Older falleRs : From Emergency to Geriatric Network (OREGoN)

March 28, 2018 updated by: University Hospital, Angers

Analyse de la Prise en Charge et de l'Orientation Des Patients de 75 Ans et Plus Consultant Pour Chute Aux Urgences du CHU Angers : données de l'évaluation Initiale et du Recueil de données effectué un an après Leur Passage Aux Urgences

The fall is a complex process associated with high morbidity and mortality, with an institutionalization rate of up to 40% and a major socio-economic impact.

The prevalence of falls increases with age. In fact, it is estimated that one-third of people over 65 and 50% of those over 80 living at home fall at least once a year, half of whom fall repeatedly.

For all these reasons, the fall is a frequent reason for emergency consultation, and is an integral part of geriatric syndromes at risk of early readmission.

The care of the elderly patient has been the subject of good practice recommendations by the Health Authority (HAS) in 2009, with the aim of referring patients to specialized geriatric care. Among these recommendations is the need to look for signs of geriatric severity of falls.

To our knowledge, few studies have investigated the applicability of HAS recommendations with the practice of emergencies; this study is part of a project to improve practices.

- Hypothesis : Due to the fast pace of emergency medicine, the complexity of elderly patients and the inherent limitations of the care system, we hypothesize that few serious fallers are included in the geriatric pathway after admission to the emergency room (ER).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

From the database of URQUAL software available at the Emergencies of Angers Hospital and the "list of diagnostics for clinical research", inclusion (over a period arbitrarily defined from October 1, 2015 to November 1, 2015) of patients aged 75 and over with a diagnosis of fall or a related reason when they are admitted to the Emergencies Room.

During the initial consultation in the Emergency Department, documentary analysis with all the signs of seriousness of the falls stated in the report, as defined by HAS 2009:

  • consequences of the fall (moderate to severe physical trauma, inability to rise from the ground and its consequences, post-fall syndrome)
  • pathologies responsible for the fall
  • repetitive nature of the fall (recent increase in the frequency of falls, association of more than 3 risk factors for falls, gait disorders)
  • situations at risk of severe falls (proven osteoporosis, use of anticoagulant drugs, social and family isolation) Search for an anterior passage of the patient in the geriatric pathway.

Collection of the patient's care pathway following this passage to the ER:

  • request for consultation or specialized geriatric care
  • return home / hospitalization / Subacute care and rehabilitation

Data collected one year after the emergency department visit, based on the information available in the URQUAL and CROSSWAY databases accessible at Angers Hospital, are:

  • search for passage in the geriatric pathway following the emergency consultation (external geriatric consultation, intervention of the mobile geriatric team, hospitalization in Geriatrics)
  • readmission to the Emergency Department of Angers University Hospital for fall
  • death Telephone call to the general practitioner one year after the initial admission, in order to search for a recurrence of fall.

This call-back makes it possible to collect data from patients readmitted for a fall in another center (clinic, hospital, etc.) or who have fallen again at home without admission to an emergency service with the aim of limiting the information and monitoring biases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Angers University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients are recruited during their passage to the Emergency Room of the University Hospital of Angers, France

Description

Inclusion Criteria:

  • Age ≥ 75 years
  • Reason for emergency consultation: fall or a related cause (fracture, head trauma, etc.)

Exclusion Criteria:

  • No one

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measure of the proportion of serious fallers included in the geriatric pathway one year after passing the emergencies.
Time Frame: 1 year
This outcome is assessed by the number of serious faller patients in the geriatric pathway.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Measure of proportion of fallers admitted to emergencies.
Time Frame: baseline
This outcome is assessed by the number of fallers admitted to emergencies.
baseline
Measure of proportion of serious fallers admitted to emergencies.
Time Frame: baseline
This outcome is assessed by the number of serious fallers admitted to emergencies.
baseline
Number of severity criteria most commonly encountered in emergencies.
Time Frame: baseline
This outcome is assessed by the emergencies data.
baseline
Measure of the proportion of patients who fell again within one year of admission to ER.
Time Frame: 1 year
This outcome is assessed by the number of patients who fell again within one year of admission to ER.
1 year
Measure of the proportion of patients included in the geriatric pathway readmitted for fall to the ER in the following year.
