- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05714332
Impacts of an Advanced Practice Physiotherapy Model of Care for Adults With a Peripheral Musculoskeletal Disorders Referred to an Orthropaedic Outpatient Clinic
Impacts of an Advanced Practice Physiotherapy Model of Care for Adults With a Peripheral Musculoskeletal Disorders Referred to an Orthropaedic Outpatient Clinic: a Prospective Observational Study
The goal of this prospective observational study is to evaluate advanced practice physiotherapy and orthopedic surgeon care and clinical outcomes for new patients with a peripheral musculoskeletal disorders consulting at the orthopedic outpatient clinic of the Hôpital Jean-Talon.
The main questions it aims to answer are: 1. To describe the models of care at the Hôpital Jean-Talon orthopedic outpatient clinic; 2. To assess change in pain, disability, quality of life and pain catastrophizing at 6, 12 and 26 weeks after the initial evaluation; 3. To assess interprofessional collaboration between the advanced practice physiotherapists and orthopedic surgeons; 4. To assess patient satisfaction with care; 5. To assess waiting time before an initial consultation.
Researchers will compare patients cared in the advanced practice physiotherapy and orthopedic surgeon group and the orthopedic surgeon only group.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H1T 2M4
- Centre de recherche de l'Hôpital Maisonneuve-Rosemont
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults with peripheral musculoskeletal disorders
- New consultation at the Hôpital Jean-Talon orthopedic outpatient clinic
- Legally able to consent
- Understand and speak French or English
- Beneficiaries of the provincial universal health insurance coverage (RAMQ)
Exclusion Criteria:
- Patients directly referred from the emergency department (not considered as patients referred to the outpatient clinic).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Advanced practice physiotherapy and orthopedic surgeon group
Patients cared by both an advanced practice physiotherapist and an orthopedic surgeon.
|
Management of their musculoskeletal condition by an advanced practice physiotherapist and an orthopedic surgeon.
|
|
Orthopedic surgeon only group
Patients cared only by an orthopedic surgeon.
|
Management of their musculoskeletal condition by an orthopedic surgeon.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief pain inventory severity
Time Frame: 6 weeks (change from baseline)
|
Pain questionnaire (0-10; higher score=worse)
|
6 weeks (change from baseline)
|
|
Brief pain inventory severity
Time Frame: 12 weeks (change from baseline)
|
Pain questionnaire (0-10; higher score=worse)
|
12 weeks (change from baseline)
|
|
Brief pain inventory severity
Time Frame: 26 weeks (change from baseline)
|
Pain questionnaire (0-10; higher score=worse)
|
26 weeks (change from baseline)
|
|
Brief pain inventory inventory
Time Frame: 6 weeks (change from baseline)
|
Pain interference (disability) questionnaire (0-10; higher score=worse)
|
6 weeks (change from baseline)
|
|
Brief pain inventory inventory
Time Frame: 12 weeks (change from baseline)
|
Pain interference (disability) questionnaire (0-10; higher score=worse)
|
12 weeks (change from baseline)
|
|
Brief pain inventory inventory
Time Frame: 26 weeks (change from baseline)
|
Pain interference (disability) questionnaire (0-10; higher score=worse)
|
26 weeks (change from baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events
Time Frame: 12 weeks
|
Rate of adverse events
|
12 weeks
|
|
Treatment and compliance
Time Frame: 12 weeks
|
Treatment received and % of treatment compliance
|
12 weeks
|
|
Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)
Time Frame: 6 weeks (change from baseline)
|
Disability questionnaire for upper extremity disorders (0-100; higher=worse)
|
6 weeks (change from baseline)
|
|
Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)
Time Frame: 12 weeks (change from baseline)
|
Disability questionnaire for upper extremity disorders (0-100; higher=worse)
|
12 weeks (change from baseline)
|
|
Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)
Time Frame: 26 weeks (change from baseline)
|
Disability questionnaire for upper extremity disorders (0-100; higher=worse)
|
26 weeks (change from baseline)
|
|
Hip disability and Osteoarthritis Outcomes Score (HOOS)
Time Frame: 6 weeks (change from baseline)
|
Disability questionnaire for hip disorders (0-100; higher=better)
|
6 weeks (change from baseline)
|
|
