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.
6 adult care NEVHC clinic sites
None
Parallel
Best Practice
Other interventionReceive clinical care consistent with current practice
Communication Intervention
Other interventionReceive standardized communication from FIT QI champion
Communication Intervention
Other interventionReceive coordination from GI liaisons
Coordination
Other interventionReceive enhanced GI care coordination
Educational Intervention
Other interventionWatch pre-colonoscopy educational video
Electronic Health Record Review
Other interventionUndergo FIT result review by Primary Care FIT Tracker
Electronic Health Record Review
Other interventionAncillary studies
Informational Intervention
Other interventionUndergo generation and review of GI FIT Tracker report
Informational Intervention
Other interventionReceive informational sheet
Interview
Other interventionAncillary studies
Patient Navigation
BehavioralReceive navigation from GI liaisons
Referral
Other interventionReceive referral
Referral
Other interventionReceive referral per standardized template
Text Message-Based Navigation Intervention
Other interventionReceive follow-up text message
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).
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.
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.
Implementation quality: patient referral
The Investigators will measure the percent of patients who receive a referral.
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.
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).
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.
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.
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Jonsson Comprehensive Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
