Actively Recruiting
Multilevel Intervention to Improve Follow-up Colonoscopy Rates After Abnormal FIT Results in Large Federally Qualified Health Center System
Led by Jonsson Comprehensive Cancer Center · Updated on 2026-02-09
1500
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a clinic-wide intervention called Primary Care-Gastrointestinal (GI) Connect aimed at increasing follow-up colonoscopy rates after abnormal fecal immunochemical test (FIT) results in patients at Federally Qualified Health Centers (FQHCs). Colorectal cancer screening using FIT is common in low-resource settings, but follow-up colonoscopy rates after abnormal results are low due to multiple barriers. This study compares the usual care with an enhanced care coordination approach to improve these follow-up rates in a large FQHC system. The study is a pragmatic, cluster randomized trial involving six clinics, divided into two groups: one receiving usual care with monthly electronic health record (EHR) reviews and standardized communication about abnormal FIT results, and the other receiving the Primary Care-GI Connect intervention. This enhanced intervention adds GI liaison coordination, patient navigation for scheduling GI appointments, standardized referral templates, colonoscopy education via informational sheets and a 20-minute video, and reminder text messages emphasizing the importance of follow-up colonoscopy. Participants will be monitored through regular EHR reviews and monthly assessments of intervention implementation quality over up to three years. Researchers will evaluate follow-up colonoscopy rates within 6, 9, and 12 months of abnormal FIT results, along with factors affecting implementation, time to colonoscopy, and cost-effectiveness. Participants may also be involved in ancillary studies including interviews and additional data collection. The study aims to understand the feasibility, value, and impact of this multilevel intervention on colorectal cancer screening adherence.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient receives care at one of six adult Northeast Valley Health Corporation clinic sites
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants' electronic health records are reviewed monthly to identify abnormal FIT results and track follow-up care.
Monthly visits for monitoring and quality assessments
Duration - Up to 6 months following abnormal FIT result
Participants with abnormal FIT results receive communication about their results, referral to gastroenterology, navigation support from GI liaisons, colonoscopy education including an informational sheet and a 20-minute educational video, and text message reminders emphasizing the importance of colonoscopy.
1 to 2 visits depending on referral and colonoscopy scheduling
Duration - Within 6 months after abnormal FIT result
Participants undergo colonoscopy as part of follow-up after an abnormal FIT result, coordinated through the clinic system.
1 colonoscopy visit
Trial Site Locations
Total: 2 locations
1
University of California at Los Angeles
Los Angeles, California, United States, 90095-1406
Actively Recruiting
2
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
Research Team
J
Jessica Tuan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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