Hip disability and Osteoarthritis Outcomes Score (HOOS)
Time Frame: 12 weeks (change from baseline)
|
Disability questionnaire for hip disorders (0-100; higher=better)
|
12 weeks (change from baseline)
|
|
Hip disability and Osteoarthritis Outcomes Score (HOOS)
Time Frame: 26 weeks (change from baseline)
|
Disability questionnaire for hip disorders (0-100; higher=better)
|
26 weeks (change from baseline)
|
|
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Time Frame: 6 weeks (change from baseline)
|
Disability questionnaire for knee disorders (0-100; higher=better)
|
6 weeks (change from baseline)
|
|
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Time Frame: 12 weeks (change from baseline)
|
Disability questionnaire for knee disorders (0-100; higher=better)
|
12 weeks (change from baseline)
|
|
Knee injury and Osteoarthritis Outcomes Score (KOOS)
Time Frame: 26 weeks (change from baseline)
|
Disability questionnaire for knee disorders (0-100; higher=better)
|
26 weeks (change from baseline)
|
|
Foot and Ankle Ability Measure (FAAM)
Time Frame: 6 weeks (change from baseline)
|
Disability questionnaire for ankle/foot disorders (0-100; higher=better)
|
6 weeks (change from baseline)
|
|
Foot and Ankle Ability Measure (FAAM)
Time Frame: 12 weeks (change from baseline)
|
Disability questionnaire for ankle/foot disorders (0-100; higher=better)
|
12 weeks (change from baseline)
|
|
Foot and Ankle Ability Measure (FAAM)
Time Frame: 26 weeks (change from baseline)
|
Disability questionnaire for ankle/foot disorders (0-100; higher=better)
|
26 weeks (change from baseline)
|
|
EQ-5D-5L
Time Frame: 6 weeks (change from baseline)
|
Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better)
|
6 weeks (change from baseline)
|
|
EQ-5D-5L
Time Frame: 12 weeks (change from baseline)
|
Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better)
|
12 weeks (change from baseline)
|
|
EQ-5D-5L
Time Frame: 26 weeks (change from baseline)
|
Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better)
|
26 weeks (change from baseline)
|
|
EQ-5D-VAS
Time Frame: 6 weeks (change from baseline)
|
Health-related quality of life questionnaire (0-100; higher=better)
|
6 weeks (change from baseline)
|
|
EQ-5D-VAS
Time Frame: 12 weeks (change from baseline)
|
Health-related quality of life questionnaire (0-100; higher=better)
|
12 weeks (change from baseline)
|
|
EQ-5D-VAS
Time Frame: 26 weeks (change from baseline)
|
Health-related quality of life questionnaire (0-100; higher=better)
|
26 weeks (change from baseline)
|
|
Pain Catastrophizing Scale (PCS)
Time Frame: 6 weeks (change from baseline)
|
Health-related quality of life questionnaire (0-50; higher=worse)
|
6 weeks (change from baseline)
|
|
Pain Catastrophizing Scale (PCS)
Time Frame: 12 weeks (change from baseline)
|
Health-related quality of life questionnaire (0-50; higher=worse)
|
12 weeks (change from baseline)
|
|
Pain Catastrophizing Scale (PCS)
Time Frame: 26 weeks (change from baseline)
|
Health-related quality of life questionnaire (0-50; higher=worse)
|
26 weeks (change from baseline)
|
|
Patient perceptions of team effectiveness (Patient-PTE)
Time Frame: 0 week (post initial consultation)
|
Perceptions of team effectiveness questionnaire (24-144; higher=better)
|
0 week (post initial consultation)
|
|
modified validated version of the 9-item visit-specific satisfaction questionnaire (VSQ-9)
Time Frame: 0 week (post initial consultation)
|
Patient satisfaction questionnaire (0-100; higher=better)
|
0 week (post initial consultation)
|
|
Modified MedRisk
Time Frame: 12 weeks
|
Patient satisfaction questionnaire (0-100; higher=better)
|
12 weeks
|
|
Modified MedRisk
Time Frame: 26 weeks
|
Patient satisfaction questionnaire (0-100; higher=better)
|
26 weeks
|
|
Provider perceptions of team effectiveness (Prodiver-PTE)
Time Frame: Through study completion (once)
|
Perceptions of team effectiveness questionnaire (26-156; higher=better)
|
Through study completion (once)
|
|
Waiting time
Time Frame: Pre-intervention
|
Waiting time (time in days and minutes)
|
Pre-intervention
|
|
Adverse events
Time Frame: 26 weeks
|
Rate of adverse events
|
26 weeks
|
|
Treatment and compliance
Time Frame: 6 weeks
|
Treatment received and % of treatment compliance
|
6 weeks
|
|
Treatment and compliance
Time Frame: 26 weeks
|
Treatment received and % of treatment compliance
|
26 weeks
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- v3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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