IMProving Adherence to Colonoscopy Through Teams and Technology
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT06191185
- Status
- Enrolling By Invitation
Conditions
- Cancer Colorectal
- Colon Cancer
- Colorectal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- BPB, No PIN — BEHAVIORALPatient-level: standard communication from care team. Clinic-level: A program of "best practices" will be implemented to improve team communication, optimize practice workflow, and identify and track patients with abnormal FIT results through colonoscopy completion.
- BPB, PIN — BEHAVIORALPatient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the short messaging service (SMS) text messaging platform, HealthySMS. Clinic-level: A program of "best practices" will be implemented to improve team communication, optimize practice workflow, and identify and track patients with abnormal FIT results through colonoscopy completion.
- No BPB, PIN — BEHAVIORALPatient-level: The patient-facing evidence-based instructions, communication, and navigation part of the intervention will leverage the SMS text messaging platform, HealthySMS.
- No BPB, No PIN — BEHAVIORALPatient-level: standard communication from their care team.
Study Details
Complete and timely colonoscopy after an abnormal stool-based colorectal cancer screening test results in early detection, cancer prevention, and reduction in mortality, but follow-up in safety-net health systems occurs in less than 50% at 6 months. The proposal will implement multi-level approach consisting of a stepped-wedge clinic-level intervention of team-based best practices co-developed with primary and specialty care, a patient-level technology intervention to provide enhanced instructions and navigation to complete diagnostic colonoscopy, and a mixed methods evaluation to explore multi-level factors contributing to intervention outcomes. Developing a solution to this high-risk and diverse population has the potential to translate to other health systems, support patient self-management, and address other patient conditions.
Key Dates
- Start date
- Jul 8, 2024
- Status verified
- Mar 2026
- Primary completion
- Mar 31, 2027
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 2,000 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Best Practices Bundle (BPB), No Patient Instructions and Navigation (PIN)BPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication. No PIN: Patients will receive usual communication from their care team.
- Experimental: BPB, PINBPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication. PIN: enhanced patient instructions and navigation (PIN).
- Experimental: No BPB, PINNo BPB: Clinic's usual practice after a patient receives an abnormal FIT result. PIN: enhanced patient instructions and navigation (PIN).
- Experimental: No BPB, No PINNo BPB: Clinic's usual practice after a patient receives an abnormal FIT result. No PIN: Patients will receive usual communication from their care team.
Primary Outcome Measure
Colonoscopy completion [ Time Frame: 6 months after abnormal FIT result ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Zuckerberg San Francisco General Hospital | San Francisco | California | 94110 | - |
Find similar trials in San Francisco, CA
Related Studies
- ColoCare Study - Colorectal Cancer CohortRecruiting · University of Utah · Los Angeles, California
- APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid TumorsPHASE2 · Recruiting · Apollomics Inc. · Los Angeles, California
- A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid TumorsPHASE1/PHASE2 · Recruiting · Merus B.V. · La Jolla, California
- Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC FusionsPHASE1/PHASE2 · Recruiting · IDEAYA Biosciences · Los Angeles, California