Comparative Effectiveness of FIT, Colonoscopy, & Usual Care Screening Strategies
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death
      can be reduced by screening. However, there is uncertainty as to which screening strategy is
      most clinically and cost-effective from a population perspective where the aim is to optimize
      completion of the entire screening process continuum. Modeling studies suggest benefits and
      harms of colonoscopy and stool blood test strategies are similar, but generally assume 100%
      participation and subsequent clinically appropriate follow up--something never achieved in
      clinical practice. Comparative effectiveness studies of testing strategies, including
      comparisons of specific tests and approaches to optimizing effective test use, are necessary.
      Safety-net health systems care for populations at increased risk for adverse CRC outcomes,
      such as the uninsured and minorities, and have more limited resources. Therefore, safety-nets
      must resolve the uncertainty regarding the most effective screening strategy. The
      investigators will conduct a system-level, randomized comparative effectiveness trial of the
      benefits, harms, and costs of 3 screening strategies over 3 years, among 6000 patients age
      50-64 years, who are not up-to-date with CRC screening, served by a large safety net health
      system. The three strategies studied will be: 1) Fecal immunochemical testing, with annual
      mailed invitation outreach (including a test kit), and a centralized process to promote
      participation and complete clinical follow up (FIT); 2) Colonoscopy, with annual mailed
      invitation outreach, and a centralized process to promote participation and complete clinical
      follow up (Colo); 3) Usual Care, with no mailed invitation outreach, and screening offered at
      primary care visits. The primary measure of benefit will be an outcome measure that
      summarizes patient-specific effective screening successes. The primary measure of harm will
      be screening non-participation. The primary measure of cost will be cost per-patient
      effectively screened. Our specific aims are to: 1) Compare benefits, harms, and costs of a
      FIT strategy versus a Colo strategy for CRC screening among patients not up-to-date with
      screening, and 2) Compare benefits, harms, and costs of a) the FIT strategy vs. Usual Care
      and b) the Colo strategy vs. Usual Care for CRC screening.
    


Intervention name(s): FIT Screening Strategy; Colon Screening Strategy
Intervention type(s): Other; Other
Intervention description(s): Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage).
Two "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.
Centralized processes to promote guideline-based follow up.; Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy.
Two "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.
Centralized processes to promote guideline-based follow up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Colorectal Neoplasms; Colorectal Cancer; Colon Cancer; Mass Screening; Health Services Research; Comparative Effectiveness Research