Clinical trial NCT06158464: The Effectiveness of a Functional Capacity Evaluation Among Persons on Sick Leave or Work Disability
Official title: The Effectiveness of a Functional Capacity Evaluation (FCE) on the Return-to-work Process in Belgium: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sick Leave
Absenteeism
Return to Work
Keywords: return-to-work
functional capacity evaluation
randomized controlled trial
workability
occupational therapy
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Haute École Léonard de Vinci
name: National Institute for Health and Disability Insurance (NIHDI), Belgium
First posted: 2023-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised controlled trial will be set up (RCT). For this purpose, 10 consulting physicians, 30 occupational therapists, and 200 persons on incapacity will be recruited. Then, persons on sick leave/work disability are randomly divided into two groups: 1) Persons in the control group receive care-as-usual without modifications. 2) Persons in the intervention group receive usual care and a functional capacity evaluation (FCE). Both groups are asked to complete questionnaires at baseline, and after 3,6, and 9 months. Primary outcome is the difference in workability at 6 months follow-up.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate Functional Capacity Evaluations in persons on sick leave or work disability. The main questions it aims to answer are:

* What is the impact of FCE on the person on sick leave/work disability (quantitative)
* What is the impact of FCE on the decision-making process by the medical advisor? (qualitative)
* What is the usability, feasibility and quality of FCE for the medical advisor, occupational therapist, mediators of the regional services, and return-to-work coordinators? (qualitative)

This is a randomized controlled trial (RCT). Participants in the control group will receive care-as-usual by the medical advisor. Participants in the intervention group will receive an FCE on top of care-as-usual. This is performed by an occupational therapist in their region, and a report of the FCE is delivered to the medical advisor. Both groups are asked to complete questionnaires at baseline, and after 3,6, and 9 months.

Researchers will compare questionnaire results from participants in the control and intervention group, to see if their workability (primary outcome), steps to return to work, expectations to return to work, return to work beliefs, time until (partial) reintegration, self-efficacy in return to work, pain scale, and illness perception (secondary outcomes) are affected differently.

Detailed description: This research project on the use of Functional Capacity Evaluations (FCE) within the context of benefit insurance in Belgium falls under the joint control of the National Institute for Sickness and Disability Insurance (RIZIV), the Haute École de Leonard Vinci and KU Leuven . KU Leuven hereby acts as the study's principal, but together with RIZIV and Haute École determines the objectives of the study as joint controllers.

An FCE consists of the evaluation of functional capacities based on medical reporting, observations and/or a series of standardised tests performed by an occupational therapist. This evaluation can give socially insured persons and medical advisors of the mutualities more insight into the participation possibilities of the socially insured person in function of the previous or next job. To date, the advisory doctor does not yet have the opportunity to have these evaluations carried out in Belgium. The aim of this study is therefore to examine the impact of these FCEs with regard to people on incapacity for work who meet the following conditions:

1. Belgian citizens on sick leave or work disability who meet the criteria determined by the article 100§1 and 100 §2 of the coordinated law of 14 July 1994, or by article 19 and/or 20 of the RD 20 July 1971.
2. The person's medical situation is stabilised (no significant evolution due to illness, procedure, treatment)
3. It is not a purely mental/psychiatric disorder
4. From the point of view of the consulting physician, there is a lack of consistent information on the capacity to return to work
5. Inclusion takes place from the 6th month of incapacity
6. The person is of working age: 18-65 years

In this RCT, 10 consulting physicians, 30 occupational therapists, and 200 persons on incapacity will be recruited. Then, persons on sick leave/work disability are randomly divided into two groups: 1) Persons in the control group receive the usual counselling by the medical advisor. 2) Persons in the intervention group receive usual care and an FCE. In the latter group, the person on sick leave is matched by the researchers to an occupational therapist in his region, and is invited to a FCE. After the evaluation, the person reviews the results with the occupational therapist, and a report of the FCE is provided to the medical advisor. Finally, the person is contacted by the medical advisor if they wish to take certain actions as a result of the FCE report. To measure the impact of the FCE, the intervention and control groups thereby complete a questionnaire at four points in time: at baseline, after 3 months, after 6 months, and after 9 months. This questionnaire is composed of validated instruments, and in addition to background characteristics, it questions work ability, self-efficacy, expectations of returning to work, any (steps taken to) return to work, pain intensity, illness perception, and beliefs regarding returning to work.

As a second objective, the impact on the medical advisors' (and other parties') decision-making process will be investigated through qualitative interviews and focus groups. To this end, a process evaluation will be conducted. This includes an examination of the implementation of the study, the usability, feasibility and quality of FCEs and their reporting, and the underlying causal mechanisms of the intervention. Using interviews and focus groups with medical advisors the impact of the FCE on the decision-making process will be investigated. Using interviews with occupational therapists, return-to-work coordinators and mediators of the regional services the usability, feasibility and quality of the FCE will be investigated.

Eligibility criteria: Inclusion Criteria:

* persons on sick leave or work disability (according to Belgian law)
* The person on sick leave/work disability is affected by an illness/injury that is considered stabilized (no significant medical evolution of the disease, nor a medical procedure or acute treatment is expected).
* The illness/injury of the person on sick leave/work disability is not mainly a mental/psychiatric disorder.
* From the point of view of the medical advisor, there is a lack of consistent information on the person on sick leave/work disability's capacity to return-to-work.
* Inclusion takes place from the 6th month of incapacity for work.
* The person on sick leave/work disability is of working age (18-65).

Exclusion Criteria:

* In the case of an accident at workplace, the medical condition of the person on sick leave/work disability has not yet been declared consolidated, meaning that the condition does not progress significantly, either naturally or with treatment.
* The medical advisor of the mutual health insurance is expecting in the near future: 1) a spontaneous return to work (total or partial), 2) a registration as a job-seeker, or 3) an end of the recognition of the work disability.
* The person on sick leave/work disability is pregnant.
* The medical advisor of the mutual health insurance perceives the person on sick leave/work disability does not have sufficient work capacity.

Primary outcomes:
measure: Workability
timeFrame: measured at baseline, and 3, 6 and 9 months post baseline
Secondary outcomes:
measure: Self-efficacy in the context of return-to-work
timeFrame: measured at baseline, and 3, 6 and 9 months post baseline
measure: Expectations to return-to-work
timeFrame: measured at baseline, and 3, 6 and 9 months post baseline
measure: Steps to return-to-work
timeFrame: measured at baseline, and 3, 6 and 9 months post baseline
measure: Pain scale
timeFrame: measured at baseline, and 3, 6 and 9 months post baseline
measure: Illness perception
timeFrame: measured at baseline, and 3, 6 and 9 months post baseline
measure: Return-to-work beliefs
timeFrame: measured at baseline, and 3, 6 and 9 months post baseline
Other outcomes:
Locations:
city: Anderlues
country: Belgium
facility: MC Hainaut
city: Antwerp
country: Belgium
facility: LM Plus Antwerpen
city: Genk
country: Belgium
facility: Helan/Medisch kabinet Genk
city: Gent
country: Belgium
facility: CM Gent
city: Leuven
country: Belgium
facility: CM Vlaams-Brabant
city: Liège
country: Belgium
facility: MC Liège
city: Oostende
country: Belgium
facility: CM Oostende
city: Saint-Hubert
country: Belgium
facility: Mutsoc Luxembourg
Study officials:
References: