Clinical trial NCT00211172: HMO Research Network CERT: Acute Myocardial Infarction
Official title: The HMO Research Network CERT: Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction (AMI)
Keywords: Acute Myocardial Infarction (AMI)
Heart Attack
Adherence
Beta-blocker
Behavior change
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2005-09-21
Enrollment: 836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente-Georgia
state: Georgia
city: Boston
country: United States
facility: Harvard Pilgrim Healthcare
state: Massachusetts
city: Minneapolis
country: United States
facility: Health Partners
state: Minnesota
city: Portland
country: United States
facility: Kaiser Permanent Center for Health Research
state: Oregon
Study officials:
affiliation: Kaiser Permanent Center for Health Research
name: David H Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.