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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736133
• Other study ID #: 6038205
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: February 16, 2025

Study information

• Verified date: April 2024
• Source: Queen's University
• Contact: Jordan Miller, PhD
• Phone: 905-872-9938
• Email: jordan.miller[@]queensu.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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:

1. Determine the feasibility of participant recruitment, assessment procedures, and retention.

2. Determine the feasibility of implementing a new PT led primary care model for hip and knee pain.

3. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 263
• Est. completion date: February 16, 2025
• Est. primary completion date: February 16, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip

Intervention

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 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 pain
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.

Locations

Country	Name	City	State
Canada	Queen's University	Kingston	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Jordan Miller, PT, PhD	Canadian Institutes of Health Research (CIHR), The Arthritis Society, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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, comorbidities, current work status, income, rurality, and ethnicity.	Baseline
Other	Comorbidities	Measured at baseline using the Functional Comorbidity Index (an 18-item list of comorbidities that are associated with physical functioning).	Baseline
Other	Chronicity of Pain	Self-reported length of time since current and first incidence of hip or knee pain	Baseline
Other	Participant Treatment Fidelity	Self-report adherence to PT advice	3 months follow-up
Primary	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	20 weeks
Primary	Assessment Procedures	The investigators consider =80% of all assessment items completed and a mean time for completion of =60 minutes acceptable.	12 months
Primary	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	12 months
Primary	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.	20 weeks
Secondary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fear of Movement	Measured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire)	Baseline and 3, 6, 9, and 12 months follow-up
Secondary	Depression Subscale	Measured using the 2-Item Patient Health Questionnaire	Baseline and 3, 6, 9, and 12 months follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	Health Care Accessibility	Percentage of participants assessed within 48 hours of calling for an appointment	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Health-Care Utilization Survey - Emergency Department Visits	Survey questions related to hip or knee pain: number of emergency department visits	12 months
Secondary	Health-Care Utilization Survey - Inpatient Hospital Stays	Survey questions related to hip or knee pain: number of overnight hospital stays	12 months
Secondary	Health-Care Utilization Survey - Surgeries, Procedures, Injections	Survey questions related to hip or knee pain: number of surgeries, procedures, and injections	12 months
Secondary	Health-Care Utilization Survey - Specialist Visits	Survey questions related to hip or knee pain: number of visits to specialists	12 months
Secondary	Health-Care Utilization Survey - Diagnostic Imaging	Survey questions related to hip or knee pain: number of diagnostic images received	12 months
Secondary	Process Outcome - Medications Prescibed	Collected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed	12 months
Secondary	Process Outcome - Diagnostic Imaging Ordered	Collected from the EMR: diagnostic images ordered for hip or knee pain	12 months
Secondary	Process Outcome - Exercises Prescribed	Collected from the EMR: exercises prescribed for hip or knee pain	12 months
Secondary	Process Outcome - Education Provided	Collected from the EMR: education provided for hip or knee pain	12 months
Secondary	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
Secondary	Process Outcome - Primary Care Visits	Collected from the EMR: visits to the primary care team for hip or knee pain	12 months
Secondary	Process Outcome - Notes to Employers or Insurers	Collected from the EMR: notes provided to employers or insurers for hip or knee pain	12 months
Secondary	Self-Report Time Lost	Self-reported time lost from work, volunteering, homemaking, and educational activities	12 months
Secondary	Assistance Needed	Self-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation	12 months
Secondary	Extra Expenses	Any extra expenses incurred as a result of hip or knee pain. Self-report	12 months
Secondary	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