Does the Knowledge of a "Non-return to Work" Predictive Score Influence Vocational Rehabilitation? (WORRK)
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|ClinicalTrials.gov Identifier: NCT02396173|
Recruitment Status : Unknown
Verified March 2015 by François Luthi, Clinique Romande de Readaptation.
Recruitment status was: Recruiting
First Posted : March 24, 2015
Last Update Posted : March 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Risk Score for non-return to work||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Does the Knowledge of a "Non-return to Work" Predictive Score Influence Vocational Rehabilitation After Orthopaedic Trauma?|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2017|
Experimental: Risk Score for non-return to work
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
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").
No Intervention: Control group
In this group the medical staff will not be informed about the risk score (WORRK).
- Allocation to the evaluation pathway (proportion of patients allocated to the Evaluation Pathway) [ Time Frame: 10 months ]The primary outcome in the WORRK study is the proportion of patients allocated to the Evaluation Pathway.
- Return to work rate [ Time Frame: 24 months ]The non-return to work rate will be assessed by questionnaire at 3, 12 and 24 months after discharge.
- the patients' satisfaction is not worse in the intervention group [ Time Frame: 10 months ]At discharge patients will fill a questionnaire to assess their satisfaction regarding the treatments received.
- the decisions makers' satisfaction with the information available for the decision process is better in the intervention group [ Time Frame: 10 months ]Medical staff will assess efficiency of the intervention through a questionnaire
- the proportion of patients changing the treatment pathway during the vocational stay is not higher in the intervention group [ Time Frame: 10 months ]To assess if patients change their clinical pathway during hospitalization. Is there any differences between the intervention and control groups.
- the calibration of the WORRK model remains satisfactory [ Time Frame: 24 months ]We will perform a new validation of the WORRK model on the population recruited from this study. The performance of the WORRK prediction tool will be assessed with measures for calibration and discrimination. For calibration we will plot the expected against the observed proportion of non-return to work per predicted risk group. Furthermore, we will use the Hosmer-Lemeshow test to define statistical significance of the calibration. For discrimination, we will plot the ROC-curve and calculate Areas under the ROC-curve (AUC). We consider the performance of the WORRL acceptable if there is good calibration (i.e. intercept not statistically different from 0 and slope of 1) and if the AUC is larger than 0.7.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02396173
|Contact: Chantal Plomb, MDemail@example.com|
|Contact: Bertrand Leger, PhDfirstname.lastname@example.org|
|Clinique Romande de Readaptation||Recruiting|
|Sion, Valais, Switzerland, 1951|
|Contact: François Luthi, MD +41276032175 email@example.com|
|Contact: Bertrand Léger, PhD +41276032076 firstname.lastname@example.org|
|Principal Investigator:||François Luthi, MD||Clinique Romande de Readaptation|