Optimization of Outpatient Surgery at the CHUM Using the LeoMed Telecare Platform

NCT04948632 | Completed

• 1 other identifier: 21.110
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery--Complications; Patient Satisfaction; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Cost-effectiveness analysis of the LeoMed® telecare platform

  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.

  1 month after the surgery

Secondary Outcomes (2)

• Cost-utility analysis of the LeoMed® telecare platform

  Change between baseline (pre-operative) and 1 month postoperative

• Patient satisfaction

  1 month after the surgery

Study Arms (2)

Complete LeoMed application

ACTIVE COMPARATOR

LeoMed application with integrated artificial intelligence

Other: Complete LeoMed application

Basic LeoMed application

PLACEBO COMPARATOR

LeoMed application without artificial intelligence

Other: Basic LeoMed application

Interventions

Complete LeoMed application OTHER

Access to the complete LeoMed application on the participant's smartphone. The day before surgery, participants will receive notifications encouraging them to use the platform to help prepare for their surgery. Safety instructions will also be sent. Postoperatively, notifications will be sent to the participants every day during the first 4 days and on the 7th day. These notifications will direct them to online forms that aim to assess their condition. On the 15th and 30th postoperative day, the platform will send a follow-up form. The platform will collect this information and classify it for appropriate management of their condition.

Complete LeoMed application

Basic LeoMed application OTHER

Access to a partial version of the LeoMed application on the patient's smartphone during a visit to the preoperative clinic. Before surgery, participants will receive a phone call to be summoned to the hospital and to remind them of the safety instructions. Postoperatively, their follow-up will not be standardized and will vary depending on their surgeon. On the 15th and 30th postoperative day, the platform will send a follow-up form. In the event of an emergency, they will receive the contact details of the CHUM Health Infoline to ensure the continuity of their care.

Basic LeoMed application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• HEC Montreal: collaborator

Study Sites (1)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (1)

• Robin F, Roy M, Kuftedjian A, Perret L, Lavoie F, Castonguay A, Pomey MP, Zaouter C, Pare G. A Medicoeconomic Evaluation of a Telehealth Platform for Elective Outpatient Surgeries: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 24;12:e44006. doi: 10.2196/44006.

  PMID: 37093634 DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Florian Robin, MD, FRCPC

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 2, 2021
• Study Start: January 21, 2022
• Primary Completion: November 1, 2023
• Study Completion: February 28, 2024
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

CA (1)