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

Primary Purpose

Hip Osteoarthritis, Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physiotherapist-led primary care model for hip and knee pain
Usual physician-led primary care model for hip and knee pain
Sponsored by
Jordan Miller, PT, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Queen's UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physiotherapist-led primary care model for hip and knee pain

Usual physician-led primary care model for hip and knee pain

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Participant Recruitment Rate
A full trial will be feasible if the investigators are able to recruit 1.5 participants per week over 12 weeks
Assessment Procedures
The investigators consider ≥80% of all assessment items completed and a mean time for completion of ≤60 minutes acceptable.
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
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.

Secondary Outcome Measures

Self-Reported Functioning
Self-report using the Lower Extremity Functional Scale (0-80 score with higher score representing higher function)
Self-Reported Pain Intensity
Measured using a numeric pain rating scale from 0 to 10 with higher scores indicating greater pain intensity.
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)
Pain Self Efficacy
Confidence in abilities to participate in usual activities using the Pain Self Efficacy Questionnaire
Catastrophic Thinking
Measured using the Pain Catastrophizing Scale (0 to 52 with higher scores indicating greater catastrophic thinking)
Fear of Movement
Measured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire)
Depression Subscale
Measured using the 2-Item Patient Health Questionnaire
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)
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)
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.
Health Care Accessibility
Percentage of participants assessed within 48 hours of calling for an appointment
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)
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)
Health-Care Utilization Survey - Medications
Survey questions related to hip or knee pain: number of medications taken. Includes type of medication, dose, frequency
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
Health-Care Utilization Survey - Emergency Department Visits
Survey questions related to hip or knee pain: number of emergency department visits
Health-Care Utilization Survey - Inpatient Hospital Stays
Survey questions related to hip or knee pain: number of overnight hospital stays
Health-Care Utilization Survey - Surgeries, Procedures, Injections
Survey questions related to hip or knee pain: number of surgeries, procedures, and injections
Health-Care Utilization Survey - Specialist Visits
Survey questions related to hip or knee pain: number of visits to specialists
Health-Care Utilization Survey - Diagnostic Imaging
Survey questions related to hip or knee pain: number of diagnostic images received
Process Outcome - Medications Prescibed
Collected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed
Process Outcome - Diagnostic Imaging Ordered
Collected from the EMR: diagnostic images ordered for hip or knee pain
Process Outcome - Exercises Prescribed
Collected from the EMR: exercises prescribed for hip or knee pain
Process Outcome - Education Provided
Collected from the EMR: education provided for hip or knee pain
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
Process Outcome - Primary Care Visits
Collected from the EMR: visits to the primary care team for hip or knee pain
Process Outcome - Notes to Employers or Insurers
Collected from the EMR: notes provided to employers or insurers for hip or knee pain
Self-Report Time Lost
Self-reported time lost from work, volunteering, homemaking, and educational activities
Assistance Needed
Self-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation
Extra Expenses
Any extra expenses incurred as a result of hip or knee pain. Self-report
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

