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

Overview

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.

Interventions

• Other Best Practice
  Receive clinical care consistent with current practice
• Other Communication Intervention
  Receive standardized communication from FIT QI champion
• Other Communication Intervention
  Receive coordination from GI liaisons
• Other Coordination
  Receive enhanced GI care coordination
• Other Educational Intervention
  Watch pre-colonoscopy educational video
• Other Electronic Health Record Review
  Undergo FIT result review by Primary Care FIT Tracker
• Other Electronic Health Record Review
  Ancillary studies
• Other Informational Intervention
  Undergo generation and review of GI FIT Tracker report
• Other Informational Intervention
  Receive informational sheet
• Other Interview
  Ancillary studies

Primary outcome measures

• Follow-up colonoscopy rates [Time frame: At 6 months]
• Implementation quality: fit tracker [Time frame: Monthly intervals up to 3 years]
• Implementation quality: patient notification [Time frame: Monthly intervals up to 3 years]
• Implementation quality: patient referral [Time frame: Monthly intervals up to 3 years]
• Implementation quality: Time to patient referral [Time frame: Monthly intervals up to 3 years]
• Implementation quality: use of referral template as percent completion of interventions [Time frame: Monthly intervals up to 3 years]
• Implementation quality: referral template in time to completion [Time frame: Monthly intervals up to 3 years]
• Implementation quality: patient education [Time frame: Monthly intervals up to 3 years]
• Implementation quality: patient education [Time frame: Monthly intervals up to 3 years]
• Implementation quality: Patient attendance: completion of a pre-colonoscopy visit [Time frame: Monthly intervals up to 3 years]

Secondary outcome measures (6)

• Time to colonoscopy [Time frame: 0-24 months]
• Follow-up colonoscopy rates [Time frame: At 9 months and at 12 months]
• Factors associated with Implementation [Time frame: At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)]
• Reported challenges to implementation [Time frame: Up to 3 years]
• Intervention adaptations [Time frame: Up to 3 years]
• Clinic and provider factors [Time frame: At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)]

Eligibility criteria

Inclusion criteria

• 6 adult care NEVHC clinic sites

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 2 centers

• University of California at Los Angeles — Los Angeles
• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT06568016 · 24-000532 · NCI-2024-05892 · 24-000532 · P30CA016042

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