Determining the Impact of a Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Trial
- Conditions
- Knee OsteoarthritisHip 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
- NCT06358521
- Lead Sponsor
- Queen's University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 728
- 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 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)
- 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.
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
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)
Depression Subscale Baseline and 3, 6, 9, and 12 months follow-up Measured using the 2-Item Patient Health Questionnaire
Fear of Movement Baseline and 3, 6, 9, and 12 months follow-up Measured using the Tampa Scale of Kinesiophobia (an 11-item 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 - 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
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)
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 - Inpatient Hospital Stays 12 months Survey questions related to hip or knee pain: number of overnight hospital stays
Process Outcome - Diagnostic Imaging Ordered 12 months Collected from the EMR: diagnostic images ordered 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
Health Care Accessibility Baseline Percentage of participants assessed within 48 hours of calling for an appointment
Process Outcome - Notes to Employers or Insurers 12 months Collected from the EMR: notes provided to employers or insurers for hip or knee pain
Health-Care Utilization Survey - Diagnostic Imaging 12 months Survey questions related to hip or knee pain: number of diagnostic images received
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)
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
Process Outcome - Primary Care Visits 12 months Collected from the EMR: visits to the primary care team for hip or knee pain
Extra Expenses 12 months Any extra expenses incurred as a result of hip or knee pain. Self-report.
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
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 - Emergency Department Visits 12 months Survey questions related to hip or knee pain: number of emergency department visits
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 prescribed 12 months Collected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed
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.
Health-Care Utilization Survey - Specialist Visits 12 months Survey questions related to hip or knee pain: number of visits to specialists
Process Outcome - Exercises Prescribed 12 months Collected from the EMR: exercises prescribed for hip or knee pain
Self-Report Time Lost 12 months Self-reported time lost from work, volunteering, homemaking, and educational activities
Trial Locations
- Locations (1)
Queen's University
🇨🇦Kingston, Ontario, Canada
Queen's University🇨🇦Kingston, Ontario, CanadaJordan MillerContact