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HMO Research Network CERT: Acute Myocardial Infarction

This study is ongoing, but not recruiting participants.
Information provided by Kaiser Permanente

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Descriptive Information Fields
Brief Title  HMO Research Network CERT: Acute Myocardial Infarction
Official Title  The HMO Research Network CERT: Acute Myocardial Infarction
Brief Summary

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.

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.

Study Phase
Study Type  Interventional
Study Design  Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary Outcome Measure  Medication Adherence, measured by proportion of days covered and medication discontinuation
Secondary Outcome Measure  Healthcare utilization and mortality
Condition  Acute Myocardial Infarction
Intervention  Behavioral: Beta-blocker adherence following a myocardial infarction
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  980
Start Date  October 2003
Completion Date September 2004
Eligibility 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

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00211172
Organization ID 2 U18 HS01391-04
Secondary IDs ††
Study Sponsor  Kaiser Permanente
Collaborators †† Agency for Healthcare Research and Quality (AHRQ)
Investigators 
Principal Investigator:     David H Smith, PhD     Kaiser Permanent Center for Health Research    
Information Provided By Kaiser Permanente
Verification Date September 2005
First Received Date  September 13, 2005
Last Updated Date April 2, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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