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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • BPB, No PIN — BEHAVIORAL
    Patient-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 — BEHAVIORAL
    Patient-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 — BEHAVIORAL
    Patient-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 — BEHAVIORAL
    Patient-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, PIN
    BPB: patient tracking and lists, audit and feedback, standardized documentation, standardization of care team communication. PIN: enhanced patient instructions and navigation (PIN).
  • Experimental: No BPB, PIN
    No BPB: Clinic's usual practice after a patient receives an abnormal FIT result. PIN: enhanced patient instructions and navigation (PIN).
  • Experimental: No BPB, No PIN
    No 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)

FacilityCityStateZIPSite coordinators
Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94110-

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