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Completed

NCT Number: NCT04242043

Feasibility Study for Improving the Relevance of Diagnostic Proposals for an Artificial Intelligence Software in the Elderly Population.

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ehpad Des Bayles, Isle, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

intel@med-feasibility

Diagnostic 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.

Primary outcomes

  1. AI diagnostic proposals

    Time frame: 1 month

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

Secondary outcomes

  1. severity diagnoses

    Time frame: 1 month

    Number of severity diagnoses proposed by the AI solution versus medical diagnosis of the remote geriatrician over the month of the study

  2. satisfaction survey

    Time frame: 1 month

    Analysis of the satisfaction survey filled in by the users (NHs nurses, participants, NHs Directors and geriatricians)

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: Intel@Med-Fais

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2020
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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