Advanced Practice Physiotherapy Care in Emergency Departments

NCT05545917 | Not Yet Recruiting DMC

• 1 other identifier: RCT ED Canada
• Study Type: interventional
• Target: 744
• Locations: 0 countries
• Sites: N/A

Brief Summary

Overcrowding in emergency departments (ED) is a major concern worldwide. Recent reports show that Canada has among the longest ED waiting times and limited access to care has been associated with poorer outcomes for many patients. Patients suffering from musculoskeletal disorders (MSKD) represent at least 25% of all ED visits and this number is expected to increase with the aging population. New collaborative models of care have been emerging in various settings, such as EDs, and physiotherapists (PT) have been identified as expert clinicians to care for patients with MSKD. These advanced practice physiotherapy (APP) models of care often allow for a more extended scope of practice for PTs in which they have direct access to patients without a physician referral, triage patients and sometimes prescribe medical imaging or medication. ED APP has emerged as a promising new ED model of care, but evidence of the efficacy and safety of such models is still limited. Only a few RCTs have been conducted and no studies have assessed the efficacy or cost-utility of physiotherapy models of care for patients with MSKD in Canadian EDs. Evaluation of the benefits of such models is highly context-dependent and systematic evaluation of these models is warranted to support further implementation in Canada. The aim of this multicenter stepped-wedge cluster RCT and cost analysis is to compare the effectiveness of a direct access APP model of care compared to usual physician ED care for persons presenting to an ED with a MSKD, in terms of pain, function, health care resources utilization and costs. Evidence-based development of new APP models of care in EDs could help improve access and quality of care for Canadians, thus relieving some of the pressure on our healthcare system by providing new innovative pathways of access to care for these patients.

Conditions

Musculoskeletal Diseases or Conditions; Emergency Department; Physiotherapy

Keywords

Emergency department; Physiotherapist; Primary care; Musculoskeletal Disorders; Advanced practice physiotherapy

Outcome Measures

Primary Outcomes (5)

• Brief Pain Inventory-Short form, Pain interference scale (BPI)

  The BPI is a self-administered questionnaire that includes seven items where the patient is asked to rate the impact of pain on various functional activities (pain interference scale) using a 10-point scale. The BPI is valid, reliable and responsive to change in MSKD populations. Change between different time points will be assessed.

  At inclusion and respectively at 4-, 12- and 26- weeks after inclusion

• Costs analyses

  For cost analyses, Time-Driven Activity Based Costing analyses to be used are based on combining process-mapping and resource level costing. The overarching objective is to calculate the costs of all resources consumed as a patient moves along a care pathway, which is determined via a collaboration between clinical and administrative staff and each step of the pathway represents direct and indirect resources consumed when providing patient care. The cost of all resources (personnel including salaries of PT and physicians, consumables, overhead, etc.) is calculated on a per minute basis (Capacity Cost Rate -CCR). The total cost of an episode of care is determined based on the type of resources utilized by a patient and the amount of time consumed. In addition to calculating costs per patient, this methodology will be applied at the 6 different sites and hence allowing us to map the care pathway used in all the different sites.

  At inclusion

• Costs analyses

  For cost analyses, Time-Driven Activity Based Costing analyses to be used are based on combining process-mapping and resource level costing. The overarching objective is to calculate the costs of all resources consumed as a patient moves along a care pathway, which is determined via a collaboration between clinical and administrative staff and each step of the pathway represents direct and indirect resources consumed when providing patient care. The cost of all resources (personnel including salaries of PT and physicians, consumables, overhead, etc.) is calculated on a per minute basis (Capacity Cost Rate -CCR). The total cost of an episode of care is determined based on the type of resources utilized by a patient and the amount of time consumed. In addition to calculating costs per patient, this methodology will be applied at the 6 different sites and hence allowing us to map the care pathway used in all the different sites.

  At 4 weeks after inclusion

• Costs analyses

  For cost analyses, Time-Driven Activity Based Costing analyses to be used are based on combining process-mapping and resource level costing. The overarching objective is to calculate the costs of all resources consumed as a patient moves along a care pathway, which is determined via a collaboration between clinical and administrative staff and each step of the pathway represents direct and indirect resources consumed when providing patient care. The cost of all resources (personnel including salaries of PT and physicians, consumables, overhead, etc.) is calculated on a per minute basis (Capacity Cost Rate -CCR). The total cost of an episode of care is determined based on the type of resources utilized by a patient and the amount of time consumed. In addition to calculating costs per patient, this methodology will be applied at the 6 different sites and hence allowing us to map the care pathway used in all the different sites.

