Clinical trial · Interventional
Promoting Informed Decisions About Cancer Screening in Older Adults
Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Screening | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Notification | Behavioral | — | UNRESOLVED |
| Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Notification only arm
- description
- Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening.
- interventionNames
- Behavioral: Notification
- type
- EXPERIMENTAL
- label
- Training and Notification arm
- description
- 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.
- interventionNames
- Behavioral: Notification
- Behavioral: Training
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDSepucha KR, Chang Y, Valentine KD, Atlas SJ, Han PKJ, Leavitt LJ, Mancini B, Richter JM, Siegel LC, Fairfield KM, Simmons LH. Shared Decision-Making in Colorectal Cancer Screening for Older Adults: A Secondary Analysis of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2429645. doi: 10.1001/jamanetworkopen.2024.29645. PMID 39178001
- DERIVEDSepucha 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. PMID 35931908