Clinical trial · Interventional
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
Multilevel Intervention to Improve Follow-up Colonoscopy Rates After Abnormal FIT Results in Large FQHC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Communication Intervention | Other | — | UNRESOLVED |
| Coordination | Other | — | UNRESOLVED |
| Educational Intervention | Other | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
| Informational Intervention | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Patient Navigation | Behavioral | — | UNRESOLVED |
| Referral | Other |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (usual care)
- description
- Patients receive clinical care consistent with current practice at NEVHC. Patients have their EHRs reviewed monthly by the Primary Care FIT Tracker for abnormal FIT results and patients with abnormal FIT results receive standardized communication from FIT QI champions about their results and receive a referral to gastroenterology.
- interventionNames
- Other: Best Practice
- Other: Communication Intervention
- Other: Electronic Health Record Review
- Other: Interview
- Other: Referral
- type
- EXPERIMENTAL
- label
- Arm II (Usual care + Primary Care - GI Connect)
- description
- 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
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 6 adult care NEVHC clinic sites
References
Publications (0)
Data not yet available