Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial
Phase: NA
Conditions: Colorectal Cancer Screening
Sponsor: Massachusetts General Hospital

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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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, PhD  
 
PROTOCOL TITLE 
Promoting Informed Decisions about Cancer Screening in Older Adults (PRIMED Study) 
 
FUNDING 
Patient-Centered Outcomes Research Institute 
 
VERSION DATE 
March 29, 2021 
 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
 
As people age, medical decisions become more complex, including conversations about cancer 
screening. For patients aged 76-85, the United States Preventive Services Task Force 
(USPSTF) advises clinicians that decisions about colorectal cancer (CRC) screening should be 
individualized based on overall health and prior screening history (C recommendation).i 
However, studies find that many older adults are not well-informed about, nor meaningfully 
engaged in, decisions about whether to continue CRC screening. Shared decision making 
(SDM) has been shown to improve the quality of decisions about initiating cancer screening but 
little is known about its effectiveness for decisions about stopping interventions. This proposal 
addresses an important gap in our understanding of how to support clinicians and older patients 
in making good decisions about whether to continue CRC screening or not.   
 
We will conduct a comparative effectiveness trial that will randomly assign clinicians at 
participating academic and community practices to one of two different decision support 
strategies. The first strategy (Registry arm) takes a population health management (PHM) 
approach and uses a patient registry to identify and track use of CRC screening among older 
adults for each clinician.  The second strategy will enhance the registry by adding an 
established, multi-faceted SDM training program for clinicians (SDM Skills arm). We will enroll 
patients of participating primary care providers (PCPs), aged 76-85, who are due or overdue for 
CRC screening, and survey them shortly after an office visit to determine the impact of the two 
strategies on outcomes of importance to patients. We plan to randomly assign about 60 
participating PCPs to the SDM skills or Registry arms, and enroll about 500 of their eligible 
patients. We will compare reports of shared decision making, patients’ knowledge, and rates of 
patients who get their preferred option for CRC screening across study arms. We will also 
compare CRC screening rates across arms and to concurrent and historical controls. Through 
this project, we will accomplish the following specific aims:  
Aim 1: Determine the impact of the approaches on patients’ involvement in decision making 
and knowledge about the risks and benefits of continued CRC screening.  
Hypothesis 1.1 (Primary outcome): Patients seen by clinicians in the SDM Skills arm will 
report more SDM discussions about cancer screening compared to the Registry arm.  

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Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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Hypothesis 2.1 (Secondary outcome): Patients seen by clinicians in the SDM Skills arm will 
have higher knowledge of the benefits and harms of CRC screening and treatment 
compared to Registry arm. 
Aim 2: Examine the effects of the interventions on patients’ preferences for screening, the 
extent to which patients receive their preferred approach to screening, and on CRC screening 
rates.  
Hypothesis 2.1 (Secondary outcome): A higher percentage of patients will receive their 
preferred approach to screening in SDM Skills arm compared to the Registry arm.  
Hypothesis 2.2: (Secondary outcome) Both interventions will reduce CRC screening rates 
compared to concurrent controls (rates of clinicians who are not involved in study).   
Aim 3: Examine the impact of the interventions on physicians’ confidence with and skills for 
SDM in this setting.  
Hypothesis 3.1: Clinicians in the SDM Skills arm will have higher confidence in their SDM 
skills.  
Hypothesis 3.2: Clinicians in the SDM Skills arm will demonstrate more SDM skills in 
simulated patient interactions than the Registry arm.   
The study will advance our understanding of how to best communicate evidence of cancer 
screening benefits and harms to older adults. Better decisions about whether or when to stop 
screening may reduce unnecessary tests and treatments and allow patients to avoid potential 
harms of screening.    
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
Colorectal cancer (CRC) is a common, lethal disease that affects both men and women. In 
2016, an estimated 135,000 people were diagnosed with CRC and 49,000 people died of it. The 
incidence of CRC increases with age, and the average age of diagnosis is 68 for men and 72 for 
women. CRC screening is widespread, and data indicate that 65% of adults over 65 were up-to-
date with CRC screening tests; however, almost one quarter of adults 75 and older have never 
been screened for CRC. The screening is performed using a variety of methods, including stool-
based testing requiring patients to collect stool specimens at home, and direct visualization 
testing such as colonoscopy. If stool-based testing is positive, then additional testing with a 
colonoscopy is recommended. There is evidence from observational and randomized trials that 
all methods for CRC screening are effective at reducing mortality attributed to colorectal cancer, 
provided the tests are conducted at recommended intervals with follow-up as needed. 
 
Although CRC screening is recommended for adults aged 50-75, the USPSTF advises 
clinicians to make an individual decision for adults aged 76-85. Older adults often have a small 
potential benefit from screening and are at higher risk for complications, particularly 
complications of colonoscopy. The choice of whether to continue or stop screening depends 
significantly on patients’ individual risk of colorectal cancer, their overall health, as well as their 
preferences for testing. Those who are able to undergo treatment if cancer is found and those 
who are otherwise healthy with long life expectancy may be more inclined to continue. Further, 
the USPSTF notes that adults aged 76-85 who have never been screened are more likely to 
benefit from CRC screening than those with prior testing. 
 
There is a growing need to address appropriate use of cancer screening tests in older adults. 
Screening for asymptomatic disease comes with costs and potential harms. Shared decision 
making (SDM) is an established approach to engaging and informing patients in medical 
decisions. Currently, there is a lack of evidence on effective interventions to support clinicians in 
communicating with patients 76-85 about the benefits and harms of cancer screening and 

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tailoring decisions to what matters most to patients. This study will compare two established 
interventions to advance our understanding of how to support clinicians in conducting SDM 
conversations with older adults who may be considering stopping cancer screening. 
 
