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临床试验/NCT03481595
NCT03481595已完成不适用

Improvement of Patient Satisfaction and Overall Outcomes Using HealthLoop to Manage the Episode of Care for THA and TKA Bundles

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2018年4月17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
294
试验地点
2
主要终点
Percentage of Participants Reporting a Problem Across al PPE-15 Domains

研究概览

简要总结

The purpose of this study is to assess the usefulness and results of orthopedic patients having access to a cell phone App called HealthLoop to utilize during the postoperative time period, compared to patients who have the usual postoperative management. The researchers want to investigate whether there any differences in outcomes and satisfaction in patients and providers.

详细描述

The purpose of this study is to assess the usefulness and results of orthopedic patients having access to a cell phone App called HealthLoop to utilize during the postoperative time period, compared to patients who have the usual postoperative management. The researchers want to investigate whether there any differences in outcomes and satisfaction in patients and providers.

HealthLoop is a mobile-device application (cell phone App) that allows physicians to monitor for signs and symptoms of potential adverse events, and communicate with patients during the postoperative recovery process. The platform enables doctors to identify patients at risk of decline in the follow up period. Patients are engaged through mobile and web-based surveys, reminders, and information personalized to the patient's specific condition or treatment plan. Alerts are sent to physicians about patients who are at risk of treatment failures, complications, or hospital readmissions. Physicians are informed if patients are trending toward an adverse outcome based on the patient's responses.

Patients who choose to participate in this Research Study will be randomly assigned (like a flip of a coin) to one of two groups. Group A will receive standard, routine medical care. Group B will be asked to use the HealthLoop application on their mobile device during the post-operative period in addition to standard, routine medical care. Patients will not be able to choose which group they will be in.

研究设计

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

  • Primary total hip arthroplasty or total knee arthroplasty patient
  • Personal or surrogate consent to participate
  • Patient has internet access or mobile access with a valid email address at the time of enrollment

排除标准

  • Staged arthroplasty procedure within 6 months of the index procedure
  • Abandoned email address of record
  • Less than 14 days until date of surgery

结局指标

主要结局

Percentage of Participants Reporting a Problem Across al PPE-15 Domains

时间窗: 90 days after index surgery

15-item patient experience questionnaire. Each response will be categorized as a problem or non-problem and reported as the percent of respondents reporting a problem, averaged across all PPE-15 domains.

次要结局

  • Number of Participants Discharged to Home(90 days after index surgery)
  • Number Participants Who Visited the Emergency Department(90 days after index surgery)
  • Number Participants With 0, 1, 2, or 3+ Outpatient Visits(90 days after index surgery)
  • Number of Participants Who Made 0, 1, 2, or 3+ Telephone Calls to the Surgical Team(90 days after index surgery)
  • Number of Participants Who Had a Reoperation(90 days after index surgery)
  • Length of Hospital Stay(90 days after index surgery)
  • Number Participants Who Were Readmitted to the Hospital(90 days after index surgery)
  • Visual Analog Scale (VAS) for Patient Satisfaction(90 days after index surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlos Higuera-Rueda

Vice Chair for Quality and Patient Safety

The Cleveland Clinic

研究点 (2)

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