Clinical trial NCT03959696: Promoting Informed Decisions About Cancer Screening in Older Adults
Official title: Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: Shared Decision Making
Patient Reported Outcomes
Continuing Medical Education
early detection of cancer
colonoscopy
colorectal cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: MaineHealth
name: Brigham and Women's Hospital
name: Newton-Wellesley Hospital
name: North Shore Medical Center
name: Patient-Centered Outcomes Research Institute
First posted: 2019-05-22
Enrollment: 536
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm, multi-site cluster randomized controlled trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Shared Decision Making Process (SDMP) Scale Score
timeFrame: About 1 week after the physician visit
Secondary outcomes:
measure: Patients' Colorectal Cancer Screening Knowledge Score
timeFrame: 1 week after physician visit
measure: Percentage of Patients Who Received Preferred Approach to Colorectal Cancer Testing
timeFrame: 1 week after physician visit (preference); 12 months after physician visit (testing)
measure: Physician's Shared Decision Making Skills
timeFrame: Baseline
measure: Colorectal Cancer Screening Rates
timeFrame: 1 year
measure: Clinician Satisfaction With the Visit
timeFrame: 1 week post visit
Other outcomes:
measure: Companion SDM Process Scale Score
timeFrame: About a week after physician visit
measure: Clinician Attitude Toward Shared Decision Making
timeFrame: Baseline
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Danvers
country: United States
facility: North Shore Medical Center
state: Massachusetts
city: Newton
country: United States
facility: Newton-Wellesley Hospital
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Karen R Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Leigh Simmons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sepucha K, Han PKJ, Chang Y, Atlas SJ, Korsen N, Leavitt L, Lee V, Percac-Lima S, Mancini B, Richter J, Scharnetzki E, Siegel LC, Valentine KD, Fairfield KM, Simmons LH. Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): a Physician Cluster Randomized Trial. J Gen Intern Med. 2023 Feb;38(2):406-413. doi: 10.1007/s11606-022-07738-4. Epub 2022 Aug 5.