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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00126750
Recruitment Status : Completed
First Posted : August 4, 2005
Results First Posted : July 23, 2015
Last Update Posted : July 23, 2015
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Myocardial Infarction Comorbidity Behavioral: VA MI Plus Interactive Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 847 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: MI-Plus: Web-enhanced Guideline Implementation for Post MI CBOC Patients
Study Start Date : September 2003
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Primary Outcome Was the Performance of Each Provider on Each of Seven Clinical Indicators [ Time Frame: 1/1/02 - 12/31/08 ]
    The investigators used an intent-to-treat approach for our main analysis, basing our outcome measures on provider's eligible patient population in each of the clinics. Performance improvement was calculated at the change (before vs after the intervention) the percentage of provider's patients with each clinical indicator. 1) change in the percentage of patients with improvements in LDL. Improvement defined as LDL-C level < previous 18 mos; 2) Change in the percentage of patients with improvements in A1c. Improvement defined as HbA1c level < previous 18 mos; 3) Change in percentage of patients prescribed Beta Blockers; 4) Change in the percentage of patients prescribed Statins; 5) Change in the percentage of patients prescribed ACEI or ARB; 6) Change in percentage of patients reaching target goal for LDL-C (<100mg/dL); 7) Change in percentage of patients reaching target goal for HbA1c (<8%).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00126750

  Hide Study 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
VA Office of Research and Development
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

Publications of Results:

Responsible Party: VA Office of Research and Development Identifier: NCT00126750     History of Changes
Other Study ID Numbers: SDR 03-090
First Posted: August 4, 2005    Key Record Dates
Results First Posted: July 23, 2015
Last Update Posted: July 23, 2015
Last Verified: June 2015

Keywords provided by VA Office of Research and Development:
Myocardial Infarction
Computer Assisted Instruction
Physician Practice Instruction
Online Systems

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