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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
Presage
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergencies focused on measuring Emergency Department visits,, machine learning, smartphone

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

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
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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
Citations:
PubMed Identifier
26208112
Citation
Clerencia-Sierra M, Calderon-Larranaga A, Martinez-Velilla N, Vergara-Mitxeltorena I, Aldaz-Herce P, Poblador-Plou B, Machon-Sobrado M, Egues-Olazabal N, Abellan-van Kan G, Prados-Torres A. Multimorbidity Patterns in Hospitalized Older Patients: Associations among Chronic Diseases and Geriatric Syndromes. PLoS One. 2015 Jul 24;10(7):e0132909. doi: 10.1371/journal.pone.0132909. eCollection 2015.
Results Reference
background
PubMed Identifier
27475008
Citation
Kahn JH, Magauran BG Jr, Olshaker JS, Shankar KN. Current Trends in Geriatric Emergency Medicine. Emerg Med Clin North Am. 2016 Aug;34(3):435-52. doi: 10.1016/j.emc.2016.04.014.
Results Reference
background
PubMed Identifier
29267333
Citation
Gasperini B, Cherubini A, Pierri F, Barbadoro P, Fedecostante M, Prospero E. Potentially preventable visits to the emergency department in older adults: Results from a national survey in Italy. PLoS One. 2017 Dec 21;12(12):e0189925. doi: 10.1371/journal.pone.0189925. eCollection 2017.
Results Reference
background
PubMed Identifier
16456194
Citation
McCusker J, Verdon J. Do geriatric interventions reduce emergency department visits? A systematic review. J Gerontol A Biol Sci Med Sci. 2006 Jan;61(1):53-62. doi: 10.1093/gerona/61.1.53.
Results Reference
background
PubMed Identifier
20687083
Citation
Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2.
Results Reference
background
PubMed Identifier
18347480
Citation
Chen CC, Wang C, Huang GH. Functional trajectory 6 months posthospitalization: a cohort study of older hospitalized patients in Taiwan. Nurs Res. 2008 Mar-Apr;57(2):93-100. doi: 10.1097/01.NNR.0000313485.18670.e2.
Results Reference
background
PubMed Identifier
20978258
Citation
Iwashyna TJ, Ely EW, Smith DM, Langa KM. Long-term cognitive impairment and functional disability among survivors of severe sepsis. JAMA. 2010 Oct 27;304(16):1787-94. doi: 10.1001/jama.2010.1553.
Results Reference
background
PubMed Identifier
23089089
Citation
Camargo CA Jr, Tsai CL, Sullivan AF, Cleary PD, Gordon JA, Guadagnoli E, Kaushal R, Magid DJ, Rao SR, Blumenthal D. Safety climate and medical errors in 62 US emergency departments. Ann Emerg Med. 2012 Nov;60(5):555-563.e20. doi: 10.1016/j.annemergmed.2012.02.018.
Results Reference
background
PubMed Identifier
21144042
Citation
Crane SJ, Tung EE, Hanson GJ, Cha S, Chaudhry R, Takahashi PY. Use of an electronic administrative database to identify older community dwelling adults at high-risk for hospitalization or emergency department visits: the elders risk assessment index. BMC Health Serv Res. 2010 Dec 13;10:338. doi: 10.1186/1472-6963-10-338.
Results Reference
background
PubMed Identifier
25586600
Citation
Hu Z, Jin B, Shin AY, Zhu C, Zhao Y, Hao S, Zheng L, Fu C, Wen Q, Ji J, Li Z, Wang Y, Zheng X, Dai D, Culver DS, Alfreds ST, Rogow T, Stearns F, Sylvester KG, Widen E, Ling XB. Real-time web-based assessment of total population risk of future emergency department utilization: statewide prospective active case finding study. Interact J Med Res. 2015 Jan 13;4(1):e2. doi: 10.2196/ijmr.4022.
Results Reference
background
PubMed Identifier
27442203
Citation
Takahashi PY, Heien HC, Sangaralingham LR, Shah ND, Naessens JM. Enhanced risk prediction model for emergency department use and hospitalizations in patients in a primary care medical home. Am J Manag Care. 2016 Jul;22(7):475-83.
Results Reference
background
PubMed Identifier
34499046
Citation
Denis F, Krakowski I. How Should Oncologists Choose an Electronic Patient-Reported Outcome System for Remote Monitoring of Patients With Cancer? J Med Internet Res. 2021 Sep 9;23(9):e30549. doi: 10.2196/30549.
