An interventional study of Physiotherapist-led primary care model for hip and knee pain and Usual physician-led primary care model for hip and knee pain in Hip Osteoarthritis and Knee Osteoarthritis, sponsored by Jordan Miller, PT, PhD. Completed at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Jordan Miller, PT, PhD · Not applicable, Interventional, and Treatment
This is a pilot 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.
Arthritis is one of the leading causes of pain, disability, and reduced quality of life in patients. Arthritis currently affects one in five Canadians (six million), which is expected to rise to nine million people by 2040. Osteoarthritis (OA) is the most common forms of arthritis, with hip and knee being two of the most common locations.
For most people, the first point of contact for their pain is their primary care provider. Due to the rise in patients seeking support at the primary care level, the shortage of primary care providers, and the high burden on these providers, patients often do not receive timely access to the care they require. A promising strategy is to have an integrated model of care where a physiotherapist (PT) is the first point of contact within interprofessional primary care teams. PTs can provide a comprehensive and efficient management strategy for patients presenting to their primary care provider with hip and knee pain complaints.
This study aims to determine the feasibility of conducting a cluster randomized trial in primary care settings in Ontario to evaluate the individual health outcomes and health system impact of implementing a new physiotherapist-led primary care model for people with hip and knee pain.
The primary objectives of this pilot study are:
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 205 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Jordan Miller, PT, PhD is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The index intervention will incorporate a PT within the primary care team and make them available at the first point of contact for people with hip or knee pain. There will be 4 key components of this intervention: 1) Initial assessment and screening; 2) Brief individualized intervention at first visit; 3) Health services navigation; 4) Providing additional PT care for people with an unmet need (e.g., no insurance coverage for PT).
Other: Physiotherapist-led primary care model for hip and knee pain
Participants will be seen by a primary care physician or a nurse practitioner, depending on the current practice at the clinic. Participants in both groups will be permitted to seek additional care outside of the primary care clinic.
Other: Usual physician-led primary care model for hip and knee pain
1. Initial assessment and screening: The PT will provide a comprehensive assessment according to established clinical practice guidelines. 2. Brief individualized intervention at first visit: The PT intervention will be at the discretion of the PT to reflect real-world PT intervention. 3. Health services navigation: Participants will be provided with options available to them in their community for rehabilitation. For example, they may be referred to community PT for ongoing management or presented with group exercise options. Participants will be assessed regarding the need for specialist referrals or resources available to manage complex clinical presentations such as comorbidity or frailty. Participants may be referred to the primary care provider if no specialized services are needed or when the PT cannot provide a direct referral. All individuals may have their medications reviewed by a physician if deemed appropriate by the PT or requested by the participant.
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
Participant Recruitment Rate
A full trial will be feasible if the investigators are able to recruit 1.5 participants per week per site over 20 weeks
Time frame: 20 weeks
Assessment Procedures
The investigators consider ≥80% of all assessment items completed and a mean time for completion of ≤60 minutes acceptable.
Time frame: 12 months
Retention
The investigators consider an attrition rate of ≤20% at 12-month follow-up successful. ≤35% attrition will be considered partially successful; however, additional retention strategies would be required for the full trial based on evidence that ≥20% attrition threatens trial validity
Time frame: 12 months
PT Treatment Fidelity
Treatment fidelity will be measured through an audit of a PT fidelity checklist and electronic medical record (EMR) to determine the consistency of the care provided. An acceptable level of fidelity will be considered ≥80% for each intervention component.
Time frame: 20 weeks
Self-Reported Functioning
Self-report using the Lower Extremity Functional Scale (0-80 score with higher score representing higher function)
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Self-Reported Pain Intensity
Measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity.
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Health-Related Quality of Life
Measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Pain Self Efficacy
Confidence in abilities to participate in usual activities using the Pain Self Efficacy Questionnaire
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Catastrophic Thinking
Measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Fear of Movement
Measured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire)
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Depression Subscale
Measured using the 2-Item Patient Health Questionnaire
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Global Rating of Change
Measured using an 11-point scale (-5 to +5 with negative scores indicating a worsening of physical functioning and positive scores indicating an improvement of physical functioning)
Time frame: 3, 6, 9, and 12 months follow-up
Satisfaction with Health Care
Measured using an 11-point scale(-5 to +5 with negative scores indicating a dissatisfaction with health care received and positive scores indicating satisfaction with health care received)
Time frame: 3, 6, 9, and 12 months follow-up
Adverse Events
Measured using an adverse events questionnaire that asks 1) if the participant has experienced any adverse events as a result of the treatments received (yes/no); 2) how long the event lasted (hours or days); 3) how severe the adverse event was (0-10 scale); 4) what adverse events were experienced.
