A Brief Case Management Intervention to Promote Personal Recovery and Prevent Psychiatric Involuntary Readmissions: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Number of involuntary readmission(s) (long-term)
研究概览
简要总结
The goal of this randomized control trial is to assess the effectiveness of a Brief Case Management (BCM) intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital.
The main questions it aims to answer are :
- Does the Brief Case Management intervention reduce the incidence of involuntary readmission18 months after the initial involuntary hospitalisation?
- What impact does the Brief Case Management intervention have on patients' involuntary readmission 6 months after the initial involuntary hospitalisation, as well as on their personal recovery, perceived coercion, satisfaction with treatment, and on their exposure to other forms of formal and informal coercion?
Participants will be randomly assigned to either the control or the intervention group, accordingly they will be asked to take part in:
Control Group:
- Three evaluation sessions (baseline, 6 and 18 months follow-up);
Intervention Group :
- Three evaluation sessions (baseline, 6 and 18 months follow-up);
- The 5 sessions of the brief case management intervention (6th session optional).
详细描述
Background: The use of coercion in psychiatry has been increasing for many years, both in Switzerland and abroad. While it is justified by the need to protect the health and safety of the concerned patients, coercion also represents an infringement of their fundamental rights. It can have negative effects on their health and care, for example, by causing post-traumatic stress disorder or leading to a breakdown in care. Having been involuntarily hospitalised in psychiatry is one of the main predictors of compulsory readmission. While numerous interventions have been proposed to limit the use of coercion, very few have been rigorously studied, and even fewer have been shown to be effective. Personal recovery involves leading a satisfying, contributory life, full of hope and meaning, despite the existence of a mental disorder and the resulting limitations. According to the WHO, services should be recovery-oriented to respect and promote human rights. To date, very little work has been done on the links between personal recovery and coercion. A brief case management intervention designed to promote the personal recovery of involuntarily hospitalised psychiatric patients has been developed in partnership with service-users. Its acceptability, feasibility and patients' satisfaction with the intervention were demonstrated in a six-month pilot phase.
Aims: The primary aim of the study is to test, by means of a randomised controlled trial, the effectiveness of the intervention in reducing involuntary readmissions incidence in a population of adult patients involuntarily hospitalised in psychiatry. The secondary aim is to assess the impact of the intervention on patients' personal recovery, perceived coercion, satisfaction with treatment, and on their exposure to other forms of formal and informal coercion.
Methods: 262 patients involuntarily hospitalised in psychiatry will be randomly assigned to either the intervention or control group. Patients in the intervention group will receive, in addition to standard care, a 5-session case management intervention starting within the first two weeks of hospitalisation and lasting a maximum of two months after discharge. During the sessions, patients will discuss their experience of coercion and its impact on their personal recovery. The intervention is designed to enable them to identify and mobilise their resources, improve their self-esteem, restore their confidence in the future and strengthen ties and collaborations with their entourage. They will also be invited to draw up a personal recovery plan. The number of involuntary readmissions at 18 months after inclusion will be measured in both groups as the primary outcome. The shorter-term impact of the intervention on the number of involuntary readmissions will also be assessed at the 6-month follow-up. Changes in personal recovery and other relevant variables, such as self-esteem, self-stigma, post-traumatic stress symptoms, satisfaction with care and exposure to other forms of formal or informal coercion, will also be measured at the 6- and 18-month follow-ups as secondary outcomes. Results will be evaluated on an Intent To Treat basis. Generalized linear models (GLMs) with a Poisson or negative binomial regression, based on overdispersion diagnostics, will be used to determine group differences. Other estimands such as treatment effect for patients who would not experience the intercurrent event will be considered as sensitivity analysis.
Expected results and impact: Promoting personal recovery of involuntarily admitted patients by helping them to develop and implement strategies that improve their mental well-being should mitigate the adverse consequences of coercion and reduce the risk of exposure to new coercive measures. This study will also provide a deeper understanding of the links between personal recovery and coercion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To have been involuntarily admitted by a medical doctor;
- •To be aged between 18 and 64 years;
- •To domiciled in the Greater Lausanne area;
排除标准
- •Patients with an organic mental disorder (F0, ICD-10);
- •Patients with intellectual disability (F7, ICD-10);
- •Patients unable to provide written consent due to a lack of discernment;
- •Patients unable to speak French well enough to participate in the study without the help of an interpreter.
研究组 & 干预措施
Control Group
Treatment as usual (TAU): standard inpatient and outpatient psychiatric care
干预措施: TAU (Other)
Intervention Group
Brief Case Management intervention
干预措施: Brief Case Management intervention (Other)
结局指标
主要结局
Number of involuntary readmission(s) (long-term)
时间窗: Assessed at 18-month follow-up (T2).
The study's primary outcome will be the number of involuntary readmissions occurred at any hospital of the Canton of Vaud 18 months after study enrolment (T2). Data on involuntary readmissions will be extracted from the Register of Protection Measures (RMP) of the Canton of Vaud and the participants medical records.
次要结局
- Number of involuntary readmission(s) (short-term)(Assessed at 6-month follow-up (T1).)
- Recovery Assessment Scale (RAS)(3 time point assessment: at baseline (T0), 6-month follow-up (T1), 18-month follow-up (T2).)
- Empowerment Scale(3 time point assessment: at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2).)
- Rosenberg Self-Esteem Scale (RSS)(3 time point assessment : at baseline (T0), 6-month follow-up (T1), 18-month follow-up (T2).)
- Paradox of Self-Stigma scale (PaSS-24)(3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2).)
- Beck Hopelessness Scale (BHS)(3 time point assessment: at baseline (T0), 6-month follow-up (T1), and 18-month follow-up (T2).)
- WHOQOL-BREF Scale(3 time point assessment : at baseline (T0), 6-month follow-up (T1), and 18-month follow-up (T2).)
- Exposure to other civil and legal measures(3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2).)
- International Trauma Questionnaire (ITQ)(3 time point assessment : at baseline (T0), 6-month follow-up (T1), 18-month follow-up (T2).)
- Pressures in Psychiatry Scale (P-PSY35)(3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2).)
- Coercion Ladder (CL)(3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month (T2).)
- Index of Fairness and the Index of Effectiveness(3 time point assessment: at baseline (T0), 6-month follow-up (T1), and 18-month follow-up (T2).)
- Satisfaction with hospital care (ANQ)(2 time point assessment : at baseline (T0) and 6-month follow-up (T1).)
- Brief INSPIRE Scale(2 time point assessment : at baseline (T0) and 6-month follow-up (T1).)
- Type and number of other formal coercive measures(3 time point assessment: at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2).)
- Number and duration of any voluntary readmission occurred during the study(2 time point assessment : at 6-month follow-up (T1) and 18-month follow-up (T2).)
- Use of recovery tools(3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2).)
- Psychiatric follow-up within the last three months(3 time point assessment : at baseline (T0), 6-month follow-up (T1) and 18-month follow-up (T2).)
研究者
Stéphane Morandi
Deputy Head of the Community Psychiatry Service, PD & MER
University of Lausanne Hospitals