Results Reference
background
PubMed Identifier
29110842
Citation
Bouazza YB, Chiairi I, El Kharbouchi O, De Backer L, Vanhoutte G, Janssens A, Van Meerbeeck JP. Patient-reported outcome measures (PROMs) in the management of lung cancer: A systematic review. Lung Cancer. 2017 Nov;113:140-151. doi: 10.1016/j.lungcan.2017.09.011. Epub 2017 Sep 23.
Results Reference
background
PubMed Identifier
31942997
Citation
Schick-Makaroff K, Karimi-Dehkordi M, Cuthbertson L, Dixon D, Cohen SR, Hilliard N, Sawatzky R. Using Patient- and Family-Reported Outcome and Experience Measures Across Transitions of Care for Frail Older Adults Living at Home: A Meta-Narrative Synthesis. Gerontologist. 2021 Apr 3;61(3):e23-e38. doi: 10.1093/geront/gnz162.
Results Reference
background
PubMed Identifier
31408458
Citation
Veyron JH, Friocourt P, Jeanjean O, Luquel L, Bonifas N, Denis F, Belmin J. Home care aides' observations and machine learning algorithms for the prediction of visits to emergency departments by older community-dwelling individuals receiving home care assistance: A proof of concept study. PLoS One. 2019 Aug 13;14(8):e0220002. doi: 10.1371/journal.pone.0220002. eCollection 2019.
Results Reference
background
PubMed Identifier
28765132
Citation
Huntley AL, Chalder M, Shaw ARG, Hollingworth W, Metcalfe C, Benger JR, Purdy S. A systematic review to identify and assess the effectiveness of alternatives for people over the age of 65 who are at risk of potentially avoidable hospital admission. BMJ Open. 2017 Aug 1;7(7):e016236. doi: 10.1136/bmjopen-2017-016236.
Results Reference
background
PubMed Identifier
34847057
Citation
Seibert K, Domhoff D, Bruch D, Schulte-Althoff M, Furstenau D, Biessmann F, Wolf-Ostermann K. Application Scenarios for Artificial Intelligence in Nursing Care: Rapid Review. J Med Internet Res. 2021 Nov 29;23(11):e26522. doi: 10.2196/26522.
Results Reference
background
PubMed Identifier
18299372
Citation
Gray JT, Walker A. Avoiding admissions from the ambulance service: a review of elderly patients with falls and patients with breathing difficulties seen by emergency care practitioners in South Yorkshire. Emerg Med J. 2008 Mar;25(3):168-71. doi: 10.1136/emj.2007.050732.
Results Reference
background
PubMed Identifier
22186262
Citation
Mason S, O'Keeffe C, Knowles E, Bradburn M, Campbell M, Coleman P, Stride C, O'Hara R, Rick J, Patterson M. A pragmatic quasi-experimental multi-site community intervention trial evaluating the impact of Emergency Care Practitioners in different UK health settings on patient pathways (NEECaP Trial). Emerg Med J. 2012 Jan;29(1):47-53. doi: 10.1136/emj.2010.103572.
Results Reference
background
PubMed Identifier
17916813
Citation
Mason S, Knowles E, Colwell B, Dixon S, Wardrope J, Gorringe R, Snooks H, Perrin J, Nicholl J. Effectiveness of paramedic practitioners in attending 999 calls from elderly people in the community: cluster randomised controlled trial. BMJ. 2007 Nov 3;335(7626):919. doi: 10.1136/bmj.39343.649097.55. Epub 2007 Oct 4.
Results Reference
background
PubMed Identifier
25874866
Citation
Soril LJ, Leggett LE, Lorenzetti DL, Noseworthy TW, Clement FM. Reducing frequent visits to the emergency department: a systematic review of interventions. PLoS One. 2015 Apr 13;10(4):e0123660. doi: 10.1371/journal.pone.0123660. eCollection 2015.
Results Reference
background
PubMed Identifier
17384419
Citation
Belmin J, Auffray JC, Berbezier C, Boirin P, Mercier S, de Reviers B, Golmard JL. Level of dependency: a simple marker associated with mortality during the 2003 heatwave among French dependent elderly people living in the community or in institutions. Age Ageing. 2007 May;36(3):298-303. doi: 10.1093/ageing/afm026. Epub 2007 Mar 24.
Results Reference
background
PubMed Identifier
29997899
Citation
O'Connell S, Palmer R, Withers K, Saha N, Puntoni S, Carolan-Rees G; PROMs, PREMs and Effectiveness Programme. Requirements for the collection of electronic PROMS either "in clinic" or "at home" as part of the PROMs, PREMs and Effectiveness Programme (PPEP) in Wales: a feasibility study using a generic PROM tool. Pilot Feasibility Stud. 2018 Jul 4;4:90. doi: 10.1186/s40814-018-0282-8. eCollection 2018.
