NCT03959696

Promoting Informed Decisions About Cancer Screening in Older Adults

Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 536 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer Screening

Interventions

Type	Name	Description
BEHAVIORAL	Notification	Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening.
BEHAVIORAL	Training	The 2-hour continuing medical education course in shared decision making, simulated patient interaction to practice skills, and monthly calls for a year to review difficult cases with clinical and shared decision making experts.

Timeline

• Start date: 2019-05-01
• Primary completion: 2022-04-30
• Completion: 2022-08-30
• First posted: 2019-05-22
• Last updated: 2025-01-06
• Results posted: 2025-01-06

Locations

5 sites across 1 country: United States