Institute of Health and Nursing Science, Medical Faculty, Martin Luther University Halle-Wittenberg, Magdeburger Str. 8, 06112 Halle (Saale), Germany.
Health Sciences, MIN Faculty, University of Hamburg, Martin-Luther-King-Platz 6, 20146 Hamburg, Germany.
Int J Nurs Stud. 2019 Aug;96:27-34. doi: 10.1016/j.ijnurstu.2019.03.017. Epub 2019 Apr 4.
Despite clear evidence for the lack of effectiveness and safety, physical restraints are frequently applied in nursing homes. Multicomponent interventions addressing nurses' attitudes and organizational culture have been effective in reducing physical restraints.
To evaluate the effectiveness of two versions of a guideline and theory-based multicomponent intervention to reduce physical restraints in nursing homes.
Pragmatic cluster randomized controlled trial.
The study was conducted in 120 nursing homes in four regions in Germany.
All residents living in the participating nursing home during follow-up, newly admitted residents were also included. A total of 12,245 residents included in the primary analysis (4126 and 3547 residents in intervention group 1 and 2 and 4572 residents in the control group).
Intervention group 1 received an updated version of a successfully tested guideline-based multicomponent intervention (comprising brief education for the nursing staff, intensive training of nominated key nurses in each cluster, introduction of a least-restraint policy and supportive material), intervention group 2 received a concise version of the original program and the control group received optimized usual care (i.e. supportive materials only). Primary outcome was physical restraint prevalence at twelve months, assessed through direct observation by blinded investigators. Intervention and control groups were compared using baseline-adjusted linear regression on cluster level, Bonferroni-adjusted for double testing. Secondary outcomes included falls, fall-related fractures, and quality of life. We also described intervention costs and performed a comprehensive process analysis.
At baseline, mean physical restraint prevalence was 17.4% and 19.6% in intervention groups 1 and 2, and 18.8% in the control group. After twelve months, mean prevalence was 14.6%, 15.7%, and 17.6%. Baseline-adjusted differences between mean prevalences were 2.0% (97.5% CI, -5.8 to 1.9) lower in intervention group 1 and 2.5% (97.5% CI, -6.4 to 1.4) lower in intervention group 2 compared to controls. Physical restraint prevalence showed a pronounced variation between the different clusters in all study groups. We found no significant differences in the secondary outcomes. According to the process evaluation, the intervention was mainly implemented as planned, but the expected change towards a least restraint culture of care was not achieved in all clusters.
Neither intervention showed a clear advantage compared to control. The pronounced center variation in physical restraint prevalence indicates that other approaches like governmental policies are needed to sustainably change physical restraint practice and reduce center variations in nursing homes.
ClinicalTrials.gov : NCT02341898.
尽管缺乏有效性和安全性的证据确凿，但身体约束仍经常在养老院中使用。针对护士态度和组织文化的多组分干预措施已被证明可有效减少身体约束。
评估两种版本的基于指南和理论的多组分干预措施在减少养老院身体约束方面的有效性。
实用的群组随机对照试验。
该研究在德国四个地区的 120 家养老院中进行。
所有在随访期间居住在参与养老院的居民，新入住的居民也包括在内。共有 12245 名居民被纳入主要分析（干预组 1 和 2 各有 4126 名和 3547 名居民，对照组有 4572 名居民）。
干预组 1 接受了经过成功测试的基于指南的多组分干预措施的更新版本（包括对护理人员的简短教育、每个群组中指定的关键护士的强化培训、引入最低约束政策和支持性材料），干预组 2 接受了原始方案的精简版，对照组接受了优化的常规护理（即仅提供支持性材料）。主要结果是通过盲法研究者进行的直接观察评估的十二个月时身体约束的流行率。使用基于群组的线性回归，在群组水平上比较干预组和对照组，通过 Bonferroni 调整进行双重测试。次要结果包括跌倒、跌倒相关骨折和生活质量。我们还描述了干预成本，并进行了全面的过程分析。
基线时，干预组 1 和 2 的身体约束流行率分别为 17.4%和 19.6%，对照组为 18.8%。十二个月后，平均流行率分别为 14.6%、15.7%和 17.6%。干预组 1 和 2 与对照组相比，平均流行率的基线调整差异分别低 2.0%（97.5%CI，-5.8 至 1.9）和 2.5%（97.5%CI，-6.4 至 1.4）。在所有研究组中，不同群组之间的身体约束流行率存在明显差异。我们没有发现次要结果有显著差异。根据过程评估，干预措施主要按计划实施，但并未在所有群组中实现预期的最低约束护理文化转变。
与对照组相比，两种干预措施均未显示出明显优势。身体约束流行率的明显中心差异表明，需要采取其他方法，如政府政策，才能可持续地改变身体约束实践，并减少养老院中中心之间的差异。
ClinicalTrials.gov：NCT02341898。
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