NCT02396173

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 24, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

March 10, 2015

Last Update Submit

January 22, 2020

Conditions

Keywords

disabilityvocationalrehabilitationprediction

Outcome Measures

Primary Outcomes (1)

  • Allocation to the evaluation pathway (proportion of patients allocated to the Evaluation Pathway)

    The primary outcome in the WORRK study is the proportion of patients allocated to the Evaluation Pathway.

    10 months

Secondary Outcomes (5)

  • Return to work rate

    24 months

  • the patients' satisfaction is not worse in the intervention group

    10 months

  • the decisions makers' satisfaction with the information available for the decision process is better in the intervention group

    10 months

  • the proportion of patients changing the treatment pathway during the vocational stay is not higher in the intervention group

    10 months

  • the calibration of the WORRK model remains satisfactory

    24 months

Study Arms (2)

Risk Score for non-return to work

EXPERIMENTAL

The WORRK model is a predictive tool (19 items) of the non-return to work risk useful for all kinds of orthopaedic trauma and for patients needing vocational rehabilitation. It is constructed with variables independent of the patient's education and language fluency. It is a short patient's bedside tool and takes less than 20 minutes.

Other: Risk Score for non-return to work

Control group

NO INTERVENTION

In this group the medical staff will not be informed about the risk score (WORRK).

Interventions

The WORRK tool will be filled in for all patients, even the patients in the control group. However, the probability score will only be accessible for the medical doctors in the intervention group, along with guidelines for interpretation ("1. With a probability score over 50% (not to return to work), patient's allocation to the "Evaluation Pathway" should be considered" "2. With a probability score over 70% (not to return to work), the "Evaluation Pathway" is probably the most suitable choice").

Risk Score for non-return to work

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Romande de Readaptation

Sion, Valais, 1951, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pain

Interventions

Risk Factors

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • François Luthi, MD

    Clinique Romande de Readaptation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior lecturer and researcher

Study Record Dates

First Submitted

March 10, 2015

First Posted

March 24, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2017

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations