in Hospital MortalityNoBedNightNCT05821491
Prognosis of Geriatric Patients With Non-bedded Night in the Emergency Department: a Multicenter Cohort Study
An observational study of in Hospital Mortality and Geriatric, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Retrospective, multicenter, French cohort study. Data from patients over 75 years of age who visited the emergency department on 12 and 13 December 2022 could be collected until their discharge from hospital and for a maximum of 30 days. Read more about this study
- Who is it for?
- Ages 76 years and older
- Conditions the study is for
- in Hospital Mortality, Geriatric
- How many people
- 1,598 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2022to 13 Jan 2023
- 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 76 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All data of eligible patients over 75 years old who visited the emergency departments of the concerned hospitals on 12 and 13 December 2022 will be collected. These data will be broken down into : * Patients who spent the night on a stretcher, * Patients who spent the night in a bed after an emergency visit.
Who may be able to join
- Patient over 75 years of age
- Emergency department patient between 12 December 8am and 14 December 8am.
- Having spent the whole of one of the 2 periods midnight-8am on a stretcher in the ED ("stretcher" group), or in an inpatient bed (including short hospitalization unit) ("inpatient bed" group).
- Decision to hospitalise after discharge from the emergency department (excluding the continuous care unit)
Who cannot join
- Patient admitted to an inpatient bed between midnight and 8am
- Patient discharged home
Trial locations and contacts
1 site in 1 country.
About this study
Retrospective, multicenter, French cohort study. Data from patients over 75 years of age who visited the emergency department on 12 and 13 December 2022 could be collected until their discharge from hospital and for a maximum of 30 days. Data from patients who spent the night on a stretcher (stretcher group) as well as from a group of patients who spent the night in a bed (hospital bed group) after a visit to the emergency department will be collected.
The characteristics of the patients and their stay in the emergency room will be collected, and their hospital stay (truncated at 30 days) will be analyzed in terms of morbidity and mortality.
Read more
Main objective:
To study the truncated 30-day in-hospital mortality of patients who spent a night on a stretcher in the emergency department.
Secondary objectives:
To describe the characteristics and hospital stay of patients who spent a night on a stretcher To compare the morbidity and mortality of patients who spent the night on a stretcher with patients who spent the night in an inpatient bed after an emergency visit;
Read the detailed description
The activity and number of admissions to emergency departments are constantly increasing, resulting in the overloading of emergency departments, a problem shared by most Western countries, for a variety of reasons. The ageing of the population and the increasing scarcity of outpatient medical services have led to an increase in the number of consultations in emergency departments by patients aged over 75. These demographic changes and the reduction in the number of hospital beds in France have led to overcrowding in emergency departments (EDs), with long waiting times for patients to be admitted to hospital. Emergency department overcrowding is directly associated with an increase in mortality at 24 hours (adjusted OR 1.42; 95%CI 1.08-1.88) and at 72 hours (adjusted OR 1.27; 95%CI 1.02-1.58) after a visit to the emergency department. Similarly, several retrospective studies report an association between in-hospital mortality and the time spent in the emergency department, and the time spent waiting for a hospital bed in particular.
The No Bed Challenge, organised by Samu Urgences de France (SUDF) in 2018, identified patients who spent the night on a stretcher waiting for a hospital bed. Beyond the long waiting time and its association with excess mortality, spending the night on a stretcher can be associated with a worsening prognosis: the conditions of care and comfort are degraded, and the risks inherent in such a nightly wait on a stretcher are multiple. It has been described that beyond 5 hours, waiting is linked with a linear increase in 30-day mortality. In addition, several retrospective studies report a longer waiting time for a downstream hospitalization bed for the geriatric patient population. This longer waiting time is also associated with the occurrence of adverse events, increasing by 3% for each hour spent in the emergency department. However, the characteristics of patients spending the night in the emergency department while waiting for a hospital bed, and their prognosis, are not known - particularly in France.
