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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Emergency department Hospital Pitié-Salpêtrière

    Paris, 75013

Other trials in France

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.

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 groups in NCT05821491
Study groupRoleWhat they receive
non-bedded nightgeriatric patients with non-bedded night in the emergency department
bedded nightgeriatric 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted20 Apr 2023
  2. Study start12 Dec 2022
  3. Primary completion13 Jan 2023
  4. Study completion13 Jan 2023

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
Cohort
Time perspective
Retrospective
Enrolment
1,598 participants (actual)
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

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.

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