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 main study is a cluster randomized trial enrolling about 60 primary care clinicians across all 
sites. We estimate including about 30-35 clinicians from primary care practices affiliated with 
Massachusetts General Hospital (MGH) and Brigham and Women’s Hospital (BWH), 10-15 
from Maine Medical Center (MMC), and 10-15 from community practices affiliated with Newton 
Wellesley Hospital (NWH) and North Shore Medical Center (NSMC).  The participating 
clinicians at each site will be placed into two groups stratified by gender and years of 
experience. Then, each group will be randomly assigned to one of two arms: Registry arm or 
Registry plus SDM Skills training arm (SDM arm). Clinicians in Registry arm will be notified 
about their patients aged 76-85 who are due for colorectal cancer screening with an upcoming 
visit. Clinician participants in the SDM arm will also receive the Registry notification and in 
addition, they will participate in a SDM skills course that includes online training and telephone-
based simulated patient interactions.  
 
After the training, study staff will track and enroll eligible patients who have upcoming visits with 
participating clinicians in both arms. We plan to enroll about 10 patients per clinician for a total 
of 500 patients. The clinicians will complete a short survey after each eligible patient visit. The 
patients will be invited to participate in the survey study and will be asked to complete a survey 
after their visit and another short survey one year later. Patients will be asked whether a 
spouse, friend or caregiver was involved in the decision-making process and if so, whether they 
would be willing to invite them to participate in the study. Study staff will follow up to enroll 
caregivers that patient participants identify and administer a short survey. We expect that about 
half of the patients will identify a caregiver, so about 250 caregivers will be surveyed.  
 
Staff will track colorectal cancer screening for 12 months after the recorded date of visit for 
participating patients, for participating clinicians and for non-participating clinicians across these 
sites to examine trends in screening over time. Historical controls will also be collected to 
calculate rates of screening across the sites for the 2 years prior to the study (approximately 
calendar years 2017 and 2018).  
 
The eligibility criteria for the clinician and patient participants are in Tables 1 and 2.  
 
Table 1: Eligibility for clinician participants  
 
Eligible 
Ineligible 
 • 
Primary Care Physician (MD or NP) 
• 
Have ≥20 potentially eligible 
patients in their panel 
• 
Use of Epic electronic health record 
• Residents, medical students  
 
 
 
 

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Version Date:  October 15, 2014 
 
  
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Table 2: Eligibility for patient participants  
 
Eligible 
Ineligible 
 • 
Adults, age 76-85 at the time of a 
scheduled visit 
• 
Scheduled for non-urgent office visit 
with a participating clinician during 
the study period 
• 
Due or overdue for colorectal 
cancer screening (e.g. never been 
screened, <1 year to follow-up 
interval indicated on last test). 
• Prior diagnosis of colon or rectal cancer, 
inflammatory bowel disease or genetic 
disorder that raises CRC risk (hereditary 
non-polyposis CRC and familial 
adenomatous polyposis) 
• Unable to consent for themselves (moderate 
to severe dementia or other major cognitive 
limitations) 
• Unable to read or write in English or Spanish  
 
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.
 
Clinicians will be recruited from primary care practices, both internal medicine and family 
medicine, affiliated with MGH, BWH, MMC, NWH and NSMC. The investigators will work with 
Steve Atlas who has an IRB approved protocol (2004P002796) to help identify the number of 
eligible patients by clinician and will then target those clinicians with high number of eligible 
patients for recruitment on the trial. IRB protocol 2004P002796 remains an active study and 
continues to operate per an IRB approved protocol and amendments. The study uses data from 
patients followed in MGH affiliated primary care practices for research and quality improvement 
purposes. The IRB protocol specifically pertains to research aspects that go beyond data used 
for administrative purposes as part of usual hospital operations. The study involves 
implementing a previously validated and published methodology to identify and link patients 
seen in MGH primary care practices to specific providers. Information is also collected on 
patient characteristics and outcomes of care. The data for this study is updated on a yearly 
basis. The information collected as part of this study can be made available to other IRB 
approved studies such as the current PRIMED submission if permitted in the IRB submission. 
Data collected as part of IRB protocol 2004P002796 will be used to identify MGH primary care 
providers with patients who meet eligibility criteria for the PRIMED submission. Though IRB 
protocol 2004P002796 will help the current submission with identifying potential primary care 
providers and patients, all aspects of contacting these providers and patients are covered in the 
current submission. Study staff will use similar methodology to identify the number of eligible 
patients by clinician for recruitment from the other Partners hospitals (BWH, NWH, NSMC) 
using RPDR and from MMC. 
 
The participating clinicians at each site will be placed into two groups stratified by gender, years 
in practice, and number of clinic sessions per week. Then, each group will be randomly 
assigned to one of two arms: Registry arm or Registry plus SDM Skills training arm (SDM arm). 
• 
Clinicians in Registry arm will complete a baseline telephone-based simulated patient 
interaction to evaluate their SDM skills. Once patient enrollment begins study staff will send 
periodic notification of their patients aged 76-85 who are due for colorectal cancer screening 
with an upcoming visit.  
• 
Clinician participants in the SDM arm will complete an online SDM skills course, two 
telephone-based simulated patient interactions, and monthly facilitated case-based 
discussions. Once patient enrollment begins, study staff will send periodic notification of 
their patients aged 76-85 who are due for colorectal cancer screening with an upcoming 
visit.   

