- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05736133
Determining the Impact of a Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Trial
Determining the Impact of a New Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Cluster Randomized Controlled Trial
Study Overview
Status
Conditions
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:
- Determine the feasibility of participant recruitment, assessment procedures, and retention.
- Determine the feasibility of implementing a new PT led primary care model for hip and knee pain.
- 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.
Study Type
Enrollment (Estimated)
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
- Phone Number: 613-530-6758
- Email: cwm2@queensu.ca
Study Locations
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Ontario
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Kingston, Ontario, Canada, K7L 3N6
- Recruiting
- Queen's University
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Contact:
- Jordan Miller
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment Procedures
Time Frame: 12 months
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The investigators consider ≥80% of all assessment items completed and a mean time for completion of ≤60 minutes acceptable.
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12 months
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Retention
Time Frame: 12 months
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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
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12 months
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Participant Recruitment Rate
Time Frame: 20 weeks
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A full trial will be feasible if the investigators are able to recruit 1.5 participants per week per site over 20 weeks
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20 weeks
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PT Treatment Fidelity
Time Frame: 20 weeks
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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.
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20 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-Reported Functioning
Time Frame: Baseline and 3, 6, 9, and 12 months follow-up
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Self-report using the Lower Extremity Functional Scale (0-80 score with higher score representing higher function)
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Baseline and 3, 6, 9, and 12 months follow-up
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Self-Reported Pain Intensity
Time Frame: Baseline and 3, 6, 9, and 12 months follow-up
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Measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity.
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Baseline and 3, 6, 9, and 12 months follow-up
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Health-Related Quality of Life
Time Frame: Baseline and 3, 6, 9, and 12 months follow-up
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Measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)
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Baseline and 3, 6, 9, and 12 months follow-up
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Pain Self Efficacy
Time Frame: Baseline and 3, 6, 9, and 12 months follow-up
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Confidence in abilities to participate in usual activities using the Pain Self Efficacy Questionnaire
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Baseline and 3, 6, 9, and 12 months follow-up
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Catastrophic Thinking
Time Frame: Baseline and 3, 6, 9, and 12 months follow-up
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Measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
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Baseline and 3, 6, 9, and 12 months follow-up
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Global Rating of Change
Time Frame: 3, 6, 9, and 12 months follow-up
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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)
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3, 6, 9, and 12 months follow-up
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Satisfaction with Health Care
Time Frame: 3, 6, 9, and 12 months follow-up
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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)
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3, 6, 9, and 12 months follow-up
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Adverse Events
Time Frame: 3, 6, 9, and 12 months follow-up
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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.
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3, 6, 9, and 12 months follow-up
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Health Care Accessibility
Time Frame: Baseline
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Percentage of participants assessed within 48 hours of calling for an appointment
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Baseline
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Health-Care Utilization - Consultations in Electronic Medical Record (EMR)
Time Frame: 12 months
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Number of consultations with primary care team members for hip or knee pain (e.g., physicians, nurse practitioners, nurses, social workers, occupational therapists)
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12 months
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Health-Care Utilization Survey - Visits to health professionals
Time Frame: 12 months
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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)
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12 months
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Health-Care Utilization Survey - Medications
Time Frame: 12 months
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Survey questions related to hip or knee pain: number of medications taken.
Includes type of medication, dose, frequency
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12 months
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Health-Care Utilization Survey - Walk-In Clinic Visits
Time Frame: 12 months
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Survey questions related to hip or knee pain: number of walk-in clinic visits outside of primary care centre
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12 months
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Health-Care Utilization Survey - Emergency Department Visits
Time Frame: 12 months
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Survey questions related to hip or knee pain: number of emergency department visits
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12 months
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Health-Care Utilization Survey - Inpatient Hospital Stays
Time Frame: 12 months
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Survey questions related to hip or knee pain: number of overnight hospital stays
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12 months
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Health-Care Utilization Survey - Surgeries, Procedures, Injections
Time Frame: 12 months
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Survey questions related to hip or knee pain: number of surgeries, procedures, and injections
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12 months
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Health-Care Utilization Survey - Specialist Visits
Time Frame: 12 months
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Survey questions related to hip or knee pain: number of visits to specialists
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12 months
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Health-Care Utilization Survey - Diagnostic Imaging
Time Frame: 12 months
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Survey questions related to hip or knee pain: number of diagnostic images received
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12 months
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Process Outcome - Medications Prescibed
Time Frame: 12 months
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Collected from the EMR: medications prescribed for hip or knee pain.
Includes the type of medication prescribed
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12 months
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Process Outcome - Diagnostic Imaging Ordered
Time Frame: 12 months
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Collected from the EMR: diagnostic images ordered for hip or knee pain
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12 months
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Process Outcome - Exercises Prescribed
Time Frame: 12 months
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Collected from the EMR: exercises prescribed for hip or knee pain
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12 months
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Process Outcome - Education Provided
Time Frame: 12 months
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Collected from the EMR: education provided for hip or knee pain
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12 months
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Process Outcome - Referrals to other health care providers (HCPs)
Time Frame: 12 months
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Collected from the EMR: referrals to other HCPs (both internal and external to the primary health care team) for hip or knee pain
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12 months
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Process Outcome - Primary Care Visits
Time Frame: 12 months
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Collected from the EMR: visits to the primary care team for hip or knee pain
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12 months
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Process Outcome - Notes to Employers or Insurers
Time Frame: 12 months
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Collected from the EMR: notes provided to employers or insurers for hip or knee pain
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12 months
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Self-Report Time Lost
Time Frame: 12 months
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Self-reported time lost from work, volunteering, homemaking, and educational activities
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12 months
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Assistance Needed
Time Frame: 12 months
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Self-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation
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12 months
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Extra Expenses
Time Frame: 12 months
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Any extra expenses incurred as a result of hip or knee pain.
Self-report
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12 months
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Cost Outcomes
Time Frame: 12 months
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Costs associated with all health utilization, self-reported time lost, assistance needed, and extra expenses.
Will be presented as aggregate and time-specific costs
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12 months
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Fear of Movement
Time Frame: Baseline and 3, 6, 9, and 12 months follow-up
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Measured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire)
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Baseline and 3, 6, 9, and 12 months follow-up
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Depression Subscale
Time Frame: Baseline and 3, 6, 9, and 12 months follow-up
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Measured using the 2-Item Patient Health Questionnaire
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Baseline and 3, 6, 9, and 12 months follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comorbidities
Time Frame: Baseline
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Measured at baseline using the Functional Comorbidity Index (an 18-item list of comorbidities that are associated with physical functioning).
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Baseline
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Baseline Characteristics
Time Frame: Baseline
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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, comorbidities, current work status, income, rurality, and ethnicity.
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Baseline
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Chronicity of Pain
Time Frame: Baseline
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Self-reported length of time since current and first incidence of hip or knee pain
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Baseline
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Participant Treatment Fidelity
Time Frame: 3 months follow-up
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Self-report adherence to PT advice
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3 months follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jordan Miller, PhD, Queen's University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6038205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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