Individual Placement and Support for Patients With Offending Histories (IPSOH)
Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings
研究概览
详细说明
This is a feasibility trial which aims to assess the feasibility of conducting a full Randomized Controlled Trial (RCT) to evaluate the effectiveness of Individual Placement and Support (IPS) in improving employment rates and associated psychosocial outcomes in forensic psychiatric populations.
Given that IPS is a complex intervention, the design of this study has drawn from the principles set out in the UK Medical Research Council (MRC) Guidance on developing and evaluating complex interventions by defining three major research strands in order to achieve the specific objectives of the study as follows:
A. Implementation of IPS in community forensic services: The specific objective of this strand is to embed the IPS model in the community forensic services in which the feasibility study will be carried out (aided by an IPS Expert), by bringing an employment specialist into clinical teams, raising awareness about IPS within the organization, forming links with IPS services in the area and developing links with employers, as well as conducting IPS fidelity reviews.
B. Feasibility Cluster Randomized Controlled Trial (RCT): The specific objectives of this strand are to estimate the parameters required to design a full RCT including:
- Means and standard deviations of the key outcome measures in order to benchmark potential effect sizes and enable sample size calculations.
- The feasibility of randomization, recruitment and retention rates to the IPS and controls;
- The suitability of the key outcome measures with respect to: reliability, acceptability, and distribution of the scores.
C. Process Evaluation: This will be carried out in parallel with the other two strands to meet other specific objectives by using the following methods:
- Qualitative interviews with staff to identify the structural, legal, organizational and individual-level to barriers and facilitators to implementation of IPS in community forensic services.
- Fidelity Reviews to assess the extent to which the services follow the principles of IPS and to assess how well the employment specialist functions within the community forensic services.
- Qualitative interviews with patients assigned to IPS in order to assess their general views of IPS, benefits from participating, disadvantages from or dislikes about participating and barriers and facilitators to implementation.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Nottingham、英国
- Nottinghamshire NHS Foundation Trust
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults over the age of 18 years
- Patients (females and males) on the caseload of the community forensic services
Exclusion Criteria:
- Patients unable to provide informed consent
- Patients not eligible to work in the UK
- Patients currently in open employment
- Patients who do not wish to work
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Individual Placement and Support
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Individual Placement and Support is a form of supported employment.
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无干预:Treatment as Usual
Treatment as Usual is comprised of routine clinical care.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Open Employment: Proportion of people in open employment
大体时间:12 Months
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Proportion of people in open employment at 12 month follow-up
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12 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of hours worked
大体时间:12 Months
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Number of hours worked at 12 month follow-up
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12 Months
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Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)
大体时间:Baseline, 6 and 12 Months
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Measured using the Brief Psychiatric Rating Scale (BPRS)
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Baseline, 6 and 12 Months
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Social Functioning as measured using the Social Functioning Questionnaire (SFQ)
大体时间:Baseline, 6 and 12 Months
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Measured using the Social Functioning Questionnaire (SFQ)
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Baseline, 6 and 12 Months
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Self-Esteem as measured using the Rosenberg's Self Esteem Scale
大体时间:Baseline, 6 and 12 Months
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Measured using the Rosenberg's Self Esteem Scale
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Baseline, 6 and 12 Months
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Work Limitations as measured using the Work Limitation Questionnaire
大体时间:Baseline, 6 and 12 Months
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Measured using the Work Limitation Questionnaire
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Baseline, 6 and 12 Months
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Quality of life as measured using SF-12v2
大体时间:Baseline, 6 and 12 Months
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Health-related quality of life as measured using SF-12v2
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Baseline, 6 and 12 Months
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Economic Costing as measured using the Client Service Receipt Inventory (CSRI)
大体时间:Baseline, 6 and 12 Months
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Measured using the Client Service Receipt Inventory (CSRI)
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Baseline, 6 and 12 Months
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Re-offending rates
大体时间:Baseline and 18 Months
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Re-offending rates
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Baseline and 18 Months
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Number of days in open employment
大体时间:12 months
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Number of days in open employment at 12 months
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12 months
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Quality of life as measured using the EQ5-D
大体时间:Baseline, 6 and 12 months
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Health-related quality of life as measured using the EQ5-D
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Baseline, 6 and 12 months
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合作者和调查者
合作者
调查人员
- 首席研究员:Najat R Khalifa, DM、Nottinghamshire Healthcare Nhs Trust
出版物和有用的链接
一般刊物
- Khalifa N, Talbot E, Schneider J, Walker DM, Bates P, Bird Y, Davies D, Brookes C, Hall J, Vollm B. Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol. BMJ Open. 2016 Jul 22;6(7):e012710. doi: 10.1136/bmjopen-2016-012710.
- Khalifa N, Talbot E, Barber S, Schneider J, Bird Y, Attfield J, Bates P, Walker DM, Vollm B. A Feasibility Cluster Randomized Controlled Trial of Individual Placement and Support (IPS) for Patients With Offending Histories. Front Psychiatry. 2020 Jan 13;10:952. doi: 10.3389/fpsyt.2019.00952. eCollection 2019.
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- KHALIFA/020415
- PB-PG-1013-32093 (其他赠款/资助编号:NIHR - Research for Patient Benefit (RfPB))
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