Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Colon cancer (CRC) is a leading cause of cancer death in the United States. Screening can
      prevent CRC death, but screening rates are suboptimal, especially for vulnerable populations
      such as those with limited or no health insurance. This striking public health challenge
      demands urgent implementation of evidence-based strategies to reduce avoidable CRC death.

      Prior research has shown that a direct-to-consumer strategy of inviting patients by mail to
      complete CRC screening may result in increased rates of screening completion. However, this
      approach has not been tested extensively in vulnerable populations, such as the
      under/uninsured, and minority populations often cared for by safety-net health systems.
      Further, it is unclear whether patients are more likely to participate in one CRC screening
      test versus another. Knowing this is important to designing programs for increasing
      screening. For example, the planning and resources required for a screening program with
      colonoscopy--which is a sensitive but invasive and expensive test--are very different from a
      program with that uses stool testing to detect microscopic blood such as an immunochemical
      stool blood test--which is a less sensitive, but non-invasive and cheap test.

      Also, it is possible designing a program with a less sensitive, but more acceptable test
      could prevent more CRC death if participation in screening is test specific. For example, if
      many more patients participate in an immunochemical stool blood test based program than a
      colonoscopy based program, even though the immunochemical stool blood test is less sensitive,
      the program may save more lives because more patients are reached.

      The aims of this trial are to:

      Aim 1. Deliver CRC screening services (mailed invitation to screening, telephone reminders,
      and systematic clinical follow up) to uninsured, unscreened patients cared for by the
      safety-net health system serving Tarrant County, Texas. Patients will be invited to either:

        1. Complete a free home-based, non-invasive immunochemical stool blood test

        2. Complete a free colonoscopy

      Aim 2. Evaluate program outcomes, including screening rates, cancers detected, and program
      costs.

      The primary outcome is screening completion.
    

Detailed description: 
      Program setting. The John Peter Smith Hospital Health System (JPS) is a safety-net health
      care system serving Tarrant County, Texas (including Fort Worth), with over 850,000 yearly
      patient encounters. JPS qualifies as a safety-net health system based on a commitment to
      deliver health care to uninsured, Medicaid participants, and other vulnerable patients18, and
      is recognized as a disproportionate share hospital. JPS offers a tax-subsidized charity
      medical program called JPS Connection for uninsured Tarrant County residents who are not
      eligible for state or federal assistance programs such as Medicaid, with qualification based
      on federal poverty income levels.

      Target population. Our specific project target population includes men and women, aged 54 to
      64, without prior CRC screening, of all races/ethnicities (including African Americans,
      Hispanics, and Whites), who are primary English or Spanish language speaking, and uninsured
      but enrolled in the JPS Connection medical assistance program. We include only those
      individuals who qualify and are enrolled in the JPS Connection medical assistance program to
      ensure that all included patients have access to a primary provider, as well as surgical and
      medical cancer care, in the event that a patient has a cancer diagnosed.

      TREATMENT (INTERVENTION) We will screen the administrative dataset that we are using to
      identify potential study participants for individuals who meet inclusion criteria. All
      patients selected to one of the programmatic screening approaches (Mailed FIT or Mailed
      Colonoscopy invitation) will receive the same, structured approach for encouragement of
      completion of CRC screening with the exception of the initial screening modality offered
      (e.g. FIT or colonoscopy). In addition, patients selected for program intervention will also
      be free to engage in usual medical care, and any associated visit-based screening at the
      discretion and preference of the individual and primary medical provider.

      Mailed invitation program procedures. Every 3 months, ¼ of the patient group selected for the
      mail out program will receive an electronic, automated phone call, alerting them that an
      invitation to participate in CRC screening will be mailed to them shortly. All invitees,
      regardless of screen-group, will receive: 1) Invitation to participate in CRC screening with
      a specific test, including discussion of importance of screening, 2) Return card that may
      request to not participate in screening/be contacted in the future ("opt out" request). The
      invitations will be sent every 3 months in batches, rather than all at once, to allocate
      manpower resources for program follow up, and colonoscopy services as necessary for positive
      tests or screening requests.