Results Reference
background
PubMed Identifier
33158824
Citation
Duncanson E, Bennett PN, Viecelli A, Dansie K, Handke W, Tong A, Palmer S, Jesudason S, McDonald SP, Morton RL; Symptom monitoring WIth Feedback Trial (SWIFT) Investigators. Feasibility and acceptability of e-PROMs data capture and feedback among patients receiving haemodialysis in the Symptom monitoring WIth Feedback Trial (SWIFT) pilot: protocol for a qualitative study in Australia. BMJ Open. 2020 Nov 6;10(11):e039014. doi: 10.1136/bmjopen-2020-039014.
Results Reference
background
PubMed Identifier
25711974
Citation
Anderson KO, Palos GR, Mendoza TR, Cleeland CS, Liao KP, Fisch MJ, Garcia-Gonzalez A, Rieber AG, Nazario LA, Valero V, Hahn KM, Person CL, Payne R. Automated pain intervention for underserved minority women with breast cancer. Cancer. 2015 Jun 1;121(11):1882-90. doi: 10.1002/cncr.29204. Epub 2015 Feb 24.
Results Reference
background
PubMed Identifier
27879472
Citation
Adam R, Burton CD, Bond CM, de Bruin M, Murchie P. Can patient-reported measurements of pain be used to improve cancer pain management? A systematic review and meta-analysis. BMJ Support Palliat Care. 2017 Dec;7(4):0. doi: 10.1136/bmjspcare-2016-001137. Epub 2016 Nov 22.
Results Reference
background
PubMed Identifier
24687538
Citation
Mooney KH, Beck SL, Friedman RH, Farzanfar R, Wong B. Automated monitoring of symptoms during ambulatory chemotherapy and oncology providers' use of the information: a randomized controlled clinical trial. Support Care Cancer. 2014 Sep;22(9):2343-50. doi: 10.1007/s00520-014-2216-1. Epub 2014 Apr 1.
Results Reference
background
PubMed Identifier
33704476
Citation
Vasey B, Ursprung S, Beddoe B, Taylor EH, Marlow N, Bilbro N, Watkinson P, McCulloch P. Association of Clinician Diagnostic Performance With Machine Learning-Based Decision Support Systems: A Systematic Review. JAMA Netw Open. 2021 Mar 1;4(3):e211276. doi: 10.1001/jamanetworkopen.2021.1276.
Results Reference
background
PubMed Identifier
34882190
Citation
Adler-Milstein J, Chen JH, Dhaliwal G. Next-Generation Artificial Intelligence for Diagnosis: From Predicting Diagnostic Labels to "Wayfinding". JAMA. 2021 Dec 28;326(24):2467-2468. doi: 10.1001/jama.2021.22396. No abstract available.
Results Reference
background
PubMed Identifier
34207198
Citation
Barrachina-Fernandez M, Maitin AM, Sanchez-Avila C, Romero JP. Wearable Technology to Detect Motor Fluctuations in Parkinson's Disease Patients: Current State and Challenges. Sensors (Basel). 2021 Jun 18;21(12):4188. doi: 10.3390/s21124188.
Results Reference
background
PubMed Identifier
28977687
Citation
Khalil H, Bell B, Chambers H, Sheikh A, Avery AJ. Professional, structural and organisational interventions in primary care for reducing medication errors. Cochrane Database Syst Rev. 2017 Oct 4;10(10):CD003942. doi: 10.1002/14651858.CD003942.pub3.
Results Reference
background
Citation
Beaudouin, Valérie and Bloch, Isabelle and Bounie, David and Bounie, David and Clémençon, Stéphan and d'Alché-Buc, Florence and Eagan, James and Maxwell, Winston and Mozharovskyi, Pavlo and Parekh, Jayneel, Flexible and Context-Specific AI Explainability: A Multidisciplinary Approach (March 23, 2020). Available at SSRN: https://ssrn.com/abstract=3559477 or http://dx.doi.org/10.2139/ssrn.3559477
Results Reference
background
PubMed Identifier
35921685
Citation
Belmin J, Villani P, Gay M, Fabries S, Havreng-Thery C, Malvoisin S, Denis F, Veyron JH. Real-world Implementation of an eHealth System Based on Artificial Intelligence Designed to Predict and Reduce Emergency Department Visits by Older Adults: Pragmatic Trial. J Med Internet Res. 2022 Sep 8;24(9):e40387. doi: 10.2196/40387.
Results Reference
derived

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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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