Clinical trial NCT05736133: Determining the Impact of a Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Trial
Official title: Determining the Impact of a New Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2023-02-21
Enrollment: 205
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 pilot cluster randomized controlled trial randomizing 14 sites to the PT-led primary care model for hip/knee pain or to the usual care model
Primary purpose: TREATMENT

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.

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: Participant Recruitment Rate
timeFrame: 20 weeks
measure: Assessment Procedures
timeFrame: 12 months
measure: Retention
timeFrame: 12 months
measure: PT Treatment Fidelity
timeFrame: 20 weeks
Secondary outcomes:
measure: Self-Reported Functioning
timeFrame: Baseline and 3, 6, 9, and 12 months follow-up
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 Accessibility
timeFrame: Baseline
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 Prescibed
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
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: