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EmergenciesVisioR-EHPADNCT05773508

Impact of Video Regulation Associated With an Emergency Kit on Night Hospitalizations of the Residents of Nursing Homes.

An observational study of Emergencies and Old Age; Debility, run by University Hospital, Angers at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 75 years and older
Conditions the study is for
Emergencies, Old Age; Debility, Nursing Caries
What is being tested?
Video regulation and emergency kit
Type of treatment
Medical device
How many people
350 participants
Where
1 siteFrance
Study dates
6 Mar 2023to 6 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 75 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: All patients for whom nursing home carers called the emergency call centre between 10pm and 7am.

Who may be able to join

  • 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

Who cannot join

  • Call between 7am and 10pm

Trial locations and contacts

1 site in 1 country.

Delphine Douillet, MD,PhD contact

+33241353637

Delphine.Douillet@chu-angers.fr

Dominique Savary, MD,PhD contact

Dominique.Savary@chu-angers.fr

France1 site, 1 recruiting
  • CHU Angers

    Angers

    Delphine Douillet, delphine.douillet@chu-angers.fr

    Recruiting

Other trials in France

About this study

Official title: Impact of Video Regulation Associated With an Emergency Kit on Night Hospitalizations of the Residents of Nursing Homes in the Emergency Medical Dispatch Center.

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.

Read the detailed 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.

Being tested
Video regulation and emergency kit
Keywords
emergency, nursing home, geriatric, telemedicine
Medical subject headings
Emergencies, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video regulation and emergency kitDevice

    Video regulation and emergency kit

Study groups in NCT05773508
Study groupRoleWhat they receive
Group with video-regulation and using of the emergency kitUse of video regulation and/or emergency kit → addressing modified by the use of one or the other
Receives: Device: Video regulation and emergency kit
Group without video-regulation and using of the emergency kitno video-regulation and no use of the emergency kit → addressing patients according to the standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of nocturnal hospitalizations

    Evaluating the impact of video-regulation on the rate of nocturnal hospitalizations of patients in a nursing home.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2023
  2. Study start6 Mar 2023
  3. Primary completion6 Mar 2025 (estimated)
  4. Study completion6 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05773508
Sponsor's protocol ID
2022-120
Acronym
VisioR-EHPAD
Status last verified
Mar 2023
First submitted
3 Mar 2023
Last updated
17 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Emergencies and Old Age; Debility, run by University Hospital, Angers at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Delphine Douillet, MD,PhD (+33241353637, Delphine.Douillet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of nocturnal hospitalizations (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.

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