Efficacy of a Remotely Administered Functional Capacity Test on Return-to-work Outcomes

Musculoskeletal Injury Clinical Trial

Official title:

Efficacy of a Remotely Administered Functional Capacity Test on Return-to-work Outcomes: a Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05370872
• Other study ID #: 44076
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2022
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, injured workers are required to visit a clinic, in-person, for functional testing as part of the rehabilitation and return-to-work process. The need for in-person testing has always caused problems for workers in remote areas without easy access to clinics. COVID-19 has made the problem of access to in-person clinical testing worse. Now, many injured workers can't receive functional testing due to COVID-19 related clinic closures and isolation restrictions. The investigators aim to develop and evaluate a functional testing protocol that can be delivered remotely to solve the problem of access to in-person clinic testing. A functional test that can be completed remotely, while the client remains in their home will increase access to timely testing, improve client satisfaction by removing the need for costly and time consuming travel, and will continue to help injured workers quickly recover and return to meaningful work. This research study will help to determine if return-to-work outcomes improve, or remain unchanged, when functional testing is completed remotely relative to in the clinic.

Description:

Functional testing, often referred to as functional capacity evaluation (FCE) has played a longstanding role within return-to-work (RTW). The goal of an FCE is to measure an assess an individual's functional capabilities (e.g., how much can the client lift? How hard can the client push? Can the client sit for a long period of time? etc.). Historically, FCE served to measure the degree of disability (i.e., reduction in physical capability) following a workplace injury and also helped to match workers with meaningful work suited to their (adapted) functional abilities. Presently, performance-based FCE, testing requiring clients to perform movements with different weighted objects (for instance, to measure how much someone can lift), is collected at patient intake to provide a functional capacity baseline which, in turn, informs patient-centered rehabilitation programming. Not only does this FCE information help support job matching when applied at the end stages of rehabilitation (fitting clients to work based on the adapted functional capabilities), but when applied early with the rehabilitation program, FCE also provides key insights to inform patient-centred rehabilitative strategies and work hardening approaches. FCE plays a central role in supporting early and safe RTW.

However, accessing in-person, in-clinic administered functional testing to provide these important baseline insights has been a longstanding problem in remote and rural communities, a problem now amplified by clinic disruptions and temporary closures across Ontario, Canada. COVID-19 has intensified the problem of the in-person, in-clinic requirements for baseline functional testing where many injured workers are unable to access or are delayed in accessing important FCE services. The lack of patient-specific information regarding functional abilities via baseline FCE is a direct barrier to patient-centered rehabilitation and limits early and safe RTW. To address this problem, the investigators test the efficacy of a remotely administered functional testing protocol as an alternative to in-person, in-clinic baseline functional testing.

The concept of a remotely delivered baseline FCE is not new, but has been limited to subjective self-report-based methods only (e.g., asking a client how much they think they can lift). Gross et al., (2014) provide evidence that a functional interviewing-based FCE (currently deployed within the Workers' Compensation Board - Alberta, Canada system) was equivalently useful in predicting RTW outcomes relative to performance-based FCE. However, performance-based FCE elements, such as low lifting tests also remain useful for predicting RTW outcomes and provide objective insight about movement characteristics. Observing how a client moves when performing a lift, for example, provides insight into their willingness to engage, any guarding behaviours they may exhibit, any observed hesitancy to move, and also provides insight into their coordination of movement. These insights are necessary to inform patient centered rehabilitation programming and to ensure that the care team has the necessary health professionals (i.e., rehabilitation to address mechanical issues relative to psychosocial barriers). The investigators believe that a hybrid FCE including self-report to estimate maximum functional levels combined with a safe, submaximal performance-based FCE to assess movement characteristics can provide key insights to best optimize early and safe RTW when using virtual FCE delivery. However, at present, no such testing paradigm exists.

