Inpatient vs Outpatient Total Knee Replacement

Study Overview
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Brief Summary
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This is a prospective cohort study comparing standard inpatient (overnight hospital stay) total knee arthroplasty with same day discharge. Patients who are medically well and have a good support structure at home will be recruited. This study will compare patient satisfaction and costs from the perspectives of the Ministry of Health, the institution, society and the patient.

Detailed Description
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Osteoarthritis (OA) is a leading cause of disability and reduced quality of life, presenting a substantial, growing burden to patients and the healthcare system (1). Total knee arthroplasty (TKA) is an established, effective interventions for advanced OA. The prevalence of knee OA is rapidly increasing, resulting in a rising demand for care. The number of procedures is expected to grow by 48%, by 2020 in the US (2). Currently, TKA along with total hip arthroplasty (THA), have a significant impact on healthcare budgets, costing approximately $1.2 billion in annual spending in Canada (3). These staggering numbers highlight the critical need to improve care delivery. A significant proportion of the overall cost of joint replacement results from the inpatient hospital stay following the procedure. Historically, the standard procedure following TKA required an inpatient hospital stay of two and a half to three weeks, however the introduction of less invasive surgical techniques, improved medical and analgesia management and comprehensive rehabilitation have enabled shorter inpatient stays. Today, the median inpatient stay following TKA is three days in Canada (3). A desire for greater autonomy by the patients as well as patients wanting early mobilization to accelerate recovery and return to activities has led some clinicians to consider an outpatient arthroplasty program. The proposed benefits of outpatient arthroplasty include similar patient outcomes with significantly lower hospital costs, and improved patient satisfaction, independence, and autonomy, however there is a lack of high-quality evidence comparing clinical outcomes of outpatient to inpatient arthroplasty models of care. A retrospective analysis of over 50,000 THA and TKA procedures found no differences in 30-day major complications or readmissions among patients with a zero to two-day hospital stay compared to those discharged on day three or four postoperative (4). Small cohort studies (5-8) suggest lower costs for outpatients and improved patient satisfaction but have inherent biases; limited to carefully selected patients in privatized health systems. It is estimated that up to 20% of the overall cost of joint replacement can be attributed to the inpatient stay in hospital at our institution (9). By discharging patients as outpatients, it could be possible to save 20% of the overall costs of joint replacement. Although these preliminary calculations are encouraging, it is not sufficient to effect change solely to achieve cost control, without consideration of safety, effectiveness and patient satisfaction. Further, it is unknown whether the financial savings will be outweighed by additional postoperative costs, increased readmissions or decreased quality of care. A full economic evaluation that simultaneously evaluates cost and effectiveness is crucial prior to implementation. The lack of high-quality evidence regarding its effectiveness warrants a rigorous comparative trial. The purpose of this study is to evaluate outpatient care pathways for TKA. Specifically, our objectives are to compare the rate of serious adverse events and estimate the cost-effectiveness of outpatient compared to standard inpatient TKA.

Official Title
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Cost and Patient Satisfaction Associated With Total Knee Arthroplasty

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: Outpatient
* Procedure: Inpatient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis of the knee Booked for primary unilateral total knee arthroplasty Have the ability to read and understand English (printed instructions are provided in English only) Home / cell phone access Planning to be discharged to home environment Patient has an adult to accompany them home post-operatively Exclusion Criteria: Cognitive issues that preclude the ability to understand instructions or provide informed consent Lack of a social supports at home American Society of Anaesthesiologists (ASA) score equal to or less than 4

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outpatient<br>Patients in the outpatient group (same day discharge following TKA) are discharged the same day following surgery. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver). | Procedure: Outpatient<br>* Patients in the outpatient group will be discharged from the hospital the same day of surgery following a total knee arthroplasty<br>|
| Active Comparator: Inpatient<br>Patients in the inpatient group (following day discharge following TKA) stay in the hospital overnight and then are discharged home the next day. All patients are required to meet the discharge criteria to be sent home (i.e., capable of using crutches, relatively free of pain, free of nausea and vomiting, free of excess bleeding, alert and oriented, given take-home medications, and in the company of a caregiver). | Procedure: Inpatient<br>* Patients in the inpatient group will be discharged from the hospital the following day after a total knee arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indirect and direct costs of treatment | ER visits, clinician visits, caregiver lost productivity, tests, etc. | 1 Year | 
| Rate of early complications and adverse events | fall, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc. | 1 Year | 
| Standardized measure of health outcome (EQ-5D) | utility score measured on a scale of 0 (death) to 1 (perfect health) | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction questionnaire | patient satisfaction with care pre-, peri- and postoperative | 2 Weeks | 
| Western Ontario McMaster Osteoarthritis Index (WOMAC) | functional outcome measured on a total scale of 0 (better function) to 100 (worse function) and made up of subscales for pain, stiffness and function | 1 Year | 
| Knee Society Score | functional outcome measured on a scale of 0 (worse function) to 100 (best function) | 1 Year | 
| Veterans Rand 12 | quality of life measured on a scale of 0 (worse) to 100 (better) using norm-based scoring | 1 Year | 
| Pain Numeric Rating Scale | pain measured on a scale from 0 (no pain) to 10 (worst pain imaginable) | 1 Year | 
| Oxford Knee Score - English for Canada | Level of function, activities of daily living, and effects of pain over preceding four weeks, measured with 12 questions each on a scale from 0 (worst outcome) to 4 (best outcome). A higher score represents a better outcome, with total score range from 1-48. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cost, Total Knee Replacement, Outpatient Surgery, Satisfaction, Arthroplasty