CHOICE: Communicating Health Options Through Information and Cancer Education

This study has been completed.
Sponsor:
Collaborators:
University of North Carolina
Aetna, Inc.
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00134589
First received: August 23, 2005
Last updated: August 3, 2009
Last verified: July 2007
  Purpose

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 Intervention Phase
Colorectal Neoplasms
Behavioral: Academic Detailing (Medical Practices)+Decision Aids (Patients)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Official Title: Increasing CRC Screening in Health Plan Members

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Completion of colorectal cancer screening

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

Enrollment: 450
Study Start Date: April 2005
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   52 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134589

Locations
United States, Georgia
Emory University Rollins School of Public Health
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
University of North Carolina
Aetna, Inc.
Investigators
Principal Investigator: Karen Glanz, PhD, MPH Emory University
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00134589     History of Changes
Other Study ID Numbers: CDC-NCCDPHP-R-01-PH-000018
Study First Received: August 23, 2005
Last Updated: August 3, 2009
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on August 26, 2014