将临床药师整合到全科医疗中：一项试点整群随机对照试验方案。

Integrating clinical pharmacists within general practice: protocol for a pilot cluster randomised controlled trial.

机构信息

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

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

出版信息

BMJ Open. 2021 Mar 22;11(3):e041541. doi: 10.1136/bmjopen-2020-041541.

DOI:10.1136/bmjopen-2020-041541

PMID:33753432

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7986865/

Abstract

INTRODUCTION

Managing patients with multiple conditions (multimorbidity) is a major challenge for healthcare systems internationally, particularly in older patients. Multimorbidity and subsequent polypharmacy increase treatment burden and the risk of potentially inappropriate prescribing, and both are complex to manage in primary care. Limited evidence suggests integration of pharmacists into general practice teams could improve medication management for patients with multimorbidity and polypharmacy. Building on findings from a non-randomised, uncontrolled General Practice Pharmacist (GPP) feasibility study conducted in Irish primary care, the aim of this study is to conduct a pilot cluster randomised controlled trial (cRCT) of the GPP study, to assess feasibility, intervention impact, costs and appropriateness of continuing to a definitive cRCT.

METHODS AND ANALYSIS

This pilot cRCT will involve 8 general practitioner (GP) practices and 120 patients. Practices will identify and recruit patients aged ≥65 years, who are taking ≥10 regular medications. Practices will be allocated to intervention or control after baseline data collection. Intervention practices will have a pharmacist integrated within their service, working with GPs, patients and practice staff to optimise prescribing and other medication-related activities. Control practices will provide standard GP care. The primary feasibility outcomes will include recruitment rate, uptake of medication reviews and study retention. For the primary clinical outcome, the number of potentially inappropriate prescribing incidences per patient will be collected. Secondary outcomes will include medication-related outcomes, patient-reported outcome measures, and data pertaining to the role and impact of the pharmacist on prescribing. In addition, economic and process evaluations will be conducted.

ETHICS AND DISSEMINATION

This trial has been approved by the Irish College of General Practitioners Research Ethics Committee and will be performed in accordance with the Declaration of Helsinki. The results will be reported in peer-reviewed journals and be presented at national and international conferences.

TRIAL REGISTRATION NUMBER

ISRCTN Registry (https://doi.org/10.1186/ISRCTN18752158).

摘要

简介

管理患有多种疾病（多种疾病）的患者是国际医疗体系面临的主要挑战，尤其是在老年患者中。多种疾病和随后的多药治疗增加了治疗负担和潜在不适当处方的风险，这两者在初级保健中都难以管理。有限的证据表明，将药剂师纳入全科医生团队可以改善患有多种疾病和多药治疗的患者的药物管理。本研究基于在爱尔兰初级保健中进行的非随机、非对照全科医生药剂师（GPP）可行性研究的结果，旨在对 GPP 研究进行试点群组随机对照试验（cRCT），以评估可行性、干预影响、成本和继续进行确定性 cRCT 的适当性。

方法和分析

本试点 cRCT 将涉及 8 家全科医生（GP）实践和 120 名患者。实践将确定并招募年龄≥65 岁、服用≥10 种常规药物的患者。在基线数据收集后，实践将被分配到干预或对照组。干预实践将有一名药剂师整合到他们的服务中，与全科医生、患者和实践工作人员合作，优化处方和其他与药物相关的活动。对照实践将提供标准的全科医生护理。主要可行性结果将包括招募率、药物审查的接受率和研究保留率。对于主要临床结果，将收集每个患者的潜在不适当处方发生率。次要结果将包括药物相关结果、患者报告的结果测量以及与药剂师对处方的作用和影响有关的数据。此外，还将进行经济和过程评估。