Assessing the clinical and organisational impact of a home-based post-operative monitoring strategy incorporating the MultiSense® device involving 80 patients aged 65 years and over who have undergone major surgery.
Evaluate the clinical and organisational impact of a post-operative home monitoring strategy incorporating the MultiSense® device in elderly patients. The study will be conducted in a multicentre setting, involving 80 patients aged 65 years and over who have undergone major surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
80
The MultiSense device will be placed on the patient's back and will allow physicians to remotely monitor six biological parameters
Western Cancer Institute of Angers
Angers, France
Bergonié Insititute
Bordeaux, France
Inter-municipal Hospital Centre of Mont-de-marsan
Mont-de-Marsan, France
Western Cancer Institute of Nantes
Nantes, France
The percentage of patients whose care was deemed satisfactory
The quality of surgical care will be assessed using a "textbook outcome" (TO) composed of the 2 following criteria : 1. A shorter-than-average stay (below the 75th percentile). 2. No emergency readmission or ER visit within 7 days of going home."
Time frame: 7 days
Average length of initial hospital stay following surgery
Time frame: 7 days
Percentage of patients requiring unscheduled care related to surgery at 30 days
Patients requiring unplanned readmission and/or a visit to the emergency department
Time frame: 30 days
Percentage of patients with at least one unplanned rehospitalization following telemonitoring and at 30 days
Time frame: 30 days
Percentage of patients with at least one visit to the emergency department following telemonitoring and at day 30
Time frame: 30 days
Percentage of patients with at least one grade 3 to 5 complication according to the Clavien-Dindo classification at 30 days
The Clavien-Dindo classification is a system used in surgery to classify postoperative complications according to their severity
Time frame: 30 days
Number of unplanned rehospitalizations and/or emergency department visits at 30 days (total and per patient)
Time frame: 30 days
Number of unscheduled visits (to a general practitioner or a surgeon) at 30 days (total and per patient)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 30 days
Quality of postoperative recovery using the French version of the fQoR-15 scale at hospital discharge (V2) and at 30 days (V4)
Assess the impact on patient's quality of life fQoR-15 : French Quality of Recovery-15 15 : corresponds to the 15 multidimensional questions that make up the score. The total score ranges from 0 to 150 The higher the score, the better the quality of post-operative recovery High score = optimal recovery Low score = impaired recovery
Time frame: 30 days
Measurement of the overall index score for the EQ-5D-5L questionnaire at preoperative assessment (V0), at hospital discharge (V2), and at 30 days (V4)
Assess the impact on patients' quality of life EQ : EuroQol, the name of the international research group that developed this tool. 5D : 5 dimensions of health assessed (mobility, independence, daily activities, pain/discomfort, and anxiety/depression). 5L : 5 levels, the 5 possible severity levels for each dimension : * Level 1 : No difficulty (or no problems). * Level 2 : Mild problems. * Level 3 : Moderate problems. * Level 4 : Severe problems. * Level 5 : Total disability (or extreme problems). A higher score indicates better health
Time frame: 30 days
Total length of hospital stay (initial admission and readmission) at 30 days
Assess the organizational impact associated with the deployment of the MULTISENSE® solution based on the HAS's mapping
Time frame: 30 days
DAOH30 (Days Alive and Out of Hospital) or Days of Independence at Home at Day 30, defined as the number of days during which the patient recovered independently at home without requiring hospitalization or rehospitalization, during the 30-day postoper
This outcome will be calculated using the following formula : DAOH30 = 30 days - (initial length of stay + duration of readmissions)
Time frame: 30 days
Percentage of patients who did not comply with remote monitoring via MultiSense® (non-compliance is defined as the patient discontinuing monitoring before reaching 80% of the scheduled duration, which corresponds to the 4th day)
Assess patient and healthcare professional satisfaction with and usability of the solution
Time frame: 4th day
Average usability score reported by healthcare professionals using the French version of the SUS (System Usability Scale) questionnaire completed at the end of the study
SUS : System Usability Scale Minimum value : 0 Maximum value : 100 Interpretation of the score : A high score indicates a positive result. The closer the score is to 100, the more the system (in this case, the MultiSense® solution) is considered to be user-friendly, intuitive and satisfactory for healthcare professionals. Conversely, a low score indicates poor usability.
Time frame: 8 months
Level of patient satisfaction as measured by a specific questionnaire completed following the remote monitoring session
This is an 'ad hoc' satisfaction questionnaire (specifically designed for the purposes of this study). Scale details : The full name given in the appendix is the Patient Satisfaction Questionnaire. It assesses levels of satisfaction with the MultiSense® solution. Scores and interpretation : the exact minimum and maximum scores are not specified, a high score corresponds to a positive result (greater patient satisfaction).
Time frame: 5th day
Level of healthcare professionals' reassurance regarding the patient's return home, assessed by a questionnaire completed at the time of discharge.
This is an 'ad hoc' satisfaction questionnaire (specifically designed for the purposes of this study). Scale details : The full name given in the appendix is the Patient Satisfaction Questionnaire. It assesses levels of satisfaction with the MultiSense® solution. Scores and interpretation : the exact minimum and maximum scores are not specified, a high score corresponds to a positive result (greater patient satisfaction).
Time frame: Day 1
Level of satisfaction among healthcare professionals, as measured by a specific questionnaire completed at the end of the study
This is an 'ad hoc' satisfaction questionnaire (specifically designed for the purposes of this study). Scale details : The full name given in the appendix is the Patient Satisfaction Questionnaire. It assesses levels of satisfaction with the MultiSense® solution. Scores and interpretation : the exact minimum and maximum scores are not specified, a high score corresponds to a positive result (greater patient satisfaction).
Time frame: 8 months