Time frame: 3, 6, 9, and 12 months follow-up
Health Care Accessibility
Percentage of participants assessed within 48 hours of calling for an appointment
Time frame: Baseline
Health-Care Utilization - Consultations in Electronic Medical Record (EMR)
Number of consultations with primary care team members for hip or knee pain (e.g., physicians, nurse practitioners, nurses, social workers, occupational therapists)
Time frame: 12 months
Health-Care Utilization Survey - Visits to health professionals
Survey questions related to hip or knee pain: number of visits to health professionals outside the primary care team (e.g., chiropractors, massage therapists, occupational therapists, physiotherapists, chronic pain clinics)
Time frame: 12 months
Health-Care Utilization Survey - Medications
Survey questions related to hip or knee pain: number of medications taken. Includes type of medication, dose, frequency
Time frame: 12 months
Health-Care Utilization Survey - Walk-In Clinic Visits
Survey questions related to hip or knee pain: number of walk-in clinic visits outside of primary care centre
Time frame: 12 months
Health-Care Utilization Survey - Emergency Department Visits
Survey questions related to hip or knee pain: number of emergency department visits
Time frame: 12 months
Health-Care Utilization Survey - Inpatient Hospital Stays
Survey questions related to hip or knee pain: number of overnight hospital stays
Time frame: 12 months
Health-Care Utilization Survey - Surgeries, Procedures, Injections
Survey questions related to hip or knee pain: number of surgeries, procedures, and injections
Time frame: 12 months
Health-Care Utilization Survey - Specialist Visits
Survey questions related to hip or knee pain: number of visits to specialists
Time frame: 12 months
Health-Care Utilization Survey - Diagnostic Imaging
Survey questions related to hip or knee pain: number of diagnostic images received
Time frame: 12 months
Process Outcome - Medications Prescibed
Collected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed
Time frame: 12 months
Process Outcome - Diagnostic Imaging Ordered
Collected from the EMR: diagnostic images ordered for hip or knee pain
Time frame: 12 months
Process Outcome - Exercises Prescribed
Collected from the EMR: exercises prescribed for hip or knee pain
Time frame: 12 months
Process Outcome - Education Provided
Collected from the EMR: education provided for hip or knee pain
Time frame: 12 months
Process Outcome - Referrals to other health care providers (HCPs)
Collected from the EMR: referrals to other HCPs (both internal and external to the primary health care team) for hip or knee pain
Time frame: 12 months
Process Outcome - Primary Care Visits
Collected from the EMR: visits to the primary care team for hip or knee pain
Time frame: 12 months
Process Outcome - Notes to Employers or Insurers
Collected from the EMR: notes provided to employers or insurers for hip or knee pain
Time frame: 12 months
Self-Report Time Lost
Self-reported time lost from work, volunteering, homemaking, and educational activities
Time frame: 12 months
Assistance Needed
Self-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation
Time frame: 12 months
Extra Expenses
Any extra expenses incurred as a result of hip or knee pain. Self-report
Time frame: 12 months
Cost Outcomes
Costs associated with all health utilization, self-reported time lost, assistance needed, and extra expenses. Will be presented as aggregate and time-specific costs
Time frame: 12 months
Baseline Characteristics
To describe the study population, the investigators will capture the following through the survey: age, sex, gender, duration of musculoskeletal pain, locations of pain, medications, comorbidities, current work status, income, rurality, and ethnicity.
Time frame: Baseline
Comorbidities
Measured at baseline using the Functional Comorbidity Index (an 18-item list of comorbidities that are associated with physical functioning).
Time frame: Baseline
Chronicity of Pain
Self-reported length of time since current and first incidence of hip or knee pain
Time frame: Baseline
Participant Treatment Fidelity
Self-report adherence to PT advice
Time frame: 3 months follow-up
Plan to share: No — The is no plan to share individual IPD with other researchers
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Jordan Miller, PT, PhD