Hip Osteoarthritis, Knee Osteoarthritis
Conditions
Brief summary
This is a 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. Osteoarthritis (OA) is the most common form of arthritis, especially in the hips and knees, which affects over four million Canadians. OA places a huge burden on society, in terms of both direct and indirect costs, including lost time at work, lost years of productivity, and decreased quality of life. People living with OA complain of chronic pain and negative impacts on their quality of life. For many, the first point of contact for their OA is their primary care provider. Due to the rise in patients seeking support through primary care and the shortage of care providers and the high burden on these providers, patients often do not receive timely access to care. Additionally, for patients without primary care providers, their first point of contact for their OA is often the emergency department (ED), which contributes to long wait times and staff burnout. The need for integrative models of care has been advocated for as an evidenced-informed and patient-centered approach to managing patients with OA. In Canada, federal and provincial governments have identified that interprofessional teams with complementary skillsets are required to address patients' multiple needs and to improve the effectiveness of the healthcare system. Research from other health conditions suggests team-based primary care can improve access to appropriate care, coordination of care, and patient outcomes. One example of such an integrated model of care is having a physiotherapist (PT) as 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 complaints related to hip and knee OA. This model of care has the potential to improve patient outcomes and positively influence the current challenges within the healthcare system. The study seeks to address the following research questions: 1. Is a PT-led primary care model for hip and knee pain effective at improving function (primary outcome), pain intensity, quality of life, global rating of change, patient satisfaction, and adverse events compared to usual physician-led primary care, when evaluated over a one-year period from the initial consultation? 2. What is the impact of a PT-led primary care model for hip and knee pain on the health system and society (healthcare access, physician workload, healthcare utilization, missed work, cost-effectiveness), evaluated over a one-year period from initial consultation? A process evaluation will be used to understand the process of implementing a PT-led primary care model, potential mechanisms of the interventions, context of delivery, and perceptions of patients and primary care providers toward the PT-led primary care model for hip and knee pain.
Interventions
1. 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. Participants will be assessed regarding the need for specialist referrals or resources available to manage complex clinical presentations. Participants may be referred to the primary care provider if no specialized services are needed or when the PT cannot provide a direct referral. 4. Additional PT care: Patients who require community PT but do not have the appropriate coverage for community-based services will be managed by the PT who provided the assessment in the primary care setting.
The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
Sponsors
Study design
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.
Intervention model description
This is a cluster randomized controlled trial randomizing 14 sites to the PT-led primary care model for hip/knee pain or to the usual physician/nurse practitioner-led care model
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Reported Functioning | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catastrophic Thinking | 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) |
| Fear of Movement | Baseline and 3, 6, 9, and 12 months follow-up | Measured using the Tampa Scale of Kinesiophobia (an 11-item questionnaire) |
| Depression Subscale | Baseline and 3, 6, 9, and 12 months follow-up | Measured using the 2-Item Patient Health Questionnaire |
| Global Rating of Change | 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) |
| Satisfaction with Health Care | 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) |
| Adverse Events | 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. |
| Health-Care Utilization - Consultations in Electronic Medical Record (EMR) | 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) |
| Health-Care Utilization Survey - Visits to health professionals | 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) |
| Health-Care Utilization Survey - Medications | 12 months | 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 | 12 months | 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 | 12 months | Survey questions related to hip or knee pain: number of emergency department visits |
| Health-Care Utilization Survey - Inpatient Hospital Stays | 12 months | Survey questions related to hip or knee pain: number of overnight hospital stays |
| Health-Care Utilization Survey - Surgeries, Procedures, Injections | 12 months | Survey questions related to hip or knee pain: number of surgeries, procedures, and injections |
| Health-Care Utilization Survey - Specialist Visits | 12 months | Survey questions related to hip or knee pain: number of visits to specialists |
| Health-Care Utilization Survey - Diagnostic Imaging | 12 months | Survey questions related to hip or knee pain: number of diagnostic images received |
| Process Outcome - Medications prescribed | 12 months | Collected from the EMR: medications prescribed for hip or knee pain. Includes the type of medication prescribed |
| Process Outcome - Diagnostic Imaging Ordered | 12 months | Collected from the EMR: diagnostic images ordered for hip or knee pain |
| Process Outcome - Exercises Prescribed | 12 months | Collected from the EMR: exercises prescribed for hip or knee pain |
| Process Outcome - Education Provided | 12 months | Collected from the EMR: education provided for hip or knee pain |
| Process Outcome - Referrals to other health care providers (HCPs) | 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 |
| Process Outcome - Primary Care Visits | 12 months | Collected from the EMR: visits to the primary care team for hip or knee pain |
| Process Outcome - Notes to Employers or Insurers | 12 months | Collected from the EMR: notes provided to employers or insurers for hip or knee pain |
| Self-Report Time Lost | 12 months | Self-reported time lost from work, volunteering, homemaking, and educational activities |
| Assistance Needed | 12 months | Self-reported assistance needed, due to hip or knee pain, for self-care, housework, shopping, or transportation |
| Extra Expenses | 12 months | Any extra expenses incurred as a result of hip or knee pain. Self-report. |
| Cost outcomes | 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 |
| Health Care Accessibility | Baseline | Percentage of participants assessed within 48 hours of calling for an appointment |
| Self-Reported Pain Intensity | 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. |
| Pain Self Efficacy | Baseline and 3, 6, 9, and 12 months follow-up | Confidence in abilities to participate in usual activities using the Pain Self Efficacy Questionnaire |
| Health-Related Quality of Life | 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) |
Countries
Canada
Contacts
Queen's University