Full Information

First Posted
February 9, 2023
Last Updated
October 2, 2023
Sponsor
Jordan Miller, PT, PhD
Collaborators
Canadian Institutes of Health Research (CIHR), The Arthritis Society, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT05736133
Brief Title
Determining the Impact of a New Physiotherapist-Led Primary Care Model for Hip and Knee Pain
Official Title
Determining the Impact of a New Physiotherapist-Led Primary Care Model for Hip and Knee Pain - A Pilot Cluster Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2, 2023 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jordan Miller, PT, PhD
Collaborators
Canadian Institutes of Health Research (CIHR), The Arthritis Society, Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking Description
Due to the nature of the new model of care and comparison, it is not possible to blind the patient participants or health care providers. Since the primary outcomes are self-reported outcome measures, the assessor is also not blind to the intervention.
Allocation
Randomized
Enrollment
263 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapist-led primary care model for hip and knee pain
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual physician-led primary care model for hip and knee pain
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapist-led primary care model for hip and knee pain
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual physician-led primary care model for hip and knee pain
Intervention Description
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
Primary Outcome Measure Information:
Title
Participant Recruitment Rate
Description
A full trial will be feasible if the investigators are able to recruit 1.5 participants per week over 12 weeks
Time Frame
12 weeks
Title
Assessment Procedures
Description
The investigators consider ≥80% of all assessment items completed and a mean time for completion of ≤60 minutes acceptable.
Time Frame
12 months
Title
Retention
Description
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
12 months
Title
PT Treatment Fidelity
Description
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
12 weeks
Secondary Outcome Measure Information:
Title
Self-Reported Functioning
Description
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
Title
Self-Reported Pain Intensity
Description
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
Title
Health-Related Quality of Life
Description
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
Title
Pain Self Efficacy
Description
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
Title
Catastrophic Thinking
Description
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
Title
Fear of Movement
Description
Measured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire)
Time Frame
Baseline and 3, 6, 9, and 12 months follow-up
Title
Depression Subscale
Description
Measured using the 2-Item Patient Health Questionnaire
Time Frame
Baseline and 3, 6, 9, and 12 months follow-up
Title
Global Rating of Change
Description
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
Title
Satisfaction with Health Care
Description
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
Title
Adverse Events
Description
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
3, 6, 9, and 12 months follow-up
Title
Health Care Accessibility
Description
Percentage of participants assessed within 48 hours of calling for an appointment
Time Frame
Baseline
Title
Health-Care Utilization - Consultations in Electronic Medical Record (EMR)
Description
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
Title
Health-Care Utilization Survey - Visits to health professionals
Description
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
Title
Health-Care Utilization Survey - Medications
Description
Survey questions related to hip or knee pain: number of medications taken. Includes type of medication, dose, frequency
Time Frame
12 months
Title
Health-Care Utilization Survey - Walk-In Clinic Visits
Description
Survey questions related to hip or knee pain: number of walk-in clinic visits outside of primary care centre
Time Frame
12 months
Title
Health-Care Utilization Survey - Emergency Department Visits
Description
Survey questions related to hip or knee pain: number of emergency department visits
Time Frame
12 months
Title
Health-Care Utilization Survey - Inpatient Hospital Stays
Description
Survey questions related to hip or knee pain: number of overnight hospital stays
Time Frame
12 months
Title
Health-Care Utilization Survey - Surgeries, Procedures, Injections
Description
Survey questions related to hip or knee pain: number of surgeries, procedures, and injections
Time Frame
12 months
Title
Health-Care Utilization Survey - Specialist Visits
Description
Survey questions related to hip or knee pain: number of visits to specialists
Time Frame
12 months
Title
Health-Care Utilization Survey - Diagnostic Imaging
Description
Survey questions related to hip or knee pain: number of diagnostic images received
Time Frame
12 months
Title
Process Outcome - Medications Prescibed
Description
Collected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed
Time Frame
12 months
Title
Process Outcome - Diagnostic Imaging Ordered
Description
Collected from the EMR: diagnostic images ordered for hip or knee pain
Time Frame
12 months
Title
Process Outcome - Exercises Prescribed
Description
Collected from the EMR: exercises prescribed for hip or knee pain
Time Frame
12 months
Title
Process Outcome - Education Provided
Description
Collected from the EMR: education provided for hip or knee pain
Time Frame
12 months
Title
Process Outcome - Referrals to other health care providers (HCPs)
Description
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
Title
Process Outcome - Primary Care Visits
Description
Collected from the EMR: visits to the primary care team for hip or knee pain
Time Frame
12 months
Title
Process Outcome - Notes to Employers or Insurers
Description
Collected from the EMR: notes provided to employers or insurers for hip or knee pain
Time Frame
12 months
Title
Self-Report Time Lost
Description
Self-reported time lost from work, volunteering, homemaking, and educational activities
Time Frame
12 months
Title
Assistance Needed
Description
Self-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation
Time Frame
12 months
Title
Extra Expenses
Description
Any extra expenses incurred as a result of hip or knee pain. Self-report
Time Frame
12 months
Title
Cost Outcomes
Description
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
12 months
Other Pre-specified Outcome Measures:
Title
Baseline Characteristics
Description
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
Title
Comorbidities
Description
Measured at baseline using the Functional Comorbidity Index (an 18-item list of comorbidities that are associated with physical functioning).
Time Frame
Baseline
Title
Chronicity of Pain
Description
Self-reported length of time since current and first incidence of hip or knee pain
Time Frame
Baseline
Title
Participant Treatment Fidelity
Description
Self-report adherence to PT advice
Time Frame
3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Miller, PhD
Phone
905-872-9938
Email
jordan.miller@queensu.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Chad McClintock, MSc
Phone
613-530-6758
Email
cwm2@queensu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jordan Miller, PhD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jordan Miller

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The is no plan to share individual IPD with other researchers

Learn more about this trial

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

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