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

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.

Study Overview

• Status: Terminated
• Conditions: Treatment as Usual; Employment, Supported
• Intervention / Treatment: Other: Individual Placement and Support

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Nottinghamshire NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Individual Placement and Support	Other: Individual Placement and Support; Individual Placement and Support is a form of supported employment.
No Intervention: Treatment as Usual; Treatment as Usual is comprised of routine clinical care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Open Employment: Proportion of people in open employment	Proportion of people in open employment at 12 month follow-up	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hours worked	Number of hours worked at 12 month follow-up	12 Months
Mental health as measured using the Brief Psychiatric Rating Scale (BPRS)	Measured using the Brief Psychiatric Rating Scale (BPRS)	Baseline, 6 and 12 Months
Social Functioning as measured using the Social Functioning Questionnaire (SFQ)	Measured using the Social Functioning Questionnaire (SFQ)	Baseline, 6 and 12 Months
Self-Esteem as measured using the Rosenberg's Self Esteem Scale	Measured using the Rosenberg's Self Esteem Scale	Baseline, 6 and 12 Months
Work Limitations as measured using the Work Limitation Questionnaire	Measured using the Work Limitation Questionnaire	Baseline, 6 and 12 Months
Quality of life as measured using SF-12v2	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)	Measured using the Client Service Receipt Inventory (CSRI)	Baseline, 6 and 12 Months
Re-offending rates	Re-offending rates	Baseline and 18 Months
Number of days in open employment	Number of days in open employment at 12 months	12 months
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

Collaborators and Investigators

• Sponsor: Nottinghamshire Healthcare NHS Trust
• Collaborators: University of Nottingham; University of Southampton; University of Leicester; Institute of Mental Health Nottingham
• Investigators: Principal Investigator: Najat R Khalifa, DM, Nottinghamshire Healthcare Nhs Trust

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study Protocol

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2015
• Primary Completion (Actual): September 15, 2017
• Study Completion (Actual): November 3, 2017

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Actual): February 12, 2018
• Last Update Submitted That Met QC Criteria: February 9, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: KHALIFA/020415; PB-PG-1013-32093 (Other Grant/Funding Number: NIHR - Research for Patient Benefit (RfPB))