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临床试验/NCT03961711
NCT03961711已完成不适用

Randomized Controlled Trial Assessing Post-operative Telemedicine Versus In-Person Clinic Visits in Hip and Knee Arthroplasty

The Hawkins Foundation2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2019年5月10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
98
试验地点
2
主要终点
Patient reported satisfaction

研究概览

简要总结

The objective of this study is to evaluate patient perspective on telemedicine used in 3 week post operative visits for knee and hip arthroplasty. It is hypothesized that patient satisfaction with telemedicine follow-up is equal to patient satisfaction with in-office followup. Patient satisfaction will be assessed at the 3-week and 9-week post-operative timepoints.

详细描述

In 2014 there were 370,770 total hip replacements and 680,150 total knee replacements performed in the United States. As the elderly proportion of the population continues to grow, it is estimated that the number of total hip arthroplasty will grow by 71 percent and total knee arthroplasty will grow by 85 percent by the year 2030 (Sloan, M The Journal of Bone and Joint Surgery 2018). As these numbers continue to rise, health care delivery must evolve into a more efficient, cost effective system without compromising the quality of the care delivered.

Telemedicine involves using electronic communications and software to provide clinical services to patients in place of an in-person visit. Benefits of telemedicine include avoiding unnecessary trips to hospitals, saving time, and reducing the number of working days missed (Asiri, A Acta Inform Med 2018). Used in general surgery followup care, anonymous survey responses demonstrated a high degree of satisfaction with 85% expressing a desire to utilize telemedicine for followup care in the future (Nikolian, V Annals of Surgery 2018). Postoperative telemedicine has been studied in many specialties, but literature exploring its use in orthopedics has been scant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • There will be two arms of this study, knee and hip patients.
  • Knee: All adult patients over the age of 18 scheduled for a primary total knee arthroplasty will be eligible for the inclusion in the study.
  • Hips: All adult patients over the age of 18 scheduled for a primary total hip arthroplasty will be eligible for the inclusion in the study.

排除标准

  • lack of access to a telephone
  • history of wound complications
  • venous thromboembolism (deep vein thrombosis and/or pulmonary embolism),
  • significant cardiac history (myocardial infarction, angina, stroke, lower limb ischemia)
  • Subject with any condition (including cognitive impairment) that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

结局指标

主要结局

Patient reported satisfaction

时间窗: 9 weeks

Client Satisfaction Questionnaire (CSQ-8) will be used to assess patient satisfaction of the 3 week encounter both at 3 and 9 weeks post-operatively. The scale of the survey ranges from 8-32, with 32 being the best score and 8 being the worst. The higher a patient scores, the more satisfied the patient is with the care provided.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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