Strategies and Opportunities to Stop Colon Cancer in Priority Populations
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Only an estimated 50 million US adults aged 50-75 are up-to-date on colorectal cancer (CRC)
      screening according to guidelines set by the federal government. CRC is 90% curable with
      timely detection and appropriate treatment of precancerous polyps; increased screening could
      reduce incidence by up to 50%. Groups least likely to undergo screening, those with minimal
      education, low income, low access to health care, recent immigrants or Hispanics, are the
      same people who frequently receive care at Federally Qualified Healthcare Center's (FQHCs).
      The use of fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) is
      exceedingly low in FQHCs (7-9% of patients in the past year) and far below national averages
      and target rates. Our results will provide valuable information on how to use electronic
      health record (EHR) resources to optimize guideline-based screening in FQHC clinics whose
      patient populations have disproportionately low CRC screening rates.

      This project, in conjunction with the research team, will use an advisory panel to direct the
      research activities. The advisory panel will be made up of clinicians, leaders, researchers,
      and patients. The panel and team will guide the development of materials, the outreach to
      patients, and the research protocol to best reach FQHC patients who are due for colorectal
      cancer screening.

      This project will be conducted in two phases, Phase I is conducting a pilot at two FQHC's,
      and Phase II is rolling out the intervention to between 20-30 clinics.
    

Detailed description: 
      Phase I (Pilot Aims)

        -  Aim 1 Conduct preliminary analyses of EHR data at two pilot clinics.

        -  Aim 2: Use codes and methods developed in Aim 1 to test the feasibility, reach,
           effectiveness, and cost of an EHR-based CRC screening intervention using a subset of 100
           patients at each of two pilot clinics. We will use codes defined in Aim 1 to create a
           Solutions-based, Epic-integrated system to track CRC screening, mail FIT kits, and track
           patient test results and receipt of follow-up care. The system will be pilot-tested in
           two clinics.

        -  Aim 3: Use results from the pilot intervention to prepare for a large-scale,
           cluster-randomized pragmatic trial across 18 OCHIN clinics (see Phase II).

      Transition from Phase I to Phase II

      -Changes to our original proposal include going from a three arm to a two-arm pragmatic
      cluster trial with revised evaluation and power calculation and refinements to the
      intervention components for both usual care (now described as enhanced usual care) and the
      intervention (now described as enhanced auto).

      Phase II (Full trial Aims)

        -  Primary Aim 1. Assess the effectiveness of a large-scale, two-arm CRC screening program
           among diverse CLINIC patients, and assess difference in CRC screening outcomes (overall
           and by age, sex, insurance status, Hispanic ethnicity/race). The intervention will
           consist of an automated data-driven, EHR-linked program for mailing FIT kits (with
           linguistically appropriate pictographic instructions and return postage) to patients due
           for CRC screening.

        -  Primary Aim 2. Assess the costs and long-term cost-effectiveness of the automated
           program.

      We have also included two secondary aims:

        -  Secondary Aim 1. Assess adoption, implementation, reach and potential maintenance and
           spread of the program, using a mixed-method rapid assessment process, field notes, and
           other ethnographic data.

        -  Secondary Aim 2. Adapt and pilot-test the adaptation of STOP CRC in an alternate EHR
           platform, Allscripts, and develop an implementation guide to assist sites in adopting
           the program.
    

Intervention name(s): Auto Plus
Intervention type(s): Other
Intervention description(s): Clinics randomized to the Auto-Plus arm will engage in all activities in the Auto arm (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to one other outreach effort.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colorectal Cancer Screening; Cancer Screening; Pragmatic Trial