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Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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Study staff will use existing functionality in the electronic medical record (EMR) via RPDR and 
Epic Reports to generate a list of patients 75 and older with CRC screening status, prior CRC 
screening results, and upcoming visit dates for each participating clinician. Staff will also work 
within the EMR at each site to develop an automated report of these items as available.  
 
Our target is to enroll approximately 10 patients per clinician for a total of 500 patients. The 
clinicians will complete a short survey after each eligible patient visit. The patients will be invited 
to participate in the survey study and will be asked to complete a survey after their visit and 
another short survey one year later. Patients will be asked whether a spouse, friend or caregiver 
was involved in the decision-making process and if so, whether they would be willing to invite 
them to participate in the study. Study staff will follow up to enroll caregivers that patient 
participants identify and administer a short survey.  We expect that about half of the patients will 
identify a caregiver, so about 250 caregivers will be surveyed.  
 
The research coordinator will track the number of study participation invitations sent to each 
clinician as well as the number of clinicians indicating interest. We will track any reason given 
for refusal to join the study as well as any reason for dropping out of the study after 
randomization for reporting in CONSORT flow diagram. Staff will track completion of each 
activity (baseline survey, simulated patient interaction, training course, etc) for each clinician 
participant.  
 
Staff will also track all patient participants screened, reason for ineligibility, the number sent 
invitation or post-visit survey packet by mail, the number who opted out or otherwise declined 
participation, those lost to follow-up for any reason, and any reasons given for the refusal to 
participate for reporting in CONSORT flow diagram. There are no formal written consent 
procedures in this study. The research presents no more than minimal risk of harm to subjects 
and involves no procedures for which written consent is normally required. Consent for the 
study will be implied by completion of the one survey for patient participants and email consent 
for clinician participants. 
 
The primary outcome for this study is whether patients report more SDM in the visit with 
participating clinicians about CRC screening in the SDM arm compared to the Registry arm. Key 
secondary outcomes will be whether patients are knowledgeable about CRC screening benefits 
and harms, and whether clinicians understand patients’ preferences and tailor screening 
decisions appropriately.   
 
Patient reported measures: patients will complete a survey shortly after the visit. 
• 
Shared Decision Making Process (SDMP) Survey: Four items assess the amount of 
shared decision making that occurs during a visit. These items are summed to generate 
a total score (0-4), with higher scores indicating greater patient involvement in decision 
making. The survey has been validated through its use in many studies, including two 
national studies of shared decision making for cancer screening and has strong 
evidence of acceptability, feasibility, reliability and validity.Error! Bookmark not defined.ii,iii The 
survey has also been endorsed by National Quality Forum as a SDM performance 
measure (#2962).  
• 
Knowledge: Five multiple choice knowledge items will assess patients’ understanding of 
colorectal cancer screening adapted from the Colorectal Cancer Screening Decision 
Quality Instrument.iv,v  A total knowledge score (0-5) will be calculated from the number 
of correct answers.  
• 
Risk perceptions: One item will assess affective risk perception, or cancer worry. This 
item will be adapted from the National Cancer Institute’s Health Information National 
Trends Survey (HINTS).vi 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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• 
Patient’s preferred approach to screening: One item will assess patients’ preferred 
approach to screening (with responses of colonoscopy, stool card test, no screening, not 
sure).  
• 
Overall health: SF-1 will be used to assess patient’s perception of overall health (poor 
to excellent)vii 
• 
Screening Recommendation and Time Spent: One item will assess the patient’s 
perception about their clinician’s recommendation about CRC screening and one item 
will assess how much time was spent discussing CRC screening in the visit.  
• 
Single Item Literacy Screener: One item that measures comfort with reading materials 
from health care providers. It has high specificity according to other, more detailed 
health literacy screening tools, and is able to be self administered.viii,ix 
• 
Demographics and CRC risk factors: items will assess factors such as education, 
employment, marital status, family history of CRC, and alcohol use.  
• 
Barriers and facilitators to screening: a subset of patients (those who did not receive 
their preferred approach to screening) will be surveyed again by phone about one year 
later to discuss any barriers or reasons why the preferred decision was not completed. 
For patients who had screening despite indicating desire to stop we will explore reasons 
for this change.     
 
Study staff will supplement patient reported data with data collected via chart review. First, staff 
will review chart to confirm eligibility (e.g. age, dates and types of prior CRC screening tests as 
well as follow up test timing recommendation, CRC cancer history, dementia or cognitive 
impairment that would prevent participation, upcoming visit dates with participating clinician). 
Second, staff will access chart of participating patients to document CRC risk factors (e.g. family 
history, BMI, inflammatory bowel disease, diabetes, smoking status), abstract screening 
discussion in the visit note, subsequent CRC tests or procedures, complications related to CRC 
testing for participants, and findings of tests. Missing patient demographic information may also 
be supplemented via chart review.   
 
Clinician, Practice and Network level CRC screening rates: We will use established, 
validated algorithms for calculating cancer screening rates using a combination of 
administrative, billing and clinical data. Dr. Atlas (co-I) led the algorithm development efforts at 
MGH and Partners, and he will work with the MMC team to ensure CRC screening rates are 
comparable across sites. Data is aggregated at the physician, practice and network (e.g. MGH, 
MMC, PCPO) level to identify the percentage of eligible patients up to date for screening during 
the historical control period, and concurrent observation period for study and non-study 
clinicians. Limited data on patient characteristics (e.g. age, gender, education, insurance status, 
etc) will be collected along with screening rates.  
 
