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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05773508
Other study ID # 2022-120
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 6, 2023
Est. completion date June 6, 2025

Study information

Verified date March 2023
Source University Hospital, Angers
Contact Delphine Douillet, MD,PhD
Phone +33241353637
Email Delphine.Douillet@chu-angers.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim is to evaluate the effectiveness of the device (emergency kit and video-medical control in emergency call centers) in reducing deep night hospitalizations of elderly people living in retirement homes.


Description:

Approximately 500,000 elderly people live in a nursing homes in France (1). Few studies concern these subjects: 2% of international research studies (1). Among the subjects hospitalised in the emergency department, those from a nursing home represent a significant proportion of the population, with a proportion of 9 to 37% (2). These are mainly elderly patients who are dependent in the acts of daily life, polypathological and with multiple medications (1,2) and for whom any aggression can lead to hospitalisation, a source of physical and psychological destabilisation (3). Unplanned hospitalisations are frequent: one resident in ten has been hospitalised in the last three months, and up to five in ten over a full year. Ninety-five percent of the reasons for hospitalisation include cardiac decompensation, the consequences of falls, respiratory disorders, confusion, febrile or non-febrile infections, particularly dermatological, dehydration and gastrointestinal disorders, particularly diarrhoea (4). These hospitalisations are considered to be avoidable in 7 to 67% of cases, depending on the authors (2). This seems to be explained in particular by the lack of availability of doctors or paramedics to identify or carry out the appropriate technical care or simple complementary examinations (5). During the night, the only staff present in these facilities are often orderlies who are less experienced in assessing emergencies. In a recent study, however, they were the ones who influenced the alert and decided to hospitalise in 40% of cases (6). The value of specific channels for nursing home patients in reducing avoidable hospitalisations has been highlighted, by favouring short non-emergency channels, particularly for complementary examinations and technical care (7). The possibility of having a rapid medical assessment on-site, a biological analysis within three hours or the implementation of intravenous hydration would avoid the systematic passage of patients residing in nursing homes through the emergency department. The value of advance directives notifying the non-resuscitation situations desired by the patient would make it possible to further reduce this figure (4). Inappropriate hospitalisations must therefore be avoided by improving decision-making procedures (8). The use of video regulation has become more widespread since the SARS-CoV-2 pandemic, allowing continuity of care while minimising the risk of virus transmission. Numerous advantages have emerged from this rapidly developing technology, in particular the possibility of remotely monitoring the progress of the most stable patients, while limiting their movements, and keeping the possibility of calling them in person if necessary. (9) However, the technology of video consultation requires an upgrade in the use of the computer tool by both patients and nursing staff (nurses, doctors). Telephone consultations may be preferred for ease of use, especially for elderly patients, as they will offer less information and more uncertain diagnoses than video consultation (10,11). A pilot study has shown that video regulation in Emergency Dispatch Center (SAMU C15 in France) is a tool that improves the decision of the regulating doctor in almost 50% of cases, particularly in the case of traumatology (12). In Maine-et-Loire, emergency kits have been in place since the end of 2022, allowing the prescription of emergency drugs by non-medical staff via video-regulation with the emergency doctor. The aim is to be able to deliver treatments during the night, so that the nursing home doctor can assess the patient's condition in the morning. The emergency kit was developed in collaboration with the EHPAD coordinating doctors, the Emergency Dispatch Center of Angers and the geriatric doctors of the University Hospital of Angers. The objective of this research is to evaluate this new device. It will compare the rate of night hospitalisation of patients residing in nursing home according to the use or not of visio-regulation coupled with the emergency kit by the Emergency physician working in the Emergency Dispatch Center. At the start of the study, not all the nursing home in the department will be equipped with an emergency kit. We will therefore compare the calls to the Emergency Dispatch Center of the nursing homes with the emergency kit and the use of visio-regulation with the calls from nursing homes that do not yet have this device.


Recruitment information / eligibility

Status Recruiting
Enrollment 350
Est. completion date June 6, 2025
Est. primary completion date March 6, 2025
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Patients residing in a medicalized nursing home equipped with a video-regulation kit (smartphone and emergency kit) - Nightly call from a paramedical staff to the emergency dispatch center for diagnosis / care / referral to the emergency room between 10 pm and 7 am Exclusion Criteria: - Call between 7am and 10pm

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Video regulation and emergency kit
Video regulation and emergency kit

Locations

Country Name City State
France CHU Angers Angers

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of nocturnal hospitalizations Evaluating the impact of video-regulation on the rate of nocturnal hospitalizations of patients in a nursing home. 24 hours
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