- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02442193
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
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Nottingham, 영국
- Nottinghamshire NHS Foundation Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Individual Placement and Support
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Individual Placement and Support is a form of supported employment.
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간섭 없음: Treatment as Usual
Treatment as Usual is comprised of routine clinical care.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Open Employment: Proportion of people in open employment
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of hours worked
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Najat R Khalifa, DM, Nottinghamshire Healthcare Nhs Trust
간행물 및 유용한 링크
일반 간행물
- 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.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KHALIFA/020415
- PB-PG-1013-32093 (기타 보조금/기금 번호: NIHR - Research for Patient Benefit (RfPB))
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