protocolSection identificationModule nctId: NCT06358521, orgStudyIdInfo id: 6040471, briefTitle: Determining the Impact of a Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-02, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2025-11-01, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Queen's University, class: OTHER, collaborators name: Canadian Institutes of Health Research (CIHR), collaborators name: The Arthritis Society, Canada, descriptionModule briefSummary: This is a cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for hip and knee pain in Canada., conditionsModule conditions: Hip Osteoarthritis, conditions: Knee Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a cluster randomized controlled trial randomizing 14 sites to the PT-led primary care model for hip/knee pain or to the usual physician/nurse practitioner-led care model, primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: Due to the nature of the new model of care and comparison, it is not possible to blind the patient participants or health care providers. Since the primary outcomes are self-reported outcome measures, the assessor is also not blind to the intervention., enrollmentInfo count: 728, type: ESTIMATED, armsInterventionsModule interventions name: Physiotherapist-led primary care model for hip and knee pain, interventions name: Usual physician-led primary care model for hip and knee pain, outcomesModule primaryOutcomes measure: Self-Reported Functioning, secondaryOutcomes measure: Self-Reported Pain Intensity, secondaryOutcomes measure: Health-Related Quality of Life, secondaryOutcomes measure: Pain Self Efficacy, secondaryOutcomes measure: Catastrophic Thinking, secondaryOutcomes measure: Fear of Movement, secondaryOutcomes measure: Depression Subscale, secondaryOutcomes measure: Global Rating of Change, secondaryOutcomes measure: Satisfaction with Health Care, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Health-Care Utilization - Consultations in Electronic Medical Record (EMR), secondaryOutcomes measure: Health-Care Utilization Survey - Visits to health professionals, secondaryOutcomes measure: Health-Care Utilization Survey - Medications, secondaryOutcomes measure: Health-Care Utilization Survey - Walk-In Clinic Visits, secondaryOutcomes measure: Health-Care Utilization Survey - Emergency Department Visits, secondaryOutcomes measure: Health-Care Utilization Survey - Inpatient Hospital Stays, secondaryOutcomes measure: Health-Care Utilization Survey - Surgeries, Procedures, Injections, secondaryOutcomes measure: Health-Care Utilization Survey - Specialist Visits, secondaryOutcomes measure: Health-Care Utilization Survey - Diagnostic Imaging, secondaryOutcomes measure: Process Outcome - Medications prescribed, secondaryOutcomes measure: Process Outcome - Diagnostic Imaging Ordered, secondaryOutcomes measure: Process Outcome - Exercises Prescribed, secondaryOutcomes measure: Process Outcome - Education Provided, secondaryOutcomes measure: Process Outcome - Referrals to other health care providers (HCPs), secondaryOutcomes measure: Process Outcome - Primary Care Visits, secondaryOutcomes measure: Process Outcome - Notes to Employers or Insurers, secondaryOutcomes measure: Self-Report Time Lost, secondaryOutcomes measure: Assistance Needed, secondaryOutcomes measure: Extra Expenses, secondaryOutcomes measure: Cost outcomes, secondaryOutcomes measure: Health Care Accessibility, otherOutcomes measure: Baseline Characteristics, otherOutcomes measure: Comorbidities, otherOutcomes measure: Chronicity of Pain, otherOutcomes measure: Participant Treatment Fidelity, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Queen's University, status: RECRUITING, city: Kingston, state: Ontario, zip: K7L3N6, country: Canada, contacts name: Jordan Miller, role: CONTACT, geoPoint lat: 44.22976, lon: -76.48101, hasResults: False