Hip OsteoarthritisNCT05736133
Determining the Impact of a Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Trial
A study testing Physiotherapist-led primary care model for hip and knee pain and Usual physician-led primary care model for hip and knee pain in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Jordan Miller, PT, PhD at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hip Osteoarthritis, Knee Osteoarthritis
- What is being tested?
- Physiotherapist-led primary care model for hip and knee pain and Usual physician-led primary care model for hip and knee pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteCanada
- Study dates
- 2 Oct 2023to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults >= 19 years who ask to book a primary care visits where the primary reason is for hip or knee pain of any duration.
Who cannot join
- Cannot understand, read, and write English
- Known cancer causing hip or knee pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Impact of a New Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Cluster Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Being tested
- Physiotherapist-led primary care model for hip and knee pain, Usual physician-led primary care model for hip and knee pain
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist-led primary care model for hip and knee painOther
- 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 or presented with group exercise options. Participants will be assessed regarding the need for specialist referrals or resources available to manage complex clinical presentations such as comorbidity or frailty. Participants may be referred to the primary care provider if no specialized services are needed or when the PT cannot provide a direct referral. All individuals may have their medications reviewed by a physician if deemed appropriate by the PT or requested by the participant.
Usual physician-led primary care model for hip and knee painOther
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapist-led primary care model for hip and knee pain | Experimental | 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). Receives: Other: Physiotherapist-led primary care model for hip and knee pain |
| Usual physician-led primary care model for hip and knee pain | Active comparator | 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. Receives: Other: Usual physician-led primary care model for hip and knee pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment Rate
A full trial will be feasible if the investigators are able to recruit 1.5 participants per week per site over 20 weeks
Measured: 20 weeks
Assessment Procedures
The investigators consider ≥80% of all assessment items completed and a mean time for completion of ≤60 minutes acceptable.
Measured: 12 months
Retention
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
Measured: 12 months
PT Treatment Fidelity
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.
Measured: 20 weeks
Secondary outcomes (31)
Self-Reported Functioning
Self-report using the Lower Extremity Functional Scale (0-80 score with higher score representing higher function)
Measured: Baseline and 3, 6, 9, and 12 months follow-up
Self-Reported Pain Intensity
Measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity.
Measured: 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)
Measured: 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
Measured: 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)
Measured: Baseline and 3, 6, 9, and 12 months follow-up
Fear of Movement
Measured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire)
Measured: Baseline and 3, 6, 9, and 12 months follow-up
Depression Subscale
Measured using the 2-Item Patient Health Questionnaire
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 3, 6, 9, and 12 months follow-up
Health Care Accessibility
Percentage of participants assessed within 48 hours of calling for an appointment
Measured: 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)
Measured: 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)
Measured: 12 months
Health-Care Utilization Survey - Medications
Survey questions related to hip or knee pain: number of medications taken. Includes type of medication, dose, frequency
Measured: 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
Measured: 12 months
Health-Care Utilization Survey - Emergency Department Visits
Survey questions related to hip or knee pain: number of emergency department visits
Measured: 12 months
Health-Care Utilization Survey - Inpatient Hospital Stays
Survey questions related to hip or knee pain: number of overnight hospital stays
Measured: 12 months
Health-Care Utilization Survey - Surgeries, Procedures, Injections
Survey questions related to hip or knee pain: number of surgeries, procedures, and injections
Measured: 12 months
Health-Care Utilization Survey - Specialist Visits
Survey questions related to hip or knee pain: number of visits to specialists
Measured: 12 months
Health-Care Utilization Survey - Diagnostic Imaging
Survey questions related to hip or knee pain: number of diagnostic images received
Measured: 12 months
Process Outcome - Medications Prescibed
Collected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed
Measured: 12 months
Process Outcome - Diagnostic Imaging Ordered
Collected from the EMR: diagnostic images ordered for hip or knee pain
Measured: 12 months
Process Outcome - Exercises Prescribed
Collected from the EMR: exercises prescribed for hip or knee pain
Measured: 12 months
Process Outcome - Education Provided
Collected from the EMR: education provided for hip or knee pain
Measured: 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
Measured: 12 months
Process Outcome - Primary Care Visits
Collected from the EMR: visits to the primary care team for hip or knee pain
Measured: 12 months
Process Outcome - Notes to Employers or Insurers
Collected from the EMR: notes provided to employers or insurers for hip or knee pain
Measured: 12 months
Self-Report Time Lost
Self-reported time lost from work, volunteering, homemaking, and educational activities
Measured: 12 months
Assistance Needed
Self-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation
Measured: 12 months
Extra Expenses
Any extra expenses incurred as a result of hip or knee pain. Self-report
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start2 Oct 2023
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot cluster randomized controlled trial randomizing 14 sites to the PT-led primary care model for hip/knee pain or to the usual care model
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jordan Miller, PT, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Arthritis Society, Canada
- Responsible party
- Sponsor-investigator, Jordan Miller, PT, PhD, Queen's University
- Investigators
- Jordan Miller, PhD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736133
- Sponsor's protocol ID
- 6038205
- Status last verified
- Mar 2025
- First submitted
- 9 Feb 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The is no plan to share individual IPD with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Impact of a New Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05736133
- Acronym / sponsor ID
- 6038205
- Conditions
- Hip Osteoarthritis, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Jordan Miller, PT, PhDUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), The Arthritis Society, Canada
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a pilot cluster randomized controlled trial randomizing 14 sites to the PT-led primary care model for hip/knee pain or to the usual care model
| Arm | Type | Receives |
|---|---|---|
| Physiotherapist-led primary care model for hip and knee pain | Experimental | Other: Physiotherapist-led primary care model for hip and knee painThe 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). |
| Usual physician-led primary care model for hip and knee pain | Active comparator | Other: Usual physician-led primary care model for hip and knee painParticipants 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults >= 19 years who ask to book a primary care visits where the primary reason is for hip or knee pain of any duration.
