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HMO Research Network CERT: Acute Myocardial Infarction

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00211172
First received: September 13, 2005
Last updated: October 7, 2014
Last verified: July 2011
  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 (AMI).

Prior to developing patient materials, focus groups were conducted with patient who had previously suffered an acute myocardial infarction (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 (AMI)
Behavioral: Beta-blocker adherence after an AMI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
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:
  • Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The primary outcome measure adherence to B-blocker therapy post intervention. Adherence was measured by the degree of prescription filling in an interval derived from pharmacy prescription records by constructing a proportion-of-days-covered per-month measure, using the quantity dispensed and days supplied from each prescription


Enrollment: 836
Study Start Date: October 2003
Study Completion Date: May 2009
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Beta-blocker adherence after an AMI
Patients received two mailings about the importance of beta blocker use.
Behavioral: Beta-blocker adherence after an AMI
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.
Other Name: Reminder mailing
No Intervention: Usual care
Patients received usual care.

Detailed Description:

Specific Aims:

  1. Assess the persistence of beta blocker use for post-acute myocardial infarction (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 AMI, 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 Health Maintenance Organizations (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
  • Beta-blocker dispensing following AMI
  • Beta-blocker dispensing 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

Publications:
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00211172     History of Changes
Other Study ID Numbers: 2 U18 HS01391-04
Study First Received: September 13, 2005
Results First Received: August 5, 2009
Last Updated: October 7, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 25, 2014