HMO Research Network CERT: Acute Myocardial Infarction

NCT ID: NCT00211172

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 836 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2009-05-31

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 (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.

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).

Conditions

Acute Myocardial Infarction (AMI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Beta-blocker adherence after an AMI

Patients received two mailings about the importance of beta blocker use.

Group Type: EXPERIMENTAL

Beta-blocker adherence after an AMI

Intervention Type: BEHAVIORAL

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.

Usual care

Patients received usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Reminder mailing

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David H Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanent Center for Health Research

Locations

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, United States

Countries

United States

References

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 Mar 10;168(5):477-83; discussion 483; quiz 447. doi: 10.1001/archinternmed.2007.132.

Reference Type: RESULT

PMID: 18332291 (View on PubMed)

Other Identifiers

2 U18 HS01391-04

Identifier Type: -

Identifier Source: org_study_id