Clinician reported measures: clinicians will complete a baseline survey and a telephone-
based simulated patient interaction (SPI) before staff start enrolling their patients onto the trial. 
They will complete a short survey after each eligible patient visit. After patient enrollment is 
complete, all clinicians will participate in a debrief interview.  
• 
Baseline clinician survey will include the same CRC knowledge items as the patients and 
3 items to assess clinicians’ confidence in their ability to present benefits and harms, to 
discuss probabilities of benefits and harms and to elicit patients’ goals and concerns during 
an office visit, each based on a five-point scale (not at all, a little, somewhat, very, and 
extremely confident). 
• 
Post visit survey: 4 items SDMP survey will be adapted for use by clinicians, time spent 
discussing CRC screening in visit, recommendation, patient’s preferred approach, and 
satisfaction with visit.  

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• 
Baseline SDM skills assessment: The telephone-based SPI will be transcribed and coded 
by two trained coders according to the well-validated Braddock’s Informed Decision Making 
framework. The Braddock framework covers the core areas of SDM skills. x,xi A total score 0-
9 will be calculated with higher scores indicating more SDM skills. 
• 
Debrief interview and survey: After patient recruitment is complete, study staff will conduct 
a brief interview with all participating clinicians and will follow a structured interview guide to 
assess clinicians’ attitudes toward SDM, their perceptions of the study and satisfaction with 
the intervention, and ideas for improvement. The clinicians will also be asked to complete a 
short, online survey to re-assess their confidence in their ability to present benefits and 
harms, to discuss probabilities of benefits and harms and to elicit patients’ goals and 
concerns during an office visit. 
 
Caregiver measures: a short survey post visit will contain SDMP survey, their perception of 
physician recommendation, their preferred approach to screening and their perception of the 
patient’s preference for screening.  
 
Adherence to intervention(s): The online training platform will track completion of modules 
and time spent on the webinar. Staff will track completion rates and time for the SPIs, delivery of 
the registry reports, participation in monthly case discussion sessions, and documentation in 
notes of CRC screening discussions in order to examine whether outcomes are affected by 
adherence to the protocol.  
Patients will self-report time spent discussing CRC screening in the visit. Finally, staff will 
conduct a short follow-up survey with a subset of patients at 12 months to confirm screening 
choice and reasons for any discrepancy between preferred and implemented approach (e.g. 
transportation, insurance, clinician recommendation, spouse/caregiver preference, other new or 
worsening illness).  
 
All study staff are Collaborative Institutional Training Initiative (CITI) certified and will receive 
training from the PI and program manager in the study protocol. We will hold regular meetings 
to review screening, enrollment and completion data, to discuss protocol and standard operating 
procedures, and to identify and mitigate any issues that arise.    
 
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.
 
The standard of care is that physicians may discuss appropriate screening options, including 
their benefits and risks with each patient and individualize a decision based on the patients’ risk, 
overall health and preferences. In this project, we will proactively remind clinicians to have these 
conversations with eligible patients about continuing colorectal cancer screening. Whether the 
physician and patient have this conversation remains at their discretion during a clinic visit. No 
tests or treatments will be administered as part of this study.  
 
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 minimal risks to participating individuals associated with or attributable to this study. 
The main risks are associated with loss of privacy of their health information. To minimize risks, 
all electronic data files that include clinician, caregiver and patient identifiers will be kept in a 

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Version Date:  October 15, 2014 
 
  
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Partners protected server and only members of the research team will have access to the files. 
Files with PHI will only be accessed from Partners computers or encrypted laptops that are 
protected with SafeBoot. All patient information on eligibility screeners, chart reviews, and 
surveys collected at MMC will be sent securely using a secure file transfer to the Partners 
network. To ensure confidentiality, all paper surveys will be identified by study code number 
only and kept in a locked file cabinet and the scanned surveys and electronic files will be on 
password protected Partners server. Study papers (screeners, notes, surveys) that have been 
scanned or entered into a database will be disposed of in the confidential shredder. To address 
issues of psychological discomfort, research assistants will inform patients that they may refuse 
to answer any question and may withdraw from the study at any time. To address privacy and 
confidentiality issues, analytic database with outcomes data will not contain any identifying 
information and will be coded by unique study ID number only. 
 
Patients will be invited to complete survey questionnaires. The time required for patient 
participants to complete each survey is about 15 minutes. Participants may opt out of the survey 
study, may refuse to answer any question (or set of questions) and may discontinue their 
participation at any time. It will also be emphasized that whether or not subjects participate will 
not impact the medical care that they receive. The caregiver’s survey should take less than 10 
minutes to complete.  
 
The clinicians in the Registry arm will spend about 1.5 hours on study related surveys and 
activities and clinicians in the SDM arm will spend about 3.5 hours on study related activities 
over the course of 12-18 months. This includes the baseline questionnaire (10 minutes), the 
simulated patient interaction (20 minutes), and the training course for those assigned to SDM 
arm (about 2 hours). Clinicians will also complete about 10 surveys after patient visits that 
should take 1-2 minutes to complete. The exit interview will be about 20 minutes.    
 
 
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.
 
Although there are no written informed consent forms, Drs. Simmons and Sepucha are 
responsible for assuring that clinician and patient participants are adequately informed prior to 
engaging in any research procedures, that all subjects meet eligibility criteria, and that the study 
is conducted according to the IRB-approved research plan. The patient population in this study 
is older, and may have significant co-morbidities which may limit life expectancy. Staff will 
confirm status of patients, particularly before contacting patient participants for the follow-up 
survey.      
 
There are no formal stopping rules for this minimal risk study.  
 
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.
 

