|- candidate number||10464|
|- NTR Number||NTR3111|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-okt-2011|
|- Secondary IDs||ECP 107 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 randomized controlled trial in Health & Motion.|
|- hypothesis||We hypothesize that the employability intervention of 'Health & Motion', which consists of integrated care and a participative workplace intervention, will be cost-effective compared to usual care.|
|- Healt Condition(s) or Problem(s) studied||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, randomized|
|- planned startdate ||1-nov-2011|
|- planned closingdate||1-nov-2013|
|- Target number of participants||140|
|- Interventions||The intervention program consists out of two components: integrated care, in which a physiotherapist, an occupational therapist and a care manager work closely together in a multidisciplinary team, and a participative workplace intervention. During this participative workplace intervention, possible adaptations at the workplace will be discussed and demonstrated in an action plan.|
First, an intake with the physiotherapist takes places. During this process, the physiotherapist tends to find out whether work interferes the health recovery of patients and whether a persons' health interferes with his/her work. When this is the case, an additional screening will be done by an occupational therapist. The occupational therapist investigates the necessity of a workplace intervention and determines the desired number of evaluation moments. All the information will be gathered in a patient file, and an action plan will be developed. After approval of the action plan (based on the information in the patient file) by the employer, the physiotherapist will be accompanied with other professionals in order to provide the patient with multidisciplinary care and a workplace intervention (as mentioned in the action plan). The duration of the intervention is patient depending. An approximation was made at: (freq. per week) 20 min. individual training, 1 hour medical training and 20 minutes evaluation. Ones, 1 ½ hour will be spent on a workplace visit and employer dialogue and ¾ hour coverage.
The control group will only receive physiotherapeutic care and no personal patient file will be made. In sum, minor attention to work disability will occur. The time investment for care as usual consists out approx. 20 minutes per week on individual training.
|- 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||www.health-motion.nl/kosteneffectiviteitsonderzoek|
|- 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, Health & Motion, Nederland|
|- Brief summary||Work is not always a standard topic during consultations with the physiotherapist, and often the occupational therapist is only involved if a patient is already absent at work. Health & Motion feels that there is a stronger need for multisiciplinairy recommendations for work activities in patients with physical complaints. A multicisciplinairy approach, together with advices on workplace adaptations, is their mission and vision for the future. Although this intervention program appears to be effective, little is known about the cost effectiveness hereof. Therefore, this study is going to evaluate the cost-effectiveness of the Health & Motion intervention program, compared to care as usual. A multicenter randomized controlled trial will be used to compare both groups.|
|- Main changes (audit trail)|
|- RECORD||25-okt-2011 - 7-nov-2011|