Determining the Impact of a Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Trial
- Conditions
- Hip OsteoarthritisKnee Osteoarthritis
- Interventions
- Other: Physiotherapist-led primary care model for hip and knee painOther: Usual physician-led primary care model for hip and knee pain
- Registration Number
- NCT05736133
- Lead Sponsor
- Jordan Miller, PT, PhD
- Brief Summary
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.
- Detailed Description
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:
1. Determine the feasibility of participant recruitment, assessment procedures, and retention.
2. Determine the feasibility of implementing a new PT led primary care model for hip and knee pain.
3. Explore the perspectives of patient participants and HCPs related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value and impact on clinic processes and patient participant outcomes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 205
- Adults >= 19 years who ask to book a primary care visits where the primary reason is for hip or knee pain of any duration.
- Cannot understand, read, and write English
- Known cancer causing hip or knee pain
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Physiotherapist-led primary care model for hip and knee pain Physiotherapist-led primary care model for hip and knee pain 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). Usual physician-led primary care model for hip and knee pain Usual physician-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.
- Primary Outcome Measures
Name Time Method Participant Recruitment Rate 20 weeks A full trial will be feasible if the investigators are able to recruit 1.5 participants per week per site over 20 weeks
Assessment Procedures 12 months The investigators consider ≥80% of all assessment items completed and a mean time for completion of ≤60 minutes acceptable.
Retention 12 months 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
PT Treatment Fidelity 20 weeks 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.
- Secondary Outcome Measures
Name Time Method Self-Reported Pain Intensity 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.
Health-Related Quality of Life 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)
Pain Self Efficacy Baseline and 3, 6, 9, and 12 months follow-up Confidence in abilities to participate in usual activities using the Pain Self Efficacy Questionnaire
Adverse Events 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.
Self-Reported Functioning 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)
Global Rating of Change 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)
Catastrophic Thinking 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)
Fear of Movement Baseline and 3, 6, 9, and 12 months follow-up Measured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire)
Satisfaction with Health Care 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)
Health-Care Utilization Survey - Walk-In Clinic Visits 12 months Survey questions related to hip or knee pain: number of walk-in clinic visits outside of primary care centre
Health-Care Utilization Survey - Inpatient Hospital Stays 12 months Survey questions related to hip or knee pain: number of overnight hospital stays
Process Outcome - Exercises Prescribed 12 months Collected from the EMR: exercises prescribed for hip or knee pain
Process Outcome - Education Provided 12 months Collected from the EMR: education provided for hip or knee pain
Assistance Needed 12 months Self-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation
Extra Expenses 12 months Any extra expenses incurred as a result of hip or knee pain. Self-report
Depression Subscale Baseline and 3, 6, 9, and 12 months follow-up Measured using the 2-Item Patient Health Questionnaire
Health-Care Utilization - Consultations in Electronic Medical Record (EMR) 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)
Health-Care Utilization Survey - Visits to health professionals 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)
Health-Care Utilization Survey - Medications 12 months Survey questions related to hip or knee pain: number of medications taken. Includes type of medication, dose, frequency
Health-Care Utilization Survey - Surgeries, Procedures, Injections 12 months Survey questions related to hip or knee pain: number of surgeries, procedures, and injections
Process Outcome - Medications Prescibed 12 months Collected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed
Process Outcome - Diagnostic Imaging Ordered 12 months Collected from the EMR: diagnostic images ordered for hip or knee pain
Health Care Accessibility Baseline Percentage of participants assessed within 48 hours of calling for an appointment
Process Outcome - Primary Care Visits 12 months Collected from the EMR: visits to the primary care team for hip or knee pain
Health-Care Utilization Survey - Emergency Department Visits 12 months Survey questions related to hip or knee pain: number of emergency department visits
Health-Care Utilization Survey - Specialist Visits 12 months Survey questions related to hip or knee pain: number of visits to specialists
Health-Care Utilization Survey - Diagnostic Imaging 12 months Survey questions related to hip or knee pain: number of diagnostic images received
Process Outcome - Referrals to other health care providers (HCPs) 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
Self-Report Time Lost 12 months Self-reported time lost from work, volunteering, homemaking, and educational activities
Cost Outcomes 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
Process Outcome - Notes to Employers or Insurers 12 months Collected from the EMR: notes provided to employers or insurers for hip or knee pain
Trial Locations
- Locations (1)
Queen's University
🇨🇦Kingston, Ontario, Canada