Open-door policy is a recommended framework to reduce coercion in psychiatric wards. However, existing observational data might not fully capture potential increases in harm and use of coercion associated with open-door policies. In this first randomised controlled trial, we compared coercive practices in open-door policy and treatment-as-usual wards in an urban hospital setting. We hypothesised that the open-door policy would be non-inferior to treatment-as-usual on the proportion of patients exposed to coercive measures. We conducted a pragmatic, randomised controlled, non-inferiority trial comparing two open-door policy wards and three treatment-as-usual acute psychiatric wards at Lovisenberg Diaconal Hospital in Oslo, Norway. An exemption from the consent requirements enabled inclusion and random allocation of all patients admitted to these wards using an open list (2:3 ratio) administrated by a team of ward nurses. The primary outcome was the proportion of patient stays with one or more coercive measures, including involuntary medication, isolation or seclusion, and physical and mechanical restraints. The non-inferiority margin was set to 15%. Primary and safety analyses were assessed using the intention-to-treat population. The trial is registered with ISRCTN registry and is complete, ISRCTN16876467. Between Feb 10, 2021, and Feb 1, 2022, we randomly assigned 556 patients to either open-door policy wards (n=245; mean age 41·6 [SD 14·5] years; 119 [49%] male; 126 [51%] female; and 180 [73%] admitted to the ward involuntarily) or treatment-as-usual wards (n=311; mean age 41·6 [4·3] years; 172 [55%] male and 138 [45%] female; 233 [75%] admitted involuntarily). Data on race and ethnicity were not collected. The open-door policy was non-inferior to treatment-as-usual on all outcomes: the proportion of patient stays with exposure to coercion was 65 (26·5%) in open-door policy wards and 104 (33·4%) in treatment-as-usual wards (risk difference 6·9%; 95% CI –0·7 to 14·5), with a similar trend for specific measures of coercion. Reported incidents of violence against staff were 0·15 per patient stay in open-door policy wards and 0·18 in treatment-as-usual wards. There were no suicides during the randomised controlled trial period. The open-door policy could be safely implemented without increased use of coercive measures. Our findings underscore the need for more reliable and relevant randomised trials to investigate how a complex intervention, such as open-door policy, can be efficiently implemented across health-care systems and contexts. South-Eastern Norway Regional Health Authority and The Research Council of Norway.

中文翻译：

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城市精神科住院病房的开放政策与常规治疗：挪威的一项务实、随机对照、非劣效性试验

开放政策是减少精神科病房强制行为的推荐框架。然而，现有的观察数据可能无法完全反映与开放政策相关的伤害和使用胁迫的潜在增加。在第一个随机对照试验中，我们比较了城市医院环境中开放政策和照常治疗病房中的强制做法。我们假设，就遭受强制措施的患者比例而言，门户开放政策并不逊色于常规治疗。我们进行了一项务实、随机对照、非劣效性试验，比较了挪威奥斯陆 Lovisenberg Diaconal 医院的两个开放政策病房和三个照常治疗的急性精神科病房。由于免除了同意要求，因此可以使用由病房护士团队管理的开放名单（2:3 比例）纳入并随机分配入住这些病房的所有患者。主要结果是接受一种或多种强制措施（包括非自愿药物、隔离或隔离以及身体和机械约束）的患者比例。非劣效裕度设定为15%。使用意向治疗人群评估主要分析和安全性分析。该试验已在 ISRCTN 注册中心注册并已完成，ISRCTN16876467。 2021 年 2 月 10 日至 2022 年 2 月 1 日期间，我们将 556 名患者随机分配到开放政策病房（n=245；平均年龄 41·6 [SD 14·5] 岁；119 [49%] 男性；126 [51%] 为女性；180 [73%] 为非自愿入住病房或按常规治疗的病房（n=311；平均年龄 41·6 [4·3] 岁；172 [55%] 为男性，138 [45%] 女性；233 [75%] 非自愿入院）。没有收集有关种族和民族的数据。开放政策在所有结果上均不劣于照常治疗：开放政策病房中遭受胁迫的患者比例为 65 例 (26·5%) 和 104 例 (33·4%)在照常治疗的病房中（风险差异 6·9%；95% CI –0·7 至 14·5），具体的强制措施也有类似的趋势。据报道，在开放式政策病房中，每名患者发生的针对工作人员的暴力事件为 0·15 起，而在照常治疗病房中，每名患者发生的暴力事件为 0·18 起。随机对照试验期间没有发生自杀事件。开放政策可以安全地实施，而无需增加使用强制措施。我们的研究结果强调需要更可靠和相关的随机试验来调查如何在医疗保健系统和环境中有效实施复杂的干预措施（例如开放政策）。挪威东南部地区卫生局和挪威研究委员会。