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

Summary: 
      This is a sub-study nested within a previously initiated clinical study (# NCT01946282)
      focusing on individuals not previously randomized at baseline to the original interventions.
      The purpose of the sub-study is to evaluate, via a randomized controlled trial design, 3
      strategies for promoting screening completion among individuals not up to date with
      colorectal cancer screening, but assigned to receive screening outreach.
    

Detailed description: 
      In the previously initiated, ongoing clinical study (# NCT01946282) investigators are testing
      a systematic colon cancer screening outreach strategy for increasing screening completion
      among uninsured patients, not up-to-date with screening. This is a Sub-study to #NCT01946282
      (IRB # 082012-086).

      Sub-study description:

      The goal of the sub-study is to identify strategies that may further increase rates of 1)
      initial participation in colorectal cancer screening, and 2) follow up of abnormal colorectal
      cancer screening tests with colonoscopy.

      At the time of the sub-study, all patients randomly assigned to receive gift card incentives
      have been enrolled. At this time only standard, non-incentive invitations continue to be
      mailed to eligible patients.

      The sub-study involves 2 parts:

      Part 1: Participants scheduled to receive mailed fecal immunochemical test (FIT) outreach for
      the first time late in the 2nd year of the study will be randomly assigned to receive one of
      three invitation letters, which vary slightly from one another.

      For the sub-study, the standard invitation letter will be replaced with one of the three
      sub-study letters. All new participants will receive one of the 3 letters during 2
      predetermined rounds of invitations (involving n=2,124 individuals). There will be 3
      conditions for the sub-study letters and individuals will be randomly assigned 1:1:1 to each
      condition. The 3 conditions are as follows:

      i) Condition 1 - control letter will be similar to the previous study letters with some
      slight wording and grammatical improvements, ii) Condition 2 - cost letter will be the
      control letter plus the addition of one sentence informing recipients of the average value of
      the FIT procedure and; iii) Condition 3 - cost/future letter will include the average value
      of FIT and a sentence assuring patients that should a follow-up test be requested, it will be
      provided free of charge.

      Rationale and plan for sub-study Part 1: Over nearly 2 years of the program the investigators
      have tested a systematic outreach strategy for increasing screening completion among
      uninsured patients, not up to date with screening. Through these carefully evaluated
      interventions, the investigators have shown that an outreach invitation strategy,
      particularly when it includes FIT invitations, markedly increases screening completion among
      the uninsured. Thirty-six percent of individuals invited to complete FIT return the test. The
      investigators believe this rate may be improved by making changes to the invitation letters.
      The sub-study hypothesis is that providing information in the letter about the value of the
      kit and attenuating concern about future cost will further increase FIT and follow-up
      response rates.

      Part 2: In part 2 of the sub-study, participants will receive their FIT results in either a
      white envelope (normal results, no immediate follow-up necessary) or a red envelope (abnormal
      result, need to follow-up with physician). The only change to this portion of the study is
      the color of the envelope patients receive.

      Rationale and plan for Part 2: With the current program, the rate of follow-up diagnostic
      colonoscopy after abnormal FIT is 58%. Since individuals with abnormal FIT have an increased
      chance of having colorectal cancer, identifying alternate strategies to improve compliance
      with diagnostic colonoscopy is desirable. Accordingly the sub-study will employ a simple
      alerting tactic through the color of the envelope (red for abnormal and white for normal).
      The investigators hypothesize that more patients will follow-up after receiving a positive
      FIT result as a result of the messaging importance of abnormal tests with a red envelope.
      Because the sub-study will be employed in 2 predetermined rounds of invitations,
      investigators will have the opportunity to conduct a pre-post analysis of the follow-up rates
      to test this hypothesis.
    

Intervention name(s): Control condition; Cost condition; Cost/Future condition
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Patients will be mailed a control invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.; Patients will be mailed a cost condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.; Patients will be mailed a cost/future condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: neoplasm; colorectal; cancer; uninsured; FIT; fecal immunochemical test