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

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.

Conditions

• Colorectal Carcinoma

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

BEHAVIORAL

Patient Navigation

Receive navigation from GI liaisons

OTHER

Referral

Receive referral

OTHER

Referral

Receive referral per standardized template

OTHER

Text Message-Based Navigation Intervention

Receive follow-up text message

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Jonsson Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Folasade P May, MD, PhD · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-22

Primary Completion

2029-02-28

Completion

2029-08-31

Countries

• United States

Study Locations