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Protocol for the Individual Placement and Support (IPS) in Pain Trial: A randomized controlled trial investigating the effectiveness of IPS for patients with chronic pain.

ABSTRACT: Work disability involves large costs to the society as well as to the individual. Work disability is common among people with chronic pain conditions, yet few effective interventions exist. Individual Placement and Support (IPS) is an evidence-based work rehabilitation model originally developed to help people with severe mental illness obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but the model has never before been tested for patients with chronic pain.The aim of the IPS in Pain trial is to investigate the effectiveness of IPS as an integrated part of the interdisciplinary treatment for patients with chronic pain in a hospital outpatient clinic. The study is a randomized controlled trial comparing pain treatment with integrated IPS to treatment as usual in unemployed patients suffering from various chronic pain conditions. The primary outcome of the study is labor market participation during 12 months after enrollment, and secondary outcomes include physical and mental health and well-being, collected at baseline, 6, and 12 months. Finally, there will be an additional long-term follow-up for the primary outcome, which will be collected through a brief phone interview at 24 months.The IPS in Pain trial will be the first report of the effectiveness of the IPS model of supported employment applied in an outpatient setting for chronic pain patients. It will thus provide important information about the effectiveness of repurposing IPS to a new patient group in great need of job support.Clinicaltrials.gov: NCT02697656 . Registered January 15th, 2016.

SUBMITTER: Linnemorken LTB

PROVIDER: S-EPMC5809966 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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Protocol for the Individual Placement and Support (IPS) in Pain Trial: A randomized controlled trial investigating the effectiveness of IPS for patients with chronic pain.

Linnemørken Lene Therese B LTB Sveinsdottir Vigdis V Knutzen Thomas T Rødevand Linn L Hernæs Kjersti Helene KH Reme Silje Endresen SE

BMC musculoskeletal disorders 20180213 1

<h4>Background</h4>Work disability involves large costs to the society as well as to the individual. Work disability is common among people with chronic pain conditions, yet few effective interventions exist. Individual Placement and Support (IPS) is an evidence-based work rehabilitation model originally developed to help people with severe mental illness obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but the model has never b ...[more]

PMID: 29433493

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Project description:BackgroundEmployment is associated with better outcomes of substance use treatment and protects against relapse after treatment completion. Unemployment rates are high for people with substance use disorders (SUD) who undergo treatment, with Norwegian estimates ranging from 81 to 91%. Evidence-based vocational models are lacking for patients in SUD treatment but exist for patients with psychosis in terms of Individual Placement and Support (IPS). The aim of the IPS for substance use disorders (IPS-SUD) trial is to investigate the effect of IPS in a SUD population.Methods/designThe IPS-SUD trial is a randomized controlled trial (RCT) comparing IPS to an enhanced control intervention. The study is a seven-site, two-arm, pragmatic, parallel-group, superiority RCT. Participants are randomly assigned (1:1) to receive either IPS plus treatment as usual (TAU) or to receive a self-help guide book and 12-h workshop plus 1-h individual vocational guidance plus TAU. Aiming to recruit 200 participants, we will be able to detect a 20% difference in the main outcome of employment with 90% power. We will make assessments at inclusion and at 6- and 12-month follow-ups and obtain outcome data on employment from national mandatory registries. The primary outcome will be at least 1 day of competitive employment during the 18-month follow-up period. Secondary employment outcomes will capture the pattern and extent of employment in terms of total time worked (days/hours), time to first employment, number of different jobs, duration of the longest employment, and sustained employment. Secondary non-employment outcomes will be substance use, mental distress, and quality of life measured by validated instruments at 6, 12, and 18 months follow-up assessments. To be eligible, participants must be between 18 and 65 years, currently unemployed and in treatment for SUD.DiscussionThe IPS-SUD trial will provide evidence for the use of IPS in a SUD population. Findings from the study will have implications for service delivery.Trial registrationClinicalTrials.gov NCT04289415 . Registered on February 28, 2020.

Project description:Objective: To examine the feasibility of conducting a fully powered randomized controlled trial (RCT) of Individual Placement and Support (IPS). IPS is a form of supported employment which aims to put people into open employment quickly and in accordance with their preferences. It is delivered by employment specialists collocated within clinical teams, and provides time unlimited support for the individual and their employer, along with welfare benefits counselling. Method: A feasibility cluster RCT of treatment as usual (TAU) plus IPS versus TAU alone was conducted over 12 months among patients with offending histories in a community forensic setting in the UK. The feasibility criteria were to achieve 50% recruitment rate; 50% completion rate for IPS; 50% completion rate of all outcome measures; and 80% acceptability rating for IPS. The primary efficacy outcome was the proportion of people in open employment at 12 months. The secondary outcomes were other vocational and educational activities; Brief Psychiatric Rating Scale; Rosenberg's Self-esteem Scale; Client Service Receipt Inventory; quality of life using the SF12-v2 and EQ5-D3; Social Functioning Questionnaire; Work Limitation Questionnaire; and reoffending. Results: Participants' mean age was 39.2 years. The majority were male (88.9), White British (72.2), and single (72.2%). Over 72% had no higher qualification beyond secondary education; mean years in education was 10.4. Over one third had schizophrenia, one fifth had depression, and the rest had personality disorder as their primary diagnosis. Participants had a lifetime average of 7.5 convictions for 15.5 offences. The recruitment rate of all referrals was 38.3% (IPS n = 11; TAU n = 7). Completion rate for IPS was 54.5, with 45.5% acceptability rating. Completion rates for outcome measures for the groups at baseline and 12 months ranged from 22.2 to 100%. The proportion of people in open employment at 12 months were 9.1 and 0% for IPS and TAU respectively. Conclusion: It is not feasible to conduct a full RCT of IPS in community forensic settings in the UK owing to recruitment and retention difficulties. Conducting a trial of this kind requires a large pool of patients from multiple sites and longer IPS implementation and recruitment periods than those of this study. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02442193.

