Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122187
Status:
COMPLETED
Last Update Posted:
2015-04-24
First Post:
2005-07-18
Brief Title:
Translation of Colorectal Cancer Screening Guidelines to Practice A System Intervention
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Translation of Colorectal Cancer Screening Guidelines A System Intervention
Status:
COMPLETED
Status Verified Date:
2013-09
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:
Colorectal cancer CRC is the second leading cause of cancer-related deaths in the United States Results from randomized clinical trials and intervention studies have suggested that implementation of a CRC screening program for men and women over age 50 results in reduced CRC mortality However for this reduction to be fully realized it is imperative that all positive screening tests are followed by complete diagnostic evaluation CDE Numerous intervention programs have been used to improve initial CRC screening rates but data indicate that outside the research setting less than half of patients with a positive fecal occult blood test FOBT screening result undergo CDE To enhance the translation of this best practice recommendation to clinical practice the investigators propose to implement an electronic event notification intervention CRC-ENS directed at making physician and system level changes to increase the proportion of patients with an abnormal FOBT that undergo CDE
Detailed Description:
Objectives 1To implement an electronic CRC screening event notification system intervention to improve complete evaluation of patients with a positive FOBT at four of eight VAMCs randomized to this intervention vs usual care
2To conduct a qualitative evaluation to identify implementation barriers and facilitators and to guide modifications of the CRC-ENS 3To conduct an outcome evaluation to determine the effectiveness of the intervention to
a increase the proportion of patients with a positive FOBT receiving CDE b reduce the time-lag between notification of a positive FOBT result and scheduling of a follow-up endoscopic procedure 4 To improve patient compliance with follow-up recommendations through combined scheduling
Methods The CRC-ENS intervention employs a relatively simple alteration to the current electronic mechanism for notifying the primary care provider PCP of when a positive FOBT is recorded With the CRC-ENS this notification will be forwarded to the gastroenterology GI clinic as well as the PCP This notification at the GI clinic will set off a cascade of events that would normally only be triggered by a consult request from the PCP In this translation study eight participating VHA sites will be randomly assigned to either the CRC-ENS intervention or usual care group The proposed project will take two years to complete During the first project year the participating sites will be recruited and randomized Pre-intervention change of awareness strategies will be initiated at all intervention sites The CRC-ENS intervention will be implemented in the second project year and formative evaluation including two sets of focus groups will be carried out throughout the intervention period Post-intervention data collection outcome evaluation and dissemination of results will be carried out in months 18-24
2To conduct a qualitative evaluation to identify implementation barriers and facilitators and to guide modifications of the CRC-ENS 3To conduct an outcome evaluation to determine the effectiveness of the intervention to
a increase the proportion of patients with a positive FOBT receiving CDE b reduce the time-lag between notification of a positive FOBT result and scheduling of a follow-up endoscopic procedure 4 To improve patient compliance with follow-up recommendations through combined scheduling
Methods The CRC-ENS intervention employs a relatively simple alteration to the current electronic mechanism for notifying the primary care provider PCP of when a positive FOBT is recorded With the CRC-ENS this notification will be forwarded to the gastroenterology GI clinic as well as the PCP This notification at the GI clinic will set off a cascade of events that would normally only be triggered by a consult request from the PCP In this translation study eight participating VHA sites will be randomly assigned to either the CRC-ENS intervention or usual care group The proposed project will take two years to complete During the first project year the participating sites will be recruited and randomized Pre-intervention change of awareness strategies will be initiated at all intervention sites The CRC-ENS intervention will be implemented in the second project year and formative evaluation including two sets of focus groups will be carried out throughout the intervention period Post-intervention data collection outcome evaluation and dissemination of results will be carried out in months 18-24
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