Individual Placement and Support for Patients With Offending Histories

Treatment as Usual Clinical Trial

— IPSOH  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02442193
• Other study ID #: KHALIFA/020415
• Secondary ID: PB-PG-1013-32093
• Status: Terminated
• Phase: N/A
• First received: May 7, 2015
• Last updated: February 9, 2018
• Start date: September 15, 2015
• Est. completion date: November 3, 2017

Study information

• Verified date: February 2018
• Source: Nottinghamshire Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: November 3, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Employment, Supported
• Treatment as Usual

Intervention

Other:
• Individual Placement and Support
Individual Placement and Support is a form of supported employment.

Locations

Country	Name	City	State
United Kingdom	Nottinghamshire NHS Foundation Trust	Nottingham

Sponsors (5)

Lead Sponsor	Collaborator
Nottinghamshire Healthcare NHS Trust	Institute of Mental Health Nottingham, University of Leicester, University of Nottingham, University of Southampton

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Khalifa N, Talbot E, Schneider J, Walker DM, Bates P, Bird Y, Davies D, Brookes C, Hall J, Völlm B. Individual placement and support (IPS) for patients with offending histories: the IPSOH feasibility cluster randomised trial protocol. BMJ Open. 2016 Jul 2 — View Citation

Outcome

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

External Links

•   Study Protocol