Charité Competence Center for Traditional and Integrative Medicine (CCCTIM), Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität Zu Berlin and Berlin Institute of Health, Berlin, Germany.
Department of Prevention, Integrative Medicine and Health Promotion, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität Zu Berlin, and Berlin Institute of Health, Berlin, Germany.
Trials. 2024 Sep 27;25(1):628. doi: 10.1186/s13063-024-08491-1.
Healthcare professionals in hospitals are exposed to a high level of professional stress, time pressure, workload, and often times poor organizational support. This makes them especially susceptible to burnout. In this pragmatic randomized controlled trial, we test the hypothesis that participation in a 9-week program (LAGOM) that was designed in close collaboration with healthcare professionals, incorporating both individual and organizational aspects reduces emotional exhaustion in healthcare professionals (primary outcome).
Eighty four nurses and physicians working at the Charité - Universitätsmedizin Berlin and the Immanuel Hospital Berlin are automatically randomized to the LAGOM program (n = 42) or to usual care (n = 42) in a one-to-one allocation rate. The primary outcome emotional exhaustion is measured by the Maslach Burnout Inventory-Human Services Survey at baseline, post-intervention, and 1-month follow-up via an online survey. Secondary outcomes include depersonalization, personal accomplishment, subjective stress, mental well-being, self-care, self-efficacy, working conditions, mindfulness, and adverse events. Electrophysiological measures for heart rate variation analysis are captured. The PRECIS-2 tool is used to characterize the degree of pragmatism in our trial. Data analysis and primary intention-to-treat analysis using repeated measures analysis of variance are performed blind to intervention allocation. Per-protocol, subgroup, and secondary outcome analyses are conducted exploratively. An advisory board consisting of various stakeholders accompanies the study process.
If LAGOM proves to be effective in reducing symptoms of burnout, the program could make an important contribution to tackling the problem of the very high burnout rates among healthcare professionals and become an integral part of preventive services offered by hospitals.
German Clinical Trials Register, DRKS00034060. Registered 31 May 2024.
医院的医疗保健专业人员面临着高水平的职业压力、时间压力、工作量，而且往往组织支持不足。这使他们特别容易出现倦怠。在这项实用的随机对照试验中，我们检验了这样一个假设，即参与一个由医疗保健专业人员密切合作设计的 9 周方案（LAGOM），该方案结合了个人和组织方面，可减少医疗保健专业人员的情绪疲惫（主要结果）。
84 名在柏林夏洛蒂医科大学和柏林伊曼纽尔医院工作的护士和医生自动按 1:1 的比例随机分配到 LAGOM 方案（n=42）或常规护理（n=42）。主要结局情绪疲惫通过在线调查，在基线、干预后和 1 个月随访时使用 Maslach 倦怠量表-人力服务调查进行测量。次要结局包括去人性化、个人成就感、主观压力、心理健康、自我保健、自我效能、工作条件、正念和不良事件。捕获心率变异性分析的电生理测量。使用 PRECIS-2 工具来描述我们试验的实用程度。数据分析和主要意向治疗分析使用重复测量方差分析进行，对干预分配进行盲法。按方案、亚组和次要结局进行探索性分析。一个由各种利益相关者组成的咨询委员会伴随研究过程。
如果 LAGOM 被证明能有效减轻倦怠症状，该方案将为解决医疗保健专业人员倦怠率非常高的问题做出重要贡献，并成为医院提供的预防服务的重要组成部分。
德国临床试验注册处，DRKS00034060。注册于 2024 年 5 月 31 日。
