Surgery--ComplicationsMEET-OSNCT04948632
Optimization of Outpatient Surgery at the CHUM Using the LeoMed Telecare Platform
A study testing Complete LeoMed application and Basic LeoMed application in people with Surgery--Complications and Patient Satisfaction, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications, Patient Satisfaction, Quality of Life
- What is being tested?
- Complete LeoMed application and Basic LeoMed application
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,000 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jan 2022to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4
About this study
Official title: A Medico-Economic Evaluation of a Telehealth Platform for Elective Outpatient Surgeries: a Trial Study
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.
Read the 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.
- Being tested
- Complete LeoMed application, Basic LeoMed application
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete LeoMed applicationOther
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.
Basic LeoMed applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Complete LeoMed application | Active comparator | LeoMed application with integrated artificial intelligence Receives: Other: Complete LeoMed application |
| Basic LeoMed application | Placebo comparator | LeoMed application without artificial intelligence Receives: Other: Basic LeoMed application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after the surgery
Secondary outcomes (2)
Cost-utility analysis of the LeoMed® telecare platform
The cost-utility analysis of the telecare platform will be evaluated with the improvement of patient's quality of life. The EQ-5D-5L-VAS will be used to assess quality of life. It is a valid questionnaire including five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN / DISCOMFORT and ANXIETY / DEPRESSION. Patient satisfaction with care services will also be assessed.
Each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions.
The VAS portion of the questionnaire EQ-5D-5L-VAS is a scale where patients are asked to indicate their overall health on the day that the questionnaire is completed, 0 = the worst health you can imagine and 100 = the best health you can imagine.
Measured: Change between baseline (pre-operative) and 1 month postoperative
Patient satisfaction
Patient satisfaction with care services and the telecare platform will also be assessed and compared between the two groups using a questionnaire.
Measured: 1 month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start21 Jan 2022
- Primary completion1 Nov 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- HEC Montreal
- Responsible party
- Sponsor
- Investigators
- Florian Robin, MD, FRCPC, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948632
- Sponsor's protocol ID
- 21.110
- Acronym
- MEET-OS
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2021
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Belliveau J, Pilote L, Grange E, Zaouter C, Roy M, Robin F. Continuous vital sign monitoring with Biobeat(R) wearable devices for post-ambulatory surgery patients: a pilot feasibility study. J Clin Monit Comput. 2025 Jun;39(3):523-531. doi: 10.1007/s10877-025-01276-0. Epub 2025 Feb 26.
PubMed 40011395Robin 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.
PubMed 37093634
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Medico-Economic Evaluation of a Telehealth Platform for Elective Outpatient Surgeries: a Trial Study
- ClinicalTrials.gov ID
- NCT04948632
- Acronym / sponsor ID
- MEET-OS / 21.110
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- HEC Montreal
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Complete LeoMed application | Active comparator | Other: Complete LeoMed applicationLeoMed application with integrated artificial intelligence |
| Basic LeoMed application | Placebo comparator | Other: Basic LeoMed applicationLeoMed application without artificial intelligence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete LeoMed applicationAccess 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. | Other | Complete LeoMed application |
| Basic LeoMed applicationAccess 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. | Other | Basic LeoMed application |
Primary outcome
Cost-effectiveness analysis of the LeoMed® telecare platform
Time frame: 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.
2 secondary outcomes
Cost-utility analysis of the LeoMed® telecare platform
Time frame: Change between baseline (pre-operative) and 1 month postoperative
Patient satisfaction
Time frame: 1 month after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Derived from this study: PubMed 40011395Belliveau J, Pilote L, Grange E, Zaouter C, Roy M, Robin F. Continuous vital sign monitoring with Biobeat(R) wearable devices for post-ambulatory surgery patients: a pilot feasibility study. J Clin Monit Comput. 2025 Jun;39(3):523-531. doi: 10.1007/s10877-025-01276-0. Epub 2025 Feb 26.
- Derived from this study: PubMed 37093634Robin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Robin, MD, FRCPC principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complete LeoMed application and Basic LeoMed application in people with Surgery--Complications and Patient Satisfaction, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-effectiveness analysis of the LeoMed® telecare platform (time frame: 1 month after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04948632, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.