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Randomized Controlled Trial
. 2018 Feb 27;18(1):55.
doi: 10.1186/s12888-018-1632-z.

Intensive home treatment for patients in acute psychiatric crisis situations: a multicentre randomized controlled trial

Jurgen Cornelis  1   2 , Ansam Barakat  3 , Jack Dekker  3   4 , Tessy Schut  5 , Sandra Berk  6 , Hans Nusselder  5 , Nikander Ruhl  6 , Jeroen Zoeteman  5 , Rien Van  3 , Aartjan Beekman  7 , Matthijs Blankers  3   8   9
Affiliations
Randomized Controlled Trial

Intensive home treatment for patients in acute psychiatric crisis situations: a multicentre randomized controlled trial

Jurgen Cornelis et al. BMC Psychiatry. .

Abstract

Background: Hospitalization is a common method to intensify care for patients experiencing a psychiatric crisis. A short-term, specialised, out-patient crisis intervention by a Crisis Resolution Team (CRT) in the Netherlands, called Intensive Home Treatment (IHT), is a viable intervention which may help reduce hospital admission days. However, research on the (cost-)effectiveness of alternatives to hospitalisation such as IHT are scarce. In the study presented in this protocol, IHT will be compared to care-as-usual (CAU) in a randomized controlled trial (RCT). CAU comprises low-intensity outpatient care and hospitalisation if necessary. In this RCT it is hypothesized that IHT will reduce inpatient days by 33% compared to CAU while safety and clinical outcomes will be non-inferior. Secondary hypotheses are that treatment satisfaction of patients and their relatives are expected to be higher in the IHT condition compared to CAU.

Methods: A 2-centre, 2-arm Zelen double consent RCT will be employed. Participants will be recruited in the Amsterdam area, the Netherlands. Clinical assessments will be carried out at baseline and at 6, 26 and 52 weeks post treatment allocation. The primary outcome measure is the number of admission days. Secondary outcomes include psychological well-being, safety and patients' and their relatives' treatment satisfaction. Alongside this RCT an economic evaluation will be carried out to assess the cost-effectiveness and cost-utility of IHT compared to CAU.

Discussion: RCTs on the effectiveness of crisis treatment in psychiatry are scarce and including patients in studies performed in acute psychiatric crisis care is a challenge due to the ethical and practical hurdles. The Zelen design may offer a feasible opportunity to carry out such an RCT. If our study finds that IHT is a safe and cost-effective alternative for CAU it may help support a further decrease of in-patient bed days and may foster the widespread implementation of IHT by mental health care organisations internationally.

Trial registration: The trial is registered in the Netherlands Trial Register as # NTR-6151 . Registered 23 November 2016.

Keywords: Admission days; Community mental health; Cost-effectiveness; Crisis resolution; Psychiatric crisis; Randomized controlled trial.

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Conflict of interest statement

Ethics approval and consent to participate

- The VUmc medical ethics committee in Amsterdam, the Netherlands gave their medical ethics approval, (# NL55432.029.16).

- During the first contact with professionals following the start of a psychiatric crisis patients are randomly allocated to one of the two treatment modalities, IHT or CAU. Written consent to participation in the trial and to treatment allocation will be sought as soon as the psychiatric condition of the patients is stabilized, ultimately 3 weeks after intake. If the patient hesitates about providing informed consent, he will have 5 days to decide about his participation. At admission, and within 24 h after screening and pre-randomisation, the mental competence of the patient to provide informed consent will be assessed using the MacCAT-CR instrument. Only after providing written informed consent, (baseline) measurements are collected by a researcher. If a patient decides not to provide informed consent, he is not included in the study and can receive any treatment deemed necessary.

Consent for publication

N/A

Competing interests

- The authors declare that they have no conflicts of interest.

- The funding body is a non-commercial organisation and there are no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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