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 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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
1,500
Receive clinical care consistent with current practice
Receive standardized communication from FIT QI champion
Receive coordination from GI liaisons
Receive enhanced GI care coordination
Watch pre-colonoscopy educational video
Undergo FIT result review by Primary Care FIT Tracker
Ancillary studies
Undergo generation and review of GI FIT Tracker report
Receive informational sheet
Ancillary studies
Receive navigation from GI liaisons
Receive referral
Receive referral per standardized template
Receive follow-up text message
University of California at Los Angeles
Los Angeles, California, United States
RECRUITINGUCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
NOT_YET_RECRUITINGFollow-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).
Time frame: 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.
Time frame: 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.
Time frame: Monthly intervals up to 3 years
Implementation quality: patient referral
The Investigators will measure the percent of patients who receive a referral.
Time frame: Monthly intervals up to 3 years
Implementation quality: Time to patient referral
The Investigators will measure the time to patient referral.
Time frame: 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.
Time frame: Monthly intervals up to 3 years
Implementation quality: referral template in time to completion
The Investigators will measure the time to completion of interventions.
Time frame: Monthly intervals up to 3 years
Implementation quality: patient education
The Investigators will measure the percent of cases in which patient education is delivered.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 3 years
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: At pre-intervention (1-2 years) and at the implementation midpoint (3-4 years)