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

NCT06568016 | Recruiting DMC

• 3 other identifiers: 24-000532NCI-2024-05892P30CA016042
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (14)

• Follow-up colonoscopy rates

  Evaluated in patients with an abnormal fecal immunochemical test (FIT) result using electronic health record data. Will use a difference-in-differences approach, assessing whether change in completion rates from baseline to the implementation period differs between the intervention and usual care conditions, thus accounting for potential differences among clinics pre-implementation. Will fit a mixed effects logistic regression model with a dependent variable of patient-level colonoscopy completion within 6 months (yes/no).

  At 6 months

• Implementation quality: fit tracker

  The Investigators will measure the percent of cases for which the FIT tracker is used, as well as its use for each step in the process. For these measures, we will also measure time to completion.

  Monthly intervals up to 3 years

• Implementation quality: patient notification

  The Investigators will measure both the percent of patients who are notified of their abnormal results as well as the time to notification.

  Monthly intervals up to 3 years

• Implementation quality: patient referral

  The Investigators will measure the percent of patients who receive a referral.

  Monthly intervals up to 3 years

• Implementation quality: Time to patient referral

  The Investigators will measure the time to patient referral.

  Monthly intervals up to 3 years

• Implementation quality: use of referral template as percent completion of interventions

  The Investigators will measure the percent completion of interventions for patients at each step.

  Monthly intervals up to 3 years

• Implementation quality: referral template in time to completion

  The Investigators will measure the time to completion of interventions.

  Monthly intervals up to 3 years

• Implementation quality: patient education

  The Investigators will measure the percent of cases in which patient education is delivered.

  Monthly intervals up to 3 years

• Implementation quality: patient education

  The Investigators will measure the time to delivery of patient education when it is offered.

  Monthly intervals up to 3 years

• Implementation quality: Patient attendance: completion of a pre-colonoscopy visit

  The Investigators will measure the percent of patients who complete a pre-colonoscopy visit.

  Monthly intervals up to 3 years

• Implementation quality: time to completion of a pre-colonoscopy visit

  The Investigators will measure the time to completion of a pre-colonoscopy visit.

  Monthly intervals up to 3 years

• Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation

  The Investigators will measure the percent of patients for which colonoscopy and pathology results are received at NEVHC.

  Monthly intervals up to 3 years

• Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation over time

  The Investigators will measure the time to retrieval of colonoscopy and pathology results received at NEVHC.

  Monthly intervals up to 3 years

• Cost-effectiveness

  Will use standard cost-effectiveness techniques (including time discounting) to conduct an incremental cost-effectiveness analysis, measuring the Incremental Cost-Effectiveness Ratio of the usual care and Primary-care GI connect intervention conditions.

  Up to 3 years

Secondary Outcomes (6)

• Time to colonoscopy

  0-24 months

• Follow-up colonoscopy rates

  At 9 months and at 12 months

• Factors associated with Implementation

  At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)

• Reported challenges to implementation

  Up to 3 years

• Intervention adaptations

  Up to 3 years

Study Arms (2)

Arm I (usual care)

ACTIVE COMPARATOR

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.

Other: Best Practice; Other: Communication Intervention; Other: Electronic Health Record Review; Other: Interview; Other: Referral

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

EXPERIMENTAL

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.

Other: Best Practice; Other: Communication Intervention; Other: Coordination; Other: Educational Intervention; Other: Electronic Health Record Review; Other: Informational Intervention; Other: Interview; Behavioral: Patient Navigation; Other: Referral; Other: Text Message-Based Navigation Intervention

Interventions

Electronic Health Record Review OTHER

Undergo FIT result review by Primary Care FIT Tracker

Arm I (usual care); Arm II (Usual care + Primary Care - GI Connect)

Informational Intervention OTHER

Undergo generation and review of GI FIT Tracker report

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

Interview OTHER

Ancillary studies

Arm I (usual care); Arm II (Usual care + Primary Care - GI Connect)

Patient Navigation BEHAVIORAL

Receive navigation from GI liaisons

Also known as: Patient Navigator Program

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

Referral OTHER

Receive referral

Also known as: Referred

Arm I (usual care)

Text Message-Based Navigation Intervention OTHER

Receive follow-up text message

Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation

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

Best Practice OTHER

Receive clinical care consistent with current practice

Also known as: standard of care, standard therapy

Arm I (usual care); Arm II (Usual care + Primary Care - GI Connect)

Communication Intervention OTHER

Receive standardized communication from FIT QI champion

Arm I (usual care); Arm II (Usual care + Primary Care - GI Connect)

Coordination OTHER

Receive enhanced GI care coordination

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

Educational Intervention OTHER

Watch pre-colonoscopy educational video

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• adult care NEVHC clinic sites

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of California at Los Angeles

Los Angeles, California, 90095-1406, United States

RECRUITING

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Methods; Interviews as Topic; Patient Navigation; Referral and Consultation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Professional Practice; Organization and Administration

Study Officials

• Folasade P May, MD, PhD

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Tuan

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 23, 2024
• Study Start: April 22, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (2)