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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Hip Osteoarthritis
• Intervention / Treatment: Other: Usual physician-led primary care model for hip and knee pain; Other: Physiotherapist-led primary care model for hip and knee pain

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 Type: Interventional
• Enrollment (Estimated): 728
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordan Miller, PhD; Phone Number: 905-872-9938; Email: jordan.miller@queensu.ca
• Study Contact Backup: Name: Chad McClintock, MSc; Email: cwm2@queensu.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L3N6
      • Recruiting
      • Queen's University
      • Contact: Jordan Miller

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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).	Other: Physiotherapist-led primary care model for hip and knee pain; Initial assessment and screening: The PT will provide a comprehensive assessment according to established clinical practice guidelines.; Brief individualized intervention at first visit: The PT intervention will be at the discretion of the PT to reflect real-world PT intervention.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Functioning	Self-report using the Lower Extremity Functional Scale (0-80 score with higher score representing higher function)	Baseline and 3, 6, 9, and 12 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Reported Pain Intensity	Measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity.	Baseline and 3, 6, 9, and 12 months follow-up
Health-Related Quality of Life	Measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)	Baseline and 3, 6, 9, and 12 months follow-up
Pain Self Efficacy	Confidence in abilities to participate in usual activities using the Pain Self Efficacy Questionnaire	Baseline and 3, 6, 9, and 12 months follow-up
Catastrophic Thinking	Measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)	Baseline and 3, 6, 9, and 12 months follow-up
Global Rating of Change	Measured using an 11-point scale (-5 to +5 with negative scores indicating a worsening of physical functioning and positive scores indicating an improvement of physical functioning)	3, 6, 9, and 12 months follow-up
Adverse Events	Measured using an adverse events questionnaire that asks 1) if the participant has experienced any adverse events as a result of the treatments received (yes/no); 2) how long the event lasted (hours or days); 3) how severe the adverse event was (0-10 scale); 4) what adverse events were experienced.	3, 6, 9, and 12 months follow-up
Health Care Accessibility	Percentage of participants assessed within 48 hours of calling for an appointment	Baseline
Health-Care Utilization - Consultations in Electronic Medical Record (EMR)	Number of consultations with primary care team members for hip or knee pain (e.g., physicians, nurse practitioners, nurses, social workers, occupational therapists)	12 months
Health-Care Utilization Survey - Visits to health professionals	Survey questions related to hip or knee pain: number of visits to health professionals outside the primary care team (e.g., chiropractors, massage therapists, occupational therapists, physiotherapists, chronic pain clinics)	12 months
Health-Care Utilization Survey - Walk-In Clinic Visits	Survey questions related to hip or knee pain: number of walk-in clinic visits outside of primary care centre	12 months
Health-Care Utilization Survey - Emergency Department Visits	Survey questions related to hip or knee pain: number of emergency department visits	12 months
Health-Care Utilization Survey - Inpatient Hospital Stays	Survey questions related to hip or knee pain: number of overnight hospital stays	12 months
Health-Care Utilization Survey - Surgeries, Procedures, Injections	Survey questions related to hip or knee pain: number of surgeries, procedures, and injections	12 months
Health-Care Utilization Survey - Specialist Visits	Survey questions related to hip or knee pain: number of visits to specialists	12 months
Health-Care Utilization Survey - Diagnostic Imaging	Survey questions related to hip or knee pain: number of diagnostic images received	12 months
Process Outcome - Diagnostic Imaging Ordered	Collected from the EMR: diagnostic images ordered for hip or knee pain	12 months
Process Outcome - Exercises Prescribed	Collected from the EMR: exercises prescribed for hip or knee pain	12 months
Process Outcome - Education Provided	Collected from the EMR: education provided for hip or knee pain	12 months
Process Outcome - Referrals to other health care providers (HCPs)	Collected from the EMR: referrals to other HCPs (both internal and external to the primary health care team) for hip or knee pain	12 months
Process Outcome - Primary Care Visits	Collected from the EMR: visits to the primary care team for hip or knee pain	12 months
Process Outcome - Notes to Employers or Insurers	Collected from the EMR: notes provided to employers or insurers for hip or knee pain	12 months
Self-Report Time Lost	Self-reported time lost from work, volunteering, homemaking, and educational activities	12 months
Assistance Needed	Self-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation	12 months
Fear of Movement	Measured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire)	Baseline and 3, 6, 9, and 12 months follow-up
Depression Subscale	Measured using the 2-Item Patient Health Questionnaire	Baseline and 3, 6, 9, and 12 months follow-up
Satisfaction with Health Care	Measured using an 11-point scale (-5 to +5 with negative scores indicating a dissatisfaction with health care received and positive scores indicating satisfaction with health care received)	3, 6, 9, and 12 months follow-up
Health-Care Utilization Survey - Medications	Survey questions related to hip or knee pain: number of medications taken. Includes type of medication, dose, frequency.	12 months
Process Outcome - Medications prescribed	Collected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed	12 months
Extra Expenses	Any extra expenses incurred as a result of hip or knee pain. Self-report.	12 months
Cost outcomes	Costs associated with all health utilization, self-reported time lost, assistance needed, and extra expenses. Will be presented as aggregate and time-specific costs	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comorbidities	Measured at baseline using the Functional Comorbidity Index (an 18-item list of comorbidities that are associated with physical functioning).	Baseline
Chronicity of Pain	Self-reported length of time since current and first incidence of hip or knee pain	Baseline
Participant Treatment Fidelity	Self-report adherence to PT advice	3 months follow-up
Baseline Characteristics	To describe the study population, the investigators will capture the following through the survey: age, sex, gender, duration of musculoskeletal pain, locations of pain, medications, current work status, income, rurality, and ethnicity.	Baseline

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: Canadian Institutes of Health Research (CIHR); The Arthritis Society, Canada
• Investigators: Principal Investigator: Jordan Miller, PhD, Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 6040471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No