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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05714332
Other study ID # v3
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 14, 2022
Est. completion date February 2024

Study information

Verified date August 2023
Source Ciusss de L'Est de l'Île de Montréal
Contact Simon Lafrance, MSc PT
Phone 1+ 438-863-3995
Email simon.lafrance.1@umontreal.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 152
Est. completion date February 2024
Est. primary completion date January 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Advanced practice physiotherapy and orthopedic surgeon management
Management of their musculoskeletal condition by an advanced practice physiotherapist and an orthopedic surgeon.
Orthopedic surgeon management
Management of their musculoskeletal condition by an orthopedic surgeon.

Locations

Country Name City State
Canada Centre de recherche de l'Hôpital Maisonneuve-Rosemont Montréal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Ciusss de L'Est de l'Île de Montréal CIUSSS du Nord-de-l'Île-de-Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief pain inventory severity Pain questionnaire (0-10; higher score=worse) 6 weeks (change from baseline)
Primary Brief pain inventory severity Pain questionnaire (0-10; higher score=worse) 12 weeks (change from baseline)
Primary Brief pain inventory severity Pain questionnaire (0-10; higher score=worse) 26 weeks (change from baseline)
Primary Brief pain inventory inventory Pain interference (disability) questionnaire (0-10; higher score=worse) 6 weeks (change from baseline)
Primary Brief pain inventory inventory Pain interference (disability) questionnaire (0-10; higher score=worse) 12 weeks (change from baseline)
Primary Brief pain inventory inventory Pain interference (disability) questionnaire (0-10; higher score=worse) 26 weeks (change from baseline)
Secondary Shortened Disability of the Arm, Shoulder and Hand (QuickDASH) Disability questionnaire for upper extremity disorders (0-100; higher=worse) 6 weeks (change from baseline)
Secondary Shortened Disability of the Arm, Shoulder and Hand (QuickDASH) Disability questionnaire for upper extremity disorders (0-100; higher=worse) 12 weeks (change from baseline)
Secondary Shortened Disability of the Arm, Shoulder and Hand (QuickDASH) Disability questionnaire for upper extremity disorders (0-100; higher=worse) 26 weeks (change from baseline)
Secondary Hip disability and Osteoarthritis Outcomes Score (HOOS) Disability questionnaire for hip disorders (0-100; higher=better) 6 weeks (change from baseline)
Secondary Hip disability and Osteoarthritis Outcomes Score (HOOS) Disability questionnaire for hip disorders (0-100; higher=better) 12 weeks (change from baseline)
Secondary Hip disability and Osteoarthritis Outcomes Score (HOOS) Disability questionnaire for hip disorders (0-100; higher=better) 26 weeks (change from baseline)
Secondary Knee injury and Osteoarthritis Outcomes Score (KOOS) Disability questionnaire for knee disorders (0-100; higher=better) 6 weeks (change from baseline)
Secondary Knee injury and Osteoarthritis Outcomes Score (KOOS) Disability questionnaire for knee disorders (0-100; higher=better) 12 weeks (change from baseline)
Secondary Knee injury and Osteoarthritis Outcomes Score (KOOS) Disability questionnaire for knee disorders (0-100; higher=better) 26 weeks (change from baseline)
Secondary Foot and Ankle Ability Measure (FAAM) Disability questionnaire for ankle/foot disorders (0-100; higher=better) 6 weeks (change from baseline)
Secondary Foot and Ankle Ability Measure (FAAM) Disability questionnaire for ankle/foot disorders (0-100; higher=better) 12 weeks (change from baseline)
Secondary Foot and Ankle Ability Measure (FAAM) Disability questionnaire for ankle/foot disorders (0-100; higher=better) 26 weeks (change from baseline)
Secondary EQ-5D-5L Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better) 6 weeks (change from baseline)
Secondary EQ-5D-5L Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better) 12 weeks (change from baseline)
Secondary EQ-5D-5L Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better) 26 weeks (change from baseline)
Secondary EQ-5D-VAS Health-related quality of life questionnaire (0-100; higher=better) 6 weeks (change from baseline)
Secondary EQ-5D-VAS Health-related quality of life questionnaire (0-100; higher=better) 12 weeks (change from baseline)
Secondary EQ-5D-VAS Health-related quality of life questionnaire (0-100; higher=better) 26 weeks (change from baseline)
Secondary Pain Catastrophizing Scale (PCS) Health-related quality of life questionnaire (0-50; higher=worse) 6 weeks (change from baseline)
Secondary Pain Catastrophizing Scale (PCS) Health-related quality of life questionnaire (0-50; higher=worse) 12 weeks (change from baseline)
Secondary Pain Catastrophizing Scale (PCS) Health-related quality of life questionnaire (0-50; higher=worse) 26 weeks (change from baseline)
Secondary Patient perceptions of team effectiveness (Patient-PTE) Perceptions of team effectiveness questionnaire (24-144; higher=better) 0 week (post initial consultation)
Secondary modified validated version of the 9-item visit-specific satisfaction questionnaire (VSQ-9) Patient satisfaction questionnaire (0-100; higher=better) 0 week (post initial consultation)
Secondary Modified MedRisk Patient satisfaction questionnaire (0-100; higher=better) 12 weeks
Secondary Modified MedRisk Patient satisfaction questionnaire (0-100; higher=better) 26 weeks
Secondary Provider perceptions of team effectiveness (Prodiver-PTE) Perceptions of team effectiveness questionnaire (26-156; higher=better) Through study completion (once)
Secondary Waiting time Waiting time (time in days and minutes) Pre-intervention
Secondary Adverse events Rate of adverse events 12 weeks
Secondary Adverse events Rate of adverse events 26 weeks
Secondary Treatment and compliance Treatment received and % of treatment compliance 6 weeks
Secondary Treatment and compliance Treatment received and % of treatment compliance 12 weeks
Secondary Treatment and compliance Treatment received and % of treatment compliance 26 weeks
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