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Protocol for the effect evaluation of Individual Placement and Support (IPS): a randomized controlled multicenter trial of IPS versus treatment as usual for patients with moderate to severe mental illness in Norway.

ABSTRACT: Roughly one third of disability pensions in Norway are issued for mental and behavioral disorders, and vocational rehabilitation offered to this group has traditionally been dominated by train-and-place approaches with assisted or sheltered employment. Based on a more innovative place-and-train approach, Individual Placement and Support (IPS) involves supported employment in real-life competitive work settings, and has shown great promise for patients with severe mental illness.The study is a multicenter Randomized Controlled Trial (RCT) of IPS in a Norwegian context, involving an effect evaluation, a process evaluation, and a cost/benefit analysis. IPS will be compared to high quality treatment as usual (TAU), with labor market participation and educational activity at 12 months post inclusion as the primary outcome. The primary outcome will be measured using register data, and the project will also include complete follow-up up to 4 years after inclusion for long-term outcome data. Secondary outcomes include mental health status, disability and quality of life, collected through survey questionnaires at baseline, and after 6 and 12 months. Participants will include patients undergoing treatment for moderate to severe mental illness who are either unemployed or on sickness or social benefits. The estimated total sample size of 400-500 will be randomly assigned to the interventions. To be eligible, participants must have an expressed desire to work, and sufficient Norwegian reading and writing skills to fill out the questionnaires.The Effect Evaluation of Individual Placement and Support (IPS) will be one of the largest randomized controlled trials to date investigating the effectiveness of IPS on competitive employment, and the first study to evaluate the effectiveness of IPS for patients with moderate to severe mental illness within a Norwegian context.Clinicaltrials.gov: NCT01964092 . Registered October 16th, 2013.

SUBMITTER: Sveinsdottir V

PROVIDER: S-EPMC4244061 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Protocol for the effect evaluation of Individual Placement and Support (IPS): a randomized controlled multicenter trial of IPS versus treatment as usual for patients with moderate to severe mental illness in Norway.

Sveinsdottir Vigdis V Løvvik Camilla C Fyhn Tonje T Monstad Karin K Ludvigsen Kari K Øverland Simon S Reme Silje Endresen SE

BMC psychiatry 20141118

<h4>Background</h4>Roughly one third of disability pensions in Norway are issued for mental and behavioral disorders, and vocational rehabilitation offered to this group has traditionally been dominated by train-and-place approaches with assisted or sheltered employment. Based on a more innovative place-and-train approach, Individual Placement and Support (IPS) involves supported employment in real-life competitive work settings, and has shown great promise for patients with severe mental illnes ...[more]

PMID: 25403470

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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.

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: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).

Project description:Importance:Individual placement and support (IPS) seems to be an effective vocational intervention for people with severe mental illness, but its effects have not yet been shown in the Danish welfare model. Also, effects may be enhanced by adding cognitive remediation and work-focused social skills training (IPS with enhancements [IPSE]). Objectives:To investigate the effects of IPS vs IPSE vs service as usual (SAU) on a population of individuals with severe mental illness in Denmark. Design, Setting, and Participants:This was an investigator-initiated, 3-group, parallel, assessor-blinded randomized clinical trial that used early-intervention teams or community mental health services in 3 Danish cities to recruit participants with severe mental illness. Participants were randomly assigned to receive IPS, IPSE, or SAU from November 2012 to February 2016, and follow-up continued until August 2017. Interventions:Participants allocated to the IPS intervention received vocational support per the principles of the IPS model. Participants in the IPSE arm received cognitive remediation and social skills training in addition to IPS. The group receiving SAU received vocational rehabilitation at the Danish job centers. Main Outcomes and Measures:The primary outcome was the number of hours in competitive employment or education during the 18-month follow-up. Secondary outcomes included intergroup differences in employment or education at any point during follow-up; time to employment or education; and cognitive and social functioning, self-esteem, and self-efficacy. Results:Of the 720 included participants (mean [SD] age, 32.8 [9.9] years; 276 [38.3%] women), 243 received IPS, 238 received IPSE, and 239 received SAU. Most participants (551 [76.5%]) were diagnosed with a schizophrenia spectrum disorder. During the 18-month follow-up, the IPSE group worked or studied a mean (SD) of 488.1 (735.6) hours, compared with 340.8 (573.8) hours in the group receiving SAU (success-rate difference [SRD], 0.151 [95% CI, 0.01-0.295]; P?=?.016). The mean (SD) in the IPS group was 411 (656.9) (SRD, 0.127 [95% CI, -0.017 to 0.276]; P?=?.004). There was no difference between IPS and IPSE in any vocational outcomes, and the 3 groups showed no differences in any nonvocational outcomes, except that the IPS and IPSE groups were more satisfied with the services received than the group receiving SAU (IPS vs SAU: SRD, 0.310 [95% CI, 0.167-0.445]); IPSE vs SAU: SRD, 0.341 [95% CI, 0.187-0.478]). Conclusions and Relevance:Compared with SAU, IPS and IPSE seem to be viable routes to increase employment and education rates in people with severe mental illness in Denmark, but no additional effects were observed by enhancing IPS. Trial Registration:ClinicalTrials.gov identifier: NCT01722344.

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.

Dataset Information

Protocol for the effect evaluation of Individual Placement and Support (IPS): a randomized controlled multicenter trial of IPS versus treatment as usual for patients with moderate to severe mental illness in Norway.

Publications

Protocol for the effect evaluation of Individual Placement and Support (IPS): a randomized controlled multicenter trial of IPS versus treatment as usual for patients with moderate to severe mental illness in Norway.

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