HMO Research Network CERT: Acute Myocardial Infarction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Kaiser Permanente.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00211172
First received: September 13, 2005
Last updated: February 24, 2009
Last verified: September 2005
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: The HMO Research Network CERT: Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Medication Adherence, measured by proportion of days covered and medication discontinuation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Healthcare utilization and mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 907
Study Start Date: October 2003
Estimated Study Completion Date: September 2010
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Beta-blocker adherence following a myocardial infarction
    The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries.
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
Accepts Healthy Volunteers:   No
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
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: 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
Kaiser Permanente
Investigators
Principal Investigator: David H Smith, PhD Kaiser Permanent Center for Health Research
  More Information

No publications provided by Kaiser Permanente

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Smith, Kaiser Permanente Center for Health Research
ClinicalTrials.gov Identifier: NCT00211172     History of Changes
Other Study ID Numbers: 2 U18 HS01391-04
Study First Received: September 13, 2005
Last Updated: February 24, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014