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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.

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.

SUBMITTER: Marsden J

PROVIDER: S-EPMC7014654 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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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.

Marsden John J Anders Paul P Clark Helen H Colocassis Kyriacos K Eastwood Brian B Knight Jonathan J Melaugh Alexandra A Quinn David D Wright Virginia V Stannard Jez J

Trials 20200211 1

<h4>Background</h4>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 Su ...[more]

PMID: 32046765

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Project description:BackgroundEmployment is a vital source for experiencing well-being and lowering the risk of long-term social marginalisation and poverty. For persons with alcohol and drug addiction, it may also improve sobriety. However, the unemployment situation for this group reflects the knowledge gap in effective interventions to support employment. While Individual Placement and Support (IPS) is recognised as evidence-based supported employment for those with serious mental health problems, no scientific evidence for the target group of addiction exists to date. The aim of the present IPS for Alcohol and Drug Addiction in Sweden (IPS-ADAS) trial is to study whether IPS has an effect on gaining employment for this group.MethodsThe IPS-ADAS trial is a multisite, pragmatic, parallel, and single-blinded, superiority randomised controlled trial (RCT). Participants (N = 330) will be randomly assigned (1:1) and participate in IPS plus treatment as usual within Addiction Services (IPS + TAU) or Traditional Vocational Rehabilitation (TVR) available plus TAU (TVR + TAU) for 12 months. The principle of intention-to-treat (ITT) will be applied. The hypothesis is that a significantly larger proportion of IPS + TAU participants will be employed for > 1 day (primary outcome), reach employment sooner, work more hours and longer periods of time, and have a higher income as compared to TVR + TAU participants at 18-month follow-up. We further anticipate that those who benefit from IPS + TAU will use less alcohol and drugs, experience better health, and use less care and support, including support from the justice system, in comparison to TVR + TAU participants, at 6, 12, and 18 months. A supplementary process evaluation, using the IPS Fidelity Scale (25 items) and adhered interviews will address delivery and receipt of the IPS as well as contextual hinders and barriers for coproduction and implementation. Working age (18-65), willingness to work, unemployment, participation in an information meeting about the RCT, treatment for addiction diagnosis, and being financially supported by welfare, constitute eligible criteria.DiscussionA primary study on the effectiveness of IPS on employment for the new target group of addictions will add to the international IPS knowledge base and inform national policy to include the underrepresented group in working life.Trial registrationWHO International Clinical Trials Registry Platform ISRCTN10492363. Registered on 14 August 2023.

Project description:People with mental illness often experience difficulties with reintegration into the workplace, although employment is known to assist these individuals in their recovery process. Traditional approaches of "first train, then place" have been recently replaced by supported employment (SE) methods that carry strategy of "first place, then train." Individual placement and support (IPS) is one of the best-studied methods of SE, which core principles are individualized assistance in rapid job search with consequent placement in a paid employment position. A considerable amount of high-quality evidence supported the superiority of IPS over conventional methods in providing improved employment rates, longer job tenure, as well as higher salaries in competitive job markets. Nonetheless, our knowledge about the IPS-mediated long-term effects is limited. This non-interventional follow-up study of a previously published randomized controlled trial (RCT) called ZhEPP aimed to understand the long-term impact of IPS after 6 years since the initial intervention. Participants from the ZhEPP trial, where 250 disability pensioners with mental illnesses were randomized into either IPS intervention group or treatment as usual group (TAU), were invited to face-to-face interviews, during which employment status, job tenure, workload, and salaries were assessed. One hundred and fourteen individuals agreed to participate in this follow-up study. Although during the first 2 years post-intervention, the IPS group had higher employment rates (40% (IPS) vs. 28% (TAU), p < 0.05 at 24 months), these differences disappeared by the time of follow-up assessments (72 months). The results indicated no substantial differences in primary outcome measures between IPS and TAU groups: employment rate (36 vs. 33%), workload (10.57 vs. 10.07 h per week), job tenure (29 vs. 28 months), and salary (20.21CHF vs. 25.02 CHF). These findings provide important insights regarding the long-term effects of IPS among individuals with mental health illnesses. Further research is required to advance the current knowledge about IPS intervention and its years-long impact.

Project description:AimsIndividual placement and support (IPS) is an evidence-based service model to support people with mental disorders in obtaining and sustaining competitive employment. IPS is increasingly offered to a broad variety of service users. In this meta-analysis we analysed the relative effectiveness of IPS for different subgroups of service users both based on the diagnosis and defined by a range of clinical, functional and personal characteristics.MethodsWe included randomised controlled trials that evaluated IPS for service users diagnosed with any mental disorder. We examined effect sizes for the between-group differences at follow-up for three outcome measures (employment rate, job duration and wages), controlling for methodological confounders (type of control group, follow-up duration and geographic region). Using sensitivity analyses of subgroup differences, we analysed moderating effects of the following diagnostic, clinical, functional and personal characteristics: severe mental illness (SMI), common mental disorders (CMD), schizophrenia spectrum disorders, mood disorders, duration of illness, the severity of symptoms, level of functioning, age, comorbid alcohol and substance use, education level and employment history.ResultsIPS is effective in improving employment outcomes compared to the control group in all subgroups, regardless of any methodological confounder. However, IPS was relatively more effective for service users with SMIs, schizophrenia spectrum disorders and a low symptom severity. Although IPS was still effective for people with CMD and with major depressive disorder, it was relatively less effective for these subgroups. IPS was equally effective after both a short and a long follow-up period. However, we found small, but clinically not meaningful, differences in effectiveness of IPS between active and passive control groups. Finally, IPS was relatively less effective in European studies compared to non-European studies, which could be explained by a potential benefits trap in high welfare countries.ConclusionsIPS is effective for all different subgroups, regardless of diagnostic, clinical, functional and personal characteristics. However, there might be a risk of false-positive subgroup outcomes and results should be handled with caution. Future research should focus on whether, and if so, how the IPS model should be adapted to better meet the vocational needs of people with CMD and higher symptom severity.

Project description:BACKGROUND:Individual Placement and Support (IPS) is an evidence-based approach to help people with severe mental illness achieve competitive employment. This article provides insight into an organizational and a financial implementation strategy for IPS in the Netherlands by exploring the perceived facilitators and barriers among participating stakeholders. The goal of this multifaceted strategy was to improve IPS implementation by improving the collaboration between all organizations involved, and realising secured IPS funding with a 'pay for performance' element. METHODS:A qualitative, explorative study among practitioners (n = 8) and decision makers (n = 7) in mental health care and vocational rehabilitation was performed using semi-structured interviews to collect rich information about the possible facilitators and barriers with regard to the organizational and financial implementation strategy for IPS. RESULTS:Important perceived facilitators were the key principles of the IPS model, regular meetings of stakeholders in mental health care and vocational rehabilitation, stakeholders' experienced ownership of IPS and collaboration, the mandate and influence of the decision makers involved and secured IPS funding. Important perceived barriers included the experienced rigidity of the IPS model fidelity scale and lack of independent fidelity reviewers, the temporary and fragmented character of the secured funding, lack of communication between decision makers and practitioners and negative attitudes and beliefs among mental health clinicians. Changes in legislation were experienced as a facilitator as well as a barrier. CONCLUSIONS:The results of this study suggest that the collaboration and IPS funding were experienced as improved by applying an organizational and a financial implementation strategy. However, considerable effort is still necessary to overcome the remaining barriers identified and to make the implementation of IPS a success in practice.

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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.

Publications

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.

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