NCT04242043

Brief Summary

The ageing of the population is accompanied by the problem of chronic pathologies and sometimes heavy dependence, requiring admission to Nursing Homes (NHs). Approximately 660,000 people currently live in NHs in France. One out of 3 NHs does not have a coordinating doctor, even though the law requires it, and access to care in these NHs is very unequal nationally and especially in the Limousin and Dordogne regions. Some Hospices may find themselves in a situation where there is no coordinating doctor and difficult access to General Practitioners (GPs) visiting a large area. This inequality of access to care results in a difference in care that can go as far as a loss of opportunity for residents who are immediately transferred to the emergency department (ED) with a risk of iatrogeny or delirium once in the ED or a risk of inappropriate hospitalization. Residents are hospitalized:

  • when the latter could have been avoided because the health care team, not knowing what attitude to adopt, prioritized hospitalization
  • Late because the resident waited for the attending physician to come, which resulted in a worsening of symptoms. The arrival of Artificial Intelligence (AI) is an opportunity to find new models of care organization that can mitigate medical desertification but also develop advanced practices in gerontology. For example, nurses will be able to intervene at a first level for early detection, better triage and early management of certain pathologies. The "MEDVIR society" AI, developed by a French company, is a medical decision support system with Artificial Intelligence and offers pre-diagnosis based on the information collected (medical and surgical history, concomitant treatments and symptoms). MEDVIR is a diagnostic aid tool and does not replace the doctor who remains at the end of the chain, the final decision-maker. Before research is conducted to integrate this technology into routine care, it is important to validate the diagnostic relevance of AI in the elderly, as it has been validated in the general population. This pilot feasibility study will then enable us to methodologically dimension a future project to evaluate the efficiency of this new care system in the management of elderly patients in medical deserts in France.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2020

Completed
Last Updated

June 21, 2022

Status Verified

October 1, 2021

Enrollment Period

9 months

First QC Date

January 23, 2020

Last Update Submit

June 14, 2022

Conditions

Keywords

Artificial IntelligenceGeriatricsdiagnostic proposals elderly

Outcome Measures

Primary Outcomes (1)

  • AI diagnostic proposals

    Number of AI diagnostic proposals in adequacy with the medical diagnosis in the month of the study

    1 month

Secondary Outcomes (2)

  • severity diagnoses

    1 month

  • satisfaction survey

    1 month

Study Arms (1)

AI

Diagnostic Test: intel@med-feasibility

Interventions

intel@med-feasibilityDIAGNOSTIC_TEST

Initial evaluation by the Nurse using the AI tool which enters into MEDVIR the patient's symptoms or functional complaints and comorbidities and is complemented by a telemedicine solution for data transmission to the remote tele-expert physician located in a regulatory center or health center. The remote doctor (a geriatrician from "Prevention Care for Elderly Unit (UPSAV) platform" of the Clinical Gerontology Division of the Limoges University Hospital) analyses the data collected by the Nurse and establishes a symptom severity criterion and a diagnosis with the help of the AI technology. Both the geriatrician and the NHs nurse are not aware of the proposals made by AI. The geriatrician can nevertheless initiate a visit to the resident's place of residence in order to verify the information necessary to establish the diagnosis and thus improve the relevance of the algorithm. For the resident, this study doesn't interfere with the usual care.

AI

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Resident in nursing home presenting a health problem that requires the call of his/her attending physician.

You may qualify if:

  • Patient aged 65 or over
  • Patient living in one of the two NHs tests
  • Patient with a functional complaint or abnormal symptoms involving the call of a physician
  • Patient or his legal representative who has not expressed his opposition to the collection of his medical and personal data
  • Patient affiliated to social security

You may not qualify if:

  • End-of-life patient
  • Patient with a clear vital emergency according to the physician
  • Chronic aphasic patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ehpad Des Bayles

Isle, 87170, France

Location

Ehpad Le Roussillon

Limoges, 87000, France

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2020

First Posted

January 27, 2020

Study Start

December 21, 2019

Primary Completion

September 22, 2020

Study Completion

September 22, 2020

Last Updated

June 21, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations