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Clinical Trials/NCT06358521
NCT06358521
Active, not recruiting
Not Applicable

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

Queen's University1 site in 1 country728 target enrollmentOctober 2, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Osteoarthritis
Sponsor
Queen's University
Enrollment
728
Locations
1
Primary Endpoint
Self-Reported Functioning
Status
Active, not recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2023
End Date
December 19, 2025
Last Updated
4 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jordan Miller, PT, PhD

Assistant Professor, School of Rehabilitation Therapy, Queen's University

Queen's University

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

Outcomes

Primary Outcomes

Self-Reported Functioning

Time Frame: 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 Outcomes

  • Pain Self Efficacy(Baseline and 3, 6, 9, and 12 months follow-up)
  • Self-Reported Pain Intensity(Baseline and 3, 6, 9, and 12 months follow-up)
  • Catastrophic Thinking(Baseline and 3, 6, 9, and 12 months follow-up)
  • Depression Subscale(Baseline and 3, 6, 9, and 12 months follow-up)
  • Fear of Movement(Baseline and 3, 6, 9, and 12 months follow-up)
  • Health-Care Utilization - Consultations in Electronic Medical Record (EMR)(12 months)
  • Health-Care Utilization Survey - Visits to health professionals(12 months)
  • Health-Care Utilization Survey - Walk-In Clinic Visits(12 months)
  • Assistance Needed(12 months)
  • Global Rating of Change(3, 6, 9, and 12 months follow-up)
  • Health-Care Utilization Survey - Medications(12 months)
  • Health-Care Utilization Survey - Inpatient Hospital Stays(12 months)
  • Process Outcome - Diagnostic Imaging Ordered(12 months)
  • Process Outcome - Education Provided(12 months)
  • Health Care Accessibility(Baseline)
  • Process Outcome - Notes to Employers or Insurers(12 months)
  • Health-Related Quality of Life(Baseline and 3, 6, 9, and 12 months follow-up)
  • Health-Care Utilization Survey - Diagnostic Imaging(12 months)
  • Process Outcome - Referrals to other health care providers (HCPs)(12 months)
  • Process Outcome - Primary Care Visits(12 months)
  • Extra Expenses(12 months)
  • Cost outcomes(12 months)
  • Satisfaction with Health Care(3, 6, 9, and 12 months follow-up)
  • Health-Care Utilization Survey - Emergency Department Visits(12 months)
  • Health-Care Utilization Survey - Surgeries, Procedures, Injections(12 months)
  • Process Outcome - Medications prescribed(12 months)
  • Adverse Events(3, 6, 9, and 12 months follow-up)
  • Health-Care Utilization Survey - Specialist Visits(12 months)
  • Process Outcome - Exercises Prescribed(12 months)
  • Self-Report Time Lost(12 months)

Study Sites (1)

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