The objective of the NoBedNight study is to study the in-hospital mortality of patients over 75 years old who spent the night on a stretcher. It will also allow us to describe the typology of these patients, and to compare them to a similar population who had access to an outpatient bed after a visit to the emergency room.
The study aim to evaluate the in-hospital mortality of patients over 75 years old spending the night on a stretcher in the emergency room while waiting for an inpatient bed by collecting data collected in the course of care.
This national retrospective multicentre cohort study will provide information on the clinical characteristics of this population, their frailty index (assessed by Charlson's Comorbidity Index) and their level of dependence (GIR scale) which will be calculated a posteriori on the data collected during care, as well as their clinical presentation, their reason for referral and the occurrence of complications during hospitalisation.
It will make it possible to evaluate the number of geriatric patients waiting for a hospital bed over a short-predefined period in our French emergency services.
The increase in the overload of emergency departments leads to regular national crises in France and in Western countries. It is important to assess the consequences on the health of patients, particularly geriatric patients.
According to the literature, the hypothesis is that mortality is increased in geriatric patients who spend a night on a stretcher in an emergency department because they do not have an inpatient bed.
In recent years, many ideas have been put forward to alleviate the overloading of emergency departments, the cause of which is multifactorial. However, obtaining precise and updated data will make it possible to evaluate the magnitude of the risks inherent in waiting for an outpatient hospital bed for elderly patients and to conclude on the mortality of patients at 30 days.
- Conditions
- in Hospital Mortality, Geriatric
- Keywords
- In-hospital mortality, Geriatric patient, Emergency unit, No-bedding night
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| non-bedded night | geriatric patients with non-bedded night in the emergency department | |
| bedded night | geriatric patients with bedded night in the emergency department |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
To study in-hospital mortality, truncated at 30 days, of patients who spent a night on a stretcher in the emergency department
Measured: 30 days after ED's admission
Secondary outcomes (2)
Lenght of hospital stay in days
Describe the hospital stay of patients who spent a night on a stretcher
Measured: End of hospitalization, truncated at 30 days
Morbidity
To compare the morbidity (complications arising during hospitalisation) of these patients who did not spend the night on a stretcher with those who spent the night in an inpatient bed after an emergency visit
Measured: End of hospitalization, truncated at 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start12 Dec 2022
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for in Hospital MortalityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821491
- Sponsor's protocol ID
- APHP221326
- Acronym
- NoBedNight
- Status last verified
- Apr 2023
- First submitted
- 16 Dec 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Geriatric Patients With Non-bedded Night in the Emergency Department: a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05821491
- Acronym / sponsor ID
- NoBedNight / APHP221326
- Conditions
- in Hospital Mortality, Geriatric
- Keywords
- In-hospital mortality, Geriatric patient, Emergency unit, No-bedding night
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,598 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 20 Apr 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.
Retrospective, multicenter, French cohort study. Data from patients over 75 years of age who visited the emergency department on 12 and 13 December 2022 could be collected until their discharge from hospital and for a maximum of 30 days. Data from patients who spent the night on a stretcher (stretcher group) as well as from a group of patients who spent the night in a bed (hospital bed group) after a visit to the emergency department will be collected.
The characteristics of the patients and their stay in the emergency room will be collected, and their hospital stay (truncated at 30 days) will be analyzed in terms of morbidity and mortality.
Main objective:
To study the truncated 30-day in-hospital mortality of patients who spent a night on a stretcher in the emergency department.
Secondary objectives:
To describe the characteristics and hospital stay of patients who spent a night on a stretcher To compare the morbidity and mortality of patients who spent the night on a stretcher with patients who spent the night in an inpatient bed after an emergency visit;
Detailed description
The activity and number of admissions to emergency departments are constantly increasing, resulting in the overloading of emergency departments, a problem shared by most Western countries, for a variety of reasons. The ageing of the population and the increasing scarcity of outpatient medical services have led to an increase in the number of consultations in emergency departments by patients aged over 75. These demographic changes and the reduction in the number of hospital beds in France have led to overcrowding in emergency departments (EDs), with long waiting times for patients to be admitted to hospital. Emergency department overcrowding is directly associated with an increase in mortality at 24 hours (adjusted OR 1.42; 95%CI 1.08-1.88) and at 72 hours (adjusted OR 1.27; 95%CI 1.02-1.58) after a visit to the emergency department. Similarly, several retrospective studies report an association between in-hospital mortality and the time spent in the emergency department, and the time spent waiting for a hospital bed in particular.
