Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States (U.S.). Results from randomized clinical trials and intervention studies have suggested that the implementation of a CRC screening program for men and women over the age of 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 a 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 the 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 a CDE.

Condition	Intervention
Colorectal Cancer Colorectal Neoplasms Colonic Neoplasms Colonic Diseases	Device: Electronic CRC Screening Event Notification System

Further Study Details: 

Primary Outcomes: FOBT positive follow-up: Baseline rates and timelines, Change in rates and timeliness between intervention and control sites, Change in rates and timeliness of pre-and post-intervention
Secondary Outcomes: To improve patient compliance through a combined scheduling/motivational telephone contact; To assess Department of Veterans Affairs (VA) primary care providers'''' knowledge, beliefs, attitudes and practices regarding FOBT screening and follow-up
Expected Total Enrollment:  80

Objectives:

The objectives of this study are:

• To implement an electronic CRC screening event notification system intervention to improve complete evaluation of patients with a positive FOBT at four of eight Department of Veterans Affairs Medical Centers (VAMCs) randomized to this intervention versus usual care;
• To conduct a qualitative evaluation to identify implementation barriers and facilitators, and to guide modifications of the CRC-ENS;
• To conduct an outcome evaluation to determine the effectiveness of the intervention to: *increase the proportion of patients with a positive FOBT receiving CDE; and *reduce the time-lag between notification of a positive FOBT result and scheduling of a follow-up endoscopic procedure;
• To improve patient compliance with follow-up recommendations through a combined scheduling/motivational telephone contact;
• To assess VA primary care providers’ knowledge, beliefs, attitudes and practices regarding FOBT screening and follow-up.

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 Veterans Health Administration (VHA) sites will be randomly assigned to either the CRC-ENS intervention or to a comparison 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 a 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.

Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00122187

Oregon
      Portland VA Medical Center, Portland,  Oregon,  97201,  United States

Study ID Numbers:  CRT 02-059
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122187
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26