Clinical trial NCT06568016: 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
Official title: Multilevel Intervention to Improve Follow-up Colonoscopy Rates After Abnormal FIT Results in Large FQHC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-08-23
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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

Primary outcomes:
measure: Follow-up colonoscopy rates
timeFrame: At 6 months
measure: Implementation quality: fit tracker
timeFrame: Monthly intervals up to 3 years
measure: Implementation quality: patient notification
timeFrame: Monthly intervals up to 3 years
measure: Implementation quality: patient referral
timeFrame: Monthly intervals up to 3 years
measure: Implementation quality: Time to patient referral
timeFrame: Monthly intervals up to 3 years
measure: Implementation quality: use of referral template as percent completion of interventions
timeFrame: Monthly intervals up to 3 years
measure: Implementation quality: referral template in time to completion
timeFrame: Monthly intervals up to 3 years
measure: Implementation quality: patient education
timeFrame: Monthly intervals up to 3 years
measure: Implementation quality: patient education
timeFrame: Monthly intervals up to 3 years
measure: Implementation quality: Patient attendance: completion of a pre-colonoscopy visit
timeFrame: Monthly intervals up to 3 years
measure: Implementation quality: time to completion of a pre-colonoscopy visit
timeFrame: Monthly intervals up to 3 years
measure: Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation
timeFrame: Monthly intervals up to 3 years
measure: Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation over time
timeFrame: Monthly intervals up to 3 years
measure: Cost-effectiveness
timeFrame: Up to 3 years
Secondary outcomes:
measure: Time to colonoscopy
timeFrame: 0-24 months
measure: Follow-up colonoscopy rates
timeFrame: At 9 months and at 12 months
measure: Factors associated with Implementation
timeFrame: At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)
measure: Reported challenges to implementation
timeFrame: Up to 3 years
measure: Intervention adaptations
timeFrame: Up to 3 years
measure: Clinic and provider factors
timeFrame: At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Folasade P May, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: