Effect of an ML Electronic Alert Management System to Reduce the Use of ED Visits and Hospitalizations
Primary Purpose
Emergencies
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PRESAGE CARE
Sponsored by
About this trial
This is an interventional prevention trial for Emergencies focused on measuring Emergency Department visits,, machine learning, smartphone
Eligibility Criteria
Inclusion Criteria:
- age of 75 yo mini
- receiving the help of a social worker
- patient should give their consent
- patient should had seen their primary care professional within the past 12 months
Exclusion Criteria:
- People with severe dependence (French national instrument, which stratifies dependency level from group iso-resources (GIR) : 1 (very severe dependency) and 2 (severe dependency)
Sites / Locations
- Grand Versailles
- Marseille-1
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control group
Arm Description
PRESAGE Care ATIH + Nurse or GP consultation
usual care
Outcomes
Primary Outcome Measures
Unplanned Hospitalization rate
Comparison between unplanned hospitalization ratio from 2 randomized groups (intervention and control arms).
P values <.05 will be considered statistically significant.
Event-free survival (EFS)
Comparison average Time for first adverse event between intervention and control groups.
P values <.05 will be considered statistically significant.
Impact on older adults and relatives' quality of life (European Quality of Life 5 Dimensions and 3 Lines scale)
Comparison of the average score of EQ5D-3L quality of life scale (European Quality of Life 5 Dimensions and 3 Lines) between intervention and control groups.
P values <.05 will be considered statistically significant.
Cost-effectiveness
Incremental cost-effectiveness ratio (ICER), QALY. Willingness-to-pay thresholds of €30,000 per quality-adjusted life year (QALY) and €90,000 per QALY were used to define a very cost-effective and cost-effective strategy, respectively
Secondary Outcome Measures
Impact on users : time needed to complete questionnaire
Time needed to complete questionnaire (minutes) : a time of less than 2 minutes will be considered acceptable
Intervention rate
Part of alert which leads to interventions and intervention time (%). Rate of over 70% is considered acceptable.
Intervention time
Mean of the duration between day of alert and day of intervention (in days). A delay of less than 4 days is considered acceptable.
Time needed to analysis patient statut
Time needed to analysis patient statut (hours and minutes) : a time of less than 15 minutes by patient will be considered acceptable
Impact on quality of care
Positive or very positive impact on quality of care : rate of over 80% is considered acceptable.
Impact on Professional' Relationship and coordination
Positive or very positive impact on professionnal relationship and coordination :rate of over 80% is considered acceptable.
Full Information
NCT ID
NCT05221697
First Posted
January 7, 2022
Last Updated
August 28, 2023
Sponsor
Presage
Collaborators
Assistance Publique Hopitaux De Marseille, Assistance Publique - Hôpitaux de Paris, University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT05221697
Brief Title
Effect of an ML Electronic Alert Management System to Reduce the Use of ED Visits and Hospitalizations
Official Title
Effect of an Electronic Alert Management System Using Caregivers' Observations and Machine Learning Algorithm to Reduce the Use of Emergency Department Visits and Unplanned Hospitalizations Among Older People
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Presage
Collaborators
Assistance Publique Hopitaux De Marseille, Assistance Publique - Hôpitaux de Paris, University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Development, validation and impact of an alert management system using social workers' observations and machine learning algorithms to predict 7-to-14-day alerts for the risk of Emergency Department (ED) Visit and unplanned hospitalization.
Multi-center trial implementation of electronic Home Care Aides-reported outcomes measure system among patients, frail adults >= 65 years living at home and receiving assistance from home care aides (HCA).
Detailed Description
On a weekly basis, after home visit, HCAs reported on participants' functional status using a smartphone application that recorded 23 functional items about each participant (e.g., ability to stand, move, eat, mood, loneliness). Predictive system using Machine learning techniques (i.e., leveraging random forest predictors) was developed and generated 7 to 14-day predictive alerts for the risk of ED visit to nurses.
