Protocol for a definitive, multi-centre, randomised controlled trial of Individual Placement and Support for people with alcohol and drug dependence
Authors: Marsden John , Anders Paul , Clark Helen , Colocassis Kyriacos , Eastwood Brian , Knight Jonathan , Melaugh Alexandra , Quinn David , Wright Virginia , Stannard Jez 
Published: September 2019

Abstract
BACKGROUND : Unemployment is highly prevalent in populations with alcohol and drug dependence and current employment support is ineffective. Individual Placement and Support (IPS) is an evidence-based intervention for competitive employment. IPS has been extensively studied with people with severe mental illness and physical disabilities, but there have been no formal randomised controlled trials in alcohol and drug dependence. The Individual Placement and Support for Alcohol and Drug Dependence (IPS-AD) trial will determine definitively the effectiveness and cost effectiveness of IPS for patients with alcohol use disorder (AUD), opioid use disorder (OUD) and other drug use disorders.DESIGN/METHODS: The IPS-AD trial is a seven-site, pragmatic, two-arm, parallel group, superiority, randomised controlled trial, with an independent process evaluation. Eligible patients – all enrolled in ongoing community treatment in England for AUD, OUD and other drug use disorders (adult, unemployed or economically inactive for at least 6 months and wishing to obtain open job market employment) – will be randomised (1:1) to receive standard employment support (treatment-as-usual [TAU]) or TAU and IPS for nine months with up to four months of in-work support. The primary outcome measure will be competitive employment status (at least one day [7 hours]) during an 18-month follow-up, determined by patient-level, trial data-linkage with national tax and state benefit databases. With an 18% target difference (for the IPS intervention), and a two-sided 5% level of statistical significance, a minimum target sample of 832 participants will give 90% power for a pre-specified, mixed-effects, multi-variable logistic regression model, using a maximum-likelihood multiple imputation approach to manage missing outcome data. IPS-AD has seven vocational secondary outcome measures: total time in competitive employment (and corresponding National Insurance contributions and tax paid); time from randomisation to first competitive employment; number of competitive job appointments; job tenure (length of longest held competitive employment); sustained employment (tenure in a single appointment for at least 13 weeks); and job search self-efficacy. A cost-benefit and cost-effectiveness analysis will be done using the primary and secondary vocational outcomes, along with a set of secondary alcohol and drug treatment-related and social and health outcomes and their associated reference costs. The study process evaluation will address complementary questions of IPS implementation and delivery.DISCUSSION : The IPS-AD trial is the first large-scale, superiority randomised controlled trial of IPS for people with alcohol and drug dependence. The study will provide definitive evidence for the effectiveness and cost-effectiveness of the IPS model and will have substantial implications for service delivery. TRIAL REGISTRATION : ISRCTN Registry, ISRCTN24159790. Registered on 1 February 2018.KEYWORDS : Individual Placement and Support, alcohol, opioids, drugs, dependence.