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There are minimal risks to individuals participating in this project. The main risks are the time 
and effort involved in participating and the potential loss of privacy. All electronic data files that 
include clinician, caregiver and patient identifiers will be kept in a Partners protected servers 
and only members of the research team will have access to the files. Files with PHI will only be 
accessed from Partners computers or encrypted laptops that are protected with SafeBoot. All 
patient information on eligibility screeners, chart reviews, and surveys collected at MMC will be 
sent securely using a secure file transfer to the Partners network. To ensure confidentiality, all 
paper surveys will be identified by study code number only and kept in a locked file cabinet and 
the scanned surveys and electronic files will be on password protected Partners server. Study 
papers (screeners, notes, surveys) that have been scanned or entered into a database will be 
disposed of in the confidential shredder. To address issues of psychological discomfort, 
research assistants will inform patients that they may refuse to answer any question and may 
withdraw from the study at any time. To address privacy and confidentiality issues, analytic 
database with outcomes data will not contain any identifying information and will be coded by 
unique study ID number only. 
 
 
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. 
 
All participating physicians will be notified of upcoming visits with eligible patients. SDM in the 
clinic visit has been shown to increase patient knowledge, reduce decisional conflict and 
improve the match between patients’ preferences and their treatment choices. Those clinicians 
randomized to the SDM Skills arm may further benefit as prior work has shown the training 
results in increased confidence and competence in conducting SDM conversations with 
patients. Clinicians in both arms may benefit from the registry report as that may prompt them to 
discuss cancer screening with their older population of patients. 
 
There are no direct benefits to patients from completing the surveys. The potential benefit to 
society is that the study will help determine the most effective approach to engaging and 
informing older patients about cancer screening.    
 
As efforts to integrate SDM into routine care expand, understanding the effectiveness of 
interventions to achieve SDM is critical. This study will provide important new information on 
comparative effectiveness of different decision support strategies promoting SDM. 
 
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.
 

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The patient recruitment is limited to older men and women 76 to 85 years of age as the clinical 
guidelines on colorectal cancer screening highlight this age group as requiring an individual 
decision and thus are appropriate to engage in shared decision making. Children, younger 
adults, and pregnant women are not eligible for this decision. We will be targeting clinicians 
across the sites who care for a diverse patient population in order to increase enrollment of 
minority patients on the trial.   
 
The clinician recruitment is focused on primary care clinicians (MD and NPs) who spend a 
significant portion of time seeing patients. Residents and other health care professional (e.g. 
RNs, social workers) are not eligible as they rarely consult patients regarding this decision.  
 
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.
 
Patient survey materials will be available in English, Spanish. We will try to include other 
languages based on the need of the population. Most patients seen at these sites speak either 
English or Spanish (>97%). Patients with other primary languages not translated for this study 
will be excluded from the survey portion of the study.  
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          https://partnershealthcare-public.sharepoint.com/ClinicalResearch/Non-
English_Speaking_Subjects.1.10.pdf
 
 
 
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 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
 
Clinicians will be recruited from primary care, internal medicine, and family medicine practices 
affiliated with MGH, BWH, MMC, NWH and NSMC. At MGH, there are about 190 adult primary 
care clinicians across 19 affiliated primary care practices, including 12 community-based 
practices and 3 hospital-based practices serving a diverse patient population in Eastern 
Massachusetts. Four of the practices are community health centers located in low-income urban 
communities around Boston and we plan to target clinicians at these centers to increase patient 
diversity. At MMC, there are 108 primary care providers at 10 affiliated primary care practices 
that will be screened for eligibility. Newton Wellesley Hospital and North Shore Medical Center 
have about 128 clinicians across 16 community practices. Current CRC screening rates for 
patients 76-85 range from 52%-65% at these sites. All participating sites use the Epic EMR with 
similar cancer screening registry functionality. 
 
Clinician recruitment: 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
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Investigators at each site will identify clinicians with a high volume of patients aged 76-85 and 
those who see patients at community health centers or centers with higher patient diversity. The 
recruitment and study procedure for clinicians is as follows: 
1. The PIs and co-investigators will inform clinicians about the study and invite their 
participation in multiple ways: through presentations at clinical leadership meetings, 
practice meetings, through HDSC newsletter, through Partners Center for Population 
Health Newsletter, and through calls, meetings and emails to individual clinicians. 
Reminder emails will be conducted for non-responders within 2 weeks of the initial 
outreach.   
2. Clinicians will indicate interest in participating in the study by contacting the PIs or study 
staff (either via email, phone or in person). 
3. Study staff will contact interested clinicians to collect information to confirm eligibility and 
to support randomization using the screener questionnaire and will send an information 
sheet to clinicians that details the requirements of the study.  
4. Clinicians will indicate their consent to participate by sending an email with their intention 
to join the study. 
5. Study staff will then run an RPDR report to identify the clinicians’ eligible patients due for 
colorectal cancer screening in the study year.  
6. Eligible Clinicians will be randomly assigned to an arm by study statistician. 
7. Clinicians assigned to the registry arm will have 4 weeks to complete: 
a. Baseline survey via RedCap or phone 
b. A telephone-based SPI conducted with standardized patients that will be 
audiotaped 
c. Short meeting with staff to review protocol and preferences for receiving the 
registry information about potentially eligible patients (e.g. 24h in advance of visit, 
weekly report, at morning huddle through medical asst) 
d. Review of their eligible patient list to indicate any patient that should not be 
approached for the study and a reason for exclusion.  
e. Study staff will send up to six reminder emails for each activity and make two 
reminder calls to encourage completion of each activity. 
8. Clinicians assigned to the SDM training arm will have 4 weeks to complete: 
a. Baseline survey via RedCap or phone 
b. The online training course  
c. A telephone-based interaction conducted with a standardized patient. Study staff 
will email feedback 1 week after completion. 
d. Short meeting with staff to review protocol and preferences for receiving the 
information about potentially eligible patients (e.g. 24h in advance of visit, weekly 
report, at morning huddle through medical asst) 
e. Review of their eligible patient list to indicate any patient that should not be 
approached for the study and a reason for exclusion.  
f. Study staff will send up to six reminder emails for each activity and make two 
reminder calls to encourage completion of each activity. 
9. Clinicians in the SDM Training arm will complete a second SPI about 8-12 weeks after 
the first and will have the opportunity to participate in monthly ‘office hours’ sessions—
conference calls open to all participants in this arm that will be facilitated by SDM 
experts, primary care physicians and/or a gastroenterologist, to discuss cases and field 
questions and challenges that come up as they put the skills into practice.  
10. After each eligible patient visit, staff will email a short questionnaire to participating 
clinicians. Staff will follow up with two reminder emails at 24 and 48 hours to complete 
the questions.  
11. After patient enrollment is complete, staff will schedule an exit interview with clinicians. 
For participants who are not able to attend in person, the interview will be conducted by 
phone.  

