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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Nottingham、イギリス
- Nottinghamshire NHS Foundation Trust
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的:Individual Placement and Support
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Individual Placement and Support is a form of supported employment.
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介入なし:Treatment as Usual
Treatment as Usual is comprised of routine clinical care.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Open Employment: Proportion of people in open employment
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of hours worked
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
協力者
捜査官
- 主任研究者:Najat R Khalifa, DM、Nottinghamshire Healthcare Nhs Trust
出版物と役立つリンク
一般刊行物
- 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.
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- KHALIFA/020415
- PB-PG-1013-32093 (その他の助成金/資金番号:NIHR - Research for Patient Benefit (RfPB))
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