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

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Device: Electronic Consult System

• Registration Number: NCT00122187
• Lead Sponsor: US Department of Veterans Affairs

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: 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2005-07-18
• Study First Submitted QC: 2005-07-18
• Study First Posted: 2005-07-21
• Study Start: 2005-08
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2013-09
• Results First Submitted: 2013-12-05
• Results First Submitted QC: 2013-12-05
• Results First Posted: 2014-01-27
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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

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Exclusion Criteria

• VA Medical Centers without electronic GI procedure documentation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electronic Consult System	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

Primary Outcome Measures

Name	Time	Method
Percent of Patients Receiving GI Consult for FOBT+ Results	6 months	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	6 months	Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results

Trial Locations

Locations (9)

VA Medical & Regional Office Center, White River; 🇺🇸 White River Junction, Vermont, United States

Tennessee Valley Healthcare System Nashville Campus, Nashville, TN; 🇺🇸 Nashville, Tennessee, United States

Southern Arizona VA Health Care System; 🇺🇸 Tucson, Arizona, United States

VA Eastern Colorado Health Care System, Denver, CO; 🇺🇸 Denver, Colorado, United States

Overton Brooks VA Medical Center; 🇺🇸 Shreveport, Louisiana, United States

Minneapolis; 🇺🇸 Minneapolis, Minnesota, United States

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States

Phoenix VA Health Care System, Phoenix, AZ; 🇺🇸 Phoenix, Arizona, United States

Durham VA Medical Center, Durham, NC; 🇺🇸 Durham, North Carolina, United States