Protocol for a multi-centre, definitive randomised controlled trial of the effectiveness of Individual Placement and Support for employment support among people with alcohol and drug dependence

John Marsden*, Paul Anders, Helen Clark, Kyriacos Colocassis, Brian Eastwood, Jonathan Knight, Alexandra Melaugh, David Quinn, Virginia Wright, Jez Stannard

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)
9 Downloads (Pure)

Abstract

Background: Unemployment is highly prevalent in populations with alcohol and drug dependence and the employment support offered in addiction-treatment programmes is ineffective. Individual Placement and Support (IPS) is an evidence-based intervention for competitive employment. IPS has been extensively studied in severe mental illness and physical disabilities, but there have been no formal randomised controlled trials (RCTs) in alcohol and drug dependence. The Individual Placement and Support for Alcohol and Drug Dependence (IPS-AD) study should determine whether IPS for patients with alcohol use disorder (AUD), opioid use disorder (OUD) and other drug use disorder is effective.

Design/methods: The IPS-AD study is a seven-site, pragmatic, two-arm, parallel-group, superiority RCT. IPS-AD includes a realist process evaluation. Eligible patients (adult, unemployed or economically inactive for at least 6 months and wishing to obtain open job market employment and enrolled in ongoing community treatment-as-usual (TAU; the control condition) in England for AUD, OUD and other drug use disorders) will be randomised (1:1) to receive TAU and any standard employment support, or TAU plus IPS (the experimental condition) for 9 months with up to 4 months of in-work support. The primary outcome measure will be competitive employment status (at least 1 day (7 h)) during an 18-month follow-up, determined by patient-level, trial-data-linkage with national tax and state benefit databases. From meta-analysis, an 18% target difference on this measure of vocational effectiveness (for the experimental intervention) and a two-sided 5% level of statistical significance, will require a minimum target sample of 832 participants to achieve 90% power for a pre-registered, mixed-effects, multi-variable logistic regression model. A maximum-likelihood multiple-imputation approach will manage missing outcome data. IPS-AD has six vocational secondary outcome measures during the 18-month follow-up: (1) total time in competitive employment (and corresponding National Insurance contributions and tax paid); (2) time from randomisation to first competitive employment; (3) number of competitive job appointments; (4) job tenure (length of longest held competitive employment); (5) sustained employment (tenure in a single appointment for at least 13 weeks); and (6) job search self-efficacy. A primary cost-benefit analysis and a secondary cost-effectiveness analysis will be done using the primary outcome and secondary vocational outcomes, respectively and will include addiction treatment and social and health outcomes and their associated reference costs. The process evaluation will address IPS implementation and delivery.

Discussion: The IPS-AD study is the first large-scale, multi-site, definitive, superiority RCT of IPS for people with alcohol and drug dependence. Findings from the study will have substantial implications for service delivery.

Trial registration: ISRCTN Registry, ID: ISRCTN24159790. Registered on 1 February 2018.

Original languageEnglish
Article number167
JournalTrials
Volume21
Issue number1
DOIs
Publication statusPublished - 11 Feb 2020

Bibliographical note

Funding Information: The study was funded by the UK Work and Health Unit. PHE is the study sponsor and holds the indemnity insurance policy: the sponsor’s representative is Dr. Elizabeth Coates, Head of Research Governance, Research Translation and Innovation Division, PHE.

In September 2017, PHE issued a call for expressions of interest to all upper-tier and unitary local authorities that commission community treatment services for Alcohol and Drug Dependence in England study collaborators. There were 20 applicants and a selection panel selected the seven sites. The views expressed in this article are the authors’ and are not necessarily those of the funder. The funder will be invited to comment on research products, but will have no role in the analysis, interpretation, report writing and the decision to submit reports for publication.

Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Publisher Copyright: © The Author(s). 2020.

Citation: Marsden, J., Anders, P., Clark, H. et al. Protocol for a multi-centre, definitive randomised controlled trial of the effectiveness of Individual Placement and Support for employment support among people with alcohol and drug dependence. Trials 21, 167 (2020).

DOI: https://doi.org/10.1186/s13063-020-4099-4

Keywords

  • Alcohol
  • Dependence
  • Drugs
  • Individual Placement and Support
  • Opioids

Fingerprint

Dive into the research topics of 'Protocol for a multi-centre, definitive randomised controlled trial of the effectiveness of Individual Placement and Support for employment support among people with alcohol and drug dependence'. Together they form a unique fingerprint.

Cite this