send via 
email. The survey will ask for participant’s name as it may be provided in a meeting. Once 
we get the survey we will mark each with a code and use the study ID code as the 
identifier. As needed, study staff will make up to three reminders via email. The brief survey 
will contain questions about the surgeon’s attitudes toward shared decision making, use of 
decision aids, and confidence in shared decision making skills. The survey participation is 
voluntary and surgeon implies consent by completing the survey and providing it back to 
study staff.  
 
Table 2: Eligibility Criteria for Cancer Screening Study 2020 
Clinical 
Context 
Eligibility Criteria 
Ineligibility Criteria  
Colon Cancer 
Screening 
• 
Between the ages of 45-75 
• 
Received a decision aid for 
colon cancer screening  
 
• 
Previous diagnosis of colon cancer 
• 
Patients with severe cognitive 
impairment who cannot consent for 
themselves 
• 
Unable to confirm primary language 
is English  
 

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Breast Cancer 
Screening 
• 
Female 
• 
Between the ages of 35-55 
• 
Received  decision aid for 
breast cancer screening  
 
 
• 
Previous diagnosis of breast cancer 
• 
Patients with severe cognitive 
impairment who cannot consent for 
themselves 
• 
Unable to confirm primary language 
is English  
 
 
Prostate Cancer 
Screening 
• 
Male 
• 
Between the ages of 45-74 
• 
Received decision aid for 
prostate cancer screening 
• 
Previous diagnosis of prostate cancer 
• 
Patients with severe cognitive 
impairment who cannot consent for 
themselves 
• 
Unable to confirm primary language 
is English  
 
Lung Cancer 
Screening 
• 
Between the ages of 50-80  
• 
Received decision aid for 
lung cancer screening  
• 
Previous diagnosis of lung cancer 
• 
Patients with severe cognitive 
impairment who cannot consent for 
themselves 
• 
Unable to confirm primary language 
is English  
 
 
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
 
See above section for study procedures.  
 
Study endpoints include: 1) demonstration of the ability to introduce and disseminate SDM 
programs to patients, 2) assessment and understanding of “prescribing” utilization, trends 
and patterns by clinician and across practices, 3) feedback from patients about receiving 
SDM programs, and their decision preferences and comfort with making a decision and 4) 
Assess the quality of shared decision making for elective surgical decisions. 
 
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
 
No diagnosis or treatments will be offered or administered as part of this study. There is no 
medical intervention as part of this study. The standard of care is that clinicians discuss 
appropriate treatment options, including their benefits and risks with each patient. The standard 
of care at these sites is also to engage patients in shared decision making and to assess patient-
reported outcomes periodically to measure the quality of care. 
 

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Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
 
There are no known risks to participating individuals associated with or attributable to this 
project. Clinicians will provide their patients with evidence-based decision aids in much the 
same way they currently provide other educational materials to their patients. Additionally, 
completed questionnaires do not capture personal identifiers nor HIPAA related information. 
Only MGH approved study staff will have access to the information crosswalk.    
 
For the mailed surgery shared decision making surveys, participants will be informed that 
they may refuse to answer any question. It will also be emphasized that whether 
participants complete the survey or not, will not impact the medical care that they receive.  
 
If the patient completes the surgery shared decision making questions as part of the PROMs 
platform, the responses will be made available in their medical record per standard practice. 
If the patient completes the PROMs by paper, the responses will not be put in the medical 
record. Patients who complete the PROMs questions will also be sent an invitation letter to 
participate in a 30-45 minute phone interview discussing their experience with elective 
surgery.  
 
Cancer Screening Project 2020:  
For the cancer screening decision making surveys, participants will be informed that they 
may refuse to answer any question. It will also be emphasized that whether participants 
complete the survey or not, it will not impact the medical care that they receive. 
Participants who wish to complete the survey electronically will be provided with a link to 
the secure Mass General Brigham REDCap survey platform. Participants may also request 
the REDCAP survey link be sent to them via email. If email is preferred, staff will discuss 
privacy and obtain permission to send the survey via email without send secure (and confirm 
address). Study staff will read the following statement to patients, "The Mass General Brigham 
standard is to send email securely. This requires you to initially set up and activate an account 
with a password. You can then use the password to access secure emails sent to you from 
Mass General Brigham.  If you prefer, we can send you “unencrypted” email that is not secure 
and could result in the unauthorized use or disclosure of your information. If you want to receive 
communications by unencrypted email despite these risks, Mass General Brigham will not be 
held responsible. Your preference to receive unencrypted email will apply to emails sent from 
this research study only. If you wish to communicate with other research staff at Mass General 
Brigham regarding additional studies, your preference will have to be documented with each 
research group.” After reading the required warning language, study staff will ask for the 
patient’s verbal agreement.    
 
 
There are minimal risks to participating in interviews. Participants may refuse to answer any 
questions and may discontinue their participation at any time. Participants’ names will not 
be identified in any reports or manuscript. 
 
Path to Lifestyle Change. Patients will be informed that they may refuse to answer any 
question. It will also be emphasized that whether patients complete the survey or not, will 
not impact the medical care that they receive. Surveys will be sent electronically using the 
Partners REDCap platform.  
 

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Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
 
 
As stated above, there are no known risks to participating individuals in this project.  The 
clinicians discuss with their patients, who are clinically eligible for one of the SDM programs, 
whether or not such a decision aid is something they are interested in receiving and 
watching.  This is done in the same manner in which other patient educational information 
in more traditional medium (i.e., handouts, brochures, pamphlets) is given to patients.  
During the course of the discussion, if the patient expresses that he/she is not interested in 
program, it will not be sent to the patient.  It is the patient’s decision whether or not to view 
the programs.   
 