The No Bed Challenge, organised by Samu Urgences de France (SUDF) in 2018, identified patients who spent the night on a stretcher waiting for a hospital bed. Beyond the long waiting time and its association with excess mortality, spending the night on a stretcher can be associated with a worsening prognosis: the conditions of care and comfort are degraded, and the risks inherent in such a nightly wait on a stretcher are multiple. It has been described that beyond 5 hours, waiting is linked with a linear increase in 30-day mortality. In addition, several retrospective studies report a longer waiting time for a downstream hospitalization bed for the geriatric patient population. This longer waiting time is also associated with the occurrence of adverse events, increasing by 3% for each hour spent in the emergency department. However, the characteristics of patients spending the night in the emergency department while waiting for a hospital bed, and their prognosis, are not known - particularly in France.
The objective of the NoBedNight study is to study the in-hospital mortality of patients over 75 years old who spent the night on a stretcher. It will also allow us to describe the typology of these patients, and to compare them to a similar population who had access to an outpatient bed after a visit to the emergency room.
The study aim to evaluate the in-hospital mortality of patients over 75 years old spending the night on a stretcher in the emergency room while waiting for an inpatient bed by collecting data collected in the course of care.
This national retrospective multicentre cohort study will provide information on the clinical characteristics of this population, their frailty index (assessed by Charlson's Comorbidity Index) and their level of dependence (GIR scale) which will be calculated a posteriori on the data collected during care, as well as their clinical presentation, their reason for referral and the occurrence of complications during hospitalisation.
It will make it possible to evaluate the number of geriatric patients waiting for a hospital bed over a short-predefined period in our French emergency services.
The increase in the overload of emergency departments leads to regular national crises in France and in Western countries. It is important to assess the consequences on the health of patients, particularly geriatric patients.
According to the literature, the hypothesis is that mortality is increased in geriatric patients who spend a night on a stretcher in an emergency department because they do not have an inpatient bed.
In recent years, many ideas have been put forward to alleviate the overloading of emergency departments, the cause of which is multifactorial. However, obtaining precise and updated data will make it possible to evaluate the magnitude of the risks inherent in waiting for an outpatient hospital bed for elderly patients and to conclude on the mortality of patients at 30 days.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-bedded night | – | –geriatric patients with non-bedded night in the emergency department |
| bedded night | – | –geriatric patients with bedded night in the emergency department |
Who may qualify
- Ages
- 76 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All data of eligible patients over 75 years old who visited the emergency departments of the concerned hospitals on 12 and 13 December 2022 will be collected. These data will be broken down into : * Patients who spent the night on a stretcher, * Patients who spent the night in a bed after an emergency visit.
Key inclusion criteria (4 listed)
- Patient over 75 years of age
- Emergency department patient between 12 December 8am and 14 December 8am.
- Having spent the whole of one of the 2 periods midnight-8am on a stretcher in the ED ("stretcher" group), or in an inpatient bed (including short hospitalization unit) ("inpatient bed" group).
- Decision to hospitalise after discharge from the emergency department (excluding the continuous care unit)
Key exclusion criteria (2 listed)
- Patient admitted to an inpatient bed between midnight and 8am
- Patient discharged home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
in-hospital mortality
Time frame: 30 days after ED's admission
To study in-hospital mortality, truncated at 30 days, of patients who spent a night on a stretcher in the emergency department
2 secondary outcomes
Lenght of hospital stay in days
Time frame: End of hospitalization, truncated at 30 days
Morbidity
Time frame: End of hospitalization, truncated at 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in Hospital Mortality and Geriatric, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 20 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: 30 days after ED's admission). 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 20 Apr 2023.