      Alert and reminder phone calls. At time of initial mailing of the invitation, a "TeleVox©"
      automated phone message, with a pre-recorded script (in both English and Spanish) will be
      generated to alert participants that an invitation is "in-the-mail." Fourteen days after
      initial mailing of the invitation, a "TeleVox©" automated reminder to respond to the
      invitation for screening with a pre-recorded script (in both English and Spanish) will be
      generated for all participants. Twenty-one to 36 days after initial invitation to testing, a
      "live" reminder phone call will be initiated by the screening coordination team for all
      individuals who have not responded to screening invitation. Up to 2 attempts will be made to
      contact individuals via phone; reaching a voice mail, an adult household member, or the
      target study participant will be considered a successful attempt. Reaching a disconnected,
      busy line, or line that rings with no answer on two attempts will be considered unsuccessful
      attempt. Continued intervention and follow up will not be based on whether or not phone call
      attempts were successful-all patients included in the program will be assessed for the
      outcome of screening participation.

      Invitation letters. The invitation letters for screening with FIT or colonoscopy will contain
      the following elements: 1) Statement that risk of getting colon cancer increases with age and
      that screening can reduce the consequences, 2) Invitation to a specific modality, (FIT or
      colonoscopy) with a succinct description of the test, 3) Number to call with questions, 4) In
      the case of colonoscopy invitation, number to call to sign up, 5) Signature from a physician
      at JPS.

      FIT procedures. Individuals assigned to FIT will be provided with written instructions on how
      to collect the stool samples for FIT testing. Kits will be mailed using return envelopes with
      pre-paid postage to a JPS.

      Colonoscopy procedures. The colonoscopy invitation will consist of an explanation of
      colonoscopy, as well as a phone number to call to schedule a colonoscopy ("direct book") or a
      pre-colonoscopy clinic visit. The decision to "direct book" for colonoscopy or to arrange for
      a pre-colonoscopy clinic visit will be based on screening nurse phone interview using a short
      screening form. If potential medical contraindications to colonoscopy are noted, a
      pre-colonoscopy visit will be scheduled with a physician at JPS. Patients with uncontrolled
      medical conditions will be referred to primary physicians for further management and to
      consider CRC screening once the condition is under control. Reasons for not scheduling
      colonoscopy will be documented. The patient will receive a date and time assignment for the
      colonoscopy procedure, and instructions on bowel preparation for the procedure. The
      preparation kit will be mailed to the patient's home. Reminder calls 5-7 days prior to the
      procedure to confirm the date and time of the procedure, review bowel preparation
      instructions, and answer any questions will occur. The day of the procedure, a history and
      physical will be performed to re-assess for any contraindications for colonoscopy. Polyps
      identified will be removed completely, with repeat colonoscopy and/or surgery if polyp
      removal not successful. Any mass lesions and any areas of inflamed or irregular colon mucosa
      will undergo biopsy. Endoscopy findings will be reviewed with each participant.

      Test Follow Up. Individuals with positive FIT will be contacted to schedule a colonoscopy,
      with the goal of test completion within 8-12 weeks of test positivity. If phone contact for
      test scheduling cannot be established, a certified letter will be sent. Individuals with
      findings of adenoma or cancer on colonoscopy will be scheduled for a follow up,
      post-colonoscopy visit with the endoscopist who performed the procedure. Individuals with
      normal FIT or colonoscopy screening tests will have a letter mailed to his or her home, as
      well as the primary outpatient clinic identified by administrative data.
    

Intervention name(s): Mailed invitations for FIT test kits; Mailed invitations for a colonoscopy; Visit Based Care
Intervention type(s): Other; Other; Other
Intervention description(s): Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.; These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.; Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.
Other intervention name(s): Polymedco Fecal Immunochemical Test
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: colorectal neoplasms; screening