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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).

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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