Translation of Colorectal Cancer Screening Guidelines to Practice: A System Intervention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00122187
First received: July 18, 2005
Last updated: April 8, 2014
Last verified: April 2014

July 18, 2005
April 8, 2014
August 2005
May 2008   (final data collection date for primary outcome measure)
  • Percent of Patients Receiving GI Consult for FOBT+ Results [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results
  • Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results
  • 2. Change in rates and timeliness between intervention and control sites: 3) Change in rates and timeliness of pre-and post-inter
  • FOBT positive follow-up:
  • 1. Baseline rates and timelines:
Complete list of historical versions of study NCT00122187 on ClinicalTrials.gov Archive Site
Not Provided
  • 1) To improve patient compliance through a combined scheduling/motivational telephone contact:
  • 2) To assess VA primary care providers' knowledge, beliefs, attitudes and practices regarding FOBT screening and follow-up.
Not Provided
Not Provided
 
Translation of Colorectal Cancer Screening Guidelines to Practice: A System Intervention
Translation of Colorectal Cancer Screening Guidelines: A System Intervention

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.

Objectives: 1.To 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.

2.To conduct a qualitative evaluation to identify implementation barriers and facilitators, and to guide modifications of the CRC-ENS. 3.To 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Colorectal Cancer
Device: Electronic Consult System
Consult system is an event notification system programmed to function within the VA electronic medical record system.
  • Experimental: Electronic Consult System
    A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
    Intervention: Device: Electronic Consult System
  • No Intervention: Usual Care
    The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

- VA Medical Centers with either CORI (Clinical Outcomes Research Initiative) or electronic notes/descriptions documenting GI endoscopic procedures

Exclusion Criteria:

- VA Medical Centers without electronic GI procedure documentation

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00122187
CRT 02-059
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Linda L. Humphrey, MD MPH Portland
Department of Veterans Affairs
April 2014

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