Clinical Trials Directory

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UnknownNCT05221697

Effect of an ML Electronic Alert Management System to Reduce the Use of ED Visits and Hospitalizations

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
800 (estimated)
Sponsor
Presage · Industry
Sex
All
Age
75 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
DEVICEPRESAGE CAREParticipants in this arm will be followed by HCA and might benefit from Nurse health interventions

Timeline

Start date
2020-09-01
Primary completion
2021-12-31
Completion
2024-06-30
First posted
2022-02-03
Last updated
2023-08-30

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT05221697. Inclusion in this directory is not an endorsement.