Department of Research, Arkin, Amsterdam, Netherlands; Psychiatric Emergency Service, Arkin, Amsterdam, Netherlands; Psychiatric Residence Training Program, Arkin, Amsterdam, Netherlands.
Department of Research, Arkin, Amsterdam, Netherlands.
Lancet Psychiatry. 2022 Aug;9(8):625-635. doi: 10.1016/S2215-0366(22)00187-0. Epub 2022 Jun 30.
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.
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).
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.
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.
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尽管去机构化已经进行了几十年，但对于急性精神病危机患者，入院后接受低强度门诊治疗仍然是常见的治疗方法。强化家庭治疗已被开发出来，作为住院治疗的替代方法，用于严重精神病危机患者。本研究旨在评估强化家庭治疗减少住院天数的潜力，并与常规治疗相比评估其临床疗效。
我们进行了一项两臂、两中心、开放标签、Zelen、双同意、实用随机对照试验。在荷兰阿姆斯特丹的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年龄在 18-65 岁之间的患者。符合 DSM-IV-TR 或 DSM-5 障碍诊断标准且处于精神危机状态且精神科医生已表明或完成临床入院的患者可以纳入。经过培训的精神科急诊服务和医院专业人员在与患者首次接触时通过自动在线预随机程序进行操作。 seeded 伪随机数发生器将患者（2:1）随机分配至强化家庭治疗或常规治疗组。随机分组后，只要患者在 14 天内有精神能力，就获得知情同意。由于本研究的性质，患者和专业人员对治疗情况并不知情。强化家庭治疗根据危机的性质和患者及家属的目标量身定制，并与他们和多学科专业团队合作制定。所有主要分析均为意向治疗，主要结局为随机分组后 12 个月的总入院天数。为了研究治疗条件对结局指标的影响，使用受限极大似然估计进行了线性混合模型分析。本试验在 Trialregister.nl（NL-6020，NTR-6151）上进行了前瞻性注册。
2016 年 11 月 15 日至 2018 年 10 月 15 日期间，共纳入 246 名患者（183 名接受强化家庭治疗，63 名接受常规治疗）。纳入的 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%）出生于荷兰，85 名（35%）出生于其他地方（47 名[19%]参与者的数据缺失）。种族数据不可用。强化家庭治疗组的平均入院天数为 42.47 天（标准差 53.92），常规治疗组为 67.02 天（标准差 79.03），减少了 24.55 天（标准差 10.73）或 36.6%（p=0.033）。记录了 26 起不良事件，其中 23 起（89%）为自杀企图。报告不良事件的患者人数在两组之间没有显著差异（强化家庭治疗组 15 例[8%]，常规治疗组 5 例[8%]；p=0.950）。有 5 名患者自杀身亡（强化家庭治疗组 3 例[2%]，常规治疗组 2 例[3%]；p=0.610）。没有与治疗相关的死亡事件发生。
强化家庭治疗是一种安全有效的精神病危机常规治疗的替代方法，可减少住院天数，使患者在社会环境中停留更长时间，具有相似的临床效果、患者满意度和不良事件。
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