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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.
Keywords
Individual Placement and Support, alcohol, opioids, drugs, dependence
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CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 21 Jan, 2020
Editor assigned
On 18 Jan, 2020
Submission checks complete
On 17 Jan, 2020
Version 1
Posted 08 Sep, 2019
No comments provided
Review #1 received
Received 14 Oct, 2019
Editorial decision: Minor revision
On 14 Oct, 2019
Reviewers invited
Invitations sent on 09 Oct, 2019
Reviewer #1 agreed
On 09 Oct, 2019
Editor assigned
On 08 Oct, 2019
Submission checks complete
On 05 Sep, 2019
First submitted
On 03 Sep, 2019
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A new preprint design is coming!
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See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 21 Jan, 2020
Editor assigned
On 18 Jan, 2020
Submission checks complete
On 17 Jan, 2020
Version 1
Posted 08 Sep, 2019
No comments provided
Review #1 received
Received 14 Oct, 2019
Editorial decision: Minor revision
On 14 Oct, 2019
Reviewers invited
Invitations sent on 09 Oct, 2019
Reviewer #1 agreed
On 09 Oct, 2019
Editor assigned
On 08 Oct, 2019
Submission checks complete
On 05 Sep, 2019
First submitted
On 03 Sep, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
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.
Figure 1
This is a list of supplementary files associated with this preprint. Click to download.
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