Overview

This trial is active, not recruiting.

Condition acute myocardial infarction
Treatment beta-blocker adherence following a myocardial infarction
Sponsor Kaiser Permanente
Collaborator Agency for Healthcare Research and Quality (AHRQ)
Start date October 2003
End date December 2005
Trial size 907 participants
Trial identifier NCT00211172, 2 U18 HS01391-04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label

Primary Outcomes

Measure
Medication Adherence, measured by proportion of days covered and medication discontinuation
time frame: 1 year

Secondary Outcomes

Measure
Healthcare utilization and mortality
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The HMO Research Network CERT: Acute Myocardial Infarction
Principal investigator David H Smith, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Kaiser Permanente.