HMO Research Network CERT: Acute Myocardial Infarction
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|ClinicalTrials.gov Identifier: NCT00211172|
Recruitment Status : Completed
First Posted : September 21, 2005
Results First Posted : October 9, 2014
Last Update Posted : October 9, 2014
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 or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction (AMI)||Behavioral: Beta-blocker adherence after an AMI||Not Applicable|
- 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.
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||836 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||The HMO Research Network CERT: Acute Myocardial Infarction|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||December 2005|
|Actual Study Completion Date :||May 2009|
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.
- Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date [ Time Frame: 9 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211172
|United States, Georgia|
|Atlanta, Georgia, United States, 30305|
|United States, Massachusetts|
|Harvard Pilgrim Healthcare|
|Boston, Massachusetts, United States, 02115|
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55440-1309|
|United States, Oregon|
|Kaiser Permanent Center for Health Research|
|Portland, Oregon, United States, 97227|
|Principal Investigator:||David H Smith, PhD||Kaiser Permanent Center for Health Research|