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HMO Research Network CERT: Acute Myocardial Infarction

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Kaiser Permanente
Agency for Healthcare Research and Quality (AHRQ)
Information provided by: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00211172
  Purpose

The primary goal of this study is to evaluate the effectiveness of direct-to-patient mailings designed to increase patient's adherence to prescribed beta-blockers following an acute myocardial infarction (heart attack).

Prior to developing patient materials, focus groups were conducted with patient who had previously suffered an AMI to identify the issues and information that patients felt were important to include in our materials as well as the best way to present the information. Additionally, patient materials were “pre-tested” with AMI patients to ensure that the materials were clear and easy to read and that the key messages were understood.


Condition Intervention
Acute Myocardial Infarction
Behavioral: Beta-blocker adherence following a myocardial infarction

MedlinePlus related topics:   Heart Attack   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:   The HMO Research Network CERT: Acute Myocardial Infarction

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Medication Adherence, measured by proportion of days covered and medication discontinuation

Secondary Outcome Measures:
  • Healthcare utilization and mortality

Estimated Enrollment:   980
Study Start Date:   October 2003
Estimated Study Completion Date:   September 2004

Detailed Description:

Specific Aims:

  1. Assess the persistence of beta blocker use for post-AMI patients following a direct to patient intervention designed to increase rates of evidence-based long-term use of medications (beta blockers, lipid lowering agents, aspirin and ACE inhibitors) that increase survival following AMI.
  2. Describe patient and system characteristics associated with differences in impact of the intervention

Research Design and Methods:

We will conduct a randomized controlled trial within the 4 participating HMOs (Kaiser Permanente Northwest, Harvard Pilgrim Health Care, Health Partners, and Kaiser Permanente Georgia). Inpatient data will be used to identify patients with a primary discharge diagnosis of AMI 4-6 months before the extraction date. Practices will be block-randomized to the intervention group or to usual care. To increase repetition of the message, there will be two personalized mailings, occurring at 4-6 months post MI, and at 9 months. The first message will include elements in the table below, and the repeat message will be shorter, but include similar information. The message will come from the patient’s own health plan with the choice of specific individual (e.g. quality assurance department, medical director, or Chief of Cardiology) being informed by our qualitative work. This intervention will be done in collaboration with the cardiovascular care committees and quality assurance departments of participating HMOs.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

Criteria

Inclusion Criteria:

Clinical diagnosis of Acute Myocardial Infarction (AMI) from 12/1/03 to 5/31/04 and beta-blocker dispensing following AMI and prior to intervention date.

Exclusion Criteria:

None

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211172

Locations
United States, Georgia
Kaiser Permanente-Georgia    
      Atlanta, Georgia, United States, 30305
United States, Massachusetts
Harvard Pilgrim Healthcare    
      Boston, Massachusetts, United States, 02115
United States, Minnesota
Health Partners    
      Minneapolis, Minnesota, United States, 55440-1309
United States, Oregon
Kaiser Permanent Center for Health Research    
      Portland, Oregon, United States, 97227

Sponsors and Collaborators

Investigators
Principal Investigator:     David H Smith, PhD     Kaiser Permanent Center for Health Research    
  More Information


Publications indexed to this study:

Study ID Numbers:   2 U18 HS01391-04
First Received:   September 13, 2005
Last Updated:   April 2, 2007
ClinicalTrials.gov Identifier:   NCT00211172
Health Authority:   United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Acute Myocardial Infarction  
Heart Attack  
Adherence  
Beta-blocker  
Behavior change  

Study placed in the following topic categories:
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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