Facilitating Risk-Appropriate Colorectal Cancer Testing - Testing the Cancer Risk Intake System (CRIS)
Condition: Colorectal Neoplasms; Colonic Neoplasms
MeSH terms: Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
Study type: Interventional

Summary: 
      This study will adapt and test a touch-screen computer program to evaluate cancer risk and
      provide patient-tailored recommendations for appropriate risk-based testing. This
      individually tailored intervention delivered right at the point of primary care and just
      prior to the office visit, can be a helpful and non-obstructive adjunct to clinical care.

      The primary aim of this project is to test whether a tailored intervention promoting
      risk-appropriate cancer testing results increases participation compared with a simple
      non-tailored reminder or no reminder. The trial is designed to determine the extent to which
      the Cancer Risk Intake System (CRIS) facilitates (1) participation in risk-appropriate
      colorectal cancer testing, as documented by electronic medical record audit; (2) patient
      receipt of risk-appropriate colorectal cancer testing recommendations from their physicians,
      as documented by electronic medical record audit; and (3) changes in patients' intent to
      participate in risk-appropriate colorectal cancer testing, as documented by patient report.

      The Family and Community Medicine and General Internal Medicine clinic databases will be used
      to identify potentially eligible patients with upcoming scheduled appointments. Because
      physicians will be the unit of random assignment, patients will be coded before study
      invitation as potential participants in the intervention or the comparison group. A random
      sample of eligible intervention and comparison group patients will be selected for contact.
      Identified patients will be mailed letters from the practices and signed by their physicians
      requesting their participation. The letters will describe a "study of beliefs and practices
      about cancer prevention and early detection" and will provide a toll-free number to refuse
      contact. One week after the mailing, patients who have not called to refuse contact will be
      called by study staff to explain the study, verify eligibility and, if the patient agrees, to
      arrange an in-person meeting at the clinic 30 minutes prior to their appointment. These calls
      will be made by trained research assistants who will follow standard calling protocols. After
      consent, participants will complete the computerized data collection (CRIS) immediately prior
      to a scheduled primary-care appointment. Intervention group patients and their physicians
      will receive a printout recommending risk-appropriate colorectal testing and ways to overcome
      perceived barriers to testing. A member of the research team will hand the patient his or her
      printout and will deliver the other printout to the physician. Comparison group patients and
      physicians will receive non-tailored printouts that are simple reminders about testing.

      The investigators will also establish a true no-contact control by conducting a retrospective
      chart review for randomly selected patients who did not receive an invitation to participate
      in the study. This no-contact control will establish a baseline screening rate. The
      investigators will then conduct analysis with the comparison and intervention group to see if
      individuals who participate in CRIS have a higher screening rate for colorectal cancer
      compared to the non-contact group. These additional data will help us better assess study
      Aims 1 and 2.
    


Intervention name(s): Tailored Printout
Intervention type(s): Behavioral
Intervention description(s): The Cancer Risk Intake System (CRIS) is a tablet-based program through which patients answer detailed questions about their colorectal cancer risk prior to an appointment. Tailoring algorithms in CRIS generate printed information for patients and their physicians summarizing their risk factors and matching them with guideline-based screening options.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Screening
Keywords: Early Detection of Cancer; Intervention Studies; Randomized Controlled Trial; Colorectal Neoplasms; Colonic Neoplasms