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Patient and caregiver recruitment:  
1. Study staff will review clinic schedules and medical records to identify eligible patients 
for participating clinicians prior to their scheduled visit. An Epic Report will be created to 
assist with this screening and eligibility review.  
2. About two weeks before the visit, the research coordinator will send a cover letter signed 
by the participating clinician and an information sheet describing the study to all eligible 
patients. The cover letter will have information for participants who wish to opt out of the 
survey. Eligible patients at Maine Medical Center will also receive a post-card they may 
send back to opt-out of the study. 
3. 1-3 days before the visit, staff will call all eligible patients who did not opt out to discuss 
the study and answer any questions. Staff will inquire about subject’s preference to 
receive survey via email or mail. 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 Partners HealthCare 
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 Partners HealthCare.  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, Partners HealthCare 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 Partners 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. The 
agreement and agreement date will be noted in the research records. Finally, staff will 
determine whether a caregiver will be involved at the visit and if so, staff will obtain 
contact information for the caregiver.  
4. After the visit, staff will send the patient a survey packet. The mailed survey packets will 
include a $5 incentive. Patients completing the survey via RedCap will receive an email 
with the direct link to the survey.  
5. Patient consent for the study will be implied by return of the completed survey.  
6. Staff will also send a survey packet to the caregiver if the patient identified one. Staff will 
make up to three reminder phone calls in an attempt to get a response and may 
complete the survey via the phone. Reminder packets will not be sent to caregivers. 
7. Staff will make up to three reminder phone calls (or emails for patients who preferred 
email). For those who don’t respond to the initial survey and reminders, study staff will 
send all patients one reminder paper survey packet. For patients who initially received 
the email link, the paper packet will include their $5 incentive to complete the survey. 
Study staff will then make up to 3 additional reminder calls to non-responders. Patients 
will be given the option to complete the survey by phone. 
8. Approximately one year after initial visit with PCP, a research coordinator will confirm 
status of each patient and will document any colorectal cancer screening tests and 
procedures completed since the visit from the medical record.  
9. Staff will identify patients who did not receive their preferred approach to colon cancer 
screening and will mail a letter notifying patients about the second survey.  The mailed 
letter notifying patients about the survey packet will contain the $5 incentive. 
10. Study staff will follow a similar protocol as with the initial survey by making up to three 
phone call attempts to reach the patient and administer the survey by phone.  
11. All participants who complete a survey will receive a thank you note.  
 
Patient and caregiver recruitment during COVID-19:  

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Given the COVID-19 pandemic, we have to make modifications to our patient recruitment 
process. Physician schedules have been in flux; with most patient appointments being 
converted to a telehealth visit and confirmed about a week before the visit. Given this new 
scheduling process, we can no longer screen patients weeks in advance of the visit, nor send 
an invitation letter to the patient about the study. Instead, we will screen visits about a week 
before the visit and send the patients the invitation cover letter, information sheet and survey 
after their visit occurs. The process is outlined below: 
1. About a week before scheduled visits, study staff will review clinic schedules and 
medical records to identify eligible patients for participating clinicians. An Epic Report will 
be created to assist with this screening and eligibility review.  
2. After confirming the visit occurred, staff will send the patient a survey packet including an 
invitation cover letter signed by the participating clinician, an information sheet 
describing the study, the survey, and a $5 incentive. The cover letter will have 
information for participants who wish to opt out of the survey. The cover letter will also 
have the REDCap online link for patients who wish to complete the survey online. 
3. Patient consent for the study will be implied by return of the completed survey.  
4. For patients who didn’t opt out, staff will make up to three reminder phone calls for the 
initial survey packet. 
5. For those who don’t respond to the initial survey and reminders, study staff will send all 
patients one reminder paper survey packet. Study staff will then make up to 3 additional 
reminder calls to non-responders. Patients will be given the option to complete the 
survey by phone. 
6. Staff will also send a survey packet to the caregiver if the patient identifies one. 
Reminder phone calls will not be conducted and reminder packets will not be sent to 
caregivers. 
7. Approximately one year after initial visit with PCP, a research coordinator will confirm 
status of each patient and will document any colorectal cancer screening tests and 
procedures completed since the visit from the medical record.  
8. Staff will send a letter about the second survey to all patients who are still alive and who 
did not receive their preferred approach to screening.  The mailed packet will contain the 
$5 incentive. 
9. Study staff will make up to three phone calls to administer the survey by phone for all 
non responders. All participants who complete a survey will receive a thank you note.  
 
