《养老院居民的药物安全 - 一项在 44 家养老院开展的实用、集群随机、对照干预试验的研究结果》。
Drug Safety for Nursing-Home Residents-Findings of a Pragmatic, Cluster-Randomized, Controlled Intervention Trialin 44 Nursing Homes.
机构信息
Institute for General Practice, Hannover Medical School; Medical Rehabilitation and Geriatrics, Hospital DIAKOVERE Henriettenstift, Hannover; Philipp Klee Institute for Clinical Pharmacology, University of Witten/Herdecke, Wuppertal; Institute for General Practice, Heinrich-Heine University Düsseldorf; Institute of General Practice, Rostock University Medical Center; Institute for General Medicine and Inter professional Care, Tübingen University Hospital; Institute of General Practice and Family Medicine, Jena University Hospital.
出版信息
Dtsch Arztebl Int. 2021 Oct 22;118(42):705-712. doi: 10.3238/arztebl.m2021.0297.
BACKGROUND
The safety of drug use by nursing-home residents can be impaired by polypharmacy, potentially inappropriate medications (PIM), and neuroleptics, as well as by a lack of adequate interprofessional coordination in the nursing home. The goal of the HIOPP-3-iTBX Trial was to improve drug safety in nursing-home residents, including a reduction of PIM and/or neu - roleptic use, by means of a complex interprofessional intervention.
METHODS
This cluster-randomized, controlled trial was performed in nursing homes in Germany. Residents over age 65 were included in the trial. The intervention was carried out over six months and consisted of four elements: a drug review by trained pharmacists, educational sessions for general practitioners and nurses, a drug safety toolbox, and change management seminars for members of the three participating professions. The nursing homes in the control group continued to provide usual care. The primary endpoint was the prescription of at least one PIM and/or at least two neuroleptic drugs simultaneously. The secondary endpoints were the incidence of falls and hospitalizations, quality of life, and health-care costs. This trial is registered in the German Clinical Trials Registry (DRKS00013588).
RESULTS
44 nursing homes with 862 residents were randomized, 23 of them (with 452 residents) to the intervention group and 21 (with 410 residents) to the control group. 41% of all nursing-home residents initially took at least one PIM and/or at least two neuroleptic drugs simultaneously. Follow-up data (including, among other things, the current drug regimen) were obtained for 773 residents. The intention-to-treat analysis continued to show no difference between the intervention group and the control group with respect to the primary endpoint.
CONCLUSION
This trial of an intervention to improve drug safety in nursing homes led neither to reduced prescribing of PIM and/or neuroleptic drugs, nor to any improvement in the overall health status of the nursing-home residents.
背景
养老院居民的药物使用安全性可能会因多种药物治疗、潜在不适当药物（PIM）和神经阻滞剂以及养老院缺乏充分的跨专业协调而受到损害。HIOPP-3-iTBX 试验的目的是通过复杂的跨专业干预措施，提高养老院居民的药物安全性，包括减少 PIM 和/或神经阻滞剂的使用。
方法
这是一项在德国养老院进行的集群随机对照试验。 年龄在 65 岁以上的居民被纳入试验。 干预措施持续六个月，包括四个要素： 经过培训的药剂师进行药物审查、为全科医生和护士举办教育课程、药物安全工具包以及为三个参与专业的成员举办变革管理研讨会。 对照组的养老院继续提供常规护理。 主要终点是同时开具至少一种 PIM 和/或至少两种神经阻滞剂。 次要终点是跌倒和住院的发生率、生活质量和医疗保健成本。 该试验在德国临床试验注册处（DRKS00013588）注册。
结果
44 家养老院的 862 名居民被随机分组，其中 23 家（452 名居民）分入干预组，21 家（410 名居民）分入对照组。 最初，所有养老院居民中有 41%同时服用至少一种 PIM 和/或至少两种神经阻滞剂。 对 773 名居民进行了随访数据（包括当前药物治疗方案等）的获取。 意向治疗分析继续显示，干预组与对照组在主要终点方面没有差异。
结论
这项旨在提高养老院药物安全性的干预试验既没有减少 PIM 和/或神经阻滞剂的处方，也没有改善养老院居民的整体健康状况。
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