跳至主要内容
临床试验/NCT04228731
NCT04228731已完成不适用

Cost and Patient Satisfaction Associated With Total Knee Arthroplasty

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's2 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2020年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
123
试验地点
2
主要终点
Rate of early complications and adverse events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Rate of early complications and adverse events

时间窗: 1 Year

fall, wound problems, pulmonary embolism, deep vein thrombosis, infection, etc.

Indirect and direct costs of treatment

时间窗: 1 Year

ER visits, clinician visits, caregiver lost productivity, tests, etc.

Standardized measure of health outcome (EQ-5D)

时间窗: 1 Year

utility score measured on a scale of 0 (death) to 1 (perfect health)

次要结局

  • Pain Numeric Rating Scale(1 Year)
  • Oxford Knee Score - English for Canada(1 Year)
  • Patient satisfaction questionnaire(2 Weeks)
  • Knee Society Score(1 Year)
  • Veterans Rand 12(1 Year)
  • Western Ontario McMaster Osteoarthritis Index (WOMAC)(1 Year)

研究者

研究点 (2)

Loading locations...

相似试验