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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Consult System
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix VA Health Care System, Phoenix, AZ
  • Southern Arizona VA Health Care System
  • VA Eastern Colorado Health Care System, Denver, CO
  • Overton Brooks VA Medical Center
  • Minneapolis
  • Durham VA Medical Center, Durham, NC
  • VA Portland Health Care System, Portland, OR
  • Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
  • VA Medical & Regional Office Center, White River

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Electronic Consult System

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Percent of Patients Receiving GI Consult for FOBT+ Results
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
Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results

Secondary Outcome Measures

Full Information

First Posted
July 18, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00122187
Brief Title
Translation of Colorectal Cancer Screening Guidelines to Practice: A System Intervention
Official Title
Translation of Colorectal Cancer Screening Guidelines: A System Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electronic Consult System
Arm Type
Experimental
Arm Description
A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
Intervention Type
Device
Intervention Name(s)
Electronic Consult System
Intervention Description
Consult system is an event notification system programmed to function within the VA electronic medical record system.
Primary Outcome Measure Information:
Title
Percent of Patients Receiving GI Consult for FOBT+ Results
Description
Percent of patients receiving GI consult within 30, 90, and 180 days of FOBT+ results
Time Frame
6 months
Title
Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results
Description
Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda L. Humphrey, MD MPH
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix VA Health Care System, Phoenix, AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Southern Arizona VA Health Care System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
VA Eastern Colorado Health Care System, Denver, CO
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Overton Brooks VA Medical Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101-4295
Country
United States
Facility Name
Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Durham VA Medical Center, Durham, NC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-2637
Country
United States
Facility Name
VA Medical & Regional Office Center, White River
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009-0001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19726776
Citation
Tsai TT, Nallamothu BK, Prasad A, Saint S, Bates ER. Clinical problem-solving. A change of heart. N Engl J Med. 2009 Sep 3;361(10):1010-6. doi: 10.1056/NEJMcps0903023. No abstract available.
Results Reference
result
PubMed Identifier
18946069
Citation
Messersmith WA, Ahnen DJ. Targeting EGFR in colorectal cancer. N Engl J Med. 2008 Oct 23;359(17):1834-6. doi: 10.1056/NEJMe0806778. No abstract available.
Results Reference
result
PubMed Identifier
21327529
Citation
Humphrey LL, Shannon J, Partin MR, O'Malley J, Chen Z, Helfand M. Improving the follow-up of positive hemoccult screening tests: an electronic intervention. J Gen Intern Med. 2011 Jul;26(7):691-7. doi: 10.1007/s11606-011-1639-3. Epub 2011 Feb 15.
Results Reference
result

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

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