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Clinical Trials/NCT05736133
NCT05736133
Completed
Not Applicable

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

Jordan Miller, PT, PhD1 site in 1 country205 target enrollmentOctober 2, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Osteoarthritis
Sponsor
Jordan Miller, PT, PhD
Enrollment
205
Locations
1
Primary Endpoint
Participant Recruitment Rate
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2, 2023
End Date
January 17, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jordan Miller, PT, PhD
Responsible Party
Sponsor 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

Participant Recruitment Rate

Time Frame: 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

Time Frame: 12 months

The investigators consider ≥80% of all assessment items completed and a mean time for completion of ≤60 minutes acceptable.

Retention

Time Frame: 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

Time Frame: 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 Outcomes

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

Study Sites (1)

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