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Evaluating a Preference-based Intervention for Increasing CRC Screening

50 Years
78 Years
Not Enrolling
Colorectal Neoplasms

Thank you

Trial Information

Evaluating a Preference-based Intervention for Increasing CRC Screening

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.

Inclusion Criteria:

- Clinic appointment at Ann Arbor or Pittsburgh VA during recruitment period.

- Age 50-78.

- Not up to date with CRC screening according to VA and USPSTF guidelines.

- At average risk for CRC (no history of CRC, adenomatous colon polyps, inflammatory
bowel disease, and no family history of CRC).

- Has current address and telephone number listed in medical record.

Exclusion Criteria:

- DNR/DNI code status.

- Metastatic cancer.

- Stage D congestive heart failure.

- Severe COPD.

- Coronary artery disease (CAD) and MI within one year or CAD and unstable angina
within 6 months.

- Dementia.

- Inability to conduct activities of daily living.

- Life expectancy less than one year.

- Other - anything else that limits CRC screening options.

- Scheduled for a colonoscopy, sigmoidoscopy, DCBE, or CTC.

- prior participation in this study

- unable to contact after 2 introductory letters (at least 6 months apart)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Outcome Measure:

CRC screening rate.

Outcome Time Frame:

Within 6 months of Decider Guider intervention.

Safety Issue:


Principal Investigator

Sarah T Hawley, PhD MPH BA

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ann Arbor VA Medical Center


United States: Federal Government

Study ID:

IIR 06-205



Start Date:

February 2009

Completion Date:

August 2012

Related Keywords:

  • Colorectal Neoplasms
  • Hospitals, Veterans
  • Mass Screening/utilization
  • Patient Preference
  • Prevention & Control
  • Epidemiology
  • Neoplasms
  • Colorectal Neoplasms



VA Ann Arbor Healthcare SystemAnn Arbor, Michigan  48113
Center for Health Equity Research and PromotionPittsburgh, Pennsylvania  15206