Cost-effectiveness Analysis of a Sustainable Employability Intervention.|
|- candidate number||10517|
|- NTR Number||NTR3136|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-nov-2011|
|- Secondary IDs||ECP107 Ethical Commission Psychology University Maastricht|
|- Public Title||Cost-effectiveness Analysis of a Sustainable Employability Intervention.|
|- Scientific Title||Cost-effectiveness Analysis of Sustainable Employability: A Dutch quasi experiment in Care for Companies/Second Care.|
|- hypothesis||We hypothesize that the employability intervention of 'Care for Companies/Second Care', which consists of integrated multidisciplinairy care for workers with physical and/or psychological care, will be cost-effective compared to usual care. |
|- Healt Condition(s) or Problem(s) studied||Mental health complaints, Cost-effectiveness , Economic evaluation, Work disability, Physical complaints, Sustainable employability|
|- Inclusion criteria||1. Diagnosed with physical complaints;|
2. Aged between 18 and 63;
3. Perform paid labor for at least 12 hours per week;
4. Ability to communicate in Dutch.
|- Exclusion criteria||1. Absenteeism for 1.5 years or longer;|
2. Fulltime students with a student job;
3. Fulltime informal caregivers;
4. Fulltime volunteers.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||20-nov-2011|
|- planned closingdate||21-nov-2013|
|- Target number of participants||140|
|- Interventions||The intervention starts with a multidisciplinary expertise. Hereby, spread over 1 or 2 days, depending on the needs of the patient, the physiotherapist (both surgery and training hall), occupational therapist, Cesar remedial therapist, psychologist and physician examine the patient. Everyone does this expertise based from their own qualities (with bio-psychosocial glasses). Based on the complaints, activities and environment a patient copes with, a modular design for each client is examined. The multidisciplinary team discusses an overall report in which history, research, conclusions, shared goals and treatment plans with sub-targets are formulated. (Which treatment components are necessary and useful?)
Besides the expert report, a plan for a treatment process will be offered to the client as well. Only after approval of this proposal, the treatment (intervention) will be started.|
Overall, three distinct types of trajectories (interventions) can be provided:
1. ‘Psychological Journey’: The nature of the complaints and the insertion of the support / treatment is a psychic. Psychological training consists roughly of a psychology module, an occupational therapy module, relaxation and a module coordination of the process. Furthermore, during the reporting process, evaluation points with the client, a three-way conversation at work (or visit), discussions within the multidisciplinary team, etc. will take place;
2. ‘Physical Journey’: The nature of the complaints and the insertion of the support / treatment is a very physical. A physical process broadly consists of a module physiotherapy, a rehabilitation module, a module Posture and movement (exercise Cesar) and the coordination of the process. (See above). Sometimes the occupational therapy module is used to apply the lessons learned in everyday life and balancing of the load of interpretation;
3. ‘Multidisciplinary Track’: The nature of the complaints and / or the insertion of the counseling / therapy directed at both physical and mental / psychological aspects.
A multidisciplinary program usually consists of modules in all disciplines, so both the physiotherapy / rehabilitation training, Cesar Exercise, occupational therapy and psychology. (And of course: coordination of the process. (See above) Depending on the progress of reintegration back to work can also be an additional module to be deployed to support the client (and empowering) to define the responsibility and to take the initiative in re-integration.
The control group will only receive care whereby no expert report, nor a plan for a treatment process will be offered to the patient. In sum, minor attention to work disability will occur.
|- Primary outcome||1. A difference of 20% in the average no. of hours/days lost from work due to work disability between the intervention and the control group at 6, 12, and 18 months;|
2. Cost per productivity lost reduction at 6, 12, and 18 months;
3. Cost per QALY at 6, 12, and 18 months.
|- Secondary outcome||1. Hours lost from work due to presenteeism;|
2. Quality of life;
3. General health;
4. Costs and productivity losses;
5. Medical care consumption.
|- Timepoints||Baseline (1 week before intervention start), 6 months, 12 months and 18 months follow-up (during and after intervention).
In order to conduct an economic evaluation and to determine whether the intervention is cost effective, Patient Self Reported Measurement tools will be used. Questions derived from different questionnaires, such as 'Nationale Enquete Arbeidsomstandigheden'(NEA), EuroQol 5Dimensions 5Levels (EQ-5D-5L), Short Form Health Survey (SF-36), Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness (TIC-P), and the productivity and disease questionnaire (PRODISQ), are combined into a retrospective self-reported questionnaire. Participation requires employees to fill in the self-reported online questionnaire at time points T0 (baseline), T1 (6 months after admission), FU1 (12 months follow-up) and FU2 (18 months follow-up). The results of the study at 18 months are expected to be extended in subsequent years.
|- Trial web site||http://www.careforcompanies.nl/|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc. C.Y.G. Noben|
|- CONTACT for SCIENTIFIC QUERIES||MSc. C.Y.G. Noben|
|- Sponsor/Initiator ||Stichting Instituut GAK (SIG)|
(Source(s) of Monetary or Material Support)
|Stichting Instituut GAK (SIG), Maastricht University, Care for Companies/Second Care, Nederland |
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||10-nov-2011 - 21-nov-2011|
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