Department of Research, Arkin Mental Health Care, Klaprozenweg 111, 1033, NN, Amsterdam, The Netherlands.
Department of Emergency Psychiatry, Arkin Mental Health Care, Amsterdam, The Netherlands.
BMC Psychiatry. 2018 Feb 27;18(1):55. doi: 10.1186/s12888-018-1632-z.
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.
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.
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.
The trial is registered in the Netherlands Trial Register as # NTR-6151 . Registered 23 November 2016.
住院是强化精神病患者治疗的常用方法。荷兰的危机解决小组（CRT）提供的短期、专门的、门诊危机干预——强化家庭治疗（IHT）是一种可行的干预措施，可以帮助减少住院天数。然而，关于替代住院的（成本）效益的研究，如 IHT，却很少。在本研究方案中，将在随机对照试验（RCT）中比较 IHT 与常规护理（CAU）。CAU 包括低强度门诊护理和必要时住院。在这项 RCT 中，假设 IHT 将使住院天数比 CAU 减少 33%，同时安全性和临床结果无差异。次要假设是，与 CAU 相比，患者及其家属对 IHT 的治疗满意度更高。
采用 2 中心、2 臂 Zelen 双同意 RCT。参与者将在荷兰阿姆斯特丹地区招募。临床评估将在基线和治疗分配后 6、26 和 52 周进行。主要结局指标是入院天数。次要结局包括心理幸福感、安全性以及患者及其家属的治疗满意度。除了这项 RCT 外，还将进行经济评估，以评估 IHT 与 CAU 相比的成本效益和成本效用。
精神病危机治疗效果的 RCT 很少，在急性精神病危机护理中纳入患者是一个挑战，因为存在伦理和实践障碍。Zelen 设计可能为进行这样的 RCT 提供一个可行的机会。如果我们的研究发现 IHT 是 CAU 的一种安全且具有成本效益的替代方案，它可能有助于支持进一步减少住院天数，并可能促进国际精神卫生保健组织更广泛地实施 IHT。
该试验在荷兰试验注册处注册为 #NTR-6151。于 2016 年 11 月 23 日注册。
