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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00122187 |
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 | Intervention |
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Colorectal Cancer |
Device: Electronic Medical Record Intervention |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Translation of Colorectal Cancer Screening Guidelines: A System Intervention |
Estimated Enrollment: | 1468 |
Study Start Date: | August 2005 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
A new consult system as compared to the usual and customary procedures.
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Device: Electronic Medical Record Intervention
An updated consult system which is automated rather than human
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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 a combined scheduling/motivational telephone contact. 5. 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 VHA sites will be randomly assigned to either the CRC-ENS intervention or 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 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 |
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
United States, Arizona | |
Carl T. Hayden VA Medical Center | |
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 | |
Denver, Colorado, United States, 80220 | |
United States, Louisiana | |
Overton Brooks VA Medical Center | |
Shreveport, Louisiana, United States, 71101-4295 | |
United States, Minnesota | |
Minneapolis | |
Minneapolis, Minnesota, United States, 55417 | |
United States, North Carolina | |
Durham VA Medical Center HSR&D COE | |
Durham, North Carolina, United States, 27705 | |
United States, Oregon | |
Portland | |
Portland, Oregon, United States, 97239 | |
United States, Tennessee | |
VA Medical Center, Nashville | |
Nashville, Tennessee, United States, 37212-2637 | |
United States, Vermont | |
VA Medical & Regional Office Center, White River | |
White River Junction, Vermont, United States, 05009-0001 |
Principal Investigator: | Linda L. Humphrey, MD MPH | Portland |
Responsible Party: | Department of Veterans Affairs ( Humphrey, Linda - Principal Investigator ) |
Study ID Numbers: | CRT 02-059 |
Study First Received: | July 18, 2005 |
Last Updated: | May 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00122187 |
Health Authority: | United States: Federal Government |
cancer colonoscopy mass screening colorectal cancer colorectal carcinoma reminder systems rectal cancers |
colorectal tumor guidelines CRC secondary prevention colorectal neoplasms colonic neoplasms colonic diseases hemoccult testing |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Rectal neoplasm |
Carcinoma Digestive System Diseases Neoplasm Metastasis Gastrointestinal Neoplasms Rectal cancer Colonic Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |