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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Carcinoma
• Intervention / Treatment: Other: Interview; Other: Electronic Health Record Review; Other: Referral; Other: Best Practice; Other: Communication Intervention; Other: Communication Intervention; Other: Electronic Health Record Review; Other: Referral; Other: Coordination; Other: Educational Intervention; Other: Informational Intervention; Other: Informational Intervention; Behavioral: Patient Navigation; Other: Text Message-Based Navigation Intervention

Detailed Description

PRIMARY OBJECTIVES:

I. Conduct a pragmatic, cluster randomized trial in 6 clinics (1500 patients) within a multi-site FQHC system to compare the effectiveness of the multilevel FQHC-GI care coordination intervention ("Primary Care-GI Connect "; 3 clinics, 750 patients) to the usual care condition (3 clinics, 750 patients) on receipt of a colonoscopy within 6 months of an abnormal FIT.

II. Systematically assess the quality of intervention implementation to understand the feasibility and relative importance of intervention elements as guided by the Multilevel Health Outcomes Framework.

III. Measure the incremental cost-effectiveness of the Primary Care-GI Connect intervention compared to usual care to understand the potential value, feasibility, and potential for dissemination.

OUTLINE: Northeast Valley Health Corporation (NEVHC) clinics are randomized to 1 of 2 arms.

ARM I: Patients receive clinical care consistent with current practice at NEVHC. Patients have their electronic health records (EHRs) reviewed monthly by the Primary Care FIT Tracker for abnormal FIT results and patients with abnormal FIT results receive standardized communication from FIT quality improvement (QI) champions about their results and receive a referral to gastroenterology.

ARM II: 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.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Tuan; Phone Number: 310-825-3181; Email: JTuan@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Not yet recruiting
      • UCLA / Jonsson Comprehensive Cancer Center
      • Principal Investigator: Folasade P. May
      • Contact: Folasade P. May; Phone Number: 310-825-4728; Email: fmay@mednet.ucla.edu
    • Los Angeles, California, United States, 90095-1406
      • Recruiting
      • University of California at Los Angeles
      • Contact: Jessica J Tuan; Phone Number: 310-825-3181; Email: jtuan@mednet.ucla.edu
      • Principal Investigator: Folasade P May, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 6 adult care NEVHC clinic sites

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Referral; Receive referral; Other Names: Referred; Other: Best Practice; Receive clinical care consistent with current practice; Other Names: standard of care; standard therapy; Other: Communication Intervention; Receive standardized communication from FIT QI champion; Other: Communication Intervention; Receive coordination from GI liaisons; Other: Electronic Health Record Review; Undergo FIT result review by Primary Care FIT Tracker; Other: Referral; Receive referral per standardized template; Other Names: Referred
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.	Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Referral; Receive referral; Other Names: Referred; Other: Best Practice; Receive clinical care consistent with current practice; Other Names: standard of care; standard therapy; Other: Communication Intervention; Receive standardized communication from FIT QI champion; Other: Communication Intervention; Receive coordination from GI liaisons; Other: Electronic Health Record Review; Undergo FIT result review by Primary Care FIT Tracker; Other: Referral; Receive referral per standardized template; Other Names: Referred; Other: Coordination; Receive enhanced GI care coordination; Other: Educational Intervention; Watch pre-colonoscopy educational video; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Informational Intervention; Undergo generation and review of GI FIT Tracker report; Other: Informational Intervention; Receive informational sheet; Behavioral: Patient Navigation; Receive navigation from GI liaisons; Other Names: Patient Navigator Program; Other: Text Message-Based Navigation Intervention; Receive follow-up text message; Other Names: Automated Text Message-Based Navigation; Text Message-Based Navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to colonoscopy	The Investigators 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.	0-24 months
Follow-up colonoscopy rates	Evaluated in patients with an abnormal 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 9 months (yes/no).	At 9 months and at 12 months
Factors associated with Implementation	The Investigators will use the Organizational Readiness to Implement Change tool to measure responses from clinic stakeholders at each site. This is a standardized tool.	At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)
Reported challenges to implementation	In qualitative interviews with stakeholders and on standardized forms, we will learn about major challenges to implementation across clinics and over time. These will be qualitative data.	Up to 3 years
Intervention adaptations	In qualitative interviews with stakeholders, we will learn whether there were any changes we need to be intended intervention components.	Up to 3 years
Clinic and provider factors	The Investigators will use EHR data to measure clinic size, location, staffing, resources, number of providers, number of patients to evaluate associations with successful intervention implementation.	At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Folasade P May, MD, PhD, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Professional Practice; Organization and Administration; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Guidelines as Topic; Quality Assurance, Health Care; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Methods; Interviews as Topic; Standard of Care; Early Intervention, Educational; Educational Status; Referral and Consultation; Practice Guidelines as Topic; Patient Navigation
• Other Study ID Numbers: 24-000532 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center); P30CA016042 (U.S. NIH Grant/Contract); NCI-2024-05892 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No