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临床试验/NCT02908373
NCT02908373已完成不适用

Measuring Impact on Safety Culture in Nursing Homes, a Multifaceted Device for the Analysis of Care Associated Adverse Events

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 1,608 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,608
试验地点
1
主要终点
impact of the coaching of the réseau QualiSanté: score expressed by the average percentages of positive responses to the "Overall perception of the safety of residents" dimension (= sum of 2 terms of positive response from the Likert scale)

研究概览

简要总结

The Réseau QualiSanté (risk management network) hardly works on risk management in nursing homes. A model to help nursing homes managers to structure and analyze adverse events has been constructed by a working group of health professionals in the Réseau QualiSanté. Several questions appeared: is the model able to increase patient safety culture of professionals working in nursing homes? How to characterize adverse events in nursing homes? How frequent are they? The main objective of this research project EHPAGE is to measure the impact of the model to structure and analyze adverse events in nursing homes on the patient safety culture of professionals. The project combines quantitative data (questionnaire) and qualitative data (interviews).

详细描述

The main objective of this research project EHPAGE is to measure the impact of the model to structure and analyze adverse events in nursing homes on the patient safety culture of professionals. The coaching model is composed of a 20 hours methodological help for each nursing home and of an implementation kit.

To answer to the main objective, quantitative and qualitative data will be collected twice during the project: before the implementation of the coaching model and 12 months after.

Secondary objectives are:

  1. To encourage the place of patient safety culture in strategic issues of nursing homes
  2. To develop patient safety culture of professionals working in nursing homes
  3. To develop a way to structure and make the reporting of adverse events in nursing homes more sustainable
  4. To describe epidemiologic characteristic of adverse events in nursing homes
  5. To propose a French validated questionnaire to evaluate patient safety culture reported by professionals in nursing homes An ancillary study is perform to describe epidemiologic characteristic of adverse events in nursing homes

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
65 Years 至 105 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Nursing homes members of the Réseau QualiSanté (risk management network)
  • Public or private legal status
  • Agreeing to participate in the project

排除标准

  • 未提供

结局指标

主要结局

impact of the coaching of the réseau QualiSanté: score expressed by the average percentages of positive responses to the "Overall perception of the safety of residents" dimension (= sum of 2 terms of positive response from the Likert scale)

时间窗: 14 months after initial diagnosis.

Initial analysis: estimate baseline characteristics of nursing homes (2 groups) Analysis of the primary endpoint primarily for professionals and secondly for nursing homes (consideration of cluster randomization) Professionals Analysis: Score of each professional "Overall perception of the safety of residents - OPOTSOR" dimension of NHSOPS questionnaire calculated for both measures in each arm Linear mixed model implemented to reflect the hierarchical data structure: score of the dimension "OPOTSOR" at assessment2 explained by the fixed effect group and the random effect of nursing homes. Adjustment with other variables if necessary Facility effect estimated with Intraclass correlation coefficient Nursing homes analysis: "Global perception of the safety of residents" dimension score of each nursing home calculated at assessment1 and 2 in each group Comparison of the average test scores at assessment2 for each nursing home

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 (1)

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