Project Director/Lead Investigator: Ma Somsouk, MD (UCSF PI); Eric Vittinghoff (Co-PI); Lisa Golden (Co-PI); Uri Ladabaum; Marguerita Lightfoot, PhD (UCSF PRC PI)
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.