The questionnaires that are included with the program or that are mailed to patients 
separately are optional. Patients can voluntarily complete them and send them back, but 
are not required to do so. An information sheet will accompany the questionnaire that 
explains the study in detail, including how we protect patient privacy, and explains that 
returning the completed surveys indicates their consent to participate in the project. We 
inform patients that we may share their survey data with their clinicians, as some providers 
have requested the feedback to make sure that their patients understand the key 
information in the program and to guide future conversations about the decision. We also 
explain that we may look at their medical record to examine whether specific tests or 
treatments were done (for example, to examine whether someone who viewed the knee 
osteoarthritis program had a knee replacement). 
 
All patients who receive a decision aid or a study survey will also be able to indicate their 
consent to be contacted in the future for other studies or to discuss their decision making 
experiences. Of those patients who’ve given consent to be contacted: study staff may 
contact these patients via email or telephone, depending on their preferred method, to 
solicit feedback on all aspects of programming.  The feedback may be obtained over the 
telephone, via email, or via focus groups.  Participation in any future contact is voluntary; 
patients may choose to not participate at any time. 
 
The completion of the provider and patient questionnaire or interview is also voluntary, and 
they may choose to skip any question they wish not to answer. No information will be 
shared that will permit identification of any individual.  
 
For patients involved in the medical chart abstraction, each patient’s information will be 
coded with a study ID to protect their privacy.     
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
 
As stated above, there are minimal known risks to participating individuals associated with 
or attributable to this project. This is a project in which patients are provided with evidence-
based decision aids in the form of DVD programs or online versions of these program, which 
aim to help them make better, more informed decisions about the screening, management, 
and treatment options available to them.  

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For patients that are invited to complete the surgery shared decision making survey, it is 
estimated that it will take <5 minutes to complete the 10-12 items. The PROMs, that are 
part of standard of care, are measured at the same time and take about 10-20 minutes, 
depending on the clinical area. For patients who are interested in the phone interview it 
should take about 20 minutes.  
 
All reasonable measures will be taken to protect the privacy of the data gathered to ensure 
that the protection of personal information. An analytic data set will be created that does 
not contain any personal identifiers. All data from the ECare reports, RPDR queries, and 
patient surveys will be kept on Partners password protected computers in a limited access 
shared drive folder. Only approved study staff will have access to the folder.  
 
The paper surveys will only contain a study ID. Participant information is linked to a study 
ID will be kept in a password-protected file on Partners shared folder and only study staff 
will have access to the folder.   
 
Cancer Screening Project 2020: 
For patients who are invited to complete the cancer screening survey, it is estimated that it 
will take 10-15 minutes to complete.  All reasonable measures will be taken to protect the 
privacy of the data gathered to ensure to ensure that the protection of personal information. 
An analytic data set will be created that does not contain any personal identifiers. All data 
from RPDR queries and patient surveys will be kept on Partners password protected 
computers in a limited access shared drive folder. Only approved study staff will have 
access to the folder. The paper surveys will only contain a study ID. Participant information 
is linked to a study ID will be kept in a password-protected file on Partners shared folder 
and only study staff will have access to the folder.   
 
In interviews, participants will be told that completing the interview is voluntary and that 
they may refuse to answer any question, at any time and can stop at any time. The major 
risk to participants will be discomfort with the interview questions. 
 
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
 
Potential benefits to participants include: 
 Increased knowledge (i.e. better understanding of treatment/screening options and the 
risks and benefits of the different options)   
 Better decision quality; reduced uncertainty and decisional conflict 
 Feeling more comfortable with decision 
 Increased patient involvement in treatment and screening decisions 
 Improved ability for patients to take into account their own values and preferences when 
making healthcare decisions 
 Improved health outcomes 

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 Increased patient satisfaction 
 
There is no direct benefit to participants who are included in the RPDR query and eCare 
reports or who complete the surgery shared decision making survey.   
 
The knowledge we expect to gain from this project include: 1) a demonstration of the ability 
to introduce and disseminate SDM programs to patients, 2) assessment and understanding 
of “prescribing” utilization, trends and patterns by clinician and across practices, 3) insight 
from patients about receiving SDM programs, and their decision preferences and comfort 
with making a decision, 4) a more comprehensive analysis of the quality of decisions for 
patients undergoing elective joint replacement and spine procedures and 5) identification of 
practices and surgeons who are able to achieve shared decision making.     
 
Cancer Screening Project 2020: 
There is no direct benefit to participants who complete the cancer screening shared decision 
making survey.  
 
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
 
Participants in this project will be adult patients with a provider in the Partners Healthcare 
System adult primary and specialty care practices. Patient decision aids are all available in 
English and Spanish except for 4 programs that are only available in English: Prediabetes: 
Choices you can make to prevent diabetes, Pregnancy: Birth Options if your baby is getting 
too big, and Pregnancy: Your birth options after cesarean, Prostate Cancer: Is radiation or 
surgery right for you. 
 
Participants will also be limited to those for whom a SDM program is clinically appropriate.  
This includes men and women with the following health problems and concerns: general 
healthcare options, low back pain (chronic, acute, spinal stenosis, and herniated disc), 
osteoarthritis of the knee or hip, coronary artery/heart disease, benign prostatic 
hyperplasia, abnormal uterine bleeding, uterine fibroids, symptoms of menopause, obesity, 
depression, ovarian cancer screening, prostate cancer screening, colorectal cancer 
screening, advance directives, diabetes, breast cancer treatment, heart failure, insomnia, 
carotid artery disease, and chronic pain.   
 
