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

Emergencies Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05221697
• Other study ID #: PRESAGE_2021-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: Presage
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Emergencies

Intervention

Device:
• PRESAGE CARE
Participants in this arm will be followed by HCA and might benefit from Nurse health interventions

Locations

Country	Name	City	State
France	Grand Versailles	Le Chesnay
France	Marseille-1	Marseille

Sponsors (4)

Lead Sponsor	Collaborator
Presage	Assistance Publique - Hôpitaux de Paris, Assistance Publique Hopitaux De Marseille, University Hospital, Lille

Country where clinical trial is conducted

France, 

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned Hospitalization rate	Comparison between unplanned hospitalization ratio from 2 randomized groups (intervention and control arms).; P values <.05 will be considered statistically significant.	through study completion, an average of 1 year
Primary	Event-free survival (EFS)	Comparison average Time for first adverse event between intervention and control groups.; P values <.05 will be considered statistically significant.	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year
Primary	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	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year
Secondary	Intervention rate	Part of alert which leads to interventions and intervention time (%). Rate of over 70% is considered acceptable.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year
Secondary	Impact on quality of care	Positive or very positive impact on quality of care : rate of over 80% is considered acceptable.	through study completion, an average of 1 year
Secondary	Impact on Professional' Relationship and coordination	Positive or very positive impact on professionnal relationship and coordination :rate of over 80% is considered acceptable.	through study completion, an average of 1 year