Recruiting

Primary Care-GI Connect

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT06568016

Conditions

Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Best Practice

Communication Intervention

Communication Intervention

Coordination

Educational Intervention

Study Details

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.

Conditions

Colorectal Carcinoma

Study ID

NCT06568016

Start date

Apr 22, 2025

Status verified date

Aug, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 6 adult care NEVHC clinic sites

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Arm I (usual care)

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.

experimental: Arm II (Usual care + Primary Care - GI Connect)

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

Best Practice

Receive clinical care consistent with current practice

Communication Intervention

Receive standardized communication from FIT QI champion

Communication Intervention

Receive coordination from GI liaisons

Coordination

Receive enhanced GI care coordination

Educational Intervention

Watch pre-colonoscopy educational video

Electronic Health Record Review

Undergo FIT result review by Primary Care FIT Tracker

Electronic Health Record Review

Ancillary studies

Informational Intervention

Undergo generation and review of GI FIT Tracker report

Informational Intervention

Receive informational sheet

Interview

Ancillary studies

Patient Navigation

Receive navigation from GI liaisons

Referral

Receive referral

Referral

Receive referral per standardized template

Text Message-Based Navigation Intervention

Receive follow-up text message

Primary outcome measure

  • 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 ]
  • Implementation quality: time to completion of a pre-colonoscopy visit [ Time Frame: Monthly intervals up to 3 years ]
  • Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation [ Time Frame: Monthly intervals up to 3 years ]
  • Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation over time [ Time Frame: Monthly intervals up to 3 years ]
  • Cost-effectiveness [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Jessica Tuan

310-825-3181JTuan@mednet.ucla.edu

Locations

University of California at Los Angeles

Recruiting

Los Angeles, California, United States, 90095-1406

Contacts

Jessica J Tuan

310-825-3181jtuan@mednet.ucla.edu

Principal Investigator:

Folasade P May, MD, PhD

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-09-02.