Feasibility Study for Improving the Relevance of Diagnostic Proposals for an Artificial Intelligence Software in the Elderly Population.
Intel@Med-Fais
1 other identifier
observational
18
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2019
Shorter than P25 for all trials
2 active sites
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
CompletedFirst Submitted
Initial submission to the registry
January 23, 2020
CompletedFirst Posted
Study publicly available on registry
January 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2020
CompletedJune 21, 2022
October 1, 2021
9 months
January 23, 2020
June 14, 2022
Conditions
Keywords
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
Interventions
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.
Eligibility Criteria
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
Ehpad Le Roussillon
Limoges, 87000, France
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