Evaluating a Preference-based Intervention for Increasing Colorectal Cancer Screening
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The goal of this study is to evaluate whether an educational tool about colorectal cancer
      (CRC) completed on a computer that helps patients clarify their CRC screening preferences
      will lead to increased screening rates for CRC compared to standard information delivered via
      computer.
    

Detailed description: 
      Background: Colorectal cancer (CRC) is a significant and preventable disease, yet CRC
      screening remains one of the lowest quality indicators in the VA healthcare system. Moreover,
      a recent VA directive recommends that CRC screening among Veterans should be based on their
      preferences, given that there is insufficient evidence to support recommending one test.
      However the impact of such a preference-based strategy on important outcomes, including
      screening adherence and cost, is unknown.

      Objectives: The broad hypothesis of the proposed study is that helping Veterans clarify their
      CRC screening preferences will lead to increased adherence. The framework conceptualizes that
      preference clarification leads to more informed decision-making and, eventually, to better
      adherence with screening. The specific aims are: 1) To test the effectiveness of a
      preference-tailored (PT) vs. standard information (SI) intervention for increasing Veterans'
      CRC screening adherence; 2) To assess the impact of the intervention on informed decision
      making, knowledge and attitudes toward screening, decisional outcomes, and intention to get
      screened; and 3) To conduct a cost effectiveness analysis of the PT intervention for
      increasing CRC screening across the VA.

      Methods: A randomized controlled trial of the PT vs. SI decision tool will be conducted in
      the Ann Arbor and Pittsburgh VA healthcare systems. The intervention was developed by the PI
      working with the Center for Health Communication Research at the University of Michigan.
      Eligible patients will be 552 (276 per group) Veterans between 50 and 78 who are due for CRC
      screening, and who have a primary care visit scheduled within the upcoming 4-6 weeks. Those
      at high risk (e.g., family or personal history of CRC) will be excluded. Providers will be
      informed of the study via regular mail and email. In Ann Arbor providers will be given the
      opportunity to opt-out their participants if they choose to do so. In Pittsburgh providers
      will be given lists of their participants as they are being considered for the study and will
      be given the chance to remove any potential participants from the contact list. Potential
      participants will be mailed an introductory letter. Those who do not opt-out will contacted
      by telephone. Participants will come to their primary care visit 40 minutes early, at which
      time they will complete informed consent. The intervention will be delivered via the
      Internet, and participants will be randomized to the PT or SI arm at the time of log-in.
      Study measures are consistent with the conceptual framework and based on the Preventive
      Health Model. Preference information will be collected through the computer program.
      Secondary outcomes and independent variables will be collected via telephone survey 3 days
      following the intervention. Adherence to screening will be collected from medical charts at 6
      months. CRC screening information in a sub-sample of 80 Ann Arbor Veterans, not in either the
      PT or SI groups, will also be collected to measure "usual care" (UC). Pittsburgh will use the
      External Peer Review Program (EPRP) for the collection of clinical performance measures, more
      specifically CRC screening rates, to serve as an effective substitute for the UC group.
      Hypotheses related to each aim will be tested using multi-level modeling to control for
      between-provider effects. The overall hypothesis is that patients in the PT group will have
      higher rates of adherence to CRC screening at the 6 month follow-up point. Cost effectiveness
      analysis will determine whether a preference-based screening strategy could be cost effective
      for the VA healthcare system. The PI will work with the investigative team to disseminate the
      results through local and national VA websites, publications and presentations.

      Status: Active, not recruiting.
    

Intervention name(s): Standard Information; Preference-tailored Information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.; A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Health Services Research
Keywords: Hospitals, Veterans; Mass Screening/utilization; Patient Preference; Prevention & Control; Epidemiology