Clinical trial NCT02396173: Does the Knowledge of a "Non-return to Work" Predictive Score Influence Vocational Rehabilitation?
Official title: Does the Knowledge of a "Non-return to Work" Predictive Score Influence Vocational Rehabilitation After Orthopaedic Trauma?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: disability
vocational
rehabilitation
prediction
Lead sponsor: Clinique Romande de Readaptation
Sponsor class: NETWORK
Collaborators: name: University of Applied Sciences of Western Switzerland
First posted: 2015-03-24
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Background: Orthopaedic trauma are a leading cause of long-lasting sick-leave and persistent disability. People suffering from persistent sick-leave often need vocational rehabilitation (VR). Vocational programs are planned to improve the likelihood of returning to work (RTW). Physical conditioning, professional evaluation and training, as well as psychological and social interventions are the core of the treatments. Efficiency of these programs is moderate and there is scope for improvements. For instance, rehabilitation programs tailored to the individual needs and potentials are called for. However, the allocation remains difficult. Decision-supportive tools may be convenient to achieve this goal. Recently, the WORRK model was proposed to assess early on the risk of non-returning to work for those patients. The main goal of this research is to measure if the WORRK model improves patients' allocation to different vocational programs according to their "non-return to work" risk.

Detailed description: Methods:

Vocational inpatients after orthopaedic trauma (n=280), aged between 18-60 years. Three different vocational pathways can be selected: Simple (for patients with low "non-return to work" risk, 5 weeks stay), Coaching (intermediate risk, 5 weeks), Evaluation (high risk, 3 weeks). Design: randomized-controlled trial. In the intervention group, the probability not to return to work estimated with the WORRK model will be offered to the clinician team before the allocation decisions. In the control group, the probability will also be estimated but not known by the clinician team. The primary outcome is the proportion of patients allocated to the Evaluation Pathway. Secondary outcomes: the patients' satisfaction is not worse in the intervention group; the decisions makers' satisfaction with the information available for the decision process is better in the intervention group; the proportion of patients changing the treatment pathway during the vocational stay is not higher in the intervention group; and the calibration of the WORRK model remains satisfactory; the non-return to work rate is not higher in the intervention group than in the control group (follow-up at 3, 12, and 24 months);

Relevance and impact:

The investigators expect that the WORRK model will improve the efficiency of vocational rehabilitation after orthopedic trauma. This will due to better allocation to the vocational pathways according to the patients' risk profile. If this is the case, an increase of the shorter vocational program is expected without jeopardizing the chance of returning to work and the patient satisfaction with quality of care. The ability of the WORRK model to detect patients with similar risk profiles could also strengthen the interest for this decision-supportive tool in clinical practice and trials.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized for a vocational rehabilitation programme after an orthopaedic trauma

Exclusion Criteria:

* Severe traumatic brain injury at time of accident (Glasgow coma Scale ≤8)
* Spinal Cord Injury
* Not capable of judgment
* Under legal custody

Primary outcomes:
measure: Allocation to the evaluation pathway (proportion of patients allocated to the Evaluation Pathway)
timeFrame: 10 months
Secondary outcomes:
measure: Return to work rate
timeFrame: 24 months
measure: the patients' satisfaction is not worse in the intervention group
timeFrame: 10 months
measure: the decisions makers' satisfaction with the information available for the decision process is better in the intervention group
timeFrame: 10 months
measure: the proportion of patients changing the treatment pathway during the vocational stay is not higher in the intervention group
timeFrame: 10 months
measure: the calibration of the WORRK model remains satisfactory
timeFrame: 24 months
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Clinique Romande de Readaptation
state: Valais
Study officials:
affiliation: Clinique Romande de Readaptation
name: François Luthi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plomb-Holmes C, Hilfiker R, Leger B, Luthi F. Impact of a non-return-to-work prognostic model (WORRK) on allocation to rehabilitation clinical pathways: A single centre parallel group randomised trial. PLoS One. 2018 Aug 2;13(8):e0201687. doi: 10.1371/journal.pone.0201687. eCollection 2018.