Project description:BackgroundIndividual Placement and Support (IPS) is an evidence-based work rehabilitation program helping people with moderate to severe mental illness to obtain ordinary employment. Although IPS has proven superior to other work rehabilitation programs, in many studies, the majority of the participants remain unemployed. Structured process evaluations of IPS that use mixed methods are scarce, although they could identify implementation aspects that may enhance its effect. The aim of the current study is to assess reach, fidelity, and identify barriers and facilitators to implement IPS.MethodsThe process evaluation was conducted alongside a randomized controlled trial including six IPS centers, comparing IPS with treatment as usual in a population of patients in treatment for moderate to severe mental illness. Mixed methods were used in the process evaluation, including focus group interviews with service providers, individual interviews and survey data from participants, and fidelity reviews using the validated IPS Fidelity Scale.ResultsThe intervention reached the intended target group. All centers reached fair to good fidelity according to the IPS Fidelity Scale within the project period (range 97-109, SD 8.1) (see Table 5). Certain fidelity items indicated implementation issues related to employer contact, community-based services, and integration with health services. Survey data showed that less than half of the participants regarded their illness as a barrier for participating in IPS and that freedom of disclosure was important. Participant interviews gave further insight into the role of the IPS specialist, emphasizing their availability and consistent job focus.ConclusionsIndications of implementation challenges across centers during the first year suggest special attention should be given to these aspects in an early phase to ensure higher fidelity from the start and thus enhance the effectiveness of IPS. The IPS specialist played an important role for participants and was described as positive, pushing in a positive way, and encouraging. More knowledge on the characteristics of successful IPS specialists could further enhance the effectiveness of the intervention.Trial registrationThe study was registered on clinicaltrials.gov prior to the inclusion period (reg.no: NCT01964092, registered 17/07/2013).Supplementary informationSupplementary information accompanies this paper at 10.1186/s43058-020-00083-9.

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: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.

Project description:BACKGROUND:Employment is good for physical and mental health, however people with severe mental illness (SMI) are often excluded from employment. Standard Individual Placement and Support (IPS) is effective in supporting around 55% of people with SMI into employment or education. Current research considers enhancements to IPS to improve outcomes for those requiring more complex interventions. Clinicians need to better understand who will benefit from these enhanced IPS interventions. This study offers a new enhanced IPS intervention and an approach to predicting who may achieve successful outcomes. METHODS:This prospective cohort study included people with SMI who participated in an enhanced IPS service and had prolonged absence from employment. Secondary data analysis was conducted of data gathered in routine clinical practice. Univariate analysis coupled with previous research and clinical consultation was used to select variables to be included in the initial model, followed by a backward stepwise approach to model building for the final multiple logistic regression model with an outcome of successful or unsuccessful goal attainment (employment or education). RESULTS:Sixty-three percent of participants in the enhanced IPS successfully attained employment or education. Significant relationships from bivariate analyses were identified between outcomes (employment or education) and seven psychosocial variables. Adapting Routines to Minimise Difficulties, Work Related Goals, and Living in an Area of Lesser Deprivation were found to be significant in predicting employment or education in the final multiple logistic regression model R2 =?0.16 (Hosmer-Lemeshow), 0.19 (Cox-Snell), 0.26 (Nagelkerke). Model ?2(7)?=?41.38 p <?.001. CONCLUSION:An enhanced IPS service had a 63% rate success in achieving employment or education, higher than comparable studies and provides an alternative to IPS-Lite and IPS-standard for more complex populations. Motivational and habitual psychosocial variables are helpful in predicting who may benefit from an enhanced IPS intervention supporting people after prolonged absence from employment. TRIAL REGISTRATION:NCT04083404 Registered 05 September 2019 (retrospectively registered).

Dataset Information

Protocol for the Individual Placement and Support (IPS) in Pain Trial: A randomized controlled trial investigating the effectiveness of IPS for patients with chronic pain.

Publications

Protocol for the Individual Placement and Support (IPS) in Pain Trial: A randomized controlled trial investigating the effectiveness of IPS for patients with chronic pain.

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