To optimize remote FCE service delivery to include both self-report and performance-based insights, the investigators aim to leverage the 2D video recording capabilities of Microsoft Teams, the CBI Health approved software application for safely and securely engaging with clients remotely. The investigators have demonstrated how movement data (which can be generated using 2D video and pose estimation) and advances in computer vision can be leveraged to generate insightful information about key movement characteristics, functional capabilities and safety. The ability for a patient to record their performance of safe, standardized, sub-maximal actions will generate essential and objective information to support patient-centered rehabilitative programing, an integral requirement for early and safe RTW.

The investigators have developed an evidence-based protocol for remote delivery of baseline functional testing for injured workers inclusive of performance-based and self-report FCE measures. The investigators now aim to evaluate if a remotely administered functional testing protocol can generate treatment recommendations and RTW outcomes that are consistent with the current status quo requiring in-person, in-clinic functional assessment. The investigators hypothesize that the remotely administered functional testing protocol will yield similar insight to in-person, in-clinic baseline FCE, such that RTW outcomes will be equal to or better when using the remotely administered functional testing protocol. The investigators also hypothesize that patient experience and satisfaction will be improved with the use of a remotely administered functional testing protocol because time and cost intensive travel barriers can be removed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Injured workers with accepted Workplace Safety and Insurance Board (WSIB) of Ontario claims referred to CBI Health for WSIB Specialty Programs related to musculoskeletal injuries of either Back and Neck, or Upper Extremity.

Exclusion Criteria:

• Under the age of 18 years,

• referred for surgery during the time of the rehabilitation programming,

• have a concurrent traumatic brain injury or mental health disorder that takes precedence over the musculoskeletal injury, or

• require the assistance of an interpreter to read, write or speak English.

Related Conditions & MeSH terms

• Low Back Disorder
• Musculoskeletal Injury
• Shoulder Disease

Intervention

Diagnostic Test:
• Remote functional testing protocol
Clients in the remote functional testing protocol group will be asked to describe their functional capacity limits using a clinician guided motivational interviewing approach and will also be asked to complete a mobility screening protocol to provide the clinician with the opportunity to observe the clients natural movements.

Locations

Country	Name	City	State
Canada	CBIH London Dundas	London	Ontario
Canada	CBIH London Fanshawe	London	Ontario
Canada	CBIH London Wonderland	London	Ontario
Canada	CBIH Nepean	Nepean	Ontario
Canada	CBIH St. Laurent	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	CBI Health

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Gross DP, Asante AK, Miciak M, Battie MC, Carroll LJ, Sun A, Mikalsky M, Huellstrung R, Niemelainen R. A cluster randomized clinical trial comparing functional capacity evaluation and functional interviewing as components of occupational rehabilitation pr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to work recommendation at intake	When referred to an musculoskeletal program of care, clients are classified into return to work categories based on their ability to meet job requirements as measured by the clinician using the functional testing protocol. The return to work recommendation at intake is used to inform the rehabilitation program.	Baseline measure - a intake into the rehabilitation program
Primary	Return to work recommendation at discharge	Once the client has completed a musculoskeletal program of care, clients are again classified into return to work categories based on their ability to meet job requirements as measured by the clinician using the functional testing protocol. The return to work recommendation at discharge is used to inform how the client is reintegrated into their workplace.	At program discharge (approximately 8-12 weeks post intake, where each client will receive a tailored program based on their return to work recommendation at intake)
Primary	Return to work status	Clients will be aske to describe their current work status at three-months post discharge by selecting 1 of 5 options (work regular, full time duties; work regular, part time duties, work light duty or modified position full time; work light duty or modified position part time; not currently working)	three-months post discharge
Secondary	Adverse events	Reports of adverse events for participating clients will be extracted from the occupational health & safety document management system.	Through study completion, and average of 1 year
Secondary	Client experience and satisfaction	Clients will complete a web survey inclusive of 3 questions that probe their experience and satisfaction with the functional testing that they received. Each question is posed using a 5-point Likert scale (strongly disagree, disagree, neither agree or disagree, agree, strongly agree).	one-week post initial functional testing session