Improving Colonoscopy Rates After Abnormal FIT Results
This study is testing a new program called "Primary Care-GI Connect" to help more people get a colonoscopy after an abnormal fecal immunochemical test (FIT) result. A FIT is a stool test that checks for signs of colorectal cancer. Getting a colonoscopy after an abnormal FIT is very important for finding and preventing colorectal cancer. This study compares the "Primary Care-GI Connect" program, which includes standardized communication, GI liaison coordination, and educational videos, to the usual care you would receive. We want to see if this new program helps more people get their colonoscopy within 6 months. The study is taking place at Federally Qualified Health Centers (FQHCs) and is open to all adults.
- Study design
- This study is a pragmatic, cluster randomized trial involving 1500 patients across 6 clinics. Clinics will be randomly assigned to either the "Primary Care-GI Connect" program or usual care.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your colonoscopy rates will be measured at 6 months. Implementation quality will be tracked monthly for up to 3 years.
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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
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Folasade P May, MD, PhD · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Follow-up colonoscopy ratesAt 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).
- Implementation quality: fit trackerMonthly 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.
- Implementation quality: patient notificationMonthly 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.
- Implementation quality: patient referralMonthly intervals up to 3 years
The Investigators will measure the percent of patients who receive a referral.
- Implementation quality: Time to patient referralMonthly intervals up to 3 years
The Investigators will measure the time to patient referral.
- Implementation quality: use of referral template as percent completion of interventionsMonthly intervals up to 3 years
The Investigators will measure the percent completion of interventions for patients at each step.
- Implementation quality: referral template in time to completionMonthly intervals up to 3 years
The Investigators will measure the time to completion of interventions.
- Implementation quality: patient educationMonthly intervals up to 3 years
The Investigators will measure the percent of cases in which patient education is delivered.
- Implementation quality: patient educationMonthly intervals up to 3 years
The Investigators will measure the time to delivery of patient education when it is offered.
- Implementation quality: Patient attendance: completion of a pre-colonoscopy visitMonthly intervals up to 3 years
The Investigators will measure the percent of patients who complete a pre-colonoscopy visit.
- Implementation quality: time to completion of a pre-colonoscopy visitMonthly intervals up to 3 years
The Investigators will measure the time to completion of a pre-colonoscopy visit.
- Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health CorporationMonthly intervals up to 3 years
The Investigators will measure the percent of patients for which colonoscopy and pathology results are received at NEVHC.
- Implementation quality: receipt of colonoscopy and pathology results at Northeast Valley Health Corporation over timeMonthly intervals up to 3 years
The Investigators will measure the time to retrieval of colonoscopy and pathology results received at NEVHC.
- Cost-effectivenessUp 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.