CHOICE: Communicating Health Options Through Information and Cancer Education
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|ClinicalTrials.gov Identifier: NCT00134589|
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : August 4, 2009
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Behavioral: Academic Detailing (Medical Practices)+Decision Aids (Patients)||Phase 4|
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|
|Intervention Model:||Factorial Assignment|
|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|
- Completion of colorectal cancer screening
- Patient's intention to ask/patient asking medical provider for colorectal cancer screening
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 ClinicalTrials.gov identifier (NCT number): NCT00134589
|United States, Georgia|
|Emory University Rollins School of Public Health|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Karen Glanz, PhD, MPH||Emory University|