Only participants who have consented to be contacted will be included to provide feedback 
over the telephone, via email or via focus groups. Study staff will only reach out to those 
participants who have provided this consent. 
 
Patients for whom a decision aid was provisionally ordered for a specialty referral will be 
contacted to provide feedback through questionnaires and individual interviews.  
 
Providers who made a specialty referral for a patient will be emailed a survey to complete 
online or by paper regarding that specific referral. Also, all eligible Partners Healthcare 
System primary care physicians, specialists, nurses and other clinic staff involved in a 
patient’s care may be asked to complete either the questionnaire or participate in an 

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interview. Study staff will work individually with those interested in the interviews, at the 
time of a specific project.  
 
Participants in the surgery shared decision making project will be adult patients who had 
surgery at a Partners Hospital for one of the four identified clinical conditions during the 
recruitment period who have been confirmed that primarily language is English. Participants 
will also be limited to those who meet the eligibility criteria laid out in Table 1. Children will 
be excluded as these conditions and procedures are not relevant for children.  
 
Cancer Screening Project 2020:  
Participants in the cancer screening shared decision making project will be adults who 
received a decision aid at a Partners Hospital for one of the four identified clinical conditions 
in the last 2 years, and English is their confirmed primary language. Participants will also be 
limited to those who meet the eligibility criteria laid out in Table 2. Children will be excluded 
as these conditions and procedures are not relevant for children.  
 
Patients in the interviews will be recruited from the database of those who received a 
decision aid in the past. Patients must also be on Patient Gateway. Physicians will be 
recruited from the same database and they will be eligible if they prescribed a patient 
decision aid in the past.  
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
 
Participants in this project will be adult patients with a provider in the Partners Healthcare 
System adult primary and specialty care practices. Patient decision aids are all available in 
English and Spanish except for 4 programs that are only available in English: Prediabetes: 
Choices you can make to prevent diabetes, Pregnancy: Birth Options if your baby is getting 
too big, and Pregnancy: Your birth options after cesarean, Prostate Cancer: Is radiation or 
surgery right for you. 
 
There are plans for more of the programs to be created in other languages; however they 
are not available at this time. We plan to include all of the non-English versions as they 
become available in the future.  
 
Currently, the PROMs surveys are not available in Spanish. When they become available in 
Spanish, we will modify our protocol to include Spanish-speaking patients in our surgery 
shared decision making survey portion of this study.  
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          http://healthcare.partners.org/phsirb/nonengco.htm 
 
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 

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participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
  
Patient participants in this project will be patients in the Partners Healthcare System adult 
primary and specialty care practices. There is no formal recruitment of patient participants, 
as this is driven purely by appropriate clinical care. The distribution of SDM programs will 
vary by practice and program. One common method is that during an office visit, clinicians 
will discuss the program with the patient to determine if he or she is interested in watching 
it, in much the same way clinicians currently discuss any patient education material they 
provide their patients. Those patients who are interested will then receive the program, 
either via the mail, email, or by picking it up from the Blum Patient and Family Learning 
Center, depending on the patient’s preference.    
 
Clinicians are interested in automating the distribution of decision aids. To accomplish this, 
we will work with clinicians and practices to identify patients at a decision point. Data will be 
collected regarding the general practice patterns for the conditions covered to understand 
the number of eligible patients. The investigators will work with Steve Atlas who has an IRB 
approved protocol to examine practice patterns for quality improvement. For example, we 
may examine the number of men seen in MGH primary care practices who have never had a 
PSA test, and then work with providers to ensure that those men receive the appropriate 
decision aid in advance of their next visit. The data will enable automation of distribution as 
well as evaluation of distribution rates to determine the proportion of eligible patients we 
are reaching with each program.  
 
Quantitative data will be collected for the number and type of programs “prescribed,” both 
overall and by physician and practice.  This data will be strictly quantitative and will not be 
associated with any individual patient or identifying information. Nothing about the patients 
will be associated with these numbers.  Furthermore, this data will be independent of active 
patient participation in the evaluation and feedback (i.e., patient questionnaires) portion of 
the project.  
 
All patients who receive a SDM program will be eligible to participate in the qualitative 
(evaluation and feedback) portion of the pilot. A questionnaire will be included with all SDM 
programs that are sent or given to patients. The questionnaires may also be incorporated 
into standard patient intake procedures at clinics, such as the touch screen computers or 
kiosks that patients use to complete standard assessments before seeing a provider in the 
orthopedic clinic. Patients can choose to complete the questionnaire and mail it back or 
complete the questionnaire over the telephone or online, thus providing implied consent 
(i.e., voluntary completion of survey or questionnaire), or they can choose to not complete 
the questionnaire.  Patients who have not returned the questionnaire within 2 weeks of the 
initial survey will receive a follow-up phone call. Reminder survey packets will be mailed 
within 4 weeks if the patient has yet to return the survey. These patients will also receive 
reminder phone calls within 2 weeks of the reminder mailing. Patients may complete the 
questionnaire by telephone during the follow-up phone call. Patients willing to complete the 
questionnaire and who have not yet viewed the decision aid will be asked only pre-viewing 
questions, and will be encouraged to view the decision aid and follow up for administration 
of the post-viewing questions.  
 
All patients who receive a decision aid will also be able to indicate their consent to be 
contacted in the future. Of those patients who’ve given consent to be contacted: study staff 
may contact these patients via email or telephone, depending on their preferred method, to 
solicit feedback on all aspects of programming. The feedback may be obtained by staff 
through individual interviews or group interviews. The information will help us make 
improvements to the patient education materials. All emails that are sent for recruitment 
will be sent in accordance with Partners’ institutional guidelines for information security. Any 

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information provided by patients will be kept confidential. Participation in any future contact 
is voluntary; patients may choose to not participate at any time. 
 
