Supporting People Involuntarily Admitted to a Psychiatric Hospital Through a Brief Case Management Intervention That Promotes Personal Recovery and Reduces the Negative Effects of Coercion: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Eligibility rate
研究概览
简要总结
The goal of this clinical trial is to assess whether a brief case management intervention aimed at promoting personal recovery and reducing the negative effects of coercion among people involuntarily admitted to a psychiatric hospital would be well accepted by them, practically feasible and useful. The main questions it aims to answer are:
- Is the case management intervention acceptable and feasible?
- What are the preliminary effects of the case management intervention on patients' personal recovery and its sub-dimensions, as well as on their level of perceived coercion and their global satisfaction with hospital care?
Participants will be asked to take part in:
- the five sessions of the case management intervention;
- two evaluation sessions (pre and post-intervention);
- a final in-depth semi-structured interview (optional).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older 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 65 years
排除标准
- •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
结局指标
主要结局
Eligibility rate
时间窗: From start of study recruitment through study recruitment completion, on average 6 months
Number of eligible patients/number of patients involuntarily hospitalised on site during study period as reported in a structured flowchart by the case managers after each site visit
Participation rate
时间窗: From start of study recruitment through study recruitment completion, on average 6 months
Number of patients accepting to participate/number of approached patients as reported in a structured flowchart by the case managers after each site visit and based on the number of signed consent forms
Drop-out rate
时间窗: Post-intervention, up to 1 month post hospital discharge
Number of patients who completed the programme/number of recruited patients as reported by case managers in a structured questionnaire detailing which intervention sessions were delivered to each patient
Intervention dosage
时间窗: Post-intervention, up to 1 month post hospital discharge
Mean number of sessions delivered per participant as reported by case managers in a structured questionnaire detailing which intervention sessions were delivered to each patient
Missing data rates
时间窗: At the end of the study, on average 9 months after the inclusion of the first participant
Percentage of missing data
Number of unexpected adverse events
时间窗: Up to 1 week after hospital admission through up to 1 month post hospital discharge
Number of unexpected adverse events related to the intervention reported in a structured form by the case managers or the investigator
Participants' acceptance and degree of satisfaction
时间窗: Post-intervention, up to 1 month post hospital discharge
Participants' acceptance and degree of satisfaction with both the intervention and the research process qualitatively assessed through semi-structured interviews
Implementation barriers and facilitating factors
时间窗: After the last included participant final evaluation, on average 8 months after the inclusion of the first participant
Barriers and facilitating factors encountered throughout the implementation process as described by some members of the hospital team, during in-depth semi-structured interviews.
次要结局
- Empowerment Scale(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
- Brief INSPIRE scale(Post-intervention, up to 1 month post hospital discharge)
- Recovery Assessment Scale (RAS)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
- Coercion Ladder (CL)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
- Satisfaction with hospital care(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
- The Paradox of Self-Stigma scale (PaSS-24)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
- Index of fairness and Index of effectiveness(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
- Rosenberg Self-Esteem Scale (RSS)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
- Beck Hopelessness Scale (BHS)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
- WHOQOL-BREF(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
- International Trauma Questionnaire (ITQ)(Two time points assessment: up to 1 week after hospital admission (pre-intervention) and up to 1 month post hospital discharge (post-intervention))
研究者
Stéphane Morandi
Deputy Head of the Community Psychiatry Service, PD & MER
University of Lausanne Hospitals