The effectiveness of intensive home treatment as a substitute for hospital admission in acute psychiatric crisis resolution in the Netherlands: a two-centre Zelen double-consent randomised controlled trial

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.