跳至主要内容
临床试验/NCT00277173
NCT00277173Unknown不适用

Improving Geriatric Drug Safety in Underserved Practices

Agency for Healthcare Research and Quality (AHRQ)1 个研究点 分布在 1 个国家目标入组 4,800 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
4,800
试验地点
1
主要终点
Change in number of total and preventable ADEs.

研究概览

简要总结

The purpose of this study is to determine whether a CRM (adapted Crew Resource Management approach proven successful in aviation as well as some inpatient medical settings) intervention is effective for reducing medication errors among older adults in primary care settings.

详细描述

Adverse drug events (ADEs) are among the most common and serious medication use concerns among older patients in primary care practices, yet they are often preventable. This translational research into practice (TRIP) pilot study uses a randomized trial to evaluate the effect of a site-level intervention in a sample of practices in medically underserved communities within the Upstate New York Practice Based Research Network (UNYNET). These sites are located in rural and urban areas and include an over-sample of minority patients. The specific aims of this study are to:

  1. Examine the feasibility of objectively assessing the impact of a CRM (adapted Crew Resource Management approach proven successful in aviation as well as some inpatient medical settings) intervention on reducing medication errors among geriatric patients in primary care settings; and

  2. Assess office staff internalization and application of CRM principles for reducing geriatric medication errors in primary care settings by examining changes in safety attitude constructs achieved

  3. with a practice enhancement assistant (PEA) and

  4. without a PEA.

Outcomes measured for Aim #1 will be change in number, severity, consequence, and stage of process of preventable ADEs. Outcomes for Aim # 2 will be change in safety climate, teamwork climate, stress recognition, and working conditions.

Fifteen sites will be randomized into one of three intervention arms: usual care, CRM only, or CRM plus a PEA. A random sample of charts of older adults (aged >64) with cardiovascular disease will be reviewed for adverse drug events over prior-year periods at baseline and post-intervention endpoints. Participatory research methods will be used to assess provider- and staff-identified barriers to implementation. This study will test the feasibility of incorporating PEA's into the practice setting to improve geriatric medication safety. The information gathered will serve as a basis for an ongoing translational research program that will lead to an RO1 application.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Educational Counseling Training
盲法
None

入排标准

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

入选标准

  • •Practice Inclusion Criteria:
  • •Practice must located in Health Professional Shortage Area or Physician Scarcity Area.
  • •Practice must be a member of the Western New York Practice-Based Research Network

排除标准

  • •Patient Inclusion Criteria (for chart review):
  • •Aged >64
  • •Cardiovascular disease
  • •Seen at the practice within the past year
  • •Patient Exclusion Criteria (for chart review):

结局指标

主要结局

Change in number of total and preventable ADEs.

Change in culture of safety

次要结局

未报告次要终点

研究者

发起方
Agency for Healthcare Research and Quality (AHRQ)
申办方类型
Fed

研究点 (1)

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