SIP14-012 Mailing FIT kits to improve colorectal cancer screening, a partnership with San Francisco Department of Public Health

Project Director/Lead Investigator: Ma Somsouk, MD (UCSF PI); Uri Ladabaum (Stanford Co-PI); Eric Vittinghoff (Co-I); Ellen Chen (Co-I);  Marguerita Lightfoot, PhD (UCSF PRC PI)

Research Findings Summary

This study enrolled more than 9,500 patients - men and women ages 50-75 - from six clinics in the San Francisco Health Network. About half of them received routine care, while the other half were mailed a stool sample test kit called (FIT). The FIT kit is a non-invasive colon cancer screening that checks for blood in the stool as a possible sign of colon cancer. Results show that mailing the FIT kits increased the number of patients who completed the screening from 21% to 49%. Participants who did not speak English, or who had done a FIT test before, were more likely to complete the test. Common barriers to participants returning the FIT kits were forgetting, not understanding, not wanting to test, or other health problems, which may be addressed during follow-up calls. Specific Aim 1: To determine if centralized panel management with mailed fecal immunochemical tests (FIT) outreach improves uptake of CRC screening compared with usual care. In collaboration with primary care providers, we will leverage the EHR system to identify asymptomatic patients not up-to-date with CRC screening. Patients will be randomized 1:1, stratified by clinic and race to mailed FIT outreach versus usual care. The primary outcome will be the difference between groups in completion rates of FIT tests at one-year from randomization. Secondary outcomes include the FIT completion rate 28 days after mailing, reasons for incomplete tests, FIT test positivity, colonoscopy completion rates and pathology findings, and the programmatic efficacy of the delivery model over time on proportion of patients up-to-date with CRC screening. Other outcomes include the CRC-specific mortality, incidence, and stage in those receiving usual care versus mailed FIT. Specific Aim 2: To determine if the mailed outreach program can be used to improve other health maintenance practices. We hypothesize that a centralized panel model program supporting CRC screening could also be used to improve other health maintenance efforts. Among patients appropriate for screening, patients will be randomized to receive information about age-appropriate health maintenance measures (e.g., mammogram, vaccinations). Specific Aim 3: To describe and compare the cost and effectiveness of the centralized panel management for mailed FIT versus usual care. We hypothesize that the administrative cost and utilization of FIT kits will drive cost up, but will be balanced by increased uptake of CRC screening. Adapting previously developed decision analytic models with Markov processes12-18, the cost and effectiveness of mailed FIT outreach versus usual care will be examined. Outcomes reported include implementation and operational cost of the outreach program (e.g., personnel, capital expenditure, and colonoscopy utilization), cost per clinical outcome (e.g., patient screened, cancer diagnosed, quality-adjusted life year), and performance incentives needed to break even.