Musculoskeletal Diseases or ConditionsNCT05545917
Advanced Practice Physiotherapy Care in Emergency Departments
A study testing Experimental: APP care in people with Musculoskeletal Diseases or Conditions and Emergency Department, run by Maisonneuve-Rosemont Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Diseases or Conditions, Emergency Department, Physiotherapy
- What is being tested?
- Experimental: APP care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 744 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Mar 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Advanced Practice Physiotherapy Care in Emergency Departments for Patients With Musculoskeletal Disorders: A Pragmatic Cluster Randomized Controlled Trial and Cost Analysis
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.
Read the 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.
- Being tested
- Experimental: APP care, Control - Usual physician care
- Keywords
- Emergency department, Physiotherapist, Primary care, Musculoskeletal Disorders, Advanced practice physiotherapy
- Medical subject headings
- Musculoskeletal Diseases, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: APP careOther
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.
Control - Usual physician careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| APP care | Experimental | The experimental arm will receive advanced practice physiotherapy care. Receives: Other: Experimental: APP care |
| Usual physician care | Active comparator | The control arm will receive usual ED physician care delivered only by an ED physician. Receives: Other: Control - Usual physician care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 26 weeks after inclusion
Secondary outcomes (10)
Pain intensity
0-10 numerical pain scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
Measured: Following initial assessment by provider in the emergency department
Disability questionnaires - Neck Disability Index (NDI)
For participants presenting with neck disorders, the Neck Disability Index (NDI) questionnaire will be completed. The score ranges from 0 to 50, with higher scores associated with higher disability levels.
Measured: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
Disability questionnaires - Oswestry Disability Index (ODI) for back related disorders
For participants presenting with back related disorders, the Oswestry Disability Index (ODI) will be completed. The total score ranges from 0% to 100%, with higher scores relating to higher disability levels.
Measured: 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)
For participants presenting with upper limb disorders, the short version of the Disability of the Arm, Shoulder and Hand (Quick DASH) will be completed. The score ranges from 0 to 100, where a higher score indicates a greater level of disability.
Measured: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
Disability questionnaires - Lower Extremity Functional Scale (LEFS)
For participants presenting with lower limb disorders, the Lower Extremity Functional Scale (LEFS) questionnaire will be completed. The score ranges from 0 to 80, with lower scores indicating lower function levels.
Measured: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
Patient satisfaction assessed by the visit-specific satisfaction questionnaire (VSQ-9)
To assess satisfaction with care, patients will be asked to complete a modified validated version of the 9-item visit-specific satisfaction questionnaire (VSQ-9). Scores can range for 7 to 35 and lower scores are associated with higher satisfaction rates.
Measured: Following initial assessment by provider in the emergency department
Wait to initial assessment
Chronometer / clock
Measured: At inclusion
Emergency department length of stay
Chronometer / clock
Measured: At inclusion
Health care resource utilization outcomes
Treatment diary:
Participants will be asked to complete a treatment diary regarding compliance with ED treatments and any health services or interventions they sought for their initial problem during the follow-up period
Measured: At 4-, 12- and 26- weeks after inclusion
Health care resource utilization outcomes
Standardized evaluation form:
Providers will complete a standardized form following their assessment and interventions, indicating diagnoses, requests for additional medical imaging or laboratory tests (if relevant), treatment plan (e.g. conservative treatment options, medication or physiotherapy care), discharge plan and referral to other professional or medical specialists, if relevant.
Measured: Immediately after initial assessment by provider in the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionMar 2026 (estimated)
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 Musculoskeletal Diseases or ConditionsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Step wedge RCT
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 744 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Francois Desmeules, Maisonneuve-Rosemont Hospital
- Investigators
- François Desmeules, Principal investigator, Maisonneuve-Rosemont Research CenterKadija Perreault, Principal investigator, Centre Interdisciplinaire de Recherche en Réadaptation et Intégration SocialeMarcel Emond, Principal investigator, CHU de Québec - Université Laval (CHUQ-UL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545917
- Sponsor's protocol ID
- RCT ED Canada
- Status last verified
- Sep 2022
- First submitted
- 4 Aug 2022
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this trial will be available upon reasonable request.
Publications
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.
PubMed 36747305
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Practice Physiotherapy Care in Emergency Departments for Patients With Musculoskeletal Disorders: A Pragmatic Cluster Randomized Controlled Trial and Cost Analysis
- ClinicalTrials.gov ID
- NCT05545917
- Acronym / sponsor ID
- RCT ED Canada
- Keywords
- Emergency department, Physiotherapist, Primary care, Musculoskeletal Disorders, Advanced practice physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 744 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 19 Sep 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Step wedge RCT
| Arm | Type | Receives |
|---|---|---|
| APP care | Experimental | Other: Experimental: APP careThe experimental arm will receive advanced practice physiotherapy care. |
| Usual physician care | Active comparator | Other: Control - Usual physician careThe control arm will receive usual ED physician care delivered only by an ED physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Experimental: APP careThe 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. | Other | APP care |
| Control - Usual physician careThe 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. | Other | Usual physician care |
Primary outcome
Brief Pain Inventory-Short form, Pain interference scale (BPI)
Time frame: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
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.
Costs analyses
Time frame: At inclusion
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.
Costs analyses
Time frame: At 4 weeks after inclusion
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.
Costs analyses
Time frame: At 12 weeks after inclusion
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.
Costs analyses
Time frame: At 26 weeks after inclusion
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.
10 secondary outcomes
Pain intensity
Time frame: Following initial assessment by provider in the emergency department
Disability questionnaires - Neck Disability Index (NDI)
Time frame: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
Disability questionnaires - Oswestry Disability Index (ODI) for back related disorders
Time frame: 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)
Time frame: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
Disability questionnaires - Lower Extremity Functional Scale (LEFS)
Time frame: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion
Patient satisfaction assessed by the visit-specific satisfaction questionnaire (VSQ-9)
Time frame: Following initial assessment by provider in the emergency department
Wait to initial assessment
Time frame: At inclusion
Emergency department length of stay
Time frame: At inclusion
Health care resource utilization outcomes
Time frame: At 4-, 12- and 26- weeks after inclusion
Health care resource utilization outcomes
Time frame: Immediately after initial assessment by provider in the emergency department
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Derived from this study: PubMed 36747305Matifat 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.
- Individual participant dataSharing planned: Yes. The data that support the findings of this trial will be available upon reasonable request.
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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 Desmeules principal investigator
Maisonneuve-Rosemont Research Center
Kadija Perreault principal investigator
Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale
Marcel Emond principal investigator
CHU de Québec - Université Laval (CHUQ-UL)
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: APP care in people with Musculoskeletal Diseases or Conditions and Emergency Department, run by Maisonneuve-Rosemont Hospital.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eveline Matifat (5142523400 ext. 5607, eveline.matifat.cemtl@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Pain Inventory-Short form, Pain interference scale (BPI) (time frame: At inclusion and respectively at 4-, 12- and 26- weeks after inclusion). The study lists 5 primary outcomes in all. 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 NCT05545917, 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 19 Sep 2022.