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NCT Number: NCT06568016

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 6 adult care NEVHC clinic sites

Treatment and study plan

Best Practice

Other

Receive clinical care consistent with current practice

Other names: standard of care, standard therapy

Communication intervention

Other

Receive standardized communication from FIT QI champion

Coordination

Other

Receive enhanced GI care coordination

Educational Intervention

Other

Watch pre-colonoscopy educational video

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Electronic Health Record Review

Other

Undergo FIT result review by Primary Care FIT Tracker

Informational intervention

Other

Undergo generation and review of GI FIT Tracker report

interview

Other

Ancillary studies

Patient Navigation

Behavioral

Receive navigation from GI liaisons

Other names: Patient Navigator Program

Referral

Other

Receive referral

Other names: Referred

Text Message-Based Navigation Intervention

Other

Receive follow-up text message

Other names: Automated Text Message-Based Navigation, Text Message-Based Navigation

Primary outcomes

  1. Follow-up colonoscopy rates

    Time frame: At 6 months

    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).

  2. Implementation quality: fit tracker

    Time frame: Monthly intervals up to 3 years

    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.

  3. Implementation quality: patient notification

    Time frame: Monthly intervals up to 3 years

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

  4. Implementation quality: patient referral

    Time frame: Monthly intervals up to 3 years

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

  5. Implementation quality: Time to patient referral

    Time frame: Monthly intervals up to 3 years

    The Investigators will measure the time to patient referral.

  6. Implementation quality: use of referral template as percent completion of interventions

    Time frame: Monthly intervals up to 3 years

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

  7. Implementation quality: referral template in time to completion

    Time frame: Monthly intervals up to 3 years

    The Investigators will measure the time to completion of interventions.

  8. Implementation quality: patient education

    Time frame: Monthly intervals up to 3 years

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

  9. Implementation quality: patient education

    Time frame: Monthly intervals up to 3 years

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

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

    Time frame: Monthly intervals up to 3 years

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

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

    Time frame: Monthly intervals up to 3 years

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

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

    Time frame: Monthly intervals up to 3 years

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

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

    Time frame: Monthly intervals up to 3 years

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

  14. Cost-effectiveness

    Time frame: Up to 3 years

    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.

Secondary outcomes

  1. Time to colonoscopy

    Time frame: 0-24 months

    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.

  2. Follow-up colonoscopy rates

    Time frame: At 9 months and at 12 months

    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).

  3. Factors associated with Implementation

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

    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.

  4. Reported challenges to implementation

    Time frame: Up to 3 years

    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.

  5. Intervention adaptations

    Time frame: Up to 3 years

    In qualitative interviews with stakeholders, we will learn whether there were any changes we need to be intended intervention components.

  6. Clinic and provider factors

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Tuan

CONTACT

[email protected]

310-825-3181

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Multilevel Intervention to Improve Follow-up Colonoscopy Rates After Abnormal FIT Results in Large FQHC

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 23, 2024
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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