 
All study staff are CITI certified and will receive training from the PI and program manager in the 
study protocol. We will hold regular meetings to review screening, enrollment and completion 
data.    
 
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
 
• 
At MGH, BWH, NWH, NSMC and MMC: 
o All clinician participants will receive a total of $100. 
o Clinicians in the SDM skills arm will receive 2-3 hours of risk management CME 
credit, as well as MOC Part II credit.  
o Clinicians’ name will be entered into a quarterly lottery for a $50 amazon gift card 
each time they complete a survey on one of their patient participants.  

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o Clinicians’ name will be entered into a lottery for a $50 amazon gift card upon 
completion of the exit survey. 
o Clinicians’ name will be entered into a lottery for a $50 amazon gift card upon 
completion of the exit interview. 
• 
Patients and caregivers will receive a $5 incentive with each survey.     
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Recruitment_Of_Research_Subjects.pdf
 
          Guidelines for Advertisements for Recruiting Subjects
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Guidelines_For_Advertisements.1.11.pdf
 
          Remuneration for Research Subjects
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Remuneration_for_Research_Subjects.pdf
 
 
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 for either patients, clinicians, or 
the non-intervention group. The research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written consent is normally required. Clinician 
consent will be implied by email indicating interest and patient and caregiver consent for the 
study will be implied by completion of the first questionnaire. 
 
Clinicians will be provided a written information sheet that describes the requirements of the 
study and will be instructed to send an email to the PIs or study staff indicating their interest in 
participating. By agreeing to be on the study, clinicians will give consent to study staff to identify 
and contact their eligible patients.  
 
Eligible patient participants will be given an information sheet that describes the risks and 
benefits of the study and a cover letter inviting them to participate in the survey. The invitation 
will include information about how to opt out of the survey portion of study. Eligible patient 
participants at Maine Medical Center will also receive a post-card that may send back to opt-out 
of the study. Eligible patients sent a survey packet during the COVID-19 pandemic will also see 
information about how to opt out of the survey portion of the study in the invitation cover letter. 
Patient subjects will be given 7 days to review the material and opt out by calling or emailing the 
study staff. Participants who do not opt out will be contacted by phone by research staff and can 
indicate their decision to accept or decline participation when contacted. Consent will be implied 
by the return of the completed survey. 
 
The principal investigators’ names and contact information will be available on the information 
sheet if participants have any questions or concerns about the study. The study staff will be 

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available by phone or email to discuss the study and answer any questions. Each site has at 
least one primary care physician co-investigator who will be available by pager and study 
staff/PI will be available by phone to answer any questions.  
 
Patients and caregivers will give verbal consent if they wish to receive surveys via unencrypted 
emails. The IRB information regarding send-secure vs. unencrypted emails will be included on 
the invitation and research staff will discuss this with the patients when they join the study. 
Patients and caregivers may also be read the IRB policy and ask for verbal consent to receive 
unencrypted emails over the phone. Participants can choose to receive the surveys via a send-
secure email or on paper in the mail if they do not wish to receive unencrypted emails. 
Participants during the COVID-19 pandemic will all receive a paper survey and may choose to 
complete the survey online via the REDCap link provided in the cover letter.  
 
Study materials will emphasize that whether or not patients participate will have no effect on the 
health care they receive. 
 
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: 
      https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb 
 
For guidance, refer to the following Partners policy: 
     Informed Consent of Research Subjects:
     https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Informed_Consent_of_Research_Subjects.pdf
 
 
 
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. 
 
The data sources will be clinician surveys, transcripts of simulated patient interactions, patient 
surveys, caregiver surveys and, electronic health record information.   
 
There are no foreseeable safety risks to participants for participating in a simulated patient 
interaction or completing a survey. 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 experience with 
similar questionnaires in other topics (including breast cancer decision making and decision 

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making for joint replacement surgery) have found that it is rare for participants to be upset. 
Nevertheless, study staff will screen for adverse events and address them as described in the 
next section.  
 
Study data will be accessible at all times for the Co-PIs to review. The project manager and co-
PIs will examine study conduct including enrollment, accrual, drop-outs, and protocol deviations 
on a weekly or every other week basis with the staff at each site. Study staff will review study 
related data including comments from the SPIs, reminder phone calls to participants, participant 
surveys and will notify the PI about any serious or moderate potential adverse events (AEs) 
immediately and any minor or potential ones at regular meetings. The Co-PIs will review AEs 
individually real-time and in aggregate on a regular basis at team meetings. No SAEs are 
expected based on the minimal risk trial. However, the Co-PIs and co-investigators will review 
potentially serious adverse events (SAEs), as soon as they are discovered. The Co-PIs will 
ensure all protocol deviations, AEs, and SAEs are reported to the IRB within required time 
frame based on severity, and will file an HRC AE Form within 10 working days as needed. 
 
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
 
No serious adverse events are expected. The name and contact information for the principal 
investigator will be included on study information sheet as well as contact for study staff and 
MGH IRB in case participants have a problem. We will have a clinical co-investigator for each 
topic who will be able to consult on any clinical issues that arise during the course of the 
interviews or 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. 
 
Study staff will be instructed to review surveys within 48 hours of receipt and to notify the PI 
about any potentially serious events immediately and all other events at regularly scheduled 
meetings. Study staff will keep records of any feedback, questions, concerns and/or complaints 
that are received and we will address them with the co-investigators and staff as needed.  
 
