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NCT Number: NCT06358521

Determining the Impact of a Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Trial

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University

Kingston, Ontario, K7L3N6, Canada

About this study

Arthritis is one of the leading causes of pain, disability, and reduced quality of life in patients. Osteoarthritis (OA) is the most common form of arthritis, especially in the hips and knees, which affects over four million Canadians. OA places a huge burden on society, in terms of both direct and indirect costs, including lost time at work, lost years of productivity, and decreased quality of life. People living with OA complain of chronic pain and negative impacts on their quality of life. For many, the first point of contact for their OA is their primary care provider. Due to the rise in patients seeking support through primary care and the shortage of care providers and the high burden on these providers, patients often do not receive timely access to care. Additionally, for patients without primary care providers, their first point of contact for their OA is often the emergency department (ED), which contributes to long wait times and staff burnout. The need for integrative models of care has been advocated for as an evidenced-informed and patient-centered approach to managing patients with OA.

In Canada, federal and provincial governments have identified that interprofessional teams with complementary skillsets are required to address patients' multiple needs and to improve the effectiveness of the healthcare system. Research from other health conditions suggests team-based primary care can improve access to appropriate care, coordination of care, and patient outcomes. One example of such an integrated model of care is having a physiotherapist (PT) as 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 complaints related to hip and knee OA. This model of care has the potential to improve patient outcomes and positively influence the current challenges within the healthcare system.

The study seeks to address the following research questions:

  • Is a PT-led primary care model for hip and knee pain effective at improving function (primary outcome), pain intensity, quality of life, global rating of change, patient satisfaction, and adverse events compared to usual physician-led primary care, when evaluated over a one-year period from the initial consultation?
  • What is the impact of a PT-led primary care model for hip and knee pain on the health system and society (healthcare access, physician workload, healthcare utilization, missed work, cost-effectiveness), evaluated over a one-year period from initial consultation? A process evaluation will be used to understand the process of implementing a PT-led primary care model, potential mechanisms of the interventions, context of delivery, and perceptions of patients and primary care providers toward the PT-led primary care model for hip and knee pain.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults >= 19 years who ask to book a primary care visits where the primary reason is for hip or knee pain of any duration.

Exclusion criteria

  • Cannot understand, read, and write English
  • Known cancer causing hip or knee pain

Treatment and study plan

Physiotherapist-led primary care model for hip and knee pain

Other
  • Initial assessment and screening: The PT will provide a comprehensive assessment according to established clinical practice guidelines.
  • Brief individualized intervention at first visit: The PT intervention will be at the discretion of the PT to reflect real-world PT intervention.
  • 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. Participants will be assessed regarding the need for specialist referrals or resources available to manage complex clinical presentations. Participants may be referred to the primary care provider if no specialized services are needed or when the PT cannot provide a direct referral.
  • Additional PT care: Patients who require community PT but do not have the appropriate coverage for community-based services will be managed by the PT who provided the assessment in the primary care setting.

Usual physician-led primary care model for hip and knee pain

Other

The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Primary outcomes

  1. Self-Reported Functioning

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    Self-report using the Lower Extremity Functional Scale (0-80 score with higher score representing higher function)

Secondary outcomes

  1. Self-Reported Pain Intensity

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    Measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity.

  2. Health-Related Quality of Life

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    Measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)

  3. Pain Self Efficacy

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    Confidence in abilities to participate in usual activities using the Pain Self Efficacy Questionnaire

  4. Catastrophic Thinking

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    Measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)

  5. Fear of Movement

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    Measured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire)

  6. Depression Subscale

    Time frame: Baseline and 3, 6, 9, and 12 months follow-up

    Measured using the 2-Item Patient Health Questionnaire

  7. Global Rating of Change

    Time frame: 3, 6, 9, and 12 months follow-up

    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)

  8. Satisfaction with Health Care

    Time frame: 3, 6, 9, and 12 months follow-up

    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)

  9. Adverse Events

    Time frame: 3, 6, 9, and 12 months follow-up

    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.

