Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 536
- Locations
- 5
- Primary Endpoint
- Shared Decision Making Process (SDMP) Scale Score
Study Overview
Brief Summary
This project aims to examine the impact of different interventions designed to help individualize colorectal cancer (CRC) screening decisions in adults aged 76-85. Clinicians will be assigned by chance to one of two arms. In the Intervention arm, clinician participants will complete a training course and will also be notified of patients in the target age group who are due for a discussion about CRC screening. In the Comparator arm, clinician participants will be notified of their patients in the target age group with an upcoming visit who are due for a discussion about CRC screening. The investigators expect that patients seen by clinicians in the intervention arm will report more involvement in the decision making process, be more knowledgeable about the risks and benefits of CRC screening, and will have better quality decisions. Further, the investigators expect that the physicians in the intervention arm will have greater confidence in and demonstrate more skills for conducting shared decision making conversations as compared to those in the control arm.
Detailed Description
This study will advance understanding of how to engage and inform older adults in decisions about whether to continue or stop colorectal cancer (CRC) screening. The study will randomly assign about 50 primary care clinicians from 5 different sites to one of two different arms. In the Intervention arm, clinician participants will complete a training course and will also be notified of patients aged 76-85 with an upcoming visit who are due for a discussion about CRC screening. In the Comparator arm, clinician participants will be notified of their patients in the target age group with an upcoming visit who are due for a discussion about CRC screening. The study staff will collect surveys from about 500 eligible patients of participating physicians shortly after their visit to determine the impact of the intervention on patient-reported measures including the amount of shared decision making, knowledge, and preferences for cancer screening. Study staff will follow patients to track colorectal cancer screening tests in the 12 months following the visit and will survey some patients again at 12 months to examine any barriers to follow through with their preferred approach. The study will also assess physician's ability to demonstrate shared decision making skills for cancer screening decisions in simulated patient interactions. Caregivers, if identified by a patient participant, will also complete a short survey evaluating the visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
Masking Description
Physician participants will not be blinded to the study arm. Patients will not be given any information on their physician's assigned arm. Statistician will be blinded to the assignment when analyzing the results.
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •For Clinicians, eligibility will not be decided by sex, gender, or age
- •Inclusion Criteria for clinicians:
- •Primary Care Physician (MD or NP)
- •Manages a panel of patients
- •Has ≥20 potentially eligible patients (age 76-85 and due for colorectal cancer screening) in their panel
- •Practices at participating site
Exclusion Criteria
- •for clinicians:
- •Residents, medical students
- •Does not manage panel of patients (e.g. urgent care clinician)
- •Patients of participating clinicians will be enrolled to evaluate the impact of the interventions.
- •Inclusion Criteria for patients:
- •Adults, age 76-85 at the time of the 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 or less to follow-up interval indicated on previous test).
- •Exclusion Criteria for patients:
- •Prior diagnosis of colon or rectal cancer, inflammatory bowel disease or genetic disorder that raises CRC risk (e.g. hereditary non-polyposis CRC and familial adenomatous polyposis)
- •Unable to consent for themselves (e.g. moderate to severe dementia or other major cognitive limitations)
- •Unable to read or write in English or Spanish
Arms & Interventions
Notification only arm
Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening.
Intervention: Notification (Behavioral)
Training and Notification arm
Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening and will complete a two-hour shared decision making communication skills training course that includes case studies, interactive exercises, and lecture content.
Intervention: Notification (Behavioral)
Training and Notification arm
Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening and will complete a two-hour shared decision making communication skills training course that includes case studies, interactive exercises, and lecture content.
Intervention: Training (Behavioral)
Outcomes
Primary Outcomes
Shared Decision Making Process (SDMP) Scale Score
Time Frame: About 1 week after the physician visit
The SDMP scale is a short, patient-reported scale that asks patients about discussion of options, pros and cons of colonoscopy and discussion of patients' preferences. Total scores range from 0-4, with higher scores indicating more shared decision making.
Secondary Outcomes
- Percentage of Patients Who Received Preferred Approach to Colorectal Cancer Testing(1 week after physician visit (preference); 12 months after physician visit (testing))
- Physician's Shared Decision Making Skills(Baseline)
- Colorectal Cancer Screening Rates(1 year)
- Patients' Colorectal Cancer Screening Knowledge Score(1 week after physician visit)
- Clinician Satisfaction With the Visit(1 week post visit)
Investigators
Karen Sepucha
Associate Professor
Massachusetts General Hospital