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

Study Overview
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Brief Summary
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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
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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 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.

Official Title
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Translation of Colorectal Cancer Screening Guidelines: A System Intervention

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: Electronic Consult System


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic Consult System<br>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<br>* Consult system is an event notification system programmed to function within the VA electronic medical record system.<br>|
| No Intervention: Usual Care<br>The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Patients Receiving GI Consult for FOBT+ Results | Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results | 6 months | 
| Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results | Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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