- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Nottingham, Regno Unito
- Nottinghamshire NHS Foundation Trust
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Individual Placement and Support
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Individual Placement and Support is a form of supported employment.
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Nessun intervento: Treatment as Usual
Treatment as Usual is comprised of routine clinical care.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Open Employment: Proportion of people in open employment
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of hours worked
Lasso di tempo: 12 Months
|
Number of hours worked at 12 month follow-up
|
12 Months
|
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Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Baseline, 6 and 12 Months
|
Measured using the Client Service Receipt Inventory (CSRI)
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Baseline, 6 and 12 Months
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Re-offending rates
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline, 6 and 12 months
|
Health-related quality of life as measured using the EQ5-D
|
Baseline, 6 and 12 months
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Najat R Khalifa, DM, Nottinghamshire Healthcare Nhs Trust
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- KHALIFA/020415
- PB-PG-1013-32093 (Altro numero di sovvenzione/finanziamento: NIHR - Research for Patient Benefit (RfPB))
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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