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| Descriptive Information Fields | |||||
| Brief Title † | HMO Research Network CERT: Acute Myocardial Infarction | ||||
| Official Title † | The HMO Research Network CERT: Acute Myocardial Infarction | ||||
| 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 (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. |
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| Detailed Description | Specific Aims:
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. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Educational/Counseling/Training, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Medication Adherence, measured by proportion of days covered and medication discontinuation | ||||
| Secondary Outcome Measure † | Healthcare utilization and mortality | ||||
| Condition † | Acute Myocardial Infarction | ||||
| Intervention † | Behavioral: Beta-blocker adherence following a myocardial infarction | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 980 | ||||
| Start Date † | October 2003 | ||||
| Completion Date | September 2004 | ||||
| Eligibility Criteria † | 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | |||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00211172 | ||||
| Organization ID | 2 U18 HS01391-04 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Kaiser Permanente | ||||
| Collaborators †† | Agency for Healthcare Research and Quality (AHRQ) | ||||
| Investigators † |
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| Information Provided By | Kaiser Permanente | ||||
| Verification Date | September 2005 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | April 2, 2007 | ||||