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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00122187
Recruitment Status : Completed
First Posted : July 21, 2005
Results First Posted : January 27, 2014
Last Update Posted : April 24, 2015
Information provided by (Responsible Party):
VA Office of Research and Development ( 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Device: Electronic Consult System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Translation of Colorectal Cancer Screening Guidelines: A System Intervention
Study Start Date : August 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Device: Electronic Consult System
Consult system is an event notification system programmed to function within the VA electronic medical record 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.

Primary Outcome Measures :
  1. 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

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00122187

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United States, Arizona
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
United States, Colorado
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, United States, 80220
United States, Louisiana
Overton Brooks VA Medical Center
Shreveport, Louisiana, United States, 71101-4295
United States, Minnesota
Minneapolis, Minnesota, United States, 55417
United States, North Carolina
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705
United States, Oregon
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97239
United States, Tennessee
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, United States, 37212-2637
United States, Vermont
VA Medical & Regional Office Center, White River
White River Junction, Vermont, United States, 05009-0001
Sponsors and Collaborators
US Department of Veterans Affairs
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Principal Investigator: Linda L. Humphrey, MD MPH VA Portland Health Care System, Portland, OR
Publications of Results:
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Responsible Party: US Department of Veterans Affairs Identifier: NCT00122187    
Other Study ID Numbers: CRT 02-059
First Posted: July 21, 2005    Key Record Dates
Results First Posted: January 27, 2014
Last Update Posted: April 24, 2015
Last Verified: September 2013
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
mass screening
colorectal cancer
colorectal carcinoma
reminder systems
rectal cancers
colorectal tumor
CRC secondary prevention
colorectal neoplasms
colonic neoplasms
colonic diseases
hemoccult testing
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases