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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
NCT06568016 · Jonsson Comprehensive Cancer Center
In plain English
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Official title
Multilevel Intervention to Improve Follow-up Colonoscopy Rates After Abnormal FIT Results in Large FQHC
About this study
PRIMARY OBJECTIVES:
I. Conduct a pragmatic, cluster randomized trial in 6 clinics (1500 patients) within a multi-site FQHC system to compare the effectiveness of the multilevel FQHC-GI care coordination intervention ("Primary Care-GI Connect "; 3 clinics, 750 patients) to the usual care condition (3 clinics, 750 patients) on receipt of a colonoscopy within 6 months of an abnormal FIT.
II. Systematically assess the quality of intervention implementation to understand the feasibility and relative importance of intervention elements as guided by the Multilevel Health Outcomes Framework.
III. Measure the incremental cost-effectiveness of the Primary Care-GI Connect intervention compared to usual care to understand the potential value, feasibility, and potential for dissemination.
OUTLINE: Northeast Valley Health Corporation (NEVHC) clinics are randomized to 1 of 2 arms.
ARM I: Patients receive clinical care consistent with current practice at NEVHC. Patients have their electronic health records (EHRs) reviewed monthly by the Primary Care FIT Tracker for abnormal FIT results and patients with abnormal FIT results receive standardized communication from FIT quality improvement (QI) champions about their results and receive a referral to gastroenterology.
ARM II: 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.
Eligibility criteria
Inclusion Criteria:
* 6 adult care NEVHC clinic sites
Study design
Enrollment target: 1500 participants
Allocation: randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2025-04-22
Estimated completion: 2029-08-31
Last updated: 2026-02-09
Interventions
Other: Best PracticeOther: Communication InterventionOther: Communication InterventionOther: CoordinationOther: Educational InterventionOther: Electronic Health Record ReviewOther: Electronic Health Record ReviewOther: Informational InterventionOther: Informational InterventionOther: InterviewBehavioral: Patient NavigationOther: ReferralOther: ReferralOther: Text Message-Based Navigation Intervention
Primary outcomes
- • Follow-up colonoscopy rates (At 6 months)
- • Implementation quality: fit tracker (Monthly intervals up to 3 years)
- • Implementation quality: patient notification (Monthly intervals up to 3 years)
Sponsor
Jonsson Comprehensive Cancer Center · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactJessica Tuan · contact · JTuan@mednet.ucla.edu · 310-825-3181
InvestigatorFolasade P May, MD, PhD · principal_investigator, UCLA / Jonsson Comprehensive Cancer Center
All locations (2)
University of California at Los AngelesRecruiting
Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer CenterNot Yet Recruiting
Los Angeles, California, United States