Translation of Colorectal Cancer Screening Guidelines to Practice: A System Intervention
1 other identifier
interventional
8
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable colorectal-cancer
Started Aug 2005
Typical duration for not_applicable colorectal-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2005
CompletedFirst Posted
Study publicly available on registry
July 21, 2005
CompletedStudy Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
January 27, 2014
CompletedApril 24, 2015
September 1, 2013
2.8 years
July 18, 2005
December 5, 2013
April 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Electronic Consult System
EXPERIMENTALA new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
Usual Care
NO INTERVENTIONThe usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
Interventions
Consult system is an event notification system programmed to function within the VA electronic medical record system.
Eligibility Criteria
You may qualify if:
- \- VA Medical Centers with either CORI (Clinical Outcomes Research Initiative) or electronic notes/descriptions documenting GI endoscopic procedures
You may not qualify if:
- \- VA Medical Centers without electronic GI procedure documentation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012, United States
Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
VA Eastern Colorado Health Care System, Denver, CO
Denver, Colorado, 80220, United States
Overton Brooks VA Medical Center
Shreveport, Louisiana, 71101-4295, United States
Minneapolis
Minneapolis, Minnesota, 55417, United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705, United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97239, United States
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637, United States
VA Medical & Regional Office Center, White River
White River Junction, Vermont, 05009-0001, United States
Related Publications (3)
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.
PMID: 19726776RESULTMessersmith 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.
PMID: 18946069RESULTHumphrey 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.
PMID: 21327529RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Half of the sites randomized did not complete the study. GI referral rates should have been nearly 100%, yet were not. Because of programming limitations, we were unable to evaluate the type of diagnostic interventions the patients received.
Results Point of Contact
- Title
- Linda Humphrey
- Organization
- VAHSRD
Study Officials
- PRINCIPAL INVESTIGATOR
Linda L. Humphrey, MD MPH
VA Portland Health Care System, Portland, OR
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2005
First Posted
July 21, 2005
Study Start
August 1, 2005
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
April 24, 2015
Results First Posted
January 27, 2014
Record last verified: 2013-09