CHOICE: Communicating Health Options Through Information and Cancer Education

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00134589
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : August 4, 2009
University of North Carolina
Aetna, Inc.
Information provided by:
Centers for Disease Control and Prevention

Brief Summary:
The purpose of this study is to determine the effectiveness of a two-component intervention, that combines academic detailing at the medical practice level and distribution of decision aids at the patient level, on adherence to colorectal cancer screening guidelines.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Behavioral: Academic Detailing (Medical Practices)+Decision Aids (Patients) Phase 4

Detailed Description:

Colorectal cancer is the second most common cause of cancer death in the United States. Early detection and intervention can significantly reduce morbidity and mortality from colorectal cancer (CRC), and current guidelines recommend that asymptomatic adults over age 50 periodically obtain screening by one of several modalities (FOBT, sigmoidoscopy, colonoscopy, or double contrast barium enema). However, CRC screening remains substantially underutilized in the U.S., and more than half of all adults do not adhere to these recommendations. This study was designed to increase CRC screening among health plan members, and involves the collaboration of a major health insurer.

We are conducting a cluster-randomized trial in health practices in Georgia and Florida, to test the effectiveness of a decision aid (video + brochures) for increasing adherence to CRC screening guidelines. Thirty-two large group practices were recruited and randomized to receive usual care (routine reminders) or an evidence-based decision aid intervention. In each practice, patients between the ages of 52 and 75, without current CRC screening history, were enrolled into the study.

In early 2007, we received a full HIPAA waiver that permitted us to send the decision aid intervention to long-term non-responders in the intervention group, and to access claims data for this group and the long-term non-responders in the usual care group. This procedure will make it possible for us to learn more about the real-world impact of the intervention.

The intervention will continue for up to 2 years for still-unscreened participants. The main outcome is receipt of an evidence-based modality of CRC screening according to the US Preventive Services Task Force Guidelines (FOBT, flexible sigmoidoscopy, colonoscopy, or double contrast barium enema).

Unique features of the proposed study include its potential to establish systems to increase screening uptake that will help fulfill HEDIS requirements; improving our understanding of how screening promotion interventions work in both White and Black populations; collaboration with a community partner of the Emory Prevention Research Center, and forging collaborative relationships between public health and health care researchers, and the affected communities of health plans and health care providers.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Official Title: Increasing CRC Screening in Health Plan Members
Study Start Date : April 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Completion of colorectal cancer screening

Secondary Outcome Measures :
  1. Patient's intention to ask/patient asking medical provider for colorectal cancer screening

Information from the National Library of Medicine

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Ages Eligible for Study:   52 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Ages 52-75
  • Aetna Health Plan member
  • Average risk for colorectal cancer
  • Did not have colorectal cancer screening within guideline time frame (1 to 10 years, depending on individual's age and type of screening)

Exclusion Criteria:

  • History of colorectal cancer, polyps, inflammatory bowel disease, upper or lower gastrointestinal bleeding, cirrhosis, chronic obstructive pulmonary disease, cancer, blindness, uncorrectable hearing loss, severe dementia, severe heart failure, severe coronary artery disease
  • Family history of colorectal cancer/polyps

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00134589

United States, Georgia
Emory University Rollins School of Public Health
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Centers for Disease Control and Prevention
University of North Carolina
Aetna, Inc.
Principal Investigator: Karen Glanz, PhD, MPH Emory University

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00134589     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-R-01-PH-000018
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: August 4, 2009
Last Verified: July 2007

Keywords provided by Centers for Disease Control and Prevention:
Academic Detailing
Decision Aid
Colorectal Cancer Screening

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases