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经验教训:整群随机养老院研究HIOPP-3 iTBX招募过程中面临的挑战

[Lessons learned: Challenges faced in the recruitment process for the cluster-randomized nursing home study HIOPP-3 iTBX].

作者信息

Kirsch Claudia, Doyle Ina-Merle, Krause Olaf, Junius-Walker Ulrike, Wiese Birgitt, Thürmann Petra, Sparenberg Lisa Christine, Wollny Anja, Fuchs Angela, Wilm Stefan, Joos Stefanie, Stolz Regina, Haumann Hannah

机构信息

Institut für Allgemeinmedizin, Medizinische Hochschule Hannover, Hannover, Deutschland.

Institut für Allgemeinmedizin, Medizinische Hochschule Hannover, Hannover, Deutschland.

出版信息

Z Evid Fortbild Qual Gesundhwes. 2020 Nov;156-157:24-32. doi: 10.1016/j.zefq.2020.07.002. Epub 2020 Aug 27.

DOI:10.1016/j.zefq.2020.07.002
PMID:32861614
Abstract

INTRODUCTION

The cluster-randomized multicenter HIOPP-3 iTBX study ('General Practitioners' Initiative to optimize Medication safety for Nursing Home Residents - using an interprofessional toolbox') aims to improve medication safety in nursing home residents through a complex interprofessional intervention focusing on neuroleptics and potentially inadequate medications. A stepwise recruitment process was used for all study participants (nursing homes, general practitioners, pharmacists, nursing home residents). The aim of this article is to describe the underlying recruitment strategy, the results of the recruitment and the measures undertaken to recruit the necessary number of participants.

METHODS

The recruitment strategy and the response rates of nursing homes, general practitioners, pharmacists and nursing home residents are described. Measures to improve recruitment at the study sites and reasons for refusal to participate were documented.

RESULTS

The response rate in nursing homes was 8.4 % (n=44). Of the pharmacists contacted by these nursing homes 70.3 % (n=52) participated, and 43.5 % (n=91) of all contacted general practitioners. Twenty-three (33.0 %) nursing homes had to be excluded from the study because no interprofessional team could be formed. Of all nursing home residents under the care of the participating general practitioners 862 (43,5%) persons and/or their caregivers gave consent to participate in the study. The recruitment for the study took 14 months. In the course of recruitment, recruitment strategies had to be adapted to local circumstances at the study sites. Reasons for non-participation varied between the different groups.

DISCUSSION AND CONCLUSION

The main challenge in the HIOPP-3 iTBX study was to form interprofessional teams in each cluster. A stepwise, partly dependent recruitment process in a large group of potential participants presents organizational challenges that should be taken into account while planning the study. In order to reach the calculated sample size in the HIOPP-3 iTBX study, a pragmatic and flexible approach, adapted to local circumstances, was required. Further studies may benefit from the experiences made in the HIOPP-3 iTBX study.

摘要

引言

集群随机多中心HIOPP - 3 iTBX研究(“全科医生优化养老院居民用药安全倡议——使用跨专业工具箱”)旨在通过一项针对抗精神病药物和潜在不适当药物的复杂跨专业干预措施,提高养老院居民的用药安全。所有研究参与者(养老院、全科医生、药剂师、养老院居民)均采用逐步招募流程。本文旨在描述潜在的招募策略、招募结果以及为招募到足够数量的参与者所采取的措施。

方法

描述了养老院、全科医生、药剂师和养老院居民的招募策略及回应率。记录了在研究地点提高招募率的措施以及拒绝参与的原因。

结果

养老院的回应率为8.4%(n = 44)。这些养老院联系的药剂师中有70.3%(n = 52)参与,所有联系的全科医生中有43.5%(n = 91)参与。23家(33.0%)养老院因无法组建跨专业团队而被排除在研究之外。参与研究的全科医生所照料的所有养老院居民中,有862人(43.5%)和/或其护理人员同意参与研究。该研究的招募工作耗时14个月。在招募过程中,招募策略必须根据研究地点的当地情况进行调整。不同群体不参与的原因各不相同。

讨论与结论

HIOPP - 3 iTBX研究的主要挑战在于在每个集群中组建跨专业团队。在一大群潜在参与者中采用逐步且部分依赖的招募流程会带来组织方面的挑战,在规划研究时应予以考虑。为了在HIOPP - 3 iTBX研究中达到计算出的样本量,需要一种务实且灵活、适应当地情况的方法。进一步的研究可能会从HIOPP - 3 iTBX研究中获得的经验中受益

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引用本文的文献

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Aging Clin Exp Res. 2023 Oct;35(10):2227-2235. doi: 10.1007/s40520-023-02513-9. Epub 2023 Aug 7.
2
Drug Safety for Nursing-Home Residents-Findings of a Pragmatic, Cluster-Randomized, Controlled Intervention Trialin 44 Nursing Homes.《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》。
Dtsch Arztebl Int. 2021 Oct 22;118(42):705-712. doi: 10.3238/arztebl.m2021.0297.