Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This is a pragmatic, randomized, controlled trial comparing whether a mailed outreach
      intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice
      of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening
      colonoscopy increases CRC screening completion compared to a mailed FIT kit outreach program
      (which does not offer an explicit choice of screening modality). The trial will be conducted
      in a racially and socioeconomically diverse cohort of patients served by an integrated safety
      net delivery system that has a "FIT first" population health screening strategy. All patients
      will also have access to whatever CRC screening is recommended through usual visit-based
      care.
    

Detailed description: 
      Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC death
      can be reduced by screening. In the NCI-funded UT Southwestern-Parkland PROSPR Center (U54
      CA163308), mailed FIT-based outreach doubled the proportion of patients up-to-date with
      screening compared to usual care. Investigators are now conducting a comparative
      effectiveness trial to evaluate the effect of a mailed invite offering a choice of FIT or
      colonoscopy (n=2,000) on one-time CRC screening completion compared to mailed FIT-based
      outreach (which does not offer an explicit choice of screening modality (n=8,000.)
      Randomization will be stratified based on whether or not patients completed a FIT within the
      prior 18-month period. Patients randomized to FIT outreach will receive: a) low-literacy
      educational letters, b) mailed screening outreach invitations, c) a one-sample home FIT kit
      and return mailer with prepaid postage, d) telephone reminder calls including one-on-one
      education, and e) centralized patient navigation for follow-up of abnormal screening results,
      and treatment for patients newly diagnosed with CRC. Patients randomized to the "choice" arm
      will receive the same materials described above; however, the educational letter will explain
      and offer the additional choice of screening by colonoscopy (instead of completing the mailed
      FIT kit). The mailing will include a low health literacy one-page option grid outlining the
      pros and cons of FIT vs. colonoscopy. We will not recommend a particular test as preferred
      but instead emphasize that both are good choices, and the patient should choose the screening
      option that seems right for them. Patients choosing colonoscopy will be provided a telephone
      number to schedule the procedure. During scheduling, patients will be triaged by study staff
      with a structured history and physical form to "direct access" colonoscopy or a
      pre-colonoscopy clinic visit. Patients choosing FIT can return the one-sample mailed FIT kit
      using the return envelope with prepaid postage.
    

Intervention name(s): FIT Screening Strategy; Choice Screening Strategy
Intervention type(s): Other; Other
Intervention description(s): Mailed outreach invitation to complete FIT. FIT Strategy invitation includes: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).
Up to three "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 offering patients the choice to complete either a FIT or schedule a colonoscopy.
Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences. Outreach includes: 1) invitation letter, 2) choice grid 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).
Up to three "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
Intervention model description: Evaluate effect of offering choice of FIT or colonoscopy (n=2,000) compared to FIT alone (n=8,000) on one-time CRC screening completion, repeat screening, and follow-up of abnormal FIT results.
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Colorectal Cancer; Colon Cancer; FIT Screening Strategy; Colon Screening Strategy; Colorectal Neoplasms; Mass Screening; Health Services Research; Comparative Effectiveness Research