Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-01 @ 2:36 PM
Study NCT ID:
NCT04948632
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2021-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimization of Outpatient Surgery at the CHUM Using the LeoMed Telecare Platform
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost-effectiveness analysis of the LeoMed® telecare platform', 'timeFrame': '1 month after the surgery', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Cost-utility analysis of the LeoMed® telecare platform', 'timeFrame': 'Change between baseline (pre-operative) and 1 month postoperative', 'description': "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.\n\nEach 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.\n\nThe 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."}, {'measure': 'Patient satisfaction', 'timeFrame': '1 month after the surgery', 'description': 'Patient satisfaction with care services and the telecare platform will also be assessed and compared between the two groups using a questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery--Complications', 'Patient Satisfaction', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '37093634', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nFollowing 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.\n\nIn 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.\n\nThe 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.\n\nA 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients over 18 years old undergoing elective outpatient surgery under general or regional anesthesia\n* Internet access for the patient or their caregiver from home\n* Written, oral and spoken comprehension of French or English\n\nExclusion Criteria:\n\n* Patient's or caregiver's inability to learn and use digital technologies\n* Conversion of outpatient to inpatient hospitalization on the day of surgery\n* Patient's refusal."}, 'identificationModule': {'nctId': 'NCT04948632', 'acronym': 'MEET-OS', 'briefTitle': 'Optimization of Outpatient Surgery at the CHUM Using the LeoMed Telecare Platform', 'organization': {'class': 'OTHER', 'fullName': "Centre hospitalier de l'Université de Montréal (CHUM)"}, 'officialTitle': 'A Medico-Economic Evaluation of a Telehealth Platform for Elective Outpatient Surgeries: a Trial Study', 'orgStudyIdInfo': {'id': '21.110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Complete LeoMed application', 'description': 'LeoMed application with integrated artificial intelligence', 'interventionNames': ['Other: Complete LeoMed application']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Basic LeoMed application', 'description': 'LeoMed application without artificial intelligence', 'interventionNames': ['Other: Basic LeoMed application']}], 'interventions': [{'name': 'Complete LeoMed application', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Complete LeoMed application']}, {'name': 'Basic LeoMed application', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Basic LeoMed application']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H2X 3E4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre hospitalier de l'Université de Montréal (CHUM)", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Florian Robin, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Centre hospitalier de l'Université de Montréal (CHUM)"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Centre hospitalier de l'Université de Montréal (CHUM)", 'class': 'OTHER'}, 'collaborators': [{'name': 'HEC Montreal', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}