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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00122187
First received: July 18, 2005
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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
Colorectal Cancer
Device: Electronic Consult System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Translation of Colorectal Cancer Screening Guidelines: A System Intervention

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Percent of Patients Receiving GI Consult for FOBT+ Results [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Percent of patients receiving GI consult plus anatomic workup within 30, 90, and 180 days of FOBT+ results


Enrollment: 8
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
Experimental: Electronic Consult System
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
Consult system is an event notification system programmed to function within the VA electronic medical record system.
No Intervention: Usual Care
The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122187

Locations
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, 97239-2964
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
Sponsors and Collaborators
Investigators
Principal Investigator: Linda L. Humphrey, MD MPH Portland
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00122187     History of Changes
Other Study ID Numbers: CRT 02-059
Study First Received: July 18, 2005
Results First Received: December 5, 2013
Last Updated: April 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 22, 2014