Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 7:39 PM
Study NCT ID:
NCT05714332
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2022-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impacts of an Advanced Practice Physiotherapy Model of Care for Adults With a Peripheral Musculoskeletal Disorders Referred to an Orthropaedic Outpatient Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2023-01-26', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brief pain inventory severity', 'timeFrame': '6 weeks (change from baseline)', 'description': 'Pain questionnaire (0-10; higher score=worse)'}, {'measure': 'Brief pain inventory severity', 'timeFrame': '12 weeks (change from baseline)', 'description': 'Pain questionnaire (0-10; higher score=worse)'}, {'measure': 'Brief pain inventory severity', 'timeFrame': '26 weeks (change from baseline)', 'description': 'Pain questionnaire (0-10; higher score=worse)'}, {'measure': 'Brief pain inventory inventory', 'timeFrame': '6 weeks (change from baseline)', 'description': 'Pain interference (disability) questionnaire (0-10; higher score=worse)'}, {'measure': 'Brief pain inventory inventory', 'timeFrame': '12 weeks (change from baseline)', 'description': 'Pain interference (disability) questionnaire (0-10; higher score=worse)'}, {'measure': 'Brief pain inventory inventory', 'timeFrame': '26 weeks (change from baseline)', 'description': 'Pain interference (disability) questionnaire (0-10; higher score=worse)'}], 'secondaryOutcomes': [{'measure': 'Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)', 'timeFrame': '6 weeks (change from baseline)', 'description': 'Disability questionnaire for upper extremity disorders (0-100; higher=worse)'}, {'measure': 'Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)', 'timeFrame': '12 weeks (change from baseline)', 'description': 'Disability questionnaire for upper extremity disorders (0-100; higher=worse)'}, {'measure': 'Shortened Disability of the Arm, Shoulder and Hand (QuickDASH)', 'timeFrame': '26 weeks (change from baseline)', 'description': 'Disability questionnaire for upper extremity disorders (0-100; higher=worse)'}, {'measure': 'Hip disability and Osteoarthritis Outcomes Score (HOOS)', 'timeFrame': '6 weeks (change from baseline)', 'description': 'Disability questionnaire for hip disorders (0-100; higher=better)'}, {'measure': 'Hip disability and Osteoarthritis Outcomes Score (HOOS)', 'timeFrame': '12 weeks (change from baseline)', 'description': 'Disability questionnaire for hip disorders (0-100; higher=better)'}, {'measure': 'Hip disability and Osteoarthritis Outcomes Score (HOOS)', 'timeFrame': '26 weeks (change from baseline)', 'description': 'Disability questionnaire for hip disorders (0-100; higher=better)'}, {'measure': 'Knee injury and Osteoarthritis Outcomes Score (KOOS)', 'timeFrame': '6 weeks (change from baseline)', 'description': 'Disability questionnaire for knee disorders (0-100; higher=better)'}, {'measure': 'Knee injury and Osteoarthritis Outcomes Score (KOOS)', 'timeFrame': '12 weeks (change from baseline)', 'description': 'Disability questionnaire for knee disorders (0-100; higher=better)'}, {'measure': 'Knee injury and Osteoarthritis Outcomes Score (KOOS)', 'timeFrame': '26 weeks (change from baseline)', 'description': 'Disability questionnaire for knee disorders (0-100; higher=better)'}, {'measure': 'Foot and Ankle Ability Measure (FAAM)', 'timeFrame': '6 weeks (change from baseline)', 'description': 'Disability questionnaire for ankle/foot disorders (0-100; higher=better)'}, {'measure': 'Foot and Ankle Ability Measure (FAAM)', 'timeFrame': '12 weeks (change from baseline)', 'description': 'Disability questionnaire for ankle/foot disorders (0-100; higher=better)'}, {'measure': 'Foot and Ankle Ability Measure (FAAM)', 'timeFrame': '26 weeks (change from baseline)', 'description': 'Disability questionnaire for ankle/foot disorders (0-100; higher=better)'}, {'measure': 'EQ-5D-5L', 'timeFrame': '6 weeks (change from baseline)', 'description': 'Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better)'}, {'measure': 'EQ-5D-5L', 'timeFrame': '12 weeks (change from baseline)', 'description': 'Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better)'}, {'measure': 'EQ-5D-5L', 'timeFrame': '26 weeks (change from baseline)', 'description': 'Health-related quality of life questionnaire (to be converted in QALYs 0-1; higher=better)'}, {'measure': 'EQ-5D-VAS', 'timeFrame': '6 weeks (change from baseline)', 'description': 'Health-related quality of life questionnaire (0-100; higher=better)'}, {'measure': 'EQ-5D-VAS', 'timeFrame': '12 weeks (change from baseline)', 'description': 'Health-related quality of life questionnaire (0-100; higher=better)'}, {'measure': 'EQ-5D-VAS', 'timeFrame': '26 weeks (change from baseline)', 'description': 'Health-related quality