Key exclusion criteria (2 listed)
- Cannot understand, read, and write English
- Known cancer causing hip or knee pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapist-led primary care model for hip and knee pain1. 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 or presented with group exercise options. Participants will be assessed regarding the need for specialist referrals or resources available to manage complex clinical presentations such as comorbidity or frailty. Participants may be referred to the primary care provider if no specialized services are needed or when the PT cannot provide a direct referral. All individuals may have their medications reviewed by a physician if deemed appropriate by the PT or requested by the participant. | Other | Physiotherapist-led primary care model for hip and knee pain |
| Usual physician-led primary care model for hip and knee painThe physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada. | Other | Usual physician-led primary care model for hip and knee pain |
Primary outcome
Participant Recruitment Rate
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
Assessment Procedures
Time frame: 12 months
The investigators consider ≥80% of all assessment items completed and a mean time for completion of ≤60 minutes acceptable.
Retention
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
PT Treatment Fidelity
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.
31 secondary outcomes
Self-Reported Functioning
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Self-Reported Pain Intensity
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Health-Related Quality of Life
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Pain Self Efficacy
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Catastrophic Thinking
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Fear of Movement
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Depression Subscale
Time frame: Baseline and 3, 6, 9, and 12 months follow-up
Global Rating of Change
Time frame: 3, 6, 9, and 12 months follow-up
Satisfaction with Health Care
Time frame: 3, 6, 9, and 12 months follow-up
Adverse Events
Time frame: 3, 6, 9, and 12 months follow-up
Health Care Accessibility
Time frame: Baseline
Health-Care Utilization - Consultations in Electronic Medical Record (EMR)
Time frame: 12 months
Health-Care Utilization Survey - Visits to health professionals
Time frame: 12 months
Health-Care Utilization Survey - Medications
Time frame: 12 months
Health-Care Utilization Survey - Walk-In Clinic Visits
Time frame: 12 months
Health-Care Utilization Survey - Emergency Department Visits
Time frame: 12 months
Health-Care Utilization Survey - Inpatient Hospital Stays
Time frame: 12 months
Health-Care Utilization Survey - Surgeries, Procedures, Injections
Time frame: 12 months
Health-Care Utilization Survey - Specialist Visits
Time frame: 12 months
Health-Care Utilization Survey - Diagnostic Imaging
Time frame: 12 months
Process Outcome - Medications Prescibed
Time frame: 12 months
Process Outcome - Diagnostic Imaging Ordered
Time frame: 12 months
Process Outcome - Exercises Prescribed
Time frame: 12 months
Process Outcome - Education Provided
Time frame: 12 months
Process Outcome - Referrals to other health care providers (HCPs)
Time frame: 12 months
Process Outcome - Primary Care Visits
Time frame: 12 months
Process Outcome - Notes to Employers or Insurers
Time frame: 12 months
Self-Report Time Lost
Time frame: 12 months
Assistance Needed
Time frame: 12 months
Extra Expenses
Time frame: 12 months
Cost Outcomes
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No. The is no plan to share individual IPD with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordan Miller, PhD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist-led primary care model for hip and knee pain and Usual physician-led primary care model for hip and knee pain in people with Hip Osteoarthritis and Knee Osteoarthritis, run by Jordan Miller, PT, PhD at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment Rate (time frame: 20 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.