Background

Although de-institutionalisation has been underway for decades, admission to hospital followed by low-intensity outpatient care remains the usual treatment for patients with an acute psychiatric crisis. Intensive home treatment has been developed for patients in a severe psychiatric crisis as an alternative to inpatient care. This study aimed to evaluate the potential of intensive home treatment to reduce bed-days and its clinical effectiveness compared with treatment as usual.

Methods

We did a two-armed, two-centre, open-label, Zelen, double-consent, pragmatic randomised controlled trial. Patients aged 18–65 years were recruited at the psychiatric emergency service and psychiatric emergency wards of the two major mental health institutions (Arkin and GGZ inGeest) in Amsterdam, the Netherlands. Patients diagnosed with at least one DSM-IV-TR or DSM-5 disorder and in a psychiatric crisis and for whom psychiatrists had indicated or completed a clinical admission could be included. Trained psychiatric emergency service and hospital professionals did the automated web-based pre-randomisation procedure upon first contact with the patient. A seeded pseudo-random number generator allocated patients (2:1) to intensive home treatment or treatment as usual. Informed consent was obtained after randomisation as soon as the patient was mentally capable within 14 days. Due to the nature of this study, patients and professionals were not masked to treatment. Intensive home treatment was tailored to the nature of the crisis and goals of patients and relatives, and developed in collaboration with them and a multidisciplinary professional team. All main analyses were intention-to-treat, and the primary outcome was the total number of admission days 12 months after randomisation. To investigate the effect of treatment conditions on the outcome measures, linear mixed modelling analyses using restricted maximum likelihood estimation were done. This trial was prospectively registered with Trialregister.nl, NL-6020 (NTR-6151).

Findings

Between Nov 15, 2016, and Oct 15, 2018, 246 patients were included in the study (183 patients with intensive home treatment vs 63 patients with treatment as usual). 135 women (55%) and 111 men (45%) were included, with a mean age of 41·01 years (range 18–65; SD 12·68). 114 participants (46%) were born in the Netherlands and 85 (35%) elsewhere (missing data on 47 [19%] participants). Ethnicity data were not available. After 12 months, the mean number of admission days in the intensive home treatment condition was 42·47 (SD 53·92) versus 67·02 (SD 79·03) for treatment as usual, a reduction of 24·55 days (SD 10·73) or 36·6% (p=0·033). 26 adverse events were registered, 23 (89%) of which were suicide attempts. The number of patients with a reported adverse event did not differ significantly between the groups (15 [8%] in the intensive home treatment group vs five [8%] in the treatment as usual group; p=0·950). Five patients died by suicide (three [2%] in the intensive home treatment group vs two [3%] in the treatment as usual group; p=0·610). No treatment-related deaths occurred.

Interpretation

Intensive home treatment is a safe and effective partial substitute for conventional psychiatric crisis care that led to a reduction in admission days, causing patients to stay longer in their social environment, with similar clinical effects, patient satisfaction and adverse events.

Funding

De Stichting tot Steun Vereniging voor Christelijke Verzorging van Geestes-en Zenuwzieken.

中文翻译：

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强化家庭治疗在荷兰解决急性精神危机中替代住院治疗的有效性：一项两中心 Zelen 双重同意随机对照试验

背景

尽管几十年来一直在进行去机构化，但入院后进行低强度门诊治疗仍然是急性精神危机患者的常规治疗方法。已经为处于严重精神危机中的患者开发了强化家庭治疗，作为住院治疗的替代方案。本研究旨在评估强化家庭治疗与常规治疗相比减少就寝时间的潜力及其临床有效性。