Patients who have indicated their consent to be contacted in the future for other studies will 
be contacted to see if they would be interested in participating in a pilot study examining 
the effectiveness of mental health decisions aids: sleeping better, depression, and anxiety. 
Patients will be contacted first by telephone and asked if they would be interested in 
participating in a survey study. If they agree to participate they will be asked to review 
some additional patient educational materials either online or on paper. After the patient 
reviews the materials, they will be asked to complete and answer the questions via phone 
with study staff at a scheduled time. Consent will be implied by the completion of the 
questionnaire. If a patient would like to complete the questionnaire via paper, an 
information sheet, questionnaire, and return-envelope will be sent to the patient. The 
project goal is to have approximately 30 eligible patients complete the survey. 
 
Patients who have indicated their consent to be contacted in the future for other studies will 
be contacted to see if they would be interested in participating in a structured interview 
either in-person or via telephone to learn more about decision making for older adults about 
whether to continue colorectal cancer screening. We may also have primary care physicians 
(PCP) identify patients who they believe would good candidates to participate in the 
interviews. The PCP will provide the patient with the information sheet and if the patient is 
interested, the PCP will provide the research staff contact information for the subject to call 
to indicate their interest in participating. Subjects will be contacted first by telephone and 
asked their interest to participate in an interview. If they agree to participate they will be 
asked whether they prefer to conduct the interview in-person or via telephone and study 
staff will schedule a mutually convenient time. Consent will be implied by the completion of 
the interview. A cover letter and an information sheet will be sent by mail or email (if 
subjects provide verbal consent to use personal email) for those interested in an interview. 
All emails that are sent for recruitment will be sent in accordance with Partners’ institutional 
guidelines for information security. The project goal is to have approximately 20 eligible 
subjects complete the interview.  
 
Patients who received a decision aid in the past will be sent a letter and information sheet to 
let them know about an upcoming research project and that if they do not want to be 
contacted about participating, they can opt-out by phone. Potentially eligible patients will be 
asked if they are users of Patient Gateway. If so, the patient will be asked about their 
interest in participating in the interview. If the patient is not on Patient Gateway, he/she will 
not be eligible. If the patient agrees to participate he/she will be sent an information sheet 
describing the study and a mutually convenient time will be scheduled for the patient to 
participate in the interview. Consent will be implied by the completion of the interview.  
 
Physicians who prescribed a patient decision aid in the past will be sent a recruitment email 
asking if they would like to participate in the 60-minute interview. The information sheet will 
also be included. The physician will be asked to reply to the email to indicate if he/she is 
interested. For physicians who respond to the email, a mutually convenient time will be 
scheduled for the physician to participate in the interview. We will recruit physicians across 
a range of practices and specialties. All emails that are sent for recruitment will be sent in 
accordance with Partners’ institutional guidelines for information security. Consent will be 
implied by the completion of the interview. 
 
Patients who received a specialty referral where their physician provisionally ordered a 
decision aid through the Clinical Referral Management System will also be contacted by the 
study staff for feedback on the referral process. Their feedback will be collected through 

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individual interviews or surveys. The information will help us to better understand decisions 
around the referral process. A cover letter and information sheet describing the study will be 
mailed to the patients so that they may choose to participate or not. Any information 
provided by patients will be kept confidential. The patients’ demographic information will be 
collected through an RPDR data collection. 
 
Physicians who have placed the referral for patients through the Clinical Referral 
Management System will also be contacted by study staff for their feedback on the referral 
process. Their feedback will be collected through an email survey. A cover letter and 
information sheet describing the study will be included in the email so that they may choose 
to participate or not. Any information provided by these providers will be kept confidential. 
All emails that are sent for recruitment will be sent in accordance with Partners’ institutional 
guidelines for information security. 
 
All eligible Partners Healthcare System primary care physicians, specialists, nurses and 
other clinic staff involved in a patient’s care may be asked to complete either the 
questionnaire or participate in an interview. The email may also include an information 
sheet describing the study. All emails that are sent for recruitment will be sent in 
accordance with Partners’ institutional guidelines for information security. Study staff will 
work individually with those interested in the interviews, at the time of a specific project.   
 
Medical chart abstraction will examine visits, testing and treatment decisions for patients 
who have both received a decision aid and those with target condition who have not. For 
patients who have not received a decision aid, the patients’ medical records will be pulled 
based on the relevant ICD-9, ICD-10, CPT codes associated with a visit, or with a provider 
within the study timeframe.  
 
For the surgery shared decision making surveys, the procedures are as follows:  
1. Work with PROMs team to schedule patients to receive the shared decision-making 
survey as part of their routine orthopedic PROMs assessment at a post-operative visit 
between 4-26 weeks post-procedure.  
2. Use eCare report and RPDR queries to generate a list of patients who are scheduled 
for or who have recently had the target procedures across the Partners hospitals, 
along with selected details about the patients, the surgery and their interactions with 
specialists.   
3. Study staff will run the report periodically and review results to confirm eligibility. A 
database of eligible surgical patients will be created and updated throughout the 
study period. Study staff may use RPDR to pull data for eligible patients that was not 
available from the eCare report. Staff may also access EHR to pull data (e.g. PROMs 
completion and responses) that is not available through RPDR.    
4. Study staff will track shared decision-making survey completion rates on the PROMs 
platform and upload survey data into the database.  
5. Staff will compare completion data to targets across topics and hospitals and if 
needed, staff will use a computer-generated allocation scheme to randomly select a 
subset of eligible surgical patients who did not receive the shared decision making 
survey on the PROMs platform to receive it in the mail.  
6. The mailing will contain a cover letter signed by the PI and Clinical Chief at each site 
inviting patients to complete the survey, an information sheet about the study, the 
survey, a $2 incentive, and self-addressed stamped return envelope. The cover letter 
will include instructions for how to opt out of the survey if subjects are not 
interested.  
7. About two weeks after the mailing, research staff will make up to three attempts to 
call subjects who did not opt out to answer questions and encourage subjects to 
complete the survey.  

