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爱尔兰初级保健中多重疾病患者减少潜在不适当处方和多重用药的整群随机对照试验的过程评估研究方案(SPPiRE)

Study protocol for a process evaluation of a cluster randomised controlled trial to reduce potentially inappropriate prescribing and polypharmacy in patients with multimorbidity in Irish primary care (SPPiRE).

作者信息

Kyne Karen, McCarthy Caroline, Kiely Bridget, Smith Susan M, Clyne Barbara

机构信息

Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.

出版信息

HRB Open Res. 2019 Aug 23;2:20. doi: 10.12688/hrbopenres.12920.2. eCollection 2019.

DOI:10.12688/hrbopenres.12920.2
PMID:32104779
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7016882/
Abstract

Multimorbidity (the presence of two or more chronic conditions) is associated with poorer health outcomes, particularly for patients with significant polypharmacy (≥15 medications), due to the higher risk of adverse events and drug interactions. The SPPiRE study will assess the effectiveness of a complex intervention to support general practitioners (GPs) to reduce potentially inappropriate prescribing and consider deprescribing in older people with multimorbidity and significant polypharmacy. The aim of the SPPiRE process evaluation is to understand how and why the intervention is effective or ineffective and to explore the potential for system wide implementation of the intervention using the Medical Research Council general themes of context, implementation and mechanism of impact. The SPPiRE study is a clustered randomised controlled trial (RCT), aiming to recruit 55 general practices and 400 patients (≥65 years) on ≥15 medications throughout the Republic of Ireland. This mixed-methods process evaluation of the SPPiRE study will integrate both quantitative and qualitative data. Quantitative data will be collected on use of the intervention elements and from GP questionnaires. Qualitative data will be collected from semi-structured telephone interviews with all intervention GPs and a purposeful sample of patients from intervention practices. The topic guide will explore barriers and facilitators to participation and implementation of the intervention. Quantitative data will be analysed using descriptive statistics. Interviews will be transcribed and analysed using thematic analysis. Quantitative and qualitative data will be then be integrated. The SPPiRE cluster RCT will provide evidence regarding the effectiveness and practicability of delivering a structured medication review in reducing polypharmacy and potentially inappropriate prescribing for patients with multimorbidity. This process evaluation will provide information on how the intervention was implemented, how it was or was not effective and the potential for a system wide implementation. ISRCTN 12752680, registration: 20/10/2016.

摘要

多病共存(即存在两种或更多种慢性病)与更差的健康结局相关,特别是对于使用大量药物(≥15种药物)的患者,因为不良事件和药物相互作用的风险更高。SPPiRE研究将评估一项综合干预措施的有效性,该措施旨在支持全科医生(GP)减少潜在的不适当用药,并考虑对患有多病共存和大量用药的老年人进行减药。SPPiRE过程评估的目的是了解该干预措施有效或无效的方式及原因,并利用医学研究理事会关于背景、实施和影响机制的总体主题,探索该干预措施在全系统实施的可能性。SPPiRE研究是一项整群随机对照试验(RCT),旨在在爱尔兰共和国招募55家全科诊所和400名(≥65岁)使用≥15种药物的患者。对SPPiRE研究的这项混合方法过程评估将整合定量和定性数据。将收集关于干预措施要素使用情况的数据以及来自全科医生问卷的数据作为定量数据。定性数据将通过对所有参与干预的全科医生进行半结构化电话访谈以及从参与干预诊所中选取的有目的的患者样本收集。主题指南将探讨参与和实施干预措施的障碍及促进因素。定量数据将使用描述性统计进行分析。访谈将进行转录并使用主题分析进行分析。然后将定量和定性数据进行整合。SPPiRE整群随机对照试验将提供证据,证明进行结构化药物审查在减少多病共存患者的多重用药和潜在不适当用药方面的有效性和实用性。该过程评估将提供有关干预措施如何实施、其有效或无效的情况以及全系统实施的可能性的信息。ISRCTN 12752680,注册时间:2016年10月20日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0ba9/7017185/2c32f8ace290/hrbopenres-2-14078-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0ba9/7017185/0f5352c4933e/hrbopenres-2-14078-g0000.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0ba9/7017185/da0ac8b4f2b3/hrbopenres-2-14078-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0ba9/7017185/2c32f8ace290/hrbopenres-2-14078-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0ba9/7017185/0f5352c4933e/hrbopenres-2-14078-g0000.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0ba9/7017185/da0ac8b4f2b3/hrbopenres-2-14078-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0ba9/7017185/2c32f8ace290/hrbopenres-2-14078-g0002.jpg

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