  At 12 weeks after inclusion

• Costs analyses

  For cost analyses, Time-Driven Activity Based Costing analyses to be used are based on combining process-mapping and resource level costing. The overarching objective is to calculate the costs of all resources consumed as a patient moves along a care pathway, which is determined via a collaboration between clinical and administrative staff and each step of the pathway represents direct and indirect resources consumed when providing patient care. The cost of all resources (personnel including salaries of PT and physicians, consumables, overhead, etc.) is calculated on a per minute basis (Capacity Cost Rate -CCR). The total cost of an episode of care is determined based on the type of resources utilized by a patient and the amount of time consumed. In addition to calculating costs per patient, this methodology will be applied at the 6 different sites and hence allowing us to map the care pathway used in all the different sites.

  At 26 weeks after inclusion

Secondary Outcomes (10)

• Pain intensity

  Following initial assessment by provider in the emergency department

• Disability questionnaires - Neck Disability Index (NDI)

  At inclusion and respectively at 4-, 12- and 26- weeks after inclusion

• Disability questionnaires - Oswestry Disability Index (ODI) for back related disorders

  At inclusion and respectively at 4-, 12- and 26- weeks after inclusion

• Disability questionnaires - short version of the Disability of the Arm, Shoulder and Hand (Quick DASH)

  At inclusion and respectively at 4-, 12- and 26- weeks after inclusion

• Disability questionnaires - Lower Extremity Functional Scale (LEFS)

  At inclusion and respectively at 4-, 12- and 26- weeks after inclusion

Study Arms (2)

APP care

EXPERIMENTAL

The experimental arm will receive advanced practice physiotherapy care.

Other: Experimental: APP care

Usual physician care

ACTIVE COMPARATOR

The control arm will receive usual ED physician care delivered only by an ED physician.

Other: Control - Usual physician care

Interventions

Experimental: APP care OTHER

The experimental arm will receive advanced physiotherapy care (APP) care. Patients will be independently managed (assessment and intervention) by a PT. The PT will make a diagnosis and initiate an intervention plan (e.g. education and exercise). If relevant, the PT will make recommendations for medical imaging tests or medication. PTs will also recommend the proper discharge from the emergency department (ED), such as hospitalization, discharge without medical consultation/follow-up or discharge with a medical follow-up or rehabilitation in an outpatient setting.

APP care

Control - Usual physician care OTHER

The control arm will receive usual ED physician care delivered only by an ED physician. This will include independent assessment, treatment and discharge by an ED physician with no physiotherapy within the ED but physician's referral to outpatient physiotherapy or other professionals/medical specialists will be possible; overall care offered by the ED physician will not be standardized but will be systematically documented.

Usual physician care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients presenting with complaints related to common minor MSKD (e.g. back pain, joint sprain, osteoarthritis, muscle pain or tendinopathy) and being triaged by the triage nurse as level 3, 4, or 5 on the Canadian Triage and Acuity Scale (CTAS);
• aged 18 years or more;
• legally able to consent;
• able to understand/speak French or English;
• beneficiary of a provincial universal health insurance coverage.

You may not qualify if:

• having injury resulting from major trauma (e.g. high velocity trauma or major motor vehicle accident);
• presenting a major musculoskeletal injury (e.g. open fractures, unreduced dislocations, open wounds or a condition that needs an urgent surgical intervention);
• presenting red flags (e.g. progressive neurological deficits or infection-related symptoms);
• consulting for a diagnosed inflammatory arthritis or other active/unstable non-musculoskeletal condition (e.g. pulmonary, cardiac, digestive or psychiatric condition) and
• consulting for a work-related MSKD eligible for workers' compensation benefits.

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Related Publications (1)

• Matifat E, Berger Pelletier E, Brison R, Hebert LJ, Roy JS, Woodhouse L, Berthelot S, Daoust R, Sirois MJ, Booth R, Gagnon R, Miller J, Tousignant-Laflamme Y, Emond M, Perreault K, Desmeules F. Advanced practice physiotherapy care in emergency departments for patients with musculoskeletal disorders: a pragmatic cluster randomized controlled trial and cost analysis. Trials. 2023 Feb 6;24(1):84. doi: 10.1186/s13063-023-07100-x.

  PMID: 36747305 DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases; Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François Desmeules

  Maisonneuve-Rosemont Research Center

  PRINCIPAL INVESTIGATOR

• Kadija Perreault

  Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale

  PRINCIPAL INVESTIGATOR

• Marcel Emond

  CHU de Québec - Université Laval (CHUQ-UL)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eveline Matifat

CONTACT

5142523400; eveline.matifat.cemtl@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Neither participants nor providers (PTs and physicians) will be blinded in this study in the context of this pragmatic RCT. An independent statistician not involved in any other parts of this trial and blinded to the participants' allocation, will conduct the statistical analyses.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor, Université de Montréal and Maisonneuve-Rosemont Hospital research center

Model Details: Step wedge RCT

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: September 19, 2022
• Study Start: October 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2026
• Last Updated: September 19, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After all analyses have been conducted and results published
• Access Criteria: The data that support the findings of this trial will be available upon reasonable request.