Department of General Practice, School of Medicine, National University of Ireland, Galway, Galway, Ireland.
HRB Primary Care Clinical Trial Network Ireland, National University of Ireland, Galway, Galway, Ireland.
BMC Fam Pract. 2019 Jan 30;20(1):22. doi: 10.1186/s12875-019-0909-8.
Patient safety research is conducted predominantly in hospital settings, with a dearth of insight from primary care, despite suggestions that 2.2% of primary care consultations result in a patient safety incident. This study aimed to assess the feasibility of an intervention intended to improve patient safety in general practice.
A randomised controlled feasibility study was conducted with general practices in the Republic of Ireland (N = 9) and Northern Ireland (N = 2), randomly assigned to the intervention (N = 5) or control (N = 6) group. The nine-month intervention consisted of: 1) repeated safety climate (SC) measurement (using GP-SafeQuest questionnaire) and feedback (comparative anonymised practice-level SC data), and 2) patient record reviews using a specialised trigger tool to identify instances of undetected patient harm. For control practices, SC was measured at baseline and study end only. The intervention's perceived usefulness and feasibility were explored via an end-of-study questionnaire and semi-structured interviews.
Thirteen practices were invited; 11 participated; 10 completed the study. At baseline, 84.8% of intervention practice staff (39/46) and 77.8% (42/54) of control practice staff completed the SC questionnaire; at the study terminus, 78.3% (36/46) of intervention practice staff and 68.5% (37/54) of control practice staff did so. Changes in SC scores, indicating improvement, were observed among the intervention practices but not in the control group. The trigger tool was applied to 188 patient records; patient safety incidents of varying severity were detected in 19.1% (36/188). Overall, 59% of intervention practice team members completed the end-of-study questionnaire, with the majority in both healthcare systems responding positively about the intervention. Interviews (N = 9) identified the intervention's usefulness in informing practice management and patient safety issues, time as a barrier to its use, and the value of group discussion of feedback.
This feasibility study suggests that a definitive randomised controlled trial of the intervention is warranted. Our findings suggest that the intervention is feasible, useful, and sustainable. Practices were willing to be recruited into the study, response and retention rates were acceptable, and there is possible evidence of a positive effect of the intervention.
The trial registration number is: ISRCTN11426121 (retrospectively registered 12th June 2018).
患者安全研究主要在医院环境中进行，尽管有研究表明 2.2%的初级保健咨询会导致患者安全事件，但初级保健的相关见解却很少。本研究旨在评估一项旨在提高一般实践中患者安全性的干预措施的可行性。
这项随机对照可行性研究在爱尔兰共和国（N=9）和北爱尔兰（N=2）的一般实践中进行，将实践随机分配到干预组（N=5）或对照组（N=6）。为期九个月的干预措施包括：1）反复测量（使用 GP-SafeQuest 问卷）和反馈（比较匿名的实践水平 SC 数据）的安全气候（SC），以及 2）使用专门的触发工具对患者记录进行审查，以识别未被发现的患者伤害实例。对于对照实践，仅在基线和研究结束时测量 SC。通过研究结束时的问卷调查和半结构化访谈来探索干预措施的感知有用性和可行性。
邀请了 13 家实践，其中 11 家参与，10 家完成了研究。在基线时，84.8%的干预实践工作人员（39/46）和 77.8%（42/54）的对照组工作人员完成了 SC 问卷；在研究终点时，78.3%（36/46）的干预实践工作人员和 68.5%（37/54）的对照组工作人员完成了问卷。在干预组中观察到 SC 评分的变化，表明有所改善，但在对照组中没有观察到。触发工具应用于 188 份患者记录，在 19.1%（36/188）的记录中发现了不同严重程度的患者安全事件。总体而言，59%的干预实践团队成员完成了研究结束时的问卷调查，两个医疗保健系统中的大多数人都对干预措施做出了积极回应。访谈（N=9）确定了干预措施在告知实践管理和患者安全问题方面的有用性、时间作为其使用的障碍，以及小组讨论反馈的价值。
这项可行性研究表明，有必要对该干预措施进行确定性随机对照试验。我们的研究结果表明，该干预措施是可行的、有用的和可持续的。实践愿意被招募参与研究，响应率和保留率是可以接受的，并且该干预措施可能有积极的效果。
试验注册号为：ISRCTN8572663（2018 年 6 月 12 日追溯注册）。
Zotero 插件