方法

我们进行了一项双臂、两中心、开放标签、Zelen、双重同意、务实的随机对照试验。荷兰阿姆斯特丹两家主要精神卫生机构（Arkin 和 GGZ inGeest）的精神科急诊服务和精神科急诊病房招募了 18-65 岁的患者。可以包括被诊断患有至少一种 DSM-IV-TR 或 DSM-5 疾病、处于精神危机中并且精神科医生已指示或完成临床入院的患者。训练有素的精神科急诊服务和医院专业人员在首次与患者接触时执行基于网络的自动化预随机化程序。种子伪随机数发生器将患者 (2:1) 分配到强化家庭治疗或照常治疗。一旦患者在 14 天内精神上有能力，就在随机分组后获得知情同意。由于这项研究的性质，患者和专业人员没有接受治疗。强化家庭治疗是根据危机的性质以及患者和亲属的目标量身定制的，并与他们和多学科专业团队合作开发。所有主要分析均为意向治疗，主要结果是随机分组后 12 个月的入院总天数。为了研究治疗条件对结果测量的影响，进行了使用限制性最大似然估计的线性混合建模分析。该试验在 Trialregister.nl, NL-6020 (NTR-6151) 进行了前瞻性注册。患者和专业人员没有接受治疗。强化家庭治疗是根据危机的性质以及患者和亲属的目标量身定制的，并与他们和多学科专业团队合作开发。所有主要分析均为意向治疗，主要结果是随机分组后 12 个月的入院总天数。为了研究治疗条件对结果测量的影响，进行了使用限制性最大似然估计的线性混合建模分析。该试验在 Trialregister.nl, NL-6020 (NTR-6151) 进行了前瞻性注册。患者和专业人员没有接受治疗。强化家庭治疗是根据危机的性质以及患者和亲属的目标量身定制的，并与他们和多学科专业团队合作开发。所有主要分析均为意向治疗，主要结果是随机分组后 12 个月的入院总天数。为了研究治疗条件对结果测量的影响，进行了使用限制性最大似然估计的线性混合建模分析。该试验在 Trialregister.nl, NL-6020 (NTR-6151) 进行了前瞻性注册。所有主要分析均为意向治疗，主要结果是随机分组后 12 个月的入院总天数。为了研究治疗条件对结果测量的影响，进行了使用限制性最大似然估计的线性混合建模分析。该试验在 Trialregister.nl, NL-6020 (NTR-6151) 进行了前瞻性注册。所有主要分析均为意向治疗，主要结果是随机分组后 12 个月的入院总天数。为了研究治疗条件对结果测量的影响，进行了使用限制性最大似然估计的线性混合建模分析。该试验在 Trialregister.nl, NL-6020 (NTR-6151) 进行了前瞻性注册。

发现

在 2016 年 11 月 15 日至 2018 年 10 月 15 日期间，246 名患者被纳入研究（183 名接受强化家庭治疗的患者与63例患者照常治疗）。包括 135 名女性 (55%) 和 111 名男性 (45%)，平均年龄为 41·01 岁（范围 18-65；标准差 12·68）。114 名参与者 (46%) 出生在荷兰，85 名 (35%) 出生在其他地方（缺少 47 名 [19%] 参与者的数据）。种族数据不可用。12 个月后，家庭强化治疗的平均入院天数为 42·47 (SD 53·92)，而照常治疗为 67·02 (SD 79·03)，减少了 24·55 天 (SD 10·73) 或 36·6% (p=0·033)。登记了 26 起不良事件，其中 23 起 (89%) 为自杀未遂。报告不良事件的患者数量在两组之间没有显着差异（强化家庭治疗组 15 [8%] vs5例[8%]在照常治疗组；p=0·950)。5 名患者死于自杀（家庭强化治疗组3 名 [2%]与常规治疗组 2 名 [3%]；p=0·610）。没有发生与治疗相关的死亡。

解释

强化家庭治疗是传统精神危机护理的安全有效的部分替代品，可减少入院天数，使患者在其社会环境中停留的时间更长，具有相似的临床效果、患者满意度和不良事件。

资金

De Stichting tot Steun Vereniging voor Christelijke Verzorging van Geestes-en Zenuwzieken。