Promoting Shared Decision-Making About Colorectal Cancer Testing for Older Adults (PRIMED) Study, Maine and Massachusetts, 2019-2022 (ICPSR 39523)

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Data Collection Notes View help for Data Collection Notes

Study Purpose View help for Study Purpose

The goal of the study was to advance our understanding of how to ensure that older adults (aged 76-85) are well-informed and involved in decisions about whether or not to continue colorectal cancer screening. There were three aims for this study (1) to determine the impact of the approaches on patients' involvement in decision making and knowledge about the risks and benefits of continued colorectal cancer screening, (2) to examine the effects of the interventions on patients' preferences for screening, the extent to which patients receive their preferred approach to screening, and on colorectal cancer screening rates, and (3) to examine the impact of the interventions on clinicians' confidence in and skills for conducting shared decision making (SDM) conversations in this setting.

Study Design View help for Study Design

The main study is a cluster randomized trial that enrolled 59 clinicians across sites from primary care practices affiliated with Massachusetts General Hospital (MGH), Brigham and Women's Hospital (BWH), Maine Medical Center (MMC), Newton Wellesley Hospital (NWH,) and North Shore Medical Center (NSMC). The eligibility criteria for clinician are Primary Care Physician (MD or NP) who have 20 potentially eligible patients in their panel who uses Epic electronic health record. PCP residents and medical students were ineligible to take part in this study. The eligibility criteria for patient participants are adults, age 76 to 85 who are due for colorectal cancer screening with an upcoming visit with a participating clinician during the study period. Patient participants who were unable to read or write English or Spanish, unable to consent for themselves, or has a prior diagnosis of colon or rectal cancer, inflammatory bowel disease or genetic disorder that raises colorectal cancer (CRC) risk are ineligible to take part in this study.

The participating clinicians at each site were placed into two groups stratified by gender, years in practice, and number of clinic sessions per week. Each group were randomly assigned to one of two arms: Registry arm or Registry plus SDM Skills training arm (SDM arm). Clinicians in Registry arm completed a baseline telephone-based simulated patient interaction to evaluate their SDM skills. Once patient enrollment started, researchers sent 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 completed an online SDM skills course, two telephone-based simulated patient interactions, and monthly facilitated case-based discussions. Once patient enrollment started, researchers sent periodic notification of their patients aged 76-85 who are due for colorectal cancer screening with an upcoming visit. Researchers used 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 also worked within the EMR at each site to develop an automated report of these items as available.

The target was to enroll approximately 10 patients per clinician for a total of 500 patients. The clinicians completed a short survey after each eligible patient visit. The patients were invited to participate in the survey study and asked to complete a survey after their visit and another short survey one year later. Patients were 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. The researchers followed up to enroll caregivers that patient participants identify and administer a short survey. The research coordinator tracked the number of study participation invitations sent to each clinician as well as the number of clinicians indicating interest. Researchers tracked 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. Researchers tracked completion of each activity (baseline survey, simulated patient interaction, training course, etc.) for each clinician participant.

Sample View help for Sample

The study was a two-arm, multi-site cluster randomized trial that enrolled adult patients, aged 76-85, at the time of a scheduled, non-urgent visit with a participating physician during the study period who were due or overdue for a colorectal cancer screening test.

Time Method View help for Time Method

Universe View help for Universe

Primary care physicians with 20 or more patients aged 76-85 due for a colorectal cancer screening or surveillance in their panel during study period.

Unit(s) of Observation View help for Unit(s) of Observation

Data Type(s) View help for Data Type(s)

Mode of Data Collection View help for Mode of Data Collection

Response Rates View help for Response Rates

DS1: Patient Post-Visit Dataset: Researchers received 469/753 (62.3%) patient post-visit surveys and found three to be ineligible, resulting in an analytic sample of 466.

DS2: Provider Dataset: Physicians enrolled (67/149, 45% consent rate) from 35 clinics within the 5 hospital networks. 59 of the 67 completed baseline study activities and enrolled patients onto the study.

DS3: Provider Post-Visit Dataset: Researchers identified patients (631/799, 79% consent rate) eligible for a colorectal cancer (CRC) screening discussion with a participating physician. After a completed visit, patients were sent the survey to complete.

Presence of Common Scales View help for Presence of Common Scales

• Patient reported measures: Patients completed a survey shortly after the visit.

• Shared Decision Making Process (SDMP): Four items assessed the amount of shared decision making that occurred during a visit. These items are summed to generate a total score (0-4), with higher scores indicating greater patient involvement in decision making.

• Knowledge: Five multiple choice knowledge items assessed patients' understanding of colorectal cancer screening adapted from the Colorectal Cancer Screening Decision Quality Instrument. A total knowledge score (0-5) was calculated from the number of correct answers.

• Risk perceptions: One item assessed affective risk perception, or cancer worry. This item was adapted from the National Cancer Institute's Health Information National Trends Survey (HINTS).

• Patient's screening preference: One item assessed patients' preferred approach to screening (with responses of colonoscopy, stool card test, no screening, not sure).

• Overall health: SF-1 was used to assess patient's perception of overall health (poor to excellent)

• Screening Recommendation and Time Spent: One item assessed the patient's perception about their clinician's recommendation about CRC screening and one item assessed 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.

• Demographics: Items assessed factors such as race, ethnicity, employment, marital status and education.

• Patient's screening intention: One item assessed how likely the patient was to follow through with their preferred approach on a 5-point scale from Definitely will to Definitely will not.

• Satisfaction: One item asked "Overall, how satisfied were you with the visit" on a 4-point scale from Extremely satisfied to Not at all satisfied.

• Family history of colorectal cancer, personal history or prior polyp removal

• Clinician reported measures: Clinicians completed a background and baseline survey before enrolling their patients onto the trial. They completed a short survey after each eligible patient visit.

• Background physician survey assessed physicians' demographics as well as their confidence and competence in having CRC conversations with patients.

• Baseline physician survey included the same CRC knowledge items as the patients and 3 items to assess physicians' 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 was adapted for use by physicians, time spent discussing CRC screening in visit, recommendation, patient's preferred approach, and satisfaction with visit.

Original Release Date View help for Original Release Date

2026-04-30

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