What is the Primary Care-GI Connect intervention studying for colorectal cancer?

This study is evaluating a clinic-wide approach to improve follow-up colonoscopy rates after abnormal FIT results in patients at Federally Qualified Health Centers. Researchers aim to see if enhanced care coordination and patient education can increase timely colonoscopy after screening. The study is sponsored by the Jonsson Comprehensive Cancer Center.

Who may be eligible for this colorectal cancer clinical trial?

Adults receiving care at one of the six Northeast Valley Health Corporation clinic sites who have had an abnormal FIT result may be eligible. The study includes patients of all genders and requires willingness to participate in follow-up procedures. Please review eligibility criteria for more details.

Is there any cost to participate in this colorectal cancer clinical trial?

Study-related care, including all study visits and procedures, is provided at no cost. Personal travel and related expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

All Genders

Healthy Volunteers

ID06568016

Improving Follow-up Colonoscopy Rates After Abnormal FIT Results at Federally Qualified Health Centers Using a Clinic-wide Care Coordination Program

Led by Jonsson Comprehensive Cancer Center · Updated on 2026-02-09

1500

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a clinic-wide intervention called Primary Care-Gastrointestinal GI Connect aimed at increasing follow-up colonoscopy rates after abnormal fecal immunochemical test FIT results in patients at Federally Qualified Health Centers FQHCs. Colorectal cancer screening using FIT is common in low-resource settings, but follow-up colonoscopy rates after abnormal results are low due to multiple barriers. This study compares the usual care with an enhanced care coordination approach to improve these follow-up rates in a large FQHC system. The study is a pragmatic, cluster randomized trial involving six clinics, divided into two groups one receiving usual care with monthly electronic health record EHR reviews and standardized communication about abnormal FIT results, and the other receiving the Primary Care-GI Connect intervention. This enhanced intervention adds GI liaison coordination, patient navigation for scheduling GI appointments, standardized referral templates, colonoscopy education via informational sheets and a 20-minute video, and reminder text messages emphasizing the importance of follow-up colonoscopy. Participants will be monitored through regular EHR reviews and monthly assessments of intervention implementation quality over up to three years. Researchers will evaluate follow-up colonoscopy rates within 6, 9, and 12 months of abnormal FIT results, along with factors affecting implementation, time to colonoscopy, and cost-effectiveness. Participants may also be involved in ancillary studies including interviews and additional data collection. The study aims to understand the feasibility, value, and impact of this multilevel intervention on colorectal cancer screening adherence.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Patient receives care at one of six adult Northeast Valley Health Corporation clinic sites

You will not qualify if you...

Research Team

Jessica Tuan

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