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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
728
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.
Queen's University
Kingston, Ontario, Canada
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
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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 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 prescribed
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
Health Care Accessibility
Percentage of participants assessed within 48 hours of calling for an appointment
Time frame: Baseline