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日本针对曾自杀未遂且被收治于医院急诊科的精神健康问题患者开展的主动病例管理与强化常规护理对比研究(ACTION-J):一项多中心随机对照试验。

Assertive case management versus enhanced usual care for people with mental health problems who had attempted suicide and were admitted to hospital emergency departments in Japan (ACTION-J): a multicentre, randomised controlled trial.

作者信息

Kawanishi Chiaki, Aruga Tohru, Ishizuka Naoki, Yonemoto Naohiro, Otsuka Kotaro, Kamijo Yoshito, Okubo Yoshiro, Ikeshita Katsumi, Sakai Akio, Miyaoka Hitoshi, Hitomi Yoshie, Iwakuma Akihiro, Kinoshita Toshihiko, Akiyoshi Jotaro, Horikawa Naoshi, Hirotsune Hideto, Eto Nobuaki, Iwata Nakao, Kohno Mototsugu, Iwanami Akira, Mimura Masaru, Asada Takashi, Hirayasu Yoshio

机构信息

Health Management and Promotion Center, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

Department of Emergency and Critical Care Medicine, Showa University School of Medicine, Tokyo, Japan.

出版信息

Lancet Psychiatry. 2014 Aug;1(3):193-201. doi: 10.1016/S2215-0366(14)70259-7. Epub 2014 Aug 5.

Abstract

BACKGROUND

Non-fatal suicide attempt is the most important risk factor for later suicide. Emergency department visits for attempted suicide are increasingly recognised as opportunities for intervention. However, no strong evidence exists that any intervention is effective at preventing repeated suicide attempts. We aimed to investigate whether assertive case management can reduce repetition of suicide attempts in people with mental health problems who had attempted suicide and were admitted to emergency departments.

METHODS

In this multicentre, randomised controlled trial in 17 hospital emergency departments in Japan, we randomly assigned people aged 20 years and older with mental health problems who had attempted suicide to receive either assertive case management (based on psychiatric diagnoses, social risks, and needs of the patients) or enhanced usual care (control), using an internet-based randomisation system. Interventions were provided until the end of the follow-up period (ie, at least 18 months and up to 5 years). Outcome assessors were masked to group allocation, but patients and case managers who provided the interventions were not. The primary outcome was the incidence of first recurrent suicidal behaviour (attempted suicide or completed suicide); secondary outcomes included completed suicide and all-cause mortality. This study is registered at ClinicalTrials.gov (NCT00736918) and UMIN-CTR (C000000444).

FINDINGS

Between July 1, 2006, and Dec 31, 2009, 914 eligible participants were randomly assigned, 460 to the assertive case management group and 456 to the enhanced usual care group. We noted no significant difference in incidence of first recurrent suicidal behaviour between the assertive case management group and the enhanced usual care group over the full study period (log-rank p=0·258). Because the proportional hazards assumption did not hold, we did ad-hoc analyses for cumulative incidence of the primary outcome at months 1, 3, 6, 12, and 18 after randomisation, adjusting for multiplicity with the Bonferroni method. Assertive case management significantly reduced the incidence of first recurrent suicidal behaviour up to the 6-month timepoint (6-month risk ratio 0·50, 95% CI 0·32-0·80; p=0·003), but not at the later timepoints. Prespecified subgroup analyses showed that the intervention had a greater effect in women (up to 18 months), and in participants younger than 40 years and those with a history of previous suicide attempts (up to 6 months). We did not identify any differences between the intervention and control groups for completed suicide (27 [6%] of 460 vs 30 [7%] of 454, log-rank p=0·660) or all-cause mortality (46 [10%] of 460 vs 42 [9%] of 454, log-rank p=0·698).

INTERPRETATION

Our results suggest that assertive case management is feasible in real-world clinical settings. Although it was not effective at reducing the incidence of repetition of suicide attempts in the long term, the results of our ad-hoc analyses suggested that it was effective for up to 6 months. This finding should be investigated in future research.

FUNDING

The Ministry of Health, Labour, and Welfare of Japan.

摘要

背景

非致命性自杀未遂是日后自杀的最重要风险因素。因自杀未遂而到急诊科就诊日益被视为进行干预的契机。然而,尚无有力证据表明任何干预措施在预防重复自杀未遂方面有效。我们旨在调查积极个案管理能否减少有自杀未遂史且因自杀未遂而入住急诊科的精神健康问题患者的自杀未遂复发情况。

方法

在日本17家医院急诊科开展的这项多中心随机对照试验中,我们使用基于互联网的随机系统,将年龄在20岁及以上、有自杀未遂史的精神健康问题患者随机分配接受积极个案管理(基于患者的精神科诊断、社会风险和需求)或强化常规护理(对照组)。干预措施持续至随访期结束(即至少18个月,最长5年)。结局评估者对分组情况不知情,但提供干预措施的患者和个案管理员知晓分组情况。主要结局是首次复发自杀行为(自杀未遂或自杀死亡)的发生率;次要结局包括自杀死亡和全因死亡率。本研究已在ClinicalTrials.gov(NCT00736918)和UMIN-CTR(C000000444)注册。

结果

在2006年7月1日至2009年12月31日期间,914名符合条件的参与者被随机分组,460名进入积极个案管理组,456名进入强化常规护理组。在整个研究期间,积极个案管理组和强化常规护理组首次复发自杀行为的发生率无显著差异(对数秩检验p = 0.258)。由于比例风险假设不成立,我们在随机分组后第1、3、6、12和18个月对主要结局的累积发生率进行了特设分析,并采用Bonferroni法对多重性进行校正。积极个案管理在6个月时间点之前显著降低了首次复发自杀行为的发生率(6个月风险比0.50,95%置信区间0.32 - 0.80;p = 0.003),但在随后的时间点则没有。预先设定的亚组分析表明,该干预措施在女性中(长达18个月)、40岁以下参与者以及有既往自杀未遂史者中(长达6个月)效果更佳。我们未发现干预组和对照组在自杀死亡(460例中的27例[6%]对454例中的30例[7%],对数秩检验p = 0.660)或全因死亡率(460例中的46例[10%]对454例中的42例[9%],对数秩检验p = 0.698)方面存在差异。

解读

我们的结果表明,积极个案管理在现实临床环境中是可行的。虽然它在长期内未能有效降低自杀未遂复发的发生率,但我们的特设分析结果表明,它在长达6个月的时间内是有效的。这一发现应在未来研究中进一步探讨。

资助

日本厚生劳动省。

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