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CHOICE: Communicating Health Options Through Information and Cancer Education

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134589
First Posted: August 25, 2005
Last Update Posted: August 4, 2009
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.
Collaborators:
University of North Carolina
Aetna, Inc.
Information provided by:
Centers for Disease Control and Prevention
August 23, 2005
August 25, 2005
August 4, 2009
April 2005
April 2009   (Final data collection date for primary outcome measure)
Completion of colorectal cancer screening
Same as current
Complete list of historical versions of study NCT00134589 on ClinicalTrials.gov Archive Site
Patient's intention to ask/patient asking medical provider for colorectal cancer screening
Same as current
Not Provided
Not Provided
 
CHOICE: Communicating Health Options Through Information and Cancer Education
Increasing CRC Screening in Health Plan Members
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Colorectal Neoplasms
Behavioral: Academic Detailing (Medical Practices)+Decision Aids (Patients)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
April 2009
April 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
52 Years to 75 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00134589
CDC-NCCDPHP-R-01-PH-000018
Not Provided
Not Provided
Not Provided
Not Provided
Centers for Disease Control and Prevention
  • University of North Carolina
  • Aetna, Inc.
Principal Investigator: Karen Glanz, PhD, MPH Emory University
Centers for Disease Control and Prevention
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP