Abstract
BackgroundUnemployment 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/methodsThe 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.DiscussionThe 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 registrationISRCTN Registry, ID: ISRCTN24159790. Registered on 1 February 2018.
Highlights
Unemployment is highly prevalent in populations with alcohol and drug dependence and the employment support offered in addiction-treatment programmes is ineffective
These questions will be answered by preregistered analyses of primary and secondary outcomes recorded across an 18-month follow-up after randomisation (Fig. 1)
All study participants will continue to be enrolled in addiction treatment and may receive standard employment support (conventionally termed treatmentas-usual (TAU) – the control condition), or they will continue to be enrolled in addiction treatment, and may receive standard employment support, and enrolled in Individual Placement and Support (IPS) – the intervention condition
Summary
Unemployment is highly prevalent in populations with alcohol and drug dependence and the employment support offered in addiction-treatment programmes is ineffective. IPS has been widely studied among people with severe mental illness and physical disability In these populations, Frederick and VanderWeele reported a meta-analysis of 30 randomised controlled trials (RCTs) of IPS versus standard employment support [7]. Frederick and VanderWeele reported a meta-analysis of 30 randomised controlled trials (RCTs) of IPS versus standard employment support [7] In these studies, participants allocated to IPS were more likely to obtain work (relative risk 1.63; 95% Confidence Interval (CI) 1.46–1.82); achieve greater job tenure (defined as duration of longest held competitive employment; Cohen’s d 0.55; 95% CI 0.33–0.79); work for longer during follow-up (d 0.46; 95% CI 0.35–0.57) and have more income (d 0.48; 95% CI 0.36–0.59)
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