A Clinic-wide Intervention (Primary Care-GI Connect) for Improving Rates of Colonoscopy After Abnormal Fecal Immunochemical Test Result in Patients at Federally Qualified Health Centers

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT06568016
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Best Practice — OTHER
    Receive clinical care consistent with current practice
  • Communication Intervention — OTHER
    Receive standardized communication from FIT QI champion
  • Communication Intervention — OTHER
    Receive coordination from GI liaisons
  • Coordination — OTHER
    Receive enhanced GI care coordination
  • Educational Intervention — OTHER
    Watch pre-colonoscopy educational video
  • Electronic Health Record Review — OTHER
    Undergo FIT result review by Primary Care FIT Tracker
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Informational Intervention — OTHER
    Undergo generation and review of GI FIT Tracker report
  • Informational Intervention — OTHER
    Receive informational sheet
  • Interview — OTHER
    Ancillary studies
  • Patient Navigation — BEHAVIORAL
    Receive navigation from GI liaisons
  • Referral — OTHER
    Receive referral
  • Referral — OTHER
    Receive referral per standardized template
  • Text Message-Based Navigation Intervention — OTHER
    Receive follow-up text message

Study Details

This clinical trial evaluates a clinic-wide intervention called Primary Care-Gastrointestinal (GI) Connect for improving follow-up colonoscopy rates in patients at a Federally Qualified Health Center (FQHC) who have an abnormal fecal immunochemical test (FIT) result. Colorectal cancer screening reduces colorectal cancer incidence and mortality but is underutilized.The most accessible, feasible, and common colorectal cancer screening modality for average-risk individuals in low resource settings such as FQHCs is the stool-based FIT. However, the benefit of FIT screening on colorectal cancer risk is realized only if individuals with abnormal FIT results undergo timely follow-up colonoscopy. Follow-up colonoscopy rates are low and there are many barriers to follow-up colonoscopy in safety net settings such as FQHCs. Effective interventions that are multi-component and improve care coordination are needed to improve abnormal FIT follow-up rates in FQHCs. The Primary Care-GI Connect intervention includes components that enhance care coordination, standardize the referral process, and engage both primary care and specialist physicians. This clinic-wide intervention may improve rates of follow-up colonoscopy after abnormal FIT results in patients seen at FQHCs.

Key Dates

Start date
Apr 22, 2025
Status verified
Feb 2026
Primary completion
Feb 28, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Arm I (usual care)
    Patients receive clinical care consistent with current practice at NEVHC. Patients have their EHRs reviewed monthly by the Primary Care FIT Tracker for abnormal FIT results and patients with abnormal FIT results receive standardized communication from FIT QI champions about their results and receive a referral to gastroenterology.
  • Experimental: Arm II (Usual care + Primary Care - GI Connect)
    Patients receive clinical care consistent with current practice at NEVHC as described in Arm I. Patients also receive enhanced GI care coordination from GI liaisons, who generate GI FIT Tracker reports and use the GI FIT Tracker reports to follow patients with abnormal FIT results. Patients receive navigation services including contact from GI liaisons about making a GI appointment and enhanced communication between GI specialists and the NEVHC. Patients receive referral to gastroenterology following a standardized referral template and receive colonoscopy education including an informational sheet at the time of referral and a 20-minute pre-colonoscopy educational video. Patients receive a text message at the time of colonoscopy referral emphasizing the importance of colonoscopy after abnormal FIT result.

Primary Outcome Measure

Follow-up colonoscopy rates [ Time Frame: At 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Folasade P. May
[email protected]
310-825-4728
Folasade P. May (PRINCIPAL_INVESTIGATOR)
University of California at Los AngelesLos AngelesCalifornia90095-1406
Jessica J Tuan
[email protected]
310-825-3181
Folasade P May, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CAUniversity of California at Los Angeles· Los Angeles, CA

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