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

June 24, 2015 updated by: US Department of Veterans Affairs

MI-Plus: Web-enhanced Guideline Implementation for Post MI CBOC Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

847

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%).
1/1/02 - 12/31/08

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 2, 2005

First Submitted That Met QC Criteria

August 2, 2005

First Posted (Estimate)

August 4, 2005

Study Record Updates

Last Update Posted (Estimate)

July 23, 2015

Last Update Submitted That Met QC Criteria

June 24, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDR 03-090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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