  10. Health-Care Utilization - Consultations in Electronic Medical Record (EMR)

    Time frame: 12 months

    Number of consultations with primary care team members for hip or knee pain (e.g., physicians, nurse practitioners, nurses, social workers, occupational therapists)

  11. Health-Care Utilization Survey - Visits to health professionals

    Time frame: 12 months

    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)

  12. Health-Care Utilization Survey - Medications

    Time frame: 12 months

    Survey questions related to hip or knee pain: number of medications taken. Includes type of medication, dose, frequency.

  13. Health-Care Utilization Survey - Walk-In Clinic Visits

    Time frame: 12 months

    Survey questions related to hip or knee pain: number of walk-in clinic visits outside of primary care centre

  14. Health-Care Utilization Survey - Emergency Department Visits

    Time frame: 12 months

    Survey questions related to hip or knee pain: number of emergency department visits

  15. Health-Care Utilization Survey - Inpatient Hospital Stays

    Time frame: 12 months

    Survey questions related to hip or knee pain: number of overnight hospital stays

  16. Health-Care Utilization Survey - Surgeries, Procedures, Injections

    Time frame: 12 months

    Survey questions related to hip or knee pain: number of surgeries, procedures, and injections

  17. Health-Care Utilization Survey - Specialist Visits

    Time frame: 12 months

    Survey questions related to hip or knee pain: number of visits to specialists

  18. Health-Care Utilization Survey - Diagnostic Imaging

    Time frame: 12 months

    Survey questions related to hip or knee pain: number of diagnostic images received

  19. Process Outcome - Medications prescribed

    Time frame: 12 months

    Collected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed

  20. Process Outcome - Diagnostic Imaging Ordered

    Time frame: 12 months

    Collected from the EMR: diagnostic images ordered for hip or knee pain

  21. Process Outcome - Exercises Prescribed

    Time frame: 12 months

    Collected from the EMR: exercises prescribed for hip or knee pain

  22. Process Outcome - Education Provided

    Time frame: 12 months

    Collected from the EMR: education provided for hip or knee pain

  23. Process Outcome - Referrals to other health care providers (HCPs)

    Time frame: 12 months

    Collected from the EMR: referrals to other HCPs (both internal and external to the primary health care team) for hip or knee pain

  24. Process Outcome - Primary Care Visits

    Time frame: 12 months

    Collected from the EMR: visits to the primary care team for hip or knee pain

  25. Process Outcome - Notes to Employers or Insurers

    Time frame: 12 months

    Collected from the EMR: notes provided to employers or insurers for hip or knee pain

  26. Self-Report Time Lost

    Time frame: 12 months

    Self-reported time lost from work, volunteering, homemaking, and educational activities

  27. Assistance Needed

    Time frame: 12 months

    Self-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation

  28. Extra Expenses

    Time frame: 12 months

    Any extra expenses incurred as a result of hip or knee pain. Self-report.

  29. Cost outcomes

    Time frame: 12 months

    Costs associated with all health utilization, self-reported time lost, assistance needed, and extra expenses. Will be presented as aggregate and time-specific costs

  30. Health Care Accessibility

    Time frame: Baseline

    Percentage of participants assessed within 48 hours of calling for an appointment

Other outcomes

  1. Baseline Characteristics

    Time frame: Baseline

    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, current work status, income, rurality, and ethnicity.

  2. Comorbidities

    Time frame: Baseline

    Measured at baseline using the Functional Comorbidity Index (an 18-item list of comorbidities that are associated with physical functioning).

  3. Chronicity of Pain

    Time frame: Baseline

    Self-reported length of time since current and first incidence of hip or knee pain

  4. Participant Treatment Fidelity

    Time frame: 3 months follow-up

    Self-report adherence to PT advice

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • The Arthritis Society, Canada

Registry information

Official study title

Determining the Impact of a New Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 10, 2024
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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