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8. One reminder mailing will be sent about three weeks after the initial to non 
responders and that will be followed by up to two reminder phone calls.   
9. For patients who have completed the PROMs questions or survey, they will be sent an 
invitation letter to participate in a 30-45 minute phone interview discussing their 
experience with elective surgery. 
10. One week after mailing, study staff will call patients who did not opt out to ask them 
if they are interested in participating in a 30-45 minute interview.  
11. Patients who complete a phone interview, will be sent a thank you letter and $20 
cash compensation.  
 
Surgeons who see patients with these conditions across the participating sites will be 
eligible for a survey. Study staff will give the paper survey to surgeons in person or send via 
email. The survey will ask for participant’s name as it may be provided in a meeting. Once 
we get the survey we will mark each with a code and use the study ID code as the 
identifier. As needed, study staff will make up to three reminders via email. The brief survey 
will contain questions about the surgeon’s attitudes toward shared decision making, use of 
decision aids, and confidence in shared decision making skills. The survey participation is 
voluntary and surgeon implies consent by completing the survey and providing it back to 
study staff. All emails that are sent for recruitment will be sent in accordance with Partners’ 
institutional guidelines for information security. 
 
Cancer Screening Project 2020:  
For the cancer screening shared decision making surveys, the procedures are as follows:  
 
1. Study staff will identify patients through the prescription log of individuals who 
received patient education materials in the form of decision aids on cancer screening 
for: breast cancer, colorectal cancer, prostate cancer, lung cancer over the last 2 
years.  
2. Study staff will mail eligible study participants a cover letter, information sheet 
describing the study, a copy of the first page of the educational materials they 
received through their Patient Gateway, a one time survey and $2 USD for their 
consideration of completing the study.  
3. Participants can choose to complete the survey and mail it back, complete the survey 
over the telephone, or online via a REDCap survey link, thus providing implied 
consent (i.e., voluntary completion of survey or questionnaire). Participants can also 
choose not to complete the survey.  
4. Study staff will make up to three reminder calls to patients regarding the survey 
within 2 weeks of the initial mailing.  
5. Study staff will send reminder survey packets within 4 weeks if the patient has yet to 
return the survey and receive up to three reminder phone calls within 2 weeks of the 
reminder mailing.  
6. Study staff will conduct a chart review to collect information on cancer screening 
tests and review visit notes related to cancer screening.  
7. Participants will be sent a thank-you letter for their participation following completion 
and research staff’s receipt of completed survey.  
 
Path to Lifestyle Change 
Patients eligible for the research study will be participants in the Path to Lifestyle Change 
program offered through the MGH Diabetes Center. The clinician in the MGH Diabetes Center 
will obtain permission to send the study information by email. In addition, the clinician will be 
available to answer questions about the study. For patients who give permission to use their 
email to send the study information, they may opt-out of the research by contacting the study 
coordinator by phone or email. For patients who do not opt-out, consent will be implied by 

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survey completion. Patients who did not opt-out will receive a secure REDCap survey link by 
email at 5 time points: one-week post baseline visit, 6 months, 12 month, 18 months and 24 
months. The protocol for following up at each time point will be the same: 1) the patients will 
receive an automated reminder from REDCap one week after each survey is sent if the patient 
has not responded, 2) one reminder phone call will be made one week after the automated 
response is sent if the patient has not responded. Study staff will offer to complete the survey 
over the phone, if the patient would prefer.  
 
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
 
Those patients participating in an individual interview will receive $20 after completion 
of the 45-minute interview. Patients completing a 1 hour audiotaped interview will 
receive $40. Focus group participants will receive $60 after completion of the 90 minute 
session. Participants will not receive any remuneration for completing questionnaires, 
including the specialty referral interview. Participants who will be participating in a 90-
minute individual interview will receive $40 after completion of the interview. Patients 
participating in the recontract survey mental health study will not receive compensation.  
 
Participants in the interviews about the patient decision aids prescribed through EPIC 
and accessed through Patient Gateway will receive $50 in cash to thank them for their 
time 
 
Participants who receive the surgery shared decision making survey in the mail will receive 
$2 cash as an incentive to promote survey completion. 
 
Cancer Screening Project 2020:  
Participants who receive the cancer screening shared decision making survey by mail will 
receive $2 as an incentive to promote survey completion.  
 
Clinician’s participating in surveys or interviews will not be compensated. 
 
Participants in the Path to Lifestyle Change program will not receive any incentives.  
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          http://healthcare.partners.org/phsirb/recruit.htm
 
          Guidelines for Advertisements for Recruiting Subjects
          http://healthcare.partners.org/phsirb/advert.htm
 
          Remuneration for Research Subjects
          http://healthcare.partners.org/phsirb/remun.htm
 
 

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CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
 
There are no formal written consent procedures in this project.  Whether or not a patient 
receives one of the SDM programs is determined by appropriate clinical care and the 
patient’s desire to receive information about his or her health problem/screening in the form 
of a shared decision-making program.  This occurs through a discussion between the patient 
and clinician during the office visit, much like any conversation that occurs when a physician 
gives educational material to a patient.      
 