This questionnaire focused on functional and clinical autonomy (ie, activities of daily life), possible medical symptoms (eg, fatigue, falls, and pain), changes in behavior (eg, recognition and aggressiveness), and communication with the HA or their surroundings. This questionnaire is composed of very simple and easy-to-understand questions, giving a global view of the person's condition. For each of the 23 questions, a yes/no answer was requested. Data recorded by HAs were sent in real time to a secure server to be analyzed by our machine learning algorithm, which predicted the risk level and displayed it on a web-based secure medical device called PRESAGE CARE, which is CE marked. Particularly, when the algorithm predicted a high-risk level, an alert was displayed in the form of a notification on the screen to the coordinating nurse of the health care network center of the district. This risk notification was accompanied by information about recent changes in the patients' functional status, identified from the HAs' records, to assist the coordinating nurse in interacting with family caregiver and other health professionals.
In the event of an alert, the coordinating nurse called the family caregiver to inquire about recent changes in the patient's health condition and for doubt removal and could then decide to ask for a health intervention according to a health intervention model developed before the start of the study. In brief, this alert-triggered health intervention (ATHI) consisted of calling the patient's nurse (if the patient had regular home visits of a nurse) or the patient's general practitioner and informing them of a worsening of the patient's functional status and a potential risk of an ED visit or unplanned hospitalization in the next few days according to the eHealth system algorithm. This model of ATHI had been presented and approved by the Agences Régionales de Santé of the regions involved in our study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergencies
Keywords
Emergency Department visits,, machine learning, smartphone
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
PRESAGE Care ATIH + Nurse or GP consultation
Arm Title
Control group
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Device
Intervention Name(s)
PRESAGE CARE
Intervention Description
Participants in this arm will be followed by HCA and might benefit from Nurse health interventions
Primary Outcome Measure Information:
Title
Unplanned Hospitalization rate
Description
Comparison between unplanned hospitalization ratio from 2 randomized groups (intervention and control arms).
P values <.05 will be considered statistically significant.
Time Frame
through study completion, an average of 1 year
Title
Event-free survival (EFS)
Description
Comparison average Time for first adverse event between intervention and control groups.
P values <.05 will be considered statistically significant.
Time Frame
through study completion, an average of 1 year
Title
Impact on older adults and relatives' quality of life (European Quality of Life 5 Dimensions and 3 Lines scale)
Description
Comparison of the average score of EQ5D-3L quality of life scale (European Quality of Life 5 Dimensions and 3 Lines) between intervention and control groups.
P values <.05 will be considered statistically significant.
Time Frame
through study completion, an average of 1 year
Title
Cost-effectiveness
Description
Incremental cost-effectiveness ratio (ICER), QALY. Willingness-to-pay thresholds of €30,000 per quality-adjusted life year (QALY) and €90,000 per QALY were used to define a very cost-effective and cost-effective strategy, respectively
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Impact on users : time needed to complete questionnaire
Description
Time needed to complete questionnaire (minutes) : a time of less than 2 minutes will be considered acceptable
Time Frame
through study completion, an average of 1 year
Title
Intervention rate
Description
Part of alert which leads to interventions and intervention time (%). Rate of over 70% is considered acceptable.
Time Frame
through study completion, an average of 1 year
Title
Intervention time
Description
Mean of the duration between day of alert and day of intervention (in days). A delay of less than 4 days is considered acceptable.
Time Frame
through study completion, an average of 1 year
Title
Time needed to analysis patient statut
Description
Time needed to analysis patient statut (hours and minutes) : a time of less than 15 minutes by patient will be considered acceptable
Time Frame
through study completion, an average of 1 year
Title
Impact on quality of care
Description
Positive or very positive impact on quality of care : rate of over 80% is considered acceptable.
Time Frame
through study completion, an average of 1 year
Title
Impact on Professional' Relationship and coordination
Description
Positive or very positive impact on professionnal relationship and coordination :rate of over 80% is considered acceptable.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age of 75 yo mini
receiving the help of a social worker
patient should give their consent
patient should had seen their primary care professional within the past 12 months
Exclusion Criteria:
People with severe dependence (French national instrument, which stratifies dependency level from group iso-resources (GIR) : 1 (very severe dependency) and 2 (severe dependency)
Facility Information:
Facility Name
Grand Versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Marseille-1
City
Marseille
ZIP/Postal Code
13011
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
anonymized Statistical data will be available
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Effect of an ML Electronic Alert Management System to Reduce the Use of ED Visits and Hospitalizations
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