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.   

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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 and the principal investigator at each site will have routine meetings during the 
study period to ensure the project proceeds as intended per the protocol. All participant 
screening and enrollment will be tracked on password protected servers using an Access or 
RedCap database. The information is stored behind a firewall and only study staff will have 
access to it as needed. 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 project manager and one of the principal 
investigators.  
 
Limited data will be kept on clinician non-responders for those who received an individual 
invitation (site, age, gender, patient volume and years in practice) as well as patient non-
responders including age, gender, physician, and all elements in the eligibility screener. This 
information will be used to examine non-response bias.   
 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
            https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/DSMP_in_Human_Subjects_Research.pdf  
          
          Reporting Unanticipated Problems (including Adverse Events)
          https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Reporting_Unanticipated_Problems_including_Adverse_Events.pdf
 
 
 
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 
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.
 
Special efforts will be made to protect the privacy of subjects. We will review the subject’s 
medial record to confirm eligibility to participate in the study.  We will have names and 
addresses of eligible participants and this information will be kept separate from the study data 
(e.g. surveys and/or interview notes). All participants--patients, clinicians and caregivers--will 
receive a code number and the surveys and other data will only be identified by code number. A 

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separate password-protected electronic file 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.   
 
All 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.
 
To promote research replicability, transparency and future use of the data, de-identified data 
sets will be created and will be available, by request, to outside researchers. 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/). 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 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.
 
No identifiable data on Partners patients will be stored outside MGH. MMC patient data that is 
collected outside Partners will be received by the MGH research team (see details below).  
 
MMC will have access to the clinician participant data across all sites, as needed, to schedule 
and conduct the simulated patient interactions. Any emails that contain identifiable clinician data 
will be sent using SendSecure, and any large files will be sent using secure file transfer. MMC 
will only have access to de-identified data sets for the Partners patients and caregivers. 
 

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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.
 
Eligibility screeners, patient, caregiver and clinician surveys, and medical record information will 
be collected from participants at MMC, by MMC-affiliated study staff. This patient health 
information is necessary for assessing patient eligibility for participation and for administering 
the study protocol.  As such, this patient information will be sent from MMC to MGH study staff 
via a secure file transfer or REDCap. The paper surveys collected at MMC will be scanned and 
sent to the MGH research team using a secure file transfer, and the paper copies will be 
transported for ultimate storage or confidential disposal at MGH.  
 
All electronic files that contain patient identifiers will be kept Partners protected servers and will 
only be accessed with Partners computers or encrypted laptops.  
 
Eligibility and medical chart review data will be collected via REDCap (Research Electronic Data 
Capture). REDCap is a free, secure, HIPAA compliant web-based application hosted by the 
Partners HealthCare Research Computing, Enterprise Research Infrastructure & Services 
(ERIS) group. The system offers easy data manipulation with audit trails, reports for monitoring 
and querying participant records, and an automated export mechanism to common statistical 
packages (SPSS, SAS, Stata, R/S-Plus).  
 
 
 
 
 
i US Preventive Services Task Force. Screening for colorectal cancer US Preventive Services Task Force 
Recommendation Statement. The Journal of the American Medical Association 2016;315(23):2564-2575. 
ii Hoffman T, Lewis CL, Pignone MP, et al. Decision-making processes for breast, colorectal, and prostate 
cancer screening: the DECISIONS survey. Medical Decision Making. 2010;30(5 Suppl):53S-64S. 
iii Sepucha K, Stringfellow V, Fowler FJ. Shared Decision Making (SDM) Process Survey: Validity and 
Reliability of a Short, Patient-Reported Measure of SDM. 2017 Society for Medical Decision Making 
Annual Meeting abstract. 
iv Sepucha K, Feibelmann S, Cosenza C, Levin CA, Pignone M. Development and evaluation of a new 
survey instrument to measure the quality of colorectal cancer screening decisions. BMC medical 
informatics and decision making. 2014;14(1):72. 
v Hoffman RM, Elmore JG, Pignone MP, Gerstein BS, Levin CA, Fairfield KM. Knowledge and values for 
cancer screening decisions: Results from a national survey. Patient Educ Couns. 2016 Apr;99(4):624-30. 
vi Health Information National Trends Survey. https://hints.cancer.gov/ Accessed December 5, 2016. 
vii DeSalvo KB, Bloser N, Reynolds K, He J, Muntner P. Mortality Prediction with a Single General Self-
Rated Health Question: A Meta-Analysis. Journal of General Internal Medicine. 2006;21(3):267-275. 
doi:10.1111/j.1525-1497.2005.00291.x. 
viii Morris NS, MacLean, CD, Chew LD, Littenberg B. The Single Item Literacy Screener: evaluation of a 
brief instrument to identify limited reading ability. BMC Family Practice. 2006;7(1):1. 
ix Brice JH, Foster MB, Principe S, Moss C, Shofer FS, Falk RJ, DeWalt DA. Single-item or two-item 
literacy screener to predict the S-TOFHLA among adult hemodialysis patients. Patient education and 
counseling. 2014;94(1):71-75. 

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x Leader A, Daskalakis C, Braddock C, Kunkel EJ, et al. Measuring Informed Decision Making about 
Prostate Cancer Screening in Primary Care. Med Dec Making. 2011; 32(2):327-36. 
xi Price EL, Bereknyei S, Kuby A, Levinson W, Braddock CH. New elements for informed decision making: 
a qualitative study of older adults’ views. Patient education and counseling. 2012;86(3):335-341.