Clinical trial NCT06358521: Determining the Impact of a Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Trial
Official title: Determining the Impact of a New Physiotherapist-led Primary Care Model for Hip and Knee Pain - A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: The Arthritis Society, Canada
First posted: 2024-04-10
Enrollment: 728
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-Reported Functioning
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
Secondary outcomes:
measure: Self-Reported Pain Intensity
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Health-Related Quality of Life
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Pain Self Efficacy
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Catastrophic Thinking
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Fear of Movement
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Depression Subscale
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
measure: Global Rating of Change
timeFrame: 3, 6, 9, and 12 months follow-up
measure: Satisfaction with Health Care
timeFrame: 3, 6, 9, and 12 months follow-up
measure: Adverse Events
timeFrame: 3, 6, 9, and 12 months follow-up
measure: Health-Care Utilization - Consultations in Electronic Medical Record (EMR)
timeFrame: 12 months
measure: Health-Care Utilization Survey - Visits to health professionals
timeFrame: 12 months
measure: Health-Care Utilization Survey - Medications
timeFrame: 12 months
measure: Health-Care Utilization Survey - Walk-In Clinic Visits
timeFrame: 12 months
measure: Health-Care Utilization Survey - Emergency Department Visits
timeFrame: 12 months
measure: Health-Care Utilization Survey - Inpatient Hospital Stays
timeFrame: 12 months
measure: Health-Care Utilization Survey - Surgeries, Procedures, Injections
timeFrame: 12 months
measure: Health-Care Utilization Survey - Specialist Visits
timeFrame: 12 months
measure: Health-Care Utilization Survey - Diagnostic Imaging
timeFrame: 12 months
measure: Process Outcome - Medications prescribed
timeFrame: 12 months
measure: Process Outcome - Diagnostic Imaging Ordered
timeFrame: 12 months
measure: Process Outcome - Exercises Prescribed
timeFrame: 12 months
measure: Process Outcome - Education Provided
timeFrame: 12 months
measure: Process Outcome - Referrals to other health care providers (HCPs)
timeFrame: 12 months
measure: Process Outcome - Primary Care Visits
timeFrame: 12 months
measure: Process Outcome - Notes to Employers or Insurers
timeFrame: 12 months
measure: Self-Report Time Lost
timeFrame: 12 months
measure: Assistance Needed
timeFrame: 12 months
measure: Extra Expenses
timeFrame: 12 months
measure: Cost outcomes
timeFrame: 12 months
measure: Health Care Accessibility
timeFrame: Baseline
Other outcomes:
measure: Baseline Characteristics
timeFrame: Baseline
measure: Comorbidities
timeFrame: Baseline
measure: Chronicity of Pain
timeFrame: Baseline
measure: Participant Treatment Fidelity
timeFrame: 3 months follow-up
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Jordan Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: