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

NCT ID: NCT06358521

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 728 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2025-12-19

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.

Conditions

Hip Osteoarthritis; Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physiotherapist-led primary care model for hip and knee pain

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).

Group Type: EXPERIMENTAL

Physiotherapist-led primary care model for hip and knee pain

Intervention Type: OTHER

1. Initial assessment and screening: The PT will provide a comprehensive assessment according to established clinical practice guidelines.

2. Brief individualized intervention at first visit: The PT intervention will be at the discretion of the PT to reflect real-world PT intervention.

3. Health services navigation: Participants will be provided with options available to them in their community for rehabilitation. For example, they may be referred to community PT for ongoing management. Participants will be assessed regarding the need for specialist referrals or resources available to manage complex clinical presentations. Participants may be referred to the primary care provider if no specialized services are needed or when the PT cannot provide a direct referral.

4. Additional PT care: Patients who require community PT but do not have the appropriate coverage for community-based services will be managed by the PT who provided the assessment in the primary care setting.

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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Interventions

Physiotherapist-led primary care model for hip and knee pain

1. Initial assessment and screening: The PT will provide a comprehensive assessment according to established clinical practice guidelines.

2. Brief individualized intervention at first visit: The PT intervention will be at the discretion of the PT to reflect real-world PT intervention.

3. Health services navigation: Participants will be provided with options available to them in their community for rehabilitation. For example, they may be referred to community PT for ongoing management. Participants will be assessed regarding the need for specialist referrals or resources available to manage complex clinical presentations. Participants may be referred to the primary care provider if no specialized services are needed or when the PT cannot provide a direct referral.

4. Additional PT care: Patients who require community PT but do not have the appropriate coverage for community-based services will be managed by the PT who provided the assessment in the primary care setting.

Intervention Type: OTHER

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

The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

The Arthritis Society, Canada

OTHER

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Jordan Miller, PT, PhD

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jordan Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Queen's University

Kingston, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

6040471

Identifier Type: -

Identifier Source: org_study_id