title: 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.
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).
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  The Ministry of Health, Labour, and Welfare of Japan.
authors.affiliation: Health Management and Promotion Center, Yokohama City University Graduate School of Medicine, Yokohama, Japan. Electronic address: chiaki.kawanishi@gmail.com.
authors.forename: Chiaki
authors.initials: C
authors.lastname: Kawanishi
authors.affiliation: Department of Emergency and Critical Care Medicine, Showa University School of Medicine, Tokyo, Japan.
authors.forename: Tohru
authors.initials: T
authors.lastname: Aruga
authors.affiliation: Center for Clinical Sciences, National Center for Global Health and Medicine, Tokyo, Japan.
authors.forename: Naoki
authors.initials: N
authors.lastname: Ishizuka
authors.affiliation: Translational Medical Center, National Center of Neurology and Psychiatry, Tokyo, Japan.
authors.forename: Naohiro
authors.initials: N
authors.lastname: Yonemoto
authors.affiliation: Department of Neuropsychiatry, Iwate Medical University, Morioka, Japan.
authors.forename: Kotaro
authors.initials: K
authors.lastname: Otsuka
authors.affiliation: Department of Emergency and Critical Care Medicine, Kitasato University School of Medicine, Sagamihara, Japan.
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Kamijo
authors.affiliation: Department of Neuropsychiatry, Nippon Medical School, Tokyo, Japan.
authors.forename: Yoshiro
authors.initials: Y
authors.lastname: Okubo
authors.affiliation: Department of Psychiatry, Nara Medical University, Kashihara, Japan.
authors.forename: Katsumi
authors.initials: K
authors.lastname: Ikeshita
authors.affiliation: Department of Neuropsychiatry, Iwate Medical University, Morioka, Japan.
authors.forename: Akio
authors.initials: A
authors.lastname: Sakai
authors.affiliation: Department of Psychiatry, Kitasato University School of Medicine, Sagamihara, Japan.
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Miyaoka
authors.affiliation: Department of Neuropsychiatry, Kinki University Faculty of Medicine, Osakasayama, Japan.
authors.forename: Yoshie
authors.initials: Y
authors.lastname: Hitomi
authors.affiliation: Department of Psychiatry, Mito Medical Center, Mito, Japan.
authors.forename: Akihiro
authors.initials: A
authors.lastname: Iwakuma
authors.affiliation: Department of Neuropsychiatry, Kansai Medical University, Hirakata, Japan.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Kinoshita
authors.affiliation: Department of Neuropsychiatry, Oita University Faculty of Medicine, Yufu, Japan.
authors.forename: Jotaro
authors.initials: J
authors.lastname: Akiyoshi
authors.affiliation: Department of Psychiatry, Saitama Medical Center, Saitama Medical University, Kawagoe, Japan.
authors.forename: Naoshi
authors.initials: N
authors.lastname: Horikawa
authors.affiliation: Department of Psychiatry, Osaka National Hospital, Osaka, Japan.
authors.forename: Hideto
authors.initials: H
authors.lastname: Hirotsune
authors.affiliation: Department of Psychiatry, Fukuoka University Faculty of Medicine, Fukuoka, Japan.
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Eto
authors.affiliation: Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Japan.
authors.forename: Nakao
authors.initials: N
authors.lastname: Iwata
authors.affiliation: Department of Emergency Medicine, Tsukuba Medical Center Hospital, Tsukuba, Japan.
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Kohno
authors.affiliation: Department of Psychiatry, Showa University School of Medicine, Tokyo, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Iwanami
authors.affiliation: Department of Neuropsychiatry, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Masaru
authors.initials: M
authors.lastname: Mimura
authors.affiliation: Department of Psychiatry, University of Tsukuba Graduate School of Comprehensive Human Sciences, Tsukuba, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Asada
authors.affiliation: Department of Psychiatry, Yokohama City University Graduate School of Medicine, Yokohama, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Hirayasu