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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06358521
Enrollment
647
Registered
2024-04-10
Start date
2023-10-02
Completion date
2025-12-19
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Osteoarthritis, Knee Osteoarthritis

Brief summary

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.

Detailed description

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: 1. 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? 2. 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.

Interventions

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. 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. 4. 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.

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

Sponsors

Queen's University
Lead SponsorOTHER
Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
The Arthritis Society, Canada
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Self-Reported FunctioningBaseline and 3, 6, 9, and 12 months follow-upSelf-report using the Lower Extremity Functional Scale (0-80 score with higher score representing higher function)

Secondary

MeasureTime frameDescription
Catastrophic ThinkingBaseline and 3, 6, 9, and 12 months follow-upMeasured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
Fear of MovementBaseline and 3, 6, 9, and 12 months follow-upMeasured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire)
Depression SubscaleBaseline and 3, 6, 9, and 12 months follow-upMeasured using the 2-Item Patient Health Questionnaire
Global Rating of Change3, 6, 9, and 12 months follow-upMeasured 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)
Satisfaction with Health Care3, 6, 9, and 12 months follow-upMeasured 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)
Adverse Events3, 6, 9, and 12 months follow-upMeasured 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.
Health-Care Utilization - Consultations in Electronic Medical Record (EMR)12 monthsNumber of consultations with primary care team members for hip or knee pain (e.g., physicians, nurse practitioners, nurses, social workers, occupational therapists)
Health-Care Utilization Survey - Visits to health professionals12 monthsSurvey 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)
Health-Care Utilization Survey - Medications12 monthsSurvey questions related to hip or knee pain: number of medications taken. Includes type of medication, dose, frequency.
Health-Care Utilization Survey - Walk-In Clinic Visits12 monthsSurvey questions related to hip or knee pain: number of walk-in clinic visits outside of primary care centre
Health-Care Utilization Survey - Emergency Department Visits12 monthsSurvey questions related to hip or knee pain: number of emergency department visits
Health-Care Utilization Survey - Inpatient Hospital Stays12 monthsSurvey questions related to hip or knee pain: number of overnight hospital stays
Health-Care Utilization Survey - Surgeries, Procedures, Injections12 monthsSurvey questions related to hip or knee pain: number of surgeries, procedures, and injections
Health-Care Utilization Survey - Specialist Visits12 monthsSurvey questions related to hip or knee pain: number of visits to specialists
Health-Care Utilization Survey - Diagnostic Imaging12 monthsSurvey questions related to hip or knee pain: number of diagnostic images received
Process Outcome - Medications prescribed12 monthsCollected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed
Process Outcome - Diagnostic Imaging Ordered12 monthsCollected from the EMR: diagnostic images ordered for hip or knee pain
Process Outcome - Exercises Prescribed12 monthsCollected from the EMR: exercises prescribed for hip or knee pain
Process Outcome - Education Provided12 monthsCollected from the EMR: education provided for hip or knee pain
Process Outcome - Referrals to other health care providers (HCPs)12 monthsCollected from the EMR: referrals to other HCPs (both internal and external to the primary health care team) for hip or knee pain
Process Outcome - Primary Care Visits12 monthsCollected from the EMR: visits to the primary care team for hip or knee pain
Process Outcome - Notes to Employers or Insurers12 monthsCollected from the EMR: notes provided to employers or insurers for hip or knee pain
Self-Report Time Lost12 monthsSelf-reported time lost from work, volunteering, homemaking, and educational activities
Assistance Needed12 monthsSelf-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation
Extra Expenses12 monthsAny extra expenses incurred as a result of hip or knee pain. Self-report.
Cost outcomes12 monthsCosts associated with all health utilization, self-reported time lost, assistance needed, and extra expenses. Will be presented as aggregate and time-specific costs
Health Care AccessibilityBaselinePercentage of participants assessed within 48 hours of calling for an appointment
Self-Reported Pain IntensityBaseline and 3, 6, 9, and 12 months follow-upMeasured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity.
Pain Self EfficacyBaseline and 3, 6, 9, and 12 months follow-upConfidence in abilities to participate in usual activities using the Pain Self Efficacy Questionnaire
Health-Related Quality of LifeBaseline and 3, 6, 9, and 12 months follow-upMeasured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORJordan Miller, PhD

Queen's University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026