Mailed FIT Outreach to Improve Colon Cancer Screening in the Safety-net System
- Conditions
- Colonic Neoplasms
- Interventions
- Behavioral: FIT Outreach
- Registration Number
- NCT02613260
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
Uptake of colorectal cancer (CRC) screening is suboptimal in the San Francisco Health Network and access to care may be limited so novel models of health care delivery are warranted. The objective of this study is to examine whether a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses.
- Detailed Description
Rationale: Since uptake of colorectal cancer (CRC) screening is suboptimal in the SF safety-net system and access to care may be limited, novel models of health care delivery are warranted. The overall hypothesis is that a centralized panel management model with mailed fecal immunochemical test (FIT) will be effective at increasing the uptake of CRC screening and could be developed and sustained within the typical parameters of cost-effectiveness and budget impact analyses. Barriers to immunization of adults include missed opportunities during visits, limited access to providers, and provider and patient beliefs of efficacy.
Design: To rigorously examine the benefit of the centralized panel management to improve uptake of CRC screening with mailed FIT, the electronic health system will be used to identify eligible patients who are not up-to-date with CRC screening. Broadly, patients will be randomized 1:1 to usual care or intervention arm, stratified by clinic, gender, prior screening, and race to receive mailed FIT kits + usual care versus usual care alone. The cost-effectiveness of no screening, usual care, and centralized management with mailed FIT outreach will be compared using mathematical simulation models.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13470
- Asymptomatic men and women
- 50 to 75 years of age
- Personal history of polyps requiring colonoscopic surveillance
- Homeless
- Severe co-morbidities limiting life expectancy e.g., advanced stage cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FIT Outreach + Usual Care FIT Outreach Patients in this study arm will receive usual care at their primary care clinic and the intervention.
- Primary Outcome Measures
Name Time Method Completion of FIT- one year One year The primary outcome is the completion rate for CRC screening one-year after randomization between mailed FIT outreach and usual care.
- Secondary Outcome Measures
Name Time Method Completed Colonoscopy One year Of the patients that had a positive FIT the percentage of patients that received a colonoscopy.
Colonoscopy Findings One year Of the patients that received a colonoscopy what were the findings (rate of any adenoma, advanced neoplasia, and colorectal cancer).
Cost Two years How much the program costed to start and the costs throughout program implementation.
Incomplete FIT- 28 days 28 days Of the patients mailed the FIT kit the number of patients that have not completed their FIT.
FIT Positive 1 year Among the patients that have completed the FIT the percentage that had a positive FIT test.
Trial Locations
- Locations (1)
University of California, San Francisco-San Francisco General Hospital
🇺🇸San Francisco, California, United States