of life questionnaire (0-100; higher=better)'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': '6 weeks (change from baseline)', 'description': 'Health-related quality of life questionnaire (0-50; higher=worse)'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': '12 weeks (change from baseline)', 'description': 'Health-related quality of life questionnaire (0-50; higher=worse)'}, {'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': '26 weeks (change from baseline)', 'description': 'Health-related quality of life questionnaire (0-50; higher=worse)'}, {'measure': 'Patient perceptions of team effectiveness (Patient-PTE)', 'timeFrame': '0 week (post initial consultation)', 'description': 'Perceptions of team effectiveness questionnaire (24-144; higher=better)'}, {'measure': 'modified validated version of the 9-item visit-specific satisfaction questionnaire (VSQ-9)', 'timeFrame': '0 week (post initial consultation)', 'description': 'Patient satisfaction questionnaire (0-100; higher=better)'}, {'measure': 'Modified MedRisk', 'timeFrame': '12 weeks', 'description': 'Patient satisfaction questionnaire (0-100; higher=better)'}, {'measure': 'Modified MedRisk', 'timeFrame': '26 weeks', 'description': 'Patient satisfaction questionnaire (0-100; higher=better)'}, {'measure': 'Provider perceptions of team effectiveness (Prodiver-PTE)', 'timeFrame': 'Through study completion (once)', 'description': 'Perceptions of team effectiveness questionnaire (26-156; higher=better)'}, {'measure': 'Waiting time', 'timeFrame': 'Pre-intervention', 'description': 'Waiting time (time in days and minutes)'}, {'measure': 'Adverse events', 'timeFrame': '12 weeks', 'description': 'Rate of adverse events'}, {'measure': 'Adverse events', 'timeFrame': '26 weeks', 'description': 'Rate of adverse events'}, {'measure': 'Treatment and compliance', 'timeFrame': '6 weeks', 'description': 'Treatment received and % of treatment compliance'}, {'measure': 'Treatment and compliance', 'timeFrame': '12 weeks', 'description': 'Treatment received and % of treatment compliance'}, {'measure': 'Treatment and compliance', 'timeFrame': '26 weeks', 'description': 'Treatment received and % of treatment compliance'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced practice', 'Physiotherapy', 'Musculoskeletal disorders', 'Orthopedic', 'Observation'], 'conditions': ['Musculoskeletal Disorders']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nResearchers will compare patients cared in the advanced practice physiotherapy and orthopedic surgeon group and the orthopedic surgeon only group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with a peripheral musculoskeletal disorders', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with peripheral musculoskeletal disorders\n* New consultation at the Hôpital Jean-Talon orthopedic outpatient clinic\n* Legally able to consent\n* Understand and speak French or English\n* Beneficiaries of the provincial universal health insurance coverage (RAMQ)\n\nExclusion Criteria:\n\n* Patients directly referred from the emergency department (not considered as patients referred to the outpatient clinic).'}, 'identificationModule': {'nctId': 'NCT05714332', 'briefTitle': 'Impacts of an Advanced Practice Physiotherapy Model of Care for Adults With a Peripheral Musculoskeletal Disorders Referred to an Orthropaedic Outpatient Clinic', 'organization': {'class': 'OTHER', 'fullName': "Ciusss de L'Est de l'Île de Montréal"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'v3'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced practice physiotherapy and orthopedic surgeon group', 'description': 'Patients cared by both an advanced practice physiotherapist and an orthopedic surgeon.', 'interventionNames': ['Other: Advanced practice physiotherapy and orthopedic surgeon management']}, {'label': 'Orthopedic surgeon only group', 'description': 'Patients cared only by an orthopedic surgeon.', 'interventionNames': ['Other: Orthopedic surgeon management']}], 'interventions': [{'name': 'Advanced practice physiotherapy and orthopedic surgeon management', 'type': 'OTHER', 'description': 'Management of their musculoskeletal condition by an advanced practice physiotherapist and an orthopedic surgeon.', 'armGroupLabels': ['Advanced practice physiotherapy and orthopedic surgeon group']}, {'name': 'Orthopedic surgeon management', 'type': 'OTHER', 'description': 'Management of their musculoskeletal condition by an orthopedic surgeon.', 'armGroupLabels': ['Orthopedic surgeon only group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre de recherche de l'Hôpital Maisonneuve-Rosemont", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be available upon resonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ciusss de L'Est de l'Île de Montréal", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}