Clinical trial NCT05545917: Advanced Practice Physiotherapy Care in Emergency Departments
Official title: Advanced Practice Physiotherapy Care in Emergency Departments for Patients With Musculoskeletal Disorders: A Pragmatic Cluster Randomized Controlled Trial and Cost Analysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Musculoskeletal Diseases or Conditions
Emergency Department
Physiotherapy
Keywords: Emergency department
Physiotherapist
Primary care
Musculoskeletal Disorders
Advanced practice physiotherapy
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-09-19
Enrollment: 744
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Step wedge RCT
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Background: Overcrowding in emergency departments (ED) is a major concern and reports show that Canada has among the longest ED wait and length of stay times. 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. Physiotherapists (PT) have been identified as expert clinicians to care for patients with MSKD and new collaborative models of care involving PTs have been emerging in ED. Traditionally, PTs provide care in EDs only after physicians have assessed patients and made a referral for physiotherapy. More autonomous PT involvement in ED models of care allows for efficient collaborative practice with physicians and other professionals and can benefit ED performance, patient outcomes, as well as healthcare resource utilization. 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 effectiveness of such models is limited. Only a few RCTs have been conducted and no studies have assessed the efficacy or cost-utility of APP models of care in Canadian EDs. Evaluation of the benefits of such models is highly context-dependent and systematic evaluation of these models is warranted to further support implementation in Canada. Objectives: 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 patient-related outcomes, health care resources utilization and costs.

Methods: This trial is a multicenter stepped-wedge cluster RCT with a cost analysis. Six EDs (clusters) will be randomized to a treatment sequence where patients will either be managed by an ED PT or receive usual ED physician care without the intervention of a PT. Seven hundred and forty four patients with a MSKD will be recruited. Main outcome measures will be the Brief Pain Inventory as well as the EQ-5D-5L for economic outcomes. Secondary measures will include validated self-reported disability questionnaires and other healthcare utilization outcomes such as prescription of imaging tests and medication. Adverse events and re-visits to ED will also be monitored. Outcomes will be collected at inclusion, at ED discharge and at 4, 12 and 26 weeks following the ED visit. Health care costs will be measured from the perspective of the public system using Time-Driven Activity Based Costing. Per-protocol and intention-to-treat analyses will be performed using linear mixed-models with a random effect for cluster and fixed effect for time. The diverse and complementary research team assembled has the required methodological expertise to successfully complete this trial and several knowledge users have been involved which assures the feasibility and maximizes the impacts of this project.

Discussion: MSKD not only represent a significant economic burden in Canada, but also have a significant impact on our health care system and the quality of life of Canadians. By providing an innovative pathway of access to care, APP care could help relieve pressure on Canadian ED and help provide efficient care for Canadians with MSKD.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Brief Pain Inventory-Short form, Pain interference scale (BPI)
timeFrame: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
measure: Costs analyses
timeFrame: At inclusion
measure: Costs analyses
timeFrame: At 4 weeks after inclusion
measure: Costs analyses
timeFrame: At 12 weeks after inclusion
measure: Costs analyses
timeFrame: At 26 weeks after inclusion
Secondary outcomes:
measure: Pain intensity
timeFrame: Following initial assessment by provider in the emergency department
measure: Disability questionnaires - Neck Disability Index (NDI)
timeFrame: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
measure: Disability questionnaires - Oswestry Disability Index (ODI) for back related disorders
timeFrame: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
measure: Disability questionnaires - short version of the Disability of the Arm, Shoulder and Hand (Quick DASH)
timeFrame: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
measure: Disability questionnaires - Lower Extremity Functional Scale (LEFS)
timeFrame: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
measure: Patient satisfaction assessed by the visit-specific satisfaction questionnaire (VSQ-9)
timeFrame: Following initial assessment by provider in the emergency department
measure: Wait to initial assessment
timeFrame: At inclusion
measure: Emergency department length of stay
timeFrame: At inclusion
measure: Health care resource utilization outcomes
timeFrame: At 4-, 12- and 26- weeks after inclusion
measure: Health care resource utilization outcomes
timeFrame: Immediately after initial assessment by provider in the emergency department
Other outcomes:
Locations:
Study officials:
affiliation: Maisonneuve-Rosemont Research Center
name: François Desmeules
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale
name: Kadija Perreault
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Québec - Université Laval (CHUQ-UL)
name: Marcel Emond
role: PRINCIPAL_INVESTIGATOR
References: