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Clinical Trials/NCT00122187
NCT00122187CompletedNot Applicable

Translation of Colorectal Cancer Screening Guidelines: A System Intervention

US Department of Veterans Affairs9 sites in 1 country8 target enrollmentStarted: August 1, 2005Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
8
Locations
9
Primary Endpoint
Percent of Patients Receiving GI Consult for FOBT+ Results

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Electronic Consult System

Experimental

A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results

Intervention: Electronic Consult System (Device)

Usual Care

No Intervention

The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.

Outcomes

Primary Outcomes

Percent of Patients Receiving GI Consult for FOBT+ Results

Time Frame: 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

Time Frame: 6 months

Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (9)

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