跳至主要内容
临床试验/NCT00981032
NCT00981032已完成不适用

Improving Implementation of the US Preventive Service Task Force Recommendation for Prophylactic Aspirin Use Among Adults at Risk for Cardiovascular Disease

Geisinger Clinic6 个研究点 分布在 1 个国家目标入组 884 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
884
试验地点
6
主要终点
Aspirin Use At Two Week Follow-Up (Measures Taken at Baseline and Follow-Up)

研究概览

简要总结

The investigators' aim is to implement an intervention to increase aspirin prophylaxis use among patients that is patient initiated, optimizes use of physician and staff time, appropriately compensates staff, provides clinicians with tools necessary for managing aspiring prophylaxis, and ensures continuous management.

详细描述

This intervention addresses a fundamental question of how clinicians need to be directly involved in motivating behavior change (i.e., aspirin prophylaxis). While complex behavior change likely demands high levels of involvement, a single simple action (aspirin prophylaxis) may not require such complex interactions.

We propose to compare the effectiveness of three models of care in a rigorous randomized controlled trial that will consist of a 3-arm, within-clinic design in which patients will be randomized to either the physician-initiated, the patient-initiated model, or to a control group in which usual care is delivered. In a patient-initiated model, patients are active participants in their own care and receive a pre-visit summary that contains an individualized risk assessment and patient education. In the physician-initiated model, patients receive the pre-visit summary and the physician uses a clinical decision support tool through the electronic health record that details the patient risk of CVD.

The specific aims of the proposed work are to compare the reliability and overall effectiveness of two different methods for motivating patients to take aspirin to prevent stroke and heart attacks as well as to develop a plan for translating the intervention into a process that is suitable for a paper-based clinic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with an appointment in the Geisinger clinic who:
  • are between the ages of 45-70 (male) or 50-70 (female), and
  • have one of the following risk factors:
  • Direct LDL > 160 mg/dl
  • HDL < 45 mg/dl (males) HDL < 35 mg/dl (females)
  • Diabetes diagnosis
  • Hypertension diagnosis
  • CAD diagnosis

排除标准

  • > 70 years
  • Stomach Ulcer History
  • Aspirin Allergy
  • Anti-coagulation Therapy History
  • Clotting Disorder Diagnosis
  • Hypersensitivity to non-steroidal anti-inflammatory agents such as Ibuprofen, Aleve, or Motrin
  • Hemorrhagic Stroke History
  • Current Aspirin use
  • 1st Outpatient Visit

结局指标

主要结局

Aspirin Use At Two Week Follow-Up (Measures Taken at Baseline and Follow-Up)

时间窗: Two Weeks

次要结局

  • Patient Knowledge of Risks/Benefits of Aspirin(Two Weeks)

研究者

申办方类型
Other

研究点 (6)

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