PainWORRKNCT02396173
Does the Knowledge of a "Non-return to Work" Predictive Score Influence Vocational Rehabilitation?
A study testing Risk Score for non-return to work in people with Pain, run by Clinique Romande de Readaptation at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Pain
- What is being tested?
- Risk Score for non-return to work
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients hospitalized for a vocational rehabilitation programme after an orthopaedic trauma
Who cannot join
- Severe traumatic brain injury at time of accident (Glasgow coma Scale ≤8)
- Spinal Cord Injury
- Not capable of judgment
- Under legal custody
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Knowledge of a "Non-return to Work" Predictive Score Influence Vocational Rehabilitation After Orthopaedic Trauma?
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Risk Score for non-return to work
- Keywords
- disability, vocational, rehabilitation, prediction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Score for non-return to workOther
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").
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 months
Secondary outcomes (5)
Return to work rate
The non-return to work rate will be assessed by questionnaire at 3, 12 and 24 months after discharge.
Measured: 24 months
the patients' satisfaction is not worse in the intervention group
At discharge patients will fill a questionnaire to assess their satisfaction regarding the treatments received.
Measured: 10 months
the decisions makers' satisfaction with the information available for the decision process is better in the intervention group
Medical staff will assess efficiency of the intervention through a questionnaire
Measured: 10 months
the proportion of patients changing the treatment pathway during the vocational stay is not higher in the intervention group
To assess if patients change their clinical pathway during hospitalization. Is there any differences between the intervention and control groups.
Measured: 10 months
the calibration of the WORRK model remains satisfactory
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Romande de Readaptation
- Sponsor type
- Research network
- Collaborators
- University of Applied Sciences of Western Switzerland
- Responsible party
- Principal investigator, François Luthi, Clinique Romande de Readaptation
- Investigators
- François Luthi, MD, Principal investigator, Clinique Romande de Readaptation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396173
- Sponsor's protocol ID
- CliniqueRR-03
- Acronym
- WORRK
- Status last verified
- Jan 2020
- First submitted
- 10 Mar 2015
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30071081
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Knowledge of a "Non-return to Work" Predictive Score Influence Vocational Rehabilitation After Orthopaedic Trauma?
- ClinicalTrials.gov ID
- NCT02396173
- Acronym / sponsor ID
- WORRK / CliniqueRR-03
- Conditions
- Pain
- Keywords
- disability, vocational, rehabilitation, prediction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Clinique Romande de ReadaptationResearch network
- Collaborators
- University of Applied Sciences of Western Switzerland
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk Score for non-return to work | Experimental | Other: Risk Score for non-return to workThe 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. |
| Control group | No intervention | –In this group the medical staff will not be informed about the risk score (WORRK). |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients hospitalized for a vocational rehabilitation programme after an orthopaedic trauma
Key exclusion criteria (4 listed)
- Severe traumatic brain injury at time of accident (Glasgow coma Scale ≤8)
- Spinal Cord Injury
- Not capable of judgment
- Under legal custody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Score for non-return to workThe 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"). | Other | Risk Score for non-return to work |
Primary outcome
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.
5 secondary outcomes
Return to work rate
Time frame: 24 months
the patients' satisfaction is not worse in the intervention group
Time frame: 10 months
the decisions makers' satisfaction with the information available for the decision process is better in the intervention group
Time frame: 10 months
the proportion of patients changing the treatment pathway during the vocational stay is not higher in the intervention group
Time frame: 10 months
the calibration of the WORRK model remains satisfactory
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Derived from this study: PubMed 30071081Plomb-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François Luthi, MD principal investigator
Clinique Romande de Readaptation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Score for non-return to work in people with Pain, run by Clinique Romande de Readaptation at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allocation to the evaluation pathway (proportion of patients allocated to the Evaluation Pathway) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02396173, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.