JMIR Publications

ABSTRACT

Background:

Hip and knee pain are leading contributors to disability, reduced quality of life, and healthcare burden in Canada. Primary care is often the first point of contact for patients with these conditions, yet timely and appropriate care is limited due to provider shortages and system pressures. Interest is growing in interprofessional primary care models that integrate physiotherapists to enhance care delivery for musculoskeletal conditions such as hip and knee pain.

Objective:

This protocol and analysis plan communicates the analysis plan for a cluster trial that aims to: (1) evaluate the effectiveness of a physiotherapist-led primary care model for hip and knee pain on physical function, pain intensity, quality of life, global rating of change, patient satisfaction, and adverse events, compared to usual physician-led primary care; and (2) assess the impact of this model on healthcare system and societal outcomes, including access to care, healthcare utilization, productivity loss, and cost-effectiveness. A process evaluation is being used to study the implementation of the model, potential mechanisms, and experiences of patients.

Methods:

This is a cluster randomized controlled trial involving 14 primary care practices randomized equally to either the physiotherapist-led or the usual physician-led primary care model for patients with hip and knee pain. Patients were recruited over a one-year period and data collection occurs at baseline, 3, 6, 9, and 12 months. The intervention integrates a physiotherapist who is available as the initial point of contact within the primary care team for patients seeking care for hip or knee pain. It includes four key components: (1) comprehensive assessment and screening; (2) brief individualized interventions during the initial visit; (3) guidance for accessing additional healthcare resources; and (4) follow-up physiotherapy for patients with unmet needs. Intervention effectiveness will be assessed using linear mixed regression, accounting for clusters and pre-specified covariates. The multi-methods process evaluation analysis will include: descriptive and comparative analysis of how the model was implemented, mediation analysis to explore potential mechanisms of the model, and qualitative exploration of patient experiences.

Results:

Primary care sites (clusters) were recruited and randomized in June and July 2023 respectively. Patient enrollment occurred from October 2023 through November 2024. The last patient follow-up survey was conducted on November 25, 2025. Extraction of data from electronic health records is expected to finish by December 19, 2025. Data analysis will begin once data collection is complete and will adhere to the predefined study protocol and analysis plan. No interim analyses were planned or completed.

Conclusions:

The findings from this trial will inform whether integrating physiotherapists into primary care teams for hip and knee pain improves patient outcomes and healthcare system efficiency. The effectiveness results and implementation evidence from the process evaluation will provide critical evidence for policymakers and health system leaders considering broader implementation of interprofessional team-based care models in primary care. Clinical Trial: The internal pilot for this trial was registered prospectively on February 9, 2023, at ClinicalTrials.gov NCT05736133; https://clinicaltrials.gov/study/NCT05736133. The fully powered trial was registered on April 5, 2024, at ClinicalTrials.gov NCT06358521; https://clinicaltrials.gov/study/NCT06358521.