HMO Research Network CERT: Acute Myocardial Infarction

Acute Myocardial Infarction (AMI) Clinical Trial

Official title:

The HMO Research Network CERT: Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211172
• Other study ID #: 2 U18 HS01391-04
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: October 7, 2014
• Start date: October 2003
• Est. completion date: May 2009

Study information

• Verified date: July 2011
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 (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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 836
• Est. completion date: May 2009
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Myocardial Infarction (AMI)
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
United States	Kaiser Permanente-Georgia	Atlanta	Georgia
United States	Harvard Pilgrim Healthcare	Boston	Massachusetts
United States	Health Partners	Minneapolis	Minnesota
United States	Kaiser Permanent Center for Health Research	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Smith DH, Kramer JM, Perrin N, Platt R, Roblin DW, Lane K, Goodman M, Nelson WW, Yang X, Soumerai SB. A randomized trial of direct-to-patient communication to enhance adherence to beta-blocker therapy following myocardial infarction. Arch Intern Med. 2008 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date	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	9 months	No