Alberta Hip and Knee Replacement Project

Study Overview
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Brief Summary
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The study aims to determine if a New Arthroplasty Care Model, established on evidence-based medicine and best practices, will improve patient outcomes and improve cost effectiveness for patients with severe degenerative joint disease of the hip or knee in Alberta

Detailed Description
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The Alberta Orthopaedic Society through its Arthroplasty Service Design Working Group has, after carefully reviewing the existing conventional approach to arthroplasty care, developed what they believe could be a much improved new evidence based arthroplasty care model. This model represents how ideally a patient would access and receive health services across the complete continuum of care. In addition, wherever possible, evidence gathered from the literature and from known best practices has been utilized to develop standards related to access, wait times, clinical quality, resource use and health outcome measures. Where no evidence or known best practices exist, a standard that best support achieving other known standards are being developed. This new evidence based arthroplasty model seeks to significantly minimize and where possible, eliminate all the current gaps and barriers to arthroplasty care. This study will seek to prove that the new evidence based arthroplasty model will deliver improved patient outcomes with improved cost effectiveness. Once proven, it is anticipated that this new evidence based arthroplasty model will become the standard of care in Alberta, and a model for other jurisdictions to use in their health service re-designs

Official Title
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A Randomized Controlled Prospective Study to Examine the Effectiveness of a New Evidence Based Arthroplasty Care Model for Patients With Severe Degenerative Joint Disease (DJD) of the Hip or Knee in Alberta

Conditions
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Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee

Intervention / Treatment
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* Other: New Care Continuum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years of age Patient is able to provide written consent Exclusion Criteria: Patient has previously undergone arthroplasty of the same hip or knee (revision) Patient has a surgical date scheduled for arthroplasty Patient requires a hip resurfacing procedure or an oxford knee Patient has a concurrent medical condition that would contraindicate the patients' ability to participate fully in the study procedures, including terminal conditions such as chronic obstructive pulmonary disease, end stage renal disease, heart failure, malignancy with an anticipated life expectancy of ≤ 2 years Patient has senile dementia or Alzheimer's disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Patients entering new care continuum | Other: New Care Continuum<br>* Patient experience surgery through newly designed arthroplasty continuum<br>|
| Active Comparator: Control<br>Patient enter existing conventional approach | Other: New Care Continuum<br>* Patient experience surgery through newly designed arthroplasty continuum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health related quality of life scores |  | 3 month and 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health resource utilization |  | 3 month and 12 months post-surgery | 
| wait time |  | Pre-surgery | 
| safety |  | 3 month and 12 months post-surgery | 
| cost utility |  | 3 month and 12 months post-surgery | 
| patient satisfaction |  | 3 month and 12 months post-surgery | 
| provider satisfaction |  | 3 month and 12 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Health services research, Intent to treat, Randomized, Controlled