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The Care Home Independent Prescribing Pharmacist Study (CHIPPS)a non-randomised feasibility study of independent pharmacist prescribing in care homes

机译:敬老院独立处方药师研究(CHIPPS):独立药剂师在敬老院处方的非随机可行性研究

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BackgroundResidents in care homes are often very frail, have complex medicine regimens and are at high risk of adverse drug events. It has been recommended that one healthcare professional should assume responsibility for their medicines management. We propose that this could be a pharmacist independent prescriber (PIP). This feasibility study aimed to test and refine the service specification and proposed study processes to inform the design and outcome measures of a definitive randomised controlled trial to examine the clinical and cost effectiveness of PIPs working in care homes compared to usual care. Specific objectives included testing processes for participant identification, recruitment and consent and assessing retention rates; determining suitability of outcome measures and data collection processes from care homes and GP practices to inform selection of a primary outcome measure; assessing service and research acceptability; and testing and refining the service specification.MethodsMixed methods (routine data, questionnaires and focus groups/interviews) were used in this non-randomised open feasibility study of a 3-month PIP intervention in care homes for older people. Data were collected at baseline and 3?months. One PIP, trained in service delivery, one GP practice and up to three care homes were recruited at each of four UK locations. For ten eligible residents (≥?65?years, on at least one regular medication) in each home, the PIP undertook management of medicines, repeat prescription authorisation, referral to other healthcare professionals and staff training. Outcomes (falls, medications, resident’s quality of life and activities of daily living, mental state and adverse events) were described at baseline and follow-up and assessed for inclusion in the main study. Participants’ views post-intervention were captured in audio-recorded focus groups and semi-structured interviews. Transcripts were thematically analysed.ResultsAcross the four locations, 44 GP practices and 16 PIPs expressed interest in taking part; all care homes invited agreed to take part. Two thirds of residents approached consented to participate (53/86). Forty residents were recruited (mean age 84?years; 61% (24) were female), and 38 participants remained at 3?months (two died). All GP practices, PIPs and care homes were retained. The number of falls per participating resident was selected as the primary outcome, following assessment of the different outcome measures against predetermined criteria. The chosen secondary outcomes/outcome measures include total falls, drug burden index (DBI), hospitalisations, mortality, activities of daily living (Barthel (proxy)) and quality of life (ED-5Q-5?L (face-to-face and proxy)) and selected items from the STOPP/START guidance that could be assessed without need for clinical judgement. No adverse drug events were reported. The PIP service was generally well received by the majority of stakeholders (care home staff, GPS, residents, relatives and other health care professionals). PIPs reported feeling more confident implementing change following the training but reported challenges accommodating the new service within their existing workload.ConclusionImplementing a PIP service in care homes is feasible and acceptable to care home residents, staff and clinicians. Findings have informed refinements to the service specification, PIP training, recruitment to the future RCT and the choice of outcomes and outcome measures. The full RCT with internal pilot started in February 2016 and results are expected to be available in mid late 2020.
机译:背景疗养院中的居民通常非常虚弱,具有复杂的药物治疗方案,并且有发生药物不良事件的高风险。建议一位医疗保健专业人员对他们的药物管理负责。我们建议这可以是独立于药剂师的处方药(PIP)。这项可行性研究旨在测试和完善服务规范,并提出研究过程,以指导确定性随机对照试验的设计和结果测量,以检查与常规护理相比在护理院工作的PIP的临床和成本效益。具体目标包括测试过程以识别参与者,征募和同意以及评估保留率;确定护理院和全科医生实践中结果指标和数据收集过程的适用性,以告知对主要结果指标的选择;评估服务和研究的可接受性;方法在本项针对老年人的3个月PIP干预的非随机开放可行性研究中,使用了混合方法(例行数据,问卷调查和焦点小组/访谈)。在基线和3个月时收集数据。在英国的四个地点中,每个地点都招聘了一名接受过服务交付培训的PIP,一名GP执业医师和多达三所养老院。对于每个家庭中的十名合格居民(≥65岁,至少使用一种常规药物),PIP进行了药物管理,重复处方授权,转介其他医疗保健专业人员和人员培训。在基线和随访中描述了结局(跌倒,药物,居民的生活质量和日常生活活动,精神状态和不良事件),并评估其是否纳入主要研究。参与者在干预后的观点被记录在音频记录的焦点小组和半结构化访谈中。结果对四个地点的成绩单进行了主题分析。结果在四个地点,有44名GP执业医师和16名PIP表示有兴趣参加。邀请的所有养老院都同意参加。接近三分之二的居民表示同意参加(53/86)。招募了四十名居民(平均年龄84岁; 61%(24岁)是女性),还有38名参与者停留在3个月内(两名死亡)。保留了所有GP做法,PIP和疗养院。在根据预定标准评估了不同结果度量之后,将每个参与居民的跌倒次数选择为主要结果。选择的次要结果/结果指标包括总跌倒,药物负担指数(DBI),住院,死亡率,日常生活活动(Barthel(代理))和生活质量(ED-5Q-5?L(面对面)和代理)),以及从STOPP / START指南中选择的项目,无需进行临床判断即可进行评估。没有不良药物事件的报道。 PIP服务通常受到大多数利益相关者(养老院工作人员,GPS,居民,亲戚和其他医疗保健专业人员)的好评。 PIP在培训后表示对实施变更感到更有信心,但在现有工作量范围内适应新服务的挑战也很严重。结论在护理院中实施PIP服务是可行的,并且对于护理院居民,员工和临床医生是可接受的。调查结果为服务规范,PIP培训,未来RCT的招募以及结果和结果度量的选择等方面的改进提供了信息。带有内部试点的完整RCT于2016年2月开始,预计结果将于2020年中后期发布。

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