Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134589
Status:
COMPLETED
Last Update Posted:
2009-08-04
First Post:
2005-08-23
Brief Title:
CHOICE Communicating Health Options Through Information and Cancer Education
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Increasing CRC Screening in Health Plan Members
Status:
COMPLETED
Status Verified Date:
2007-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 US 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None