Clinical trial NCT04948632: Optimization of Outpatient Surgery at the CHUM Using the LeoMed Telecare Platform
Official title: A Medico-Economic Evaluation of a Telehealth Platform for Elective Outpatient Surgeries: a Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery--Complications
Patient Satisfaction
Quality of Life
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: HEC Montreal
First posted: 2021-07-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, randomized, controlled study comparing, in patients undergoing outpatient surgery at the CHUM, a group of patients benefiting from optimized support and follow-up using the LeoMed telecare platform (Group A) with a group benefiting from the current standard of care (Group B).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cost-effectiveness analysis of the LeoMed® telecare platform
timeFrame: 1 month after the surgery
Secondary outcomes:
measure: Cost-utility analysis of the LeoMed® telecare platform
timeFrame: Change between baseline (pre-operative) and 1 month postoperative
measure: Patient satisfaction
timeFrame: 1 month after the surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Florian Robin, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: