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
NCT Number: NCT06568016
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colorectal Carcinoma
Interventions: OTHER: Best Practice|OTHER: Communication Intervention|OTHER: Communication Intervention|OTHER: Coordination|OTHER: Educational Intervention|OTHER: Electronic Health Record Review|OTHER: Electronic Health Record Review|OTHER: Informational Intervention|OTHER: Informational Intervention|OTHER: Interview|BEHAVIORAL: Patient Navigation|OTHER: Referral|OTHER: Referral|OTHER: Text Message-Based Navigation Intervention
Sponsor: Jonsson Comprehensive Cancer Center
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1500
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-12-01
Completion Date: 2027-12-01
Locations: UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, 90095, United States

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.

Primary Outcome Measures: 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 both the percent patients who receive a referral as well as time to referral. ., Monthly intervals up to 3 years|Implementation quality: use of referral template, The Investigators will measure both the percent completion of interventions for patients at each step as well as the time to completion., Monthly intervals up to 3 years|Implementation quality: patient education, The Investigators will measure the percent of cases in which the patient education is delivered and the time to delivery., Monthly intervals up to 3 years|Implementation quality: patient attendance, The Investigators will measure the percent of patients who complete a pre-colonoscopy visit, as well as the time to completion., 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, as well as the time to retrieval., 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 Outcome Measures: 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)