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社区药剂师干预对痴呆症患者护理负担的影响:一项干预方案的制定与随机可行性试验

Impact of interventions by a community pharmacist on care burden for people with dementia: development and randomized feasibility trial of an intervention protocol.

作者信息

Nanaumi Yoko, Yoshitani Atsushi, Onda Mitsuko

机构信息

Advance Pharma Research Office, 3-6-2 Ukyo, Nara, 631-0805, Japan.

Nara City Pharmaceutical Association, 768, Kidera-cho, Nara, 630-8306, Japan.

出版信息

Pilot Feasibility Stud. 2022 Jun 2;8(1):118. doi: 10.1186/s40814-022-01071-7.

Abstract

BACKGROUND

Traditionally, the role of pharmacists has been to manage and monitor pharmacotherapy for patients with dementia. However, additional intervention by community pharmacists to collect and share patient information with other professionals may help reduce the care burden among caregivers. The aims of this study were to examine (1) the feasibility of a designed community pharmacist working procedure in dementia care and (2) the expected impact of pharmacist intervention on care burden.

METHODS

This was a randomized, open-label, parallel-group feasibility study, involving eight Nara City pharmaceutical association member pharmacies that provided consent to participate. These pharmacies were assigned to an intervention group or a control group at a 1:1 ratio. The subjects were patients with dementia and their primary caregivers that visited the participating pharmacies and provided consent to participate. Pharmacists in the intervention group actively collected information from the patients' family physicians and care managers and intervened to address medication-related problems, while those in the control group only performed their normal duties. The primary endpoint was a change in the caregiver's score on the Japanese version of Zarit Caregiver Burden interview (J-ZBI) from the baseline to after 5 months of follow-up. The changes in mean J-ZBI scores from the beginning to the end of the study period of the two groups were compared.

RESULTS

Obtaining consent from caregivers was certainly difficult, but possible. Pharmacists managed to fill out the survey form while practising pharmaceutical care. Totally, nine patients and nine caregivers in the intervention group and nine patients and eight caregivers in the control group completed the study. The changes in J-ZBI scores could be calculated for seven cases in the intervention group and five cases in the control group. The J-ZBI scores were found to decrease by 1.0 in the intervention group and increase by 3.0 in the control group.

CONCLUSIONS

The protocol presented was considered feasible, but, the intervention process needs to be simplified in order to conduct a large study. Also, improvements are needed in the various survey forms and in the explanatory documents for caregivers. Although the sample size was small, the effect sizes suggested that community pharmacist interventions for patient with dementia may reduce the care burden for caregivers.

TRIAL REGISTRATION

UMIN000039949 (registration date: 1 April 2020, retrospectively registered).

摘要

背景

传统上,药剂师的职责是管理和监测痴呆症患者的药物治疗。然而,社区药剂师通过额外干预来收集患者信息并与其他专业人员共享,可能有助于减轻护理人员的护理负担。本研究的目的是检验:(1)设计的社区药剂师在痴呆症护理中的工作程序的可行性;(2)药剂师干预对护理负担的预期影响。

方法

这是一项随机、开放标签、平行组可行性研究,纳入了八家同意参与的奈良市药学协会成员药店。这些药店以1:1的比例被分配到干预组或对照组。研究对象为前往参与研究的药店并同意参与的痴呆症患者及其主要护理人员。干预组的药剂师积极从患者的家庭医生和护理经理那里收集信息,并对与用药相关的问题进行干预,而对照组的药剂师只履行其正常职责。主要终点是护理人员在日本版的 Zarit 护理负担访谈量表(J-ZBI)上从基线到随访5个月后的得分变化。比较两组在研究期间开始到结束时 J-ZBI 平均得分的变化。

结果

获得护理人员的同意确实很困难,但并非不可能。药剂师在提供药学服务的同时设法填写了调查问卷。干预组共有9名患者和9名护理人员,对照组有9名患者和8名护理人员完成了研究。干预组有7例、对照组有5例可以计算 J-ZBI 得分的变化。发现干预组的 J-ZBI 得分下降了1.0,而对照组上升了3.0。

结论

所提出的方案被认为是可行的,但为了进行大规模研究,干预过程需要简化。此外,各种调查问卷和给护理人员的解释文件也需要改进。尽管样本量较小,但效应量表明,社区药剂师对痴呆症患者的干预可能会减轻护理人员的护理负担。

试验注册

UMIN000039949(注册日期:2020年4月1日,追溯注册)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bed5/9161485/f1f09d7ad43b/40814_2022_1071_Fig1_HTML.jpg

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