Primary Care–GI Connect to improve colonoscopy follow-up after an abnormal FIT
Multilevel Intervention to Improve Follow-up Colonoscopy Rates After Abnormal FIT Results in Large FQHC
NA · Jonsson Comprehensive Cancer Center · NCT06568016
This trial tests whether a clinic-wide Primary Care–GI Connect program helps patients at community health centers get colonoscopies within six months after an abnormal fecal immunochemical test (FIT).
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Sex | All |
| Sponsor | Jonsson Comprehensive Cancer Center (other) |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT06568016 on ClinicalTrials.gov |
What this trial studies
This is a pragmatic, cluster-randomized trial in six Federally Qualified Health Center (FQHC) clinics (about 1,500 patients) comparing usual care to a multilevel care-coordination program called Primary Care–GI Connect. Clinics are randomized 3 versus 3; usual care includes monthly EHR FIT tracking and standardized result communication, while the intervention adds GI liaisons who provide enhanced coordination and navigation. The trial measures colonoscopy receipt within six months of an abnormal FIT and also systematically examines implementation quality using a multilevel framework. Investigators will measure incremental cost-effectiveness to inform feasibility and potential for broader dissemination.
Who should consider this trial
Good fit: Adults receiving care at the participating NEVHC FQHC clinics who have an abnormal FIT result are the intended participants for this program.
Not a fit: Patients who are not screened with FIT, who already completed a timely follow-up colonoscopy, or who decline coordination services are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could increase timely colonoscopy completion after abnormal FITs and reduce missed or late-detected colorectal cancers in underserved populations.
How similar studies have performed: Prior multicomponent care-coordination and navigation interventions in safety-net settings have shown improved follow-up colonoscopy rates in some studies, though effects vary by context and intensity.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 6 adult care NEVHC clinic sites
Where this trial is running
Los Angeles, California and 1 other locations
- University of California at Los Angeles — Los Angeles, California, United States (RECRUITING)
- UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Folasade P May, MD, PhD — UCLA / Jonsson Comprehensive Cancer Center
- Study coordinator: Jessica Tuan
- Email: JTuan@mednet.ucla.edu
- Phone: 310-825-3181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Colorectal Carcinoma