Patients who receive a SDM program will also receive an information sheet describing the 
study and a questionnaire. Patients can choose to complete the questionnaire and mail it 
back, online, or complete the questionnaire over the telephone, thus providing implied 
consent (i.e., voluntary completion of survey or questionnaire), or they can choose to not 
complete the questionnaire. There will be routine post-card reminders and follow-up phone 
calls made to patients who have not returned the questionnaire within 2 weeks of the initial 
survey. Reminder survey packets will be mailed within 4 weeks if the patient has yet to 
return the survey. These patients will also receive reminder phone calls within 2 weeks of 
the reminder mailing.  It will be mentioned to the patient as a reminder that they can return 
the questionnaire, if they wish, or complete the questionnaire over the telephone. Patients 
willing to complete the questionnaire and who have not yet viewed the decision aid will be 
asked only pre-viewing questions, and will be encouraged to view the decision aid and 
follow up for administration of the post-viewing questions. 
  
The data collected in the questionnaires pertains to the processes of shared decision-making 
and receiving the program, how helpful the program was to the patient in making their 
decision, the effect the program had on decision preference, what the patient thinks about 
the available options, and how they feel about making a decision. 
 
The provider survey, and specialty referral survey, will not have formal written consent 
either, and consent will be implied by the return of the completed survey. The provider 
questionnaire will provide us with valuable feedback regarding the dissemination of the SDM 
programs, as well as their perspective barriers and/or benefits to prescribe and refer to 
eligible patients. Clinician consent will be implied by agreeing to participate in the interviews 
or completing a survey. Clinicians will be provided with a study information sheet as well.  
 
For the patients in the specialty referral survey, no formal written consent will be collected. 
Patients’ consent will be implied by the return of the completed survey or completion of a 
telephone interview. A cover letter and information sheet describing the purpose and time 
commitment of the study will be mailed to the patients so that they may choose to 
participate or not. A reminder phone call will be placed for those who haven’t completed the 
questionnaire within a 2-week timeframe. They can choose to complete the survey over the 
phone at that point. 
 
For those patients who’ve given consent to be re-contacted: study staff may contact these 
patients via email or telephone, depending on their preferred method, to invite them to 
participate in an individual or group interview or via survey. An information sheet describing 
the interview study, time commitment and remuneration (if applicable) will be provided. If 

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interested, patients will contact staff and schedule an interview or participate in the phone 
survey. Consent to participate will be implied by completion of the interview and/or survey.    
 
For the surgery shared decision making surveys, there are no formal written consent 
procedures in this project. When the survey is included as part of the PROMs application, it 
is part of the standard of care. When surveys are mailed to patients, consent is implied by 
the completion and return of the survey. Study staff will protect the privacy of research 
study participants. Patients can skip any question and may stop at any time. There are no 
procedures in this research for which written consent is normally required. For the mailed 
survey, eligible participants will receive a cover letter signed by the chief of orthopedic 
surgery or medical director of the specific service from each site and the principal 
investigator inviting them to complete the survey, as well as an information sheet that will 
provide details about the survey study. Participants can review the questions and choose 
whether or not they wish to participate. Surgeons who receive a surgery shared decision 
making survey will have implied consent by completing and returning the survey. Survey 
participation is voluntary.  
 
Cancer Screening Study 2020:  
No formal written consent will be obtained for participants of the cancer screening study 
survey. Potential participants will be mailed an information sheet containing information 
about the study and inviting participation. Participants may review the questions and the 
information provided in the mailing packet and choose whether or not they wish to 
participate. Participants may also contact study staff to opt out of the study. Consent for 
participation will be implied by the return of completed survey by mail or online via the 
REDCap survey link. Participants may request the REDCAP survey link be sent to their email. 
Study staff will read the IRB policy regarding send-secure vs. unencrypted emails and obtain 
verbal consent from participants via telephone to send the survey link via email based on 
participant email preference. Survey participation is voluntary.  
 
All participants in the Path to Lifestyle Change program will be asked permission to send 
them an email about this research project. If the participant gives permission to use their 
email, he/she will be emailed a cover letter and fact sheet explaining the research project 
per Partners guidelines. The cover letter will ask participants to opt-out if they do not want 
to participate in the survey research. For participants who do not opt-out, they will be sent 
an email with a secure link to a REDCap survey at each of the four timepoints. Consent will 
be implied by completion of the REDCap surveys.  
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
http://healthcare.partners.org/phsirb/newapp.htm#Newapp
 
For guidance, refer to the following Partners policy: 
          Informed Consent of Research Subjects
          http://healthcare.partners.org/phsirb/infcons.htm
 
 
 

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DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
 
While there are no known risks or safety concerns to participating individuals associated 
with or attributable to viewing information about health topics and voluntarily answering 
questionnaires, we will monitor patient feedback obtained in the questionnaires and any 
conversations they might have with their clinician in which they express complaints or 
problems related to the project. The Stoeckle Center staff are available to answer questions 
or concerns that patients might have.  We plan to keep records of any feedback, questions, 
concerns and/or complaints received about the project and will address them as necessary.   
 
