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临床试验/NCT00211172
NCT00211172已完成不适用

The HMO Research Network CERT: Acute Myocardial Infarction

Kaiser Permanente7 个研究点 分布在 1 个国家目标入组 836 人开始时间: 2003年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
836
试验地点
7
主要终点
Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

Beta-blocker adherence after an AMI

Experimental

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

干预措施: Beta-blocker adherence after an AMI (Behavioral)

Usual care

No Intervention

Patients received usual care.

结局指标

主要结局

Adjusted Mean Monthly Percent of Days Covered With B-blocker Following Intervention Date

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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