Queen's University
Kingston, Ontario, K7L 3N6, Canada
NCT Number: NCT05736133
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.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Kingston, Ontario, K7L 3N6, Canada
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
Time frame: 20 weeks
A full trial will be feasible if the investigators are able to recruit 1.5 participants per week per site over 20 weeks
Time frame: 12 months
The investigators consider ≥80% of all assessment items completed and a mean time for completion of ≤60 minutes acceptable.
Time frame: 12 months
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
Time frame: 20 weeks
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.
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Self-report using the Lower Extremity Functional Scale (0-80 score with higher score representing higher function)
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity.
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Measured using the EuroQoL-5D-5L (0 to 100 with greater scores indicating greater self-reported health related quality of life)
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Confidence in abilities to participate in usual activities using the Pain Self Efficacy Questionnaire
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Measured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire)
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Measured using the 2-Item Patient Health Questionnaire
Time frame: 3, 6, 9, and 12 months follow-up
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)
Time frame: 3, 6, 9, and 12 months follow-up
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)
Time frame: 3, 6, 9, and 12 months follow-up
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.
Time frame: Baseline
Percentage of participants assessed within 48 hours of calling for an appointment
Time frame: 12 months
Number of consultations with primary care team members for hip or knee pain (e.g., physicians, nurse practitioners, nurses, social workers, occupational therapists)
Time frame: 12 months
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)
Time frame: 12 months
Survey questions related to hip or knee pain: number of medications taken. Includes type of medication, dose, frequency
Time frame: 12 months
Survey questions related to hip or knee pain: number of walk-in clinic visits outside of primary care centre
Time frame: 12 months
Survey questions related to hip or knee pain: number of emergency department visits
Time frame: 12 months
Survey questions related to hip or knee pain: number of overnight hospital stays
Time frame: 12 months
Survey questions related to hip or knee pain: number of surgeries, procedures, and injections
Time frame: 12 months
Survey questions related to hip or knee pain: number of visits to specialists
Time frame: 12 months
Survey questions related to hip or knee pain: number of diagnostic images received
Time frame: 12 months
Collected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed
Time frame: 12 months
Collected from the EMR: diagnostic images ordered for hip or knee pain
Time frame: 12 months
Collected from the EMR: exercises prescribed for hip or knee pain
Time frame: 12 months
Collected from the EMR: education provided for hip or knee pain
Time frame: 12 months
Collected from the EMR: referrals to other HCPs (both internal and external to the primary health care team) for hip or knee pain
Time frame: 12 months
Collected from the EMR: visits to the primary care team for hip or knee pain
Time frame: 12 months
Collected from the EMR: notes provided to employers or insurers for hip or knee pain
Time frame: 12 months
Self-reported time lost from work, volunteering, homemaking, and educational activities
Time frame: 12 months
Self-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation
Time frame: 12 months
Any extra expenses incurred as a result of hip or knee pain. Self-report
Time frame: 12 months
Costs associated with all health utilization, self-reported time lost, assistance needed, and extra expenses. Will be presented as aggregate and time-specific costs
Time frame: Baseline
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.
Time frame: Baseline
Measured at baseline using the Functional Comorbidity Index (an 18-item list of comorbidities that are associated with physical functioning).
Time frame: Baseline
Self-reported length of time since current and first incidence of hip or knee pain
Time frame: 3 months follow-up
Self-report adherence to PT advice
Jordan Miller, PT, PhD
Other
Determining the Impact of a New Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Cluster Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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