Clinical trial NCT00122187: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-07-21
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Percent of Patients Receiving GI Consult for FOBT+ Results
timeFrame: 6 months
measure: Percent of Patients Receiving GI Consult Plus Anatomic Workup for FOBT+ Results
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Health Care System, Phoenix, AZ
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver, CO
state: Colorado
city: Shreveport
country: United States
facility: Overton Brooks VA Medical Center
state: Louisiana
city: Minneapolis
country: United States
facility: Minneapolis
state: Minnesota
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
city: Nashville
country: United States
facility: Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
state: Tennessee
city: White River Junction
country: United States
facility: VA Medical & Regional Office Center, White River
state: Vermont
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Linda L. Humphrey, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.