Jordan Sue, Banner Timothy, Gabe-Walters Marie, Mikhail Jane M, Round Jeff, Snelgrove Sherrill, Storey Mel, Wilson Douglas, Hughes David
College of Human and Health Sciences, Swansea University, Swansea, UK.
Welsh School of Pharmacy, Cardiff University, Cardiff, UK.
BMJ Open. 2018 Sep 28;8(9):e023377. doi: 10.1136/bmjopen-2018-023377.
Improved medicines' management could lead to real and sustainable improvements to the care of older adults. The overuse of mental health medicines has featured in many reports, and insufficient patient monitoring has been identified as an important cause of medicine-related harms. Nurse-led monitoring using the structured adverse drug reaction (ADRe) profile identifies and addresses the adverse effects of mental health medicines. Our study investigates clinical impact and what is needed to sustain utilisation in routine practice in care homes.
This process evaluation will use interviews and observations with the participants of all five homes involved in earlier research, and five newly recruited homes caring for people prescribed mental health medicines. The ADRe profile is implemented by nurses, within existing resources, to check for signs and symptoms of ADRs, initiate amelioration and share findings with pharmacists and prescribers for medication review. Outcome measures are the numbers and nature of problems addressed and understanding of changes needed to optimise clinical gain and sustain implementation. Data will be collected by 30 observations and 30 semistructured interviews. Clinical gains will be described and narrated. Interview analysis will be based on the constant comparative method.
Ethical approval was conferred by the National Health Service Wales Research Ethics Committee. If the ADRe profile can be sustained in routine practice, it has potential to (1) improve the lives of patients, for example, by reducing pain and sedation, and (2) assist in early identification of problems caused by ADRs. Therefore, in addition to peer-reviewed publications and conferences, we shall communicate our findings to healthcare professionals, policy-makers and sector regulators.
NCT03110471.
改善药物管理可切实且可持续地提升对老年人的护理水平。诸多报告都提及了精神类药物的过度使用问题，而患者监测不足已被确认为药物相关危害的一个重要原因。由护士主导、使用结构化药物不良反应（ADRe）档案进行监测，可识别并处理精神类药物的不良反应。我们的研究旨在调查其临床影响以及在养老院日常实践中维持其使用所需的条件。
本过程评估将对参与早期研究的所有五家养老院的参与者以及另外五家新招募的、为开具精神类药物的患者提供护理服务的养老院的参与者进行访谈和观察。护士在现有资源范围内实施ADRe档案，以检查药物不良反应的体征和症状，启动改善措施，并与药剂师和开处方者分享结果，以便进行药物审查。结果指标包括所处理问题的数量和性质，以及对优化临床效益和维持实施所需变化的理解。将通过30次观察和30次半结构化访谈收集数据。将对临床效益进行描述和叙述。访谈分析将基于持续比较法。
威尔士国民保健服务研究伦理委员会已授予伦理批准。如果ADRe档案能够在日常实践中得以维持，它有可能（1）改善患者的生活，例如通过减轻疼痛和镇静作用，以及（2）有助于早期识别药物不良反应所导致的问题。因此，除了在同行评审的出版物和会议上交流外，我们还将把研究结果传达给医疗保健专业人员、政策制定者和行业监管机构。
NCT03110471。
