Sheard Laura, O'Hara Jane, Armitage Gerry, Wright John, Cocks Kim, McEachan Rosemary, Watt Ian, Lawton Rebecca
Yorkshire Quality & Safety Research Group, Bradford Institute for Health Research, Bradford Royal Infirmary, Bradford BD9 6RJ, England.
Trials. 2014 Oct 29;15:420. doi: 10.1186/1745-6215-15-420.
Estimates show that as many as one in 10 patients are harmed while receiving hospital care. Previous strategies to improve safety have focused on developing incident reporting systems and changing systems of care and professional behaviour, with little involvement of patients. The need to engage with patients about the quality and safety of their care has never been more evident with recent high profile reviews of poor hospital care all emphasising the need to develop and support better systems for capturing and responding to the patient perspective on their care. Over the past 3 years, our research team have developed, tested and refined the PRASE (Patient Reporting and Action for a Safe Environment) intervention, which gains patient feedback about quality and safety on hospital wards.
METHODS/DESIGN: A multi-centre, cluster, wait list design, randomised controlled trial with an embedded qualitative process evaluation. The aim is to assess the efficacy of the PRASE intervention, in achieving patient safety improvements over a 12-month period.The trial will take place across 32 hospital wards in three NHS Hospital Trusts in the North of England. The PRASE intervention comprises two tools: (1) a 44-item questionnaire which asks patients about safety concerns and issues; and (2) a proforma for patients to report (a) any specific patient safety incidents they have been involved in or witnessed and (b) any positive experiences. These two tools then provide data which are fed back to wards in a structured feedback report. Using this report, ward staff are asked to hold action planning meetings (APMs) in order to action plan, then implement their plans in line with the issues raised by patients in order to improve patient safety and the patient experience.The trial will be subjected to a rigorous qualitative process evaluation which will enable interpretation of the trial results.
fieldworker diaries, ethnographic observation of APMs, structured interviews with APM lead and collection of key data about intervention wards. Intervention fidelity will be assessed primarily by adherence to the intervention via scoring based on an adapted framework.
This study will be one of the largest patient safety trials ever conducted, involving 32 hospital wards. The results will further understanding about how patient feedback on the safety of care can be used to improve safety at a ward level. Incorporating the 'patient voice' is critical if patient feedback is to be situated as an integral part of patient safety improvements.
ISRCTN07689702, 16 Aug 2013.
据估计，多达十分之一的患者在接受医院护理时受到伤害。以往改善安全的策略主要集中在建立事件报告系统以及改变护理系统和专业行为，患者参与度很低。随着近期对糟糕医院护理的高调审查都强调需要开发和支持更好的系统来收集和回应患者对其护理的看法，让患者参与其护理质量和安全的必要性从未像现在这样明显。在过去3年里，我们的研究团队开发、测试并完善了PRASE（患者安全环境报告与行动）干预措施，该措施可收集患者对医院病房质量和安全的反馈。
方法/设计：一项多中心、整群、等待列表设计的随机对照试验，并进行嵌入式定性过程评估。目的是评估PRASE干预措施在12个月内改善患者安全方面的效果。该试验将在英格兰北部三个国民保健服务医院信托基金的32个医院病房进行。PRASE干预措施包括两个工具：（1）一份44项的问卷，询问患者有关安全问题和担忧；（2）一份表格，供患者报告（a）他们所涉及或目睹的任何特定患者安全事件，以及（b）任何积极体验。然后，这两个工具提供的数据会以结构化反馈报告的形式反馈给病房。利用这份报告，要求病房工作人员召开行动计划会议（APM），以便制定行动计划，然后根据患者提出的问题实施计划，以提高患者安全和患者体验。该试验将进行严格的定性过程评估，这将有助于对试验结果进行解读。
实地工作者日记、对行动计划会议的人种学观察、对行动计划负责人的结构化访谈以及收集有关干预病房的关键数据。干预保真度将主要通过基于一个改编框架的评分来评估对干预措施的遵守情况。
这项研究将是有史以来规模最大的患者安全试验之一，涉及32个医院病房。研究结果将进一步加深对如何利用患者对护理安全的反馈来提高病房层面安全性的理解。如果要将患者反馈作为改善患者安全不可或缺的一部分，纳入“患者声音”至关重要。
ISRCTN07689702，2013年8月16日。
