Web-Enhanced Guideline Implementation for Post MI CBOC Patients (VA MI Plus)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00126750
First received: August 2, 2005
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

To assist busy primary care clinicians in VA Community Based Outpatient Clinics (CBOCs) in managing complex patients by providing a single, interactive, and personalized source of information regarding applicable guidelines for post-MI patients. Specifically, 1) the investigators will identify barriers to provider adherence to guidelines within VHA clinics; 2) Apply guideline-based performance measures to electronic medical records (CPRS) and associated administrative data; 3) Implement the interactive Internet intervention developed by the NHLBI study, after inclusion of VA-specific components, including performance feedback for CBOC clinicians; and 4) Test hypotheses on the intervention's effectiveness, sustainability, and cost-effectiveness in both the VA and Medicare populations. This will include a randomized controlled trial with the CBOC as a unit of randomization.


Condition Intervention
Myocardial Infarction
Comorbidity
Behavioral: VA MI Plus Interactive

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: MI-Plus: Web-enhanced Guideline Implementation for Post MI CBOC Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Performance data obtained from patients' records of consenting participants (providers) to feedback performance data to intervention group and for hypothesis testing. [ Time Frame: 6/30/10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in performance of study indicators pre/post-intervention will be compared between control and intervention arms [ Time Frame: 6/30/10 ] [ Designated as safety issue: No ]

Enrollment: 394
Study Start Date: September 2003
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Behavioral: VA MI Plus Interactive
The experimental intervention, customized to the individual clinician in real-time consists of Internet learning modules integrating case-based education with audit, feedback, and benchmarking of practice profiles.

Detailed Description:

Some 7.1 million Americans and an estimated 250,000 Veterans actively using VHA are Myocardial Infarction (MI) survivors. To date, most guideline interventions focus on a single patient condition, but ambulatory post-MI patients are frequently more complex, multiple comorbidities, and conflicting guidelines applicable to them. For example, whereas JNC-6 guidelines for the treatment of hypertension suggest pharmacological treatment at blood pressures above 140/80 mm Hg, to be initiated with diuretics or beta-blockers as first line agents, other guidance suggests that for post-MI patients with diabetes, treatment cut-offs should be lower and ACE-inhibitors may be considered as optimal first-line agents. On October 1, 2002, the University of Alabama at Birmingham (UAB) began a study funded by the National Heart, Lung, and Blood institute (NHLBI) as an RO1 (Kiefe, PI (25%), Weissman, co-PI (20%)) to conduct a randomized trial, MI-plus to increase provider adherence to guidelines for post-MI patients. That NHLBI-funded study targets Medicare beneficiaries and their primary care providers in Alabama. Its primary goal is to develop and test with a randomized controlled trial, an Internet-based multimodal guideline implementation strategy. The investigators propose, herewith, to extend and adapt this study to a nationwide sample of VA post-MI patients and their primary care providers in the VA.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Potential subjects are defined as any VA-employed physician, PA, or CRNP who is a CBOC provider. All such providers will be offered the opportunity to participate and will have the option to agree to participate or not. Performance measure data from records of post-MI patients of the above providers will be extracted to test the experimental intervention. (Note: No individually identifying patient information will be extracted.) All VA-employed CBOC providers (physicians, PAs, CRNPs) will be offered the opportunity to participate in this study. Any subject may refuse to participate or to discontinue participation at will at any point in the study without consequence.

Exclusion Criteria:

Potential subjects must be VA-employed physician, PA, or CRNP who is a CBOC provider. No such healthcare providers will be excluded from the study.

  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: NCT00126750

  Hide Study Locations
Locations
United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
United States, Arkansas
Fayetteville, AR
Fayetteville, Arkansas, United States, 72703
United States, California
Long Beach
Long Beach, California, United States, 90822
VA Medical Center
San Francisco, California, United States, 94121
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, Florida
Bay Pines VA Healthcare System, Pay Pines, FL
Bay Pines, Florida, United States, 33708
VA Medical Center, Miami
Miami, Florida, United States, 33125
United States, Georgia
VA Medical Center, Decatur
Decatur, Georgia, United States, 30033
United States, Illinois
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, United States, 60612
VA Illiana Health Care System
Danville, Illinois, United States, 61832
United States, Iowa
VA Medical Center Iowa City
Iowa City, Iowa, United States, 52246
United States, Kansas
VA Eastern Kansas Health Care System - Topeka
Topeka, Kansas, United States, 66622
Robert J. Dole VAMC & ROC
Wichita, Kansas, United States, 67218
United States, Kentucky
VA Medical Center, Louisville
Louisville, Kentucky, United States, 40206
United States, Louisiana
Overton Brooks VA Medical Center, Shreveport, LA
Shreveport, Louisiana, United States, 71101
United States, Massachusetts
Edith Nourse Rogers Memorial Veterans Hospital
Bedford, Massachusetts, United States, 01730
VA Boston Health Care System, Jamaica Plain
Boston, Massachusetts, United States, 02130
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48105
Battle Creek, MI
Battle Creek, Michigan, United States, 49015
United States, Mississippi
VA Gulf Coast Veterans Health Care System
Biloxi, Mississippi, United States, 39531
United States, Missouri
Harry S. Truman Memorial VA Medical Center
Columbia, Missouri, United States, 65201-5297
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
VA Medical Center, St Louis
St Louis, Missouri, United States, 63106
United States, New Jersey
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, United States, 07018
United States, New York
Albany VA Medical Center: Samuel S. Stratton
Albany, New York, United States, 12208
No Longer Valid, Use 528A8
Albany, New York, United States, 12208
Franklin Delano Roosevelt Campus of VAHVHCS
Montrose, New York, United States, 10548
New York, NY
New York, New York, United States, 10010
United States, Ohio
VA Medical Center, Cincinnati
Cincinnati, Ohio, United States, 45220
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106-3800
United States, Pennsylvania
Coatesville, PA
Coatesville, Pennsylvania, United States, 19320
Lebanon, PA
Lebanon, Pennsylvania, United States, 17042
United States, Rhode Island
VA Medical Center, Providence
Providence, Rhode Island, United States, 02908-4799
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799
United States, Tennessee
VA Medical Center
Nashville, Tennessee, United States, 37212-2637
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Vermont
VA Medical & Regional Office Center, White River
White River Junction, Vermont, United States, 05009-0001
United States, Wisconsin
William S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, United States, 53705
Clement J. Zablocki VAMC
Milwaukee, Wisconsin, United States, 53295-1000
Puerto Rico
San Juan VAMC
San Juan, Puerto Rico, 00921-3201
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas K Houston, MD MPH Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Principal Investigator: Ellen Funkhouser, DrPH MS BS VA Medical Center, Birmingham
  More Information

Publications:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00126750     History of Changes
Other Study ID Numbers: SDR 03-090
Study First Received: August 2, 2005
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Myocardial Infarction
Comorbidities
Guidelines
Computer Assisted Instruction
Physician Practice Instruction
Online Systems

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014