The main risks to patients will be loss of privacy. Questionnaires will include solely, a coded 
unique numeric identifier for each patient and provider. Therefore, all completed 
questionnaires will be stripped of any personal identifiers and/or HIPAA related information. 
Only MGH approved study staff for this protocol will have access to the information 
crosswalk needed to link this unique identifier with confidential personal information. The 
completed, coded questionnaires will be returned, where study staff will enter the de-
identified data into a secured online data warehouse. Data will be stored using a secure, 
online data warehouse hosted by the DatStat Company. All DatStat servers used for data 
collection are housed in a server room. The server room is in a building with 24/7 alarm 
security. Any building compromise will sound the alarm and generate a call to the building 
supervisor and police, who will subsequently notify DatStat personnel of the intrusion. 
Protection of servers from remote attacks is accomplished with a dedicated hardware 
Watchguard firewall with auditing enabled at the recommended settings. Watchguard 
LiveSecurity keeps IT staff advised of all known security alerts. The firewall ensures that all 
traffic is closely monitored and suspicious packets blocked from access to the production 
systems. Security patches are applied to DatStat servers on a timely and ongoing basis. 
Logs are created by the web servers to increase the accountability and are essential in 
investigating incidents after the fact. Access to data stored in the server is available only to 
MGH approved study staffs that are assigned specified usernames and passwords within 
which to log in. Study staff at the sponsor and participating sites are also assigned specified 
user names and passwords and can access only the aggregated study data. Users are 
logged out after a period of time. A listing of the users with a description of their access 
privileges is available within the application. The following are logged: failed and successful 
logins, attempts to access files/directories without authority, successful and failed attempts 
to access sensitive data.  
  
All emails that are sent for recruitment will be sent in accordance with Partners’ institutional 
guidelines for information security. 
 
Only approved study staff will have contact with the patients who’ve consented to 
participate in the qualitative feedback sessions.  Any information provided by these patients 
will be kept confidential. Individual interviews will be hosted by two study staff.  One will 

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follow a prepared interview script and the other will take detailed notes. There will also be 
at least two study staff, one acting as facilitator who will follow similar script as the phone 
interview, and one as note-taker, during the group sessions. All notes will be stripped of any 
personal identifiers and/or HIPAA related information. The individual interviews that will be 
conducted for the weblink decision aid videos will have two study staff, one as a note-taker 
and the other as a guide to assist the participate in viewing the online video. The videos will 
be viewed through the Healthwise website. No personal information will be captured during 
the qualitative feedback sessions.  It will be stated upfront during the focus group sessions 
that no personal information discussed is to leave the room. 
 
The medical chart abstraction data will be stored in a database on a Partners password 
protected computer. Only study staff will have access to this database. A study code will be 
used to protect the confidentiality of patients.  
 
Data collection for surgery shared decision making survey, will be from the medical record 
and patient surveys and surgeon surveys. There are no foreseeable safety risks to 
participants for completing the survey. Study staff will protect the privacy of research study 
participants as described in the Privacy and Confidentiality section.  
 
Cancer Screening Survey Study 2020:  
Data collection for the cancer screening survey will be from medical records and patient 
surveys. There are no risks to participant safety in completing the survey. To mitigate risk 
of loss to patient privacy all surveys will be coded with unique numeric identifier for each 
patient. The medical chart abstraction data will be stored in a database on a Partners 
password protected computer. Only study staff will have access to this database. Study staff 
will protect the privacy of research study participants as described in the Privacy and 
Confidentiality section.   
 
It is possible that participants may be upset by a question in the interview or survey, 
although our prior experience using these questionnaires with patients who have knee 
osteoarthritis or low back pain have found that it is very rare for participants to be upset. 
Nevertheless, study staff will screen surveys for adverse events and address them as 
described in the next section.  
 
There are no formal stopping rules for this minimal risk study.   
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
 
Any adverse event or patient complaint that occurs as a result of or related to this pilot 
project will be addressed immediately upon receiving it. We will also relay any such event to 
the Informed Medical Decisions Foundation if it pertains directly to the SDM program.  
Again, the Health Decision Sciences Center (HDSC) staff are available to address any 
questions or concerns that are received from the patients, either directly or through the 

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patients’ clinician.  We will keep records of any feedback, questions, concerns and/or 
complaints that are received, and we will address them immediately and appropriately. 
 
The HDSC have clinical co-investigators in primary care and surgery who will be able to 
consult with study staff on any clinical issues that become apparent. For example, if patients 
raise a clinical issue with study staff during the course of phone reminders or on the written 
surveys. However, if a serious adverse event occurs relating to the study, then the principal 
investigator will report the event to the IRB within 24 hours and will file an HRC Adverse 
Event Form within 10 working days. If a mild or moderate adverse event occurs, the 
principal investigator will summarize the event in the progress report at continuing review. 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
The study staff will routinely review the program “prescription” log as well as all incoming 
questionnaires for monitoring purposes.  Monitoring of the prescription log will also be done 
by the HDSC staff, as they are the ones who receive and process all requests for SDM 
programs.  Other quality assurance monitoring will be accomplished through the patient and 
provider questionnaires and interviews. The study staff and the principal investigator will 
have routine meetings during the study period to ensure the project proceeds as intended 
per the protocol. We will track recruitment rates and response rates weekly and identify 
issues as they come up. The study staff will complete all required documents for the study 
binder and this will be reviewed quarterly by the principal investigator.  
 
The principal investigator will speak with the study staff on a weekly basis and as-needed to 
ensure that the protocol is being followed. This research does not entail physical risks. We 
have procedures in place to minimize risks to loss of privacy. 
 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
          http://healthcare.partners.org/phsirb/datasafe.htm
 
          Adverse Event Reporting Guidelines
          http://healthcare.partners.org/phsirb/adverse.htm
 
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 

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record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
 
As the goals of this study are to 1) demonstrate the ability to introduce and disseminate 
SDM programs to patients, 2) assess and understand “prescribing” utilization, trends and 
patterns by clinician and across practices, 3) obtain feedback from patients about receiving 
SDM programs, their decision preferences and comfort with making a decision, and 4) 
assess the quality of shared decision making for elective surgical decisions.  
 
The study staff will process and manage the distribution and return of programs and 
questionnaires.  Once questionnaires have been returned, the study IDs will be removed so 
that any ability to link the questionnaires back to patients is removed prior to any review, 
database entry or analysis of the data.  Patient identifiers on the program log (name, 
address and phone number) will be removed before a copy of it is given to study staff.  The 
study database will not contain any patient information.  In this way, the privacy of the 
subjects and confidentiality of the data collected will be maintained.   
 
No personal information will be captured during the qualitative feedback sessions. Patient 
privacy will be maintained.  All notes will be stripped of any personal identifiers and/or 
HIPAA related information.   
 
The interviews will be recorded. The interview data will be identified by a code only. Once 
the interview is completed, we will not keep the link that ties the participant to the 
interview. To ensure confidentiality, all study materials will be kept in locked file cabinets 
and on electronic drives on a Partners password-protected computer to which only the study 
staff has access. 
 
For the surgery shared decision making survey, study staff will run eCare reports and RPDR 
queries to gather information on potentially eligible subjects and will review the subject’s 
medical record to confirm eligibility. We will have names and addresses of eligible 
participants and this information will be kept separate from the study data (e.g. PROMs 
patient survey data). A separate file on a password-protected Partners shared drive will 
contain the codes linked to identifying information. Only the MGH study staff and 
investigators will have access to this file. These will be kept as long as required by the 
research project. After the study has been completed the personal contact information of all 
eligible participants will be destroyed.   
 
Cancer Screening Study 2020:  
For the cancer screening study, researchers will identify patients who received a decision aid 
in the HDSC database and will run RPDR queries to gather contact information on potentially 
eligible subjects and confirm eligibility. We will have names and addresses of eligible 
participants and this information will be kept separate from the study data (e.g. patient 
surveys). All patients will receive a code number and the surveys will only be identified by 
code number. A separate file on a password-protected Partners shared drive will contain the 
codes linked to identifying information. Only the MGH study staff and investigators will have 
access to this file. These will be kept as long as required by the research project. After the 

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study has been completed the personal contact information of all eligible participants will be 
destroyed.  
 
All paper files (e.g. eligibility screeners) that contain PHI will be kept in a locked file cabinet 
or in a secure offsite file storage location or on a password protected Partners shared drive.  
 
Patient confidentiality will be maintained as is routine for all patient care privacy guidelines. 
All research staff are CITI certified and will be trained on the importance of data 
confidentiality. 
 
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.
 
The de-identified program and decision aid survey data will be shared with the sponsor, the 
Informed Medical Decisions Foundation. The sponsor is hosting the data warehouse 
described in detail above and it will aggregate de-identified data from other sites that are 
funded to collect the same data on implementation of the DVDs/booklets at primary care 
sites across the country. The data will not contain any identifiers and other investigators, 
including the sponsor, will not be able to link the data to individual subjects.   
 
A written summary of the interviews that does not contain any personal identifiers will be 
shared with the Healthwise, who is the funder. 
 
Cancer screening study 2020:  
The research team is committed to making resources and data from this proposed research 
study available to other investigators in the research community. The patient information 
sheet states the data will be de-identified and made available to others for analysis and 
research following study completion. The study team will create a clean and de-identified 
copy of the final data set which will include patient survey data in addition to the limited 
demographics and cancer screening test. Information for investigators interested in using 
this data will be made available on the Health Decision Sciences Center website and in 
publications of the data. Dr. Sepucha will share a de-identified data set with outside 
investigators at no cost, per approved MGH/Partners policies for data sharing. We will never 
share the key that will enable an investigator to link the coded data to an individual. 
Investigators from other sites will be able to request the data and will be required to 
complete a data use agreement that ensures that all local IRB requirements are met before 
using the data, that they will not attempt to identify any data in the dataset, and that they 
will not share the data set with anyone outside their project team. We will also make 
information necessary to interpret the data, such as study protocols, data dictionaries, and 
survey tools available to interested investigators.   
  
After the study results have been published, de-identified data sets will also be deposited in 
an open access service such as, ICPSR (https://www.icpsr.umich.edu/icpsrweb/). This is to 
promote research replicability, transparency and future use of the data. On ICPSR, 
individuals must register and agree to ICPSR’s Responsible Use statement prior to accessing 
datasets. Additionally, before a dataset is made available for access, ICPSR completes a 
detailed review of all datasets to assess disclosure risk. If necessary, ICPSR modifies data to 
reduce disclosure risk or limits access to datasets for which modifying the data would 
substantially limit their utility or the risk of disclosure remains high. No information that 

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contains identifiers or that could be used to link an individual to the data will be included in 
the de-identified data set. The information sheets will contain the following language:  After 
the study is completed, all identifiable information will be removed from the data and after 
removal, the de-identified information will be deposited in an open access service to 
promote use of the data by other researchers.   
 
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
 
Since there will be no identifying information in the data submitted to the sponsor it will not 
be possible for an individual to withdraw their information. We have submitted the approval 
for the protocol held by the sponsor that covers the aggregation of data from MGH and 
other participating sites.  
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
 
Study staff at MGH will be able to access the aggregated data that the sponsor has collected 
from other participating sites. MGH study staff will not be able to link data to individual 
subjects from other participating sites. We have attached the IRB approval held by the 
sponsor that covers the aggregation of data from MGH and the other participating sites.