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.
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.
Dominique Savary, MD,PhD contact
France1 site, 1 recruiting
- Recruiting
CHU Angers
Angers
Delphine Douillet, delphine.douillet@chu-angers.fr
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.
- Conditions
- Emergencies, Old Age; Debility, Nursing Caries
- 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 group | Role | What they receive |
|---|---|---|
| Group with video-regulation and using of the emergency kit | Use 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 kit | no 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.
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.
- First posted17 Mar 2023
- Study start6 Mar 2023
- Primary completion6 Mar 2025 (estimated)
- Study completion6 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05773508
- Acronym / sponsor ID
- VisioR-EHPAD / 2022-120
- Conditions
- Emergencies, Old Age; Debility, Nursing Caries
- Keywords
- emergency, nursing home, geriatric, telemedicine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 6 Mar 2025 (estimated)
- Study completion
- 6 Jun 2025 (estimated)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with video-regulation and using of the emergency kit | – | Device: Video regulation and emergency kitUse of video regulation and/or emergency kit → addressing modified by the use of one or the other |
| Group without video-regulation and using of the emergency kit | – | –no video-regulation and no use of the emergency kit → addressing patients according to the standard of care |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients for whom nursing home carers called the emergency call centre between 10pm and 7am.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Call between 7am and 10pm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video regulation and emergency kitVideo regulation and emergency kit | Device | Group with video-regulation and using of the emergency kit |
Primary outcome
Rate of nocturnal hospitalizations
Time frame: 24 hours
Evaluating the impact of video-regulation on the rate of nocturnal hospitalizations of patients in a nursing home.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Savary, MD,PhD contact
1 site in 1 country: see every site and its status.
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.