Primary Care Research Unit of Mallorca, Balearic Islands Health Service, Palma, Balearic Islands, Spain.
GRAPP-caIB, Balearic Islands Health Research Institute (IdISBa), Palma, Balearic Islands, Spain.
BMJ Open. 2019 Dec 23;9(12):e031367. doi: 10.1136/bmjopen-2019-031367.
Despite the enormous potential for adverse events in primary healthcare (PHC), the knowledge about how to improve patient safety in this context is still sparse. We describe the methods for the development and evaluation of an intervention targeted at PHC professionals to improve patient safety in Spanish PHC centres.
The intervention will consist in using the patient reported experiences and outcomes of safety in primary care (PREOS-PC) survey to gather patient-reported experiences and outcomes concerning the safety of the healthcare patients receive in their PHC centres, and feed that information back to the PHC professionals to help them identify opportunities for safer healthcare provision. The study will involve three stages. Stage 1 (developing the intervention) will involve: (i) qualitative study with 40 PHC providers to optimise the acceptability and perceived utility of the proposed intervention; (ii) Spanish translation, cross-cultural adaptation and validation of the PREOS-PC survey; (iii) developing the intervention components; and (iv) developing an online tool to electronically administrate PREOS-PC and automatically generate feedback reports to PHC centres. Stage 2 (piloting the intervention) will involve a 3-month feasibility (one group pre-post) study in 10 PHC centres (500 patients, 260 providers). Stage 3 (evaluating the intervention) will involve: (i) a 12-month, two-arm, two-level cluster randomised controlled trial (1248 PHC professionals within 48 PHC centres; with randomisation at the centre level in a 1:1 ratio) to evaluate the impact of the intervention on patient safety culture (primary outcome), patient-reported safety experiences and outcomes (using the PREOS-PC survey), and avoidable hospitalisations; (ii) qualitative study with 20 PHC providers to evaluate the acceptability and perceived utility of the intervention and identify implementation barriers.
The study was approved by the Ethics Committee of the Balearic Islands (CEI IB: 3686/18) with the 1964 Helsinki Declaration and its later amendments. The results will be disseminated in peer-reviewed publications and national and international conferences.
NCT03837912; pre-results.
尽管初级医疗保健（PHC）存在巨大的不良事件风险，但关于如何改善这一领域患者安全的知识仍然匮乏。我们描述了一种针对 PHC 专业人员的干预措施的开发和评估方法，旨在提高西班牙 PHC 中心的患者安全。
该干预措施将使用患者报告的初级保健安全体验和结果（PREOS-PC）调查来收集患者对其在 PHC 中心接受的医疗保健安全性的体验和结果报告，并将这些信息反馈给 PHC 专业人员，以帮助他们发现提供更安全医疗保健的机会。该研究将涉及三个阶段。第 1 阶段（开发干预措施）将包括：（i）对 40 名 PHC 提供者进行定性研究，以优化拟议干预措施的可接受性和感知效用；（ii）PREOS-PC 调查的西班牙翻译、跨文化适应性和验证；（iii）开发干预措施组成部分；以及（iv）开发一个在线工具，以电子方式管理 PREOS-PC 并自动生成反馈报告给 PHC 中心。第 2 阶段（干预措施的试点）将涉及 10 个 PHC 中心（500 名患者，260 名提供者）为期 3 个月的可行性（一组预-后）研究。第 3 阶段（干预措施的评估）将包括：（i）为期 12 个月、2 组、2 级聚类随机对照试验（48 个 PHC 中心内的 1248 名 PHC 专业人员；中心水平的随机分配比例为 1:1），以评估干预措施对患者安全文化（主要结局）、患者报告的安全体验和结果（使用 PREOS-PC 调查）以及可避免的住院治疗的影响；（ii）对 20 名 PHC 提供者进行定性研究，以评估干预措施的可接受性和感知效用，并确定实施障碍。
该研究已获得巴利阿里群岛伦理委员会（CEI IB：3686/18）的批准，符合 1964 年赫尔辛基宣言及其后修正案。研究结果将在同行评议的出版物和国内外会议上发表。
NCT03837912；预结果。
