Department of Medical Sociology, Faculty of Medicine, Institute of the History, Philosophy and Ethics of Medicine, Ulm University, Parkstr. 11, 89073, Ulm, Germany.
Arbeit und Zukunft e.V, Hamburg, Germany.
BMC Public Health. 2020 Aug 25;20(1):1281. doi: 10.1186/s12889-020-09290-4.
In the present investigation the study protocol and the results at baseline of a workplace intervention are reported. It is hypothesised that the reduction of the physical and psychosocial workload of healthcare workers increases 1 their self-assessed physical and mental work ability, and 2. clients' satisfaction with care.
Two-arm, cluster-randomised trial. Outcome data on workers and clients are collected in questionnaires at baseline, and two follow-ups between 2019 and 2021. Participants of the interventions are healthcare workers of 11 healthcare providers in Germany. At baseline, the intervention arm comprised 22 clusters (n = 174 workers); the control arm, 47 clusters (n = 276). The intervention consists of interviews and workshops, in which employees propose measures aiming to reduce the physical and psychosocial load, and strengthen resources at work. The primary outcome is the workers' physical and mental work ability. The secondary outcome is the clients' satisfaction with care.
There was no evidence of substantial differences between trial arms at baseline concerning the outcomes. The design effect estimates for physical and mental work ability were 1.29 and 1.05, respectively. At the end of the trial, effect sizes of at least 0.30 and 0.27 at the 80% power and 5% significance levels can be attained.
The results suggest that the implementation of the study design has been satisfactory. The intervention is expected to provide evidence of relatively small to medium-size effects of the intervention activities on the work ability of healthcare workers and the clients' satisfaction with care.
Registration trial DRKS00021138 on the German Registry of Clinical Studies (DRKS), retrospectively registered on 25 March, 2020.
本研究报告了一项工作场所干预的研究方案和基线结果。研究假设减少医护人员的体力和心理工作量会增加以下两个方面：1. 他们自我评估的身体和心理工作能力；2. 客户对护理的满意度。
采用两臂、整群随机试验。在基线、2019 年至 2021 年之间的两次随访中，使用问卷收集工人和客户的结果数据。干预组的参与者为德国 11 家医疗保健机构的医护人员。在基线时，干预组包括 22 个集群（n=174 名工人）；对照组包括 47 个集群（n=276 名工人）。干预措施包括访谈和研讨会，员工在这些会议中提出旨在减轻体力和心理负荷、加强工作资源的措施。主要结果是工人的身体和心理工作能力。次要结果是客户对护理的满意度。
在基线时，试验组之间在结果方面没有明显差异。身体和心理工作能力的设计效果估计分别为 1.29 和 1.05。在试验结束时，在 80%的功效和 5%的显著性水平下，可以达到至少 0.30 和 0.27 的效应大小。
结果表明，研究设计的实施是令人满意的。预计该干预措施将为干预活动对医护人员工作能力和客户对护理满意度的相对较小到中等规模的影响提供证据。
德国临床研究注册处（DRKS）上的注册试验 DRKS00021138，于 2020 年 3 月 25 日进行了回溯性注册。
