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Clinical Trials/NCT06358521
NCT06358521CompletedNot Applicable

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

Queen's University2 sites in 1 country647 target enrollmentStarted: October 2, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
647
Locations
2
Primary Endpoint
Self-Reported Functioning

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Masking Description

Due to the nature of the new model of care and comparison, it is not possible to blind the patient participants or health care providers. Since the primary outcomes are self-reported outcome measures, the assessor is also not blind to the intervention.

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Physiotherapist-led primary care model for hip and knee pain

Experimental

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).

Intervention: Physiotherapist-led primary care model for hip and knee pain (Other)

Usual physician-led primary care model for hip and knee pain

Active Comparator

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.

Intervention: Usual physician-led primary care model for hip and knee pain (Other)

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

  • Health Care Accessibility(Baseline)
  • Self-Reported Pain Intensity(Baseline and 3, 6, 9, and 12 months follow-up)
  • Pain Self Efficacy(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)
  • 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)
  • Assistance Needed(12 months)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jordan Miller, PT, PhD

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

Queen's University

Study Sites (2)

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