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临床试验/NCT00323258
NCT00323258已完成不适用

PILOT-EBM: Patient Focused Intervention to Improve Long-term Adherence to Evidence Based Medications

Duke University2 个研究点 分布在 1 个国家目标入组 143 人开始时间: 2006年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
143
试验地点
2
主要终点
Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of a program to help patients with heart disease stay on their heart medications.

详细描述

Heart disease is the leading cause of death for men and women in the United States. For patients with documented coronary artery disease (CAD), anti-platelet agents, beta-blockers and statins have all been shown to improve survival and reduce the frequency of myocardial infarction. Yet, previous research by the Duke CERTs has shown that in a population of over 28,000 patients with documented CAD, only 21% reported consistent use of triple therapy with aspirin, beta-blockers and lipid lowering therapy. These results stimulated the Duke CERTs to devise an intervention to improve adherence to these life-saving medications.

Comparisons: Patients admitted to Duke University Hospital or Southeastern Regional Medical Center (SRMC) with CAD or CAD plus heart failure who agree to participate, will be randomized to an intervention or control arm. The control group will receive usual care, which consists of routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the Duke physician to the community physician. In addition to usual care, the intervention group will receive focused medication counseling in the hospital by the clinical pharmacist-investigator, who will identify and address potential barriers to medication adherence and will reinforce the importance of taking evidence-based medications long term. Discharge medications will be shared with the community pharmacist. The community pharmacist will monitor for problems with adherence and communicate issues back to the patient and the patient's care team.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • 18 years of age or older
  • Utilize a pharmacy in Durham, Robeson, Person, Granville, or Vance County, NC
  • Have coronary artery disease (CAD) documented in the medical record by one of the following:
  • A diagnosis of unstable angina or acute myocardial infarction (ST segment elevation or non-ST segment elevation myocardial infarction)
  • A cardiac catheterization demonstrating CAD greater than or equal to 50 narrowing of artery)
  • Prior angioplasty
  • Prior coronary artery stent
  • Prior coronary artery bypass graft surgery (CABG)
  • Plan to have their prescription medications filled and refilled by one of the participating pharmacies
  • Prescribed aspirin or another antiplatelet, a beta-blocker and statin agent (referred to as triple therapy for this study) at discharge. If a patient has a true contraindication to any of the three medication groups in triple therapy, they will still be eligible for the study

排除标准

  • Providers predict an anticipated hospital stay of less than 48 hours
  • Patient plans to use a pharmacy outside of Durham, Robeson, Person, Granville, or Vance County, NC
  • Patient is unable to give consent (cognitively impaired, does not speak English, or has altered mental status)
  • Patient transferred to Cardiothoracic Surgery service for CABG
  • Patient has terminal condition and may not survive until 6-month follow-up
  • Patient lives in a correctional or long-term care facility
  • Patient will be unable to participate in follow-up phone call (hearing impaired without caregiver who can help or does not have a phone)
  • Patient is a known participant in the Duke Heart Failure Program
  • Patient does not agree to use only the one Durham, Robeson, Person, Granville, or Vance County pharmacy throughout the study period

结局指标

主要结局

Patient-reported Adherence to Triple Therapy (Aspirin/Antiplatelet; Beta Blocker; and Statin) at 6 Months

时间窗: 6 months

Percent of patients in each group adherent to triple therapy (aspirin/antiplatelet; beta blocker; and statin) 6 months after discharge as assessed by medication history obtained during a follow-up phone call by a blinded pharmacist

次要结局

  • Percent of Patients Adherent to Beta-blocker and Statin Via Refill Records(6 months)
  • Percent of Patients Adherent to Beta-blocker Via Refill Records(6 months)
  • Percent of Patients Adherent to Statin Via Refill Records(6 months)
  • Death in Intervention Patients Compared to Usual Care(6 months)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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