Evidence-Based Colorectal Cancer Screening for the Uninsured
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Through this program, the investigators will test a systematic colon cancer screening
      outreach strategy for increasing screening completion among uninsured patients, not
      up-to-date with screening. The intervention will consist of mailed screening invitations,
      with processes such as phone reminders to promote screening and evidence based follow up. All
      patients will be randomly assigned to receive mailed invitations to complete a home fecal
      immunochemical test (FIT). Some patients will be randomly assigned to receive a small
      financial incentive on completion of FIT testing.
    

Detailed description: 
      All patients meeting inclusion/exclusion criteria will receive mailed invitation and FIT kit
      to complete screening, with processes to promote screening completion. The list of eligible
      patients will be divided into 5 groups so that the expected group of 10,000 patients will
      receive invitations spread out in time, so as to avoid overwhelming the system. The
      invitation letters emphasize importance of colorectal cancer screening, encourage the patient
      to complete FIT screening with the enclosed FIT kit, and will be signed by John Pter Smith
      (JPS) investigators as representatives of JPS primary care physicians.

      The invitation kit will include a 1-sample POLYMEDCO Sensor FIT, including simplified
      instructions on how to perform the test, as well as a return mailer with prepaid postage.
      Diet/medication restriction will not be required. Kits will be returned to JPS and processed
      per manufacturer recommendations.

      Automated and "live" phone call reminders to encourage screening completion will be sent at
      time of invite and within week 1 of the invitation. Up to two "live" phone call reminders
      will be attempted 2 to 3 weeks post invitation, using English and Spanish standard scripts.

      Follow up for patients with a normal test in Year 1 will consist of repeat screening
      invitations in Year 2 and Year 3 consistent with guideline recommended annual FIT for
      colorectal screening. Follow up for patients with an abnormal FIT will consist of navigation
      to complete a colonoscopy. Patients with abnormal FIT will be called by the screening team
      within 1 week to report the result and facilitate direct scheduling of colonoscopy or a
      pre-colonoscopy visit. Follow up of patients with a colorectal cancer will consist of
      navigation to first treatment consultation visit. A surgery or oncology clinic follow up will
      be scheduled for all patients with a colorectal cancer diagnosis if such follow up is not
      already scheduled by the colonoscopist who diagnosed the colorectal cancer. Reminder calls
      for these visits will be made daily for up to one week.

      A group of 2,000 individuals will be randomly assigned to receive a modest financial
      incentive to complete screening, in addition to the organized outreach program. The incentive
      will consist of a gift card in one of two small dollar amounts to a local retailer.
      Incentives will be mailed by the JPS outreach team, in exchange for successful FIT
      completion, after the FIT has been returned.

      Follow up for determining screening completion for all included patients will be through the
      end of Year 3 regardless of whether or not patients respond to screening invitations. Once
      included, patients will remain in the program unless they no longer meet age criteria.
      Patients in both the standard (non-incentive) and incentive invitation groups who do not
      respond to initial invitation will be followed for screening outcomes, but will not receive
      repeat invitations. For patients who die on follow up or who do not have additional health
      system encounters, follow up will be censored at time of death or last health encounter,
      respectively.

      Each year, patients who newly meet our inclusion/exclusion criteria will be included in the
      program. For example, patients newly turning 50 in year 2 or 3 meeting all other
      inclusion/exclusion criteria will receive screening outreach. Similarly, a 60 year old
      patient new to the JPS system and meeting inclusion/exclusion criteria will also receive
      screening outreach.
    

Intervention name(s): FIT Invitation Only; FIT plus $5 Incentive; FIT plus $10 Incentive
Intervention type(s): Other; Other; Other
Intervention description(s): Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes with instructions, followed up with live and TELEVOX reminder phone calls.; Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes with instructions, followed up with live and TELEVOX reminder phone calls. Patients are offered a small incentive to complete their screening.; Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes with instructions, followed up with live and TELEVOX reminder phone calls. Patients are offered a small incentive to complete their screening.
Other intervention name(s): POLYMEDCO Fecal Immunochemical Test (FIT); John Peter Smith Health System; POLYMEDCO Fecal Immunochemical Test (FIT); John Peter Smith Health System; POLYMEDCO Fecal Immunochemical Test (FIT)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: neoplasm; colorectal; cancer; uninsured; FIT; Fecal Immunochemical Test