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Individual Placement and Support for Patients With Offending Histories (IPSOH)

9. februar 2018 oppdatert av: Najat Khalifa, Nottinghamshire Healthcare NHS Trust

Individual Placement and Support (IPS) for Patients With Offending Histories: Feasibility of an Evidence-based Approach in Forensic Mental Health Settings

The overall aim of the study is to assess the feasibility of conducting a 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.

Studieoversikt

Detaljert beskrivelse

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:

  1. Means and standard deviations of the key outcome measures in order to benchmark potential effect sizes and enable sample size calculations.
  2. The feasibility of randomization, recruitment and retention rates to the IPS and controls;
  3. 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:

  1. 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.
  2. 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.
  3. 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.

Studietype

Intervensjonell

Registrering (Faktiske)

18

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Nottingham, Storbritannia
        • Nottinghamshire NHS Foundation Trust

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Individual Placement and Support
Individual Placement and Support is a form of supported employment.
Ingen inngripen: Treatment as Usual
Treatment as Usual is comprised of routine clinical care.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Open Employment: Proportion of people in open employment
Tidsramme: 12 Months
Proportion of people in open employment at 12 month follow-up
12 Months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of hours worked
Tidsramme: 12 Months
Number of hours worked at 12 month follow-up
12 Months
Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)
Tidsramme: Baseline, 6 and 12 Months
Measured using the Brief Psychiatric Rating Scale (BPRS)
Baseline, 6 and 12 Months
Social Functioning as measured using the Social Functioning Questionnaire (SFQ)
Tidsramme: Baseline, 6 and 12 Months
Measured using the Social Functioning Questionnaire (SFQ)
Baseline, 6 and 12 Months
Self-Esteem as measured using the Rosenberg's Self Esteem Scale
Tidsramme: Baseline, 6 and 12 Months
Measured using the Rosenberg's Self Esteem Scale
Baseline, 6 and 12 Months
Work Limitations as measured using the Work Limitation Questionnaire
Tidsramme: Baseline, 6 and 12 Months
Measured using the Work Limitation Questionnaire
Baseline, 6 and 12 Months
Quality of life as measured using SF-12v2
Tidsramme: Baseline, 6 and 12 Months
Health-related quality of life as measured using SF-12v2
Baseline, 6 and 12 Months
Economic Costing as measured using the Client Service Receipt Inventory (CSRI)
Tidsramme: Baseline, 6 and 12 Months
Measured using the Client Service Receipt Inventory (CSRI)
Baseline, 6 and 12 Months
Re-offending rates
Tidsramme: Baseline and 18 Months
Re-offending rates
Baseline and 18 Months
Number of days in open employment
Tidsramme: 12 months
Number of days in open employment at 12 months
12 months
Quality of life as measured using the EQ5-D
Tidsramme: Baseline, 6 and 12 months
Health-related quality of life as measured using the EQ5-D
Baseline, 6 and 12 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Najat R Khalifa, DM, Nottinghamshire Healthcare Nhs Trust

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. september 2015

Primær fullføring (Faktiske)

15. september 2017

Studiet fullført (Faktiske)

3. november 2017

Datoer for studieregistrering

Først innsendt

7. mai 2015

Først innsendt som oppfylte QC-kriteriene

8. mai 2015

Først lagt ut (Anslag)

13. mai 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. februar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. februar 2018

Sist bekreftet

1. februar 2018

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • KHALIFA/020415
  • PB-PG-1013-32093 (Annet stipend/finansieringsnummer: NIHR - Research for Patient Benefit (RfPB))

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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