Hanskamp-Sebregts Mirelle, Zegers Marieke, Boeijen Wilma, Westert Gert P, van Gurp Petra J, Wollersheim Hub
BMC Health Serv Res. 2013 Jun 22;13:226. doi: 10.1186/1472-6963-13-226.
Auditing of patient safety aims at early detection of risks of adverse events and is intended to encourage the continuous improvement of patient safety. The auditing should be an independent, objective assurance and consulting system. Auditing helps an organisation accomplish its objectives by bringing a systematic, disciplined approach to evaluating and improving the effectiveness of risk management, control, and governance. Audits are broadly conducted in hospitals, but little is known about their effects on the behaviour of healthcare professionals and patient safety outcomes. This study was initiated to evaluate the effects of patient safety auditing in hospital care and to explore the processes and mechanisms underlying these effects.
Our study aims to evaluate an audit system to monitor and improve patient safety in a hospital setting. We are using a mixed-method evaluation with a before-and-after study design in eight departments of one university hospital in the period October 2011-July 2014. We measure several outcomes 3 months before the audit and 15 months after the audit. The primary outcomes are adverse events and complications. The secondary outcomes are experiences of patients, the standardised mortality ratio, prolonged hospital stay, patient safety culture, and team climate. We use medical record reviews, questionnaires, hospital administrative data, and observations to assess the outcomes. A process evaluation will be used to find out which components of internal auditing determine the effects.
We report a study protocol of an effect and process evaluation to determine whether auditing improves patient safety in hospital care. Because auditing is a complex intervention targeted on several levels, we are using a combination of methods to collect qualitative and quantitative data about patient safety at the patient, professional, and department levels. This study is relevant for hospitals that want to early detect unsafe care and improve patient safety continuously.
Netherlands Trial Register (NTR): NTR3343.
患者安全审计旨在早期发现不良事件风险，并旨在鼓励持续改进患者安全。审计应是一个独立、客观的保证和咨询系统。审计通过采用系统、规范的方法来评估和改进风险管理、控制及治理的有效性，帮助组织实现其目标。医院广泛开展审计工作，但对于其对医护人员行为和患者安全结果的影响却知之甚少。本研究旨在评估医院护理中患者安全审计的效果，并探索这些效果背后的过程和机制。
我们的研究旨在评估一个用于监测和改善医院环境中患者安全的审计系统。我们在一所大学医院的八个科室采用了前后对照的混合方法评估，研究时间段为2011年10月至2014年7月。我们在审计前3个月和审计后15个月测量了多个结果。主要结果是不良事件和并发症。次要结果是患者体验、标准化死亡率、住院时间延长、患者安全文化和团队氛围。我们使用病历审查、问卷调查、医院行政数据和观察来评估这些结果。将采用过程评估来找出内部审计的哪些组成部分决定了这些效果。
我们报告了一项关于效果和过程评估的研究方案，以确定审计是否能改善医院护理中的患者安全。由于审计是一项针对多个层面的复杂干预措施，我们正在结合多种方法，在患者、专业人员和科室层面收集关于患者安全的定性和定量数据。本研究对于希望早期发现不安全护理并持续改善患者安全的医院具有重要意义。
荷兰试验注册库（NTR）：NTR33,43。
