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临床试验/NCT04948632
NCT04948632已完成不适用

A Medico-Economic Evaluation of a Telehealth Platform for Elective Outpatient Surgeries: a Trial Study

Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,000
试验地点
2
主要终点
Cost-effectiveness analysis of the LeoMed® telecare platform

研究概览

简要总结

The main objective of this study is to carry out a medico-economic evaluation of a new platform for outpatient surgical care, by comparing the effectiveness and utility of the deployment of this trajectory on patients and the health system to a control group.

详细描述

Outpatient surgery allows the patient to leave the hospital on the day of their surgery and thus avoid complete hospitalization. There are many advantages to this practice. Patients can remain in the comfort of their own home with the support of their family caregivers and the healthcare system can avoid incurring additional hospital costs and redirect these savings to other critical needs. However, despite the advantages of outpatient surgery, the tools and measures currently in place to supervise the preparation before the operation and the follow-up after the operation are suboptimal.

Following surgery, adverse events such as moderate to severe pain, nausea/vomiting, infection and bleeding from the operative site are very rarely sought out and detected by healthcare facilities. However, these are the main causes of readmissions or emergency consultations for patients.

In order to optimize the care offer, the anesthesiology department, the innovation and artificial intelligence center of the CHUM as well as the Quebec telecare platform LeoMed have joined forces in order to offer, through a health application, follow-up and personalized support for patients undergoing outpatient surgery.

The investigators believe that the integration of this platform in the course of care will allow early diagnosis of the main postoperative complications and therefore, prevent calls to the Health-Info line, emergency room returns, as well as readmissions or unscheduled postoperative consultations.

A patient-as-partner approach has been chosen in the initial phase, where 12 patients having had an outpatient surgery less than 6 months ago, will be recruited to test the platform. Another 12 patients, scheduled to undergo an outpatient surgery, will test the optimized support and follow up application. Their feedback will help to correct and/or improve the platform, if necessary.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

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

  • Patients over 18 years old undergoing elective outpatient surgery under general or regional anesthesia
  • Internet access for the patient or their caregiver from home
  • Written, oral and spoken comprehension of French or English

排除标准

  • Patient's or caregiver's inability to learn and use digital technologies
  • Conversion of outpatient to inpatient hospitalization on the day of surgery
  • Patient's refusal.

研究组 & 干预措施

Complete LeoMed application

Active Comparator

LeoMed application with integrated artificial intelligence

干预措施: Complete LeoMed application (Other)

Basic LeoMed application

Placebo Comparator

LeoMed application without artificial intelligence

干预措施: Basic LeoMed application (Other)

结局指标

主要结局

Cost-effectiveness analysis of the LeoMed® telecare platform

时间窗: 1 month after the surgery

The cost-effectiveness of the telecare platform deployment will be evaluated by the assessment of direct costs. These costs include unanticipated cancellations of the surgery on the day of surgery, calls at the CHUM local health info line, calls at the Quebec health info line (811), visits to the emergency department, unplanned readmissions or medical visits (family physician or outpatient clinic) for a problem related to the procedure.

次要结局

  • Cost-utility analysis of the LeoMed® telecare platform(Change between baseline (pre-operative) and 1 month postoperative)
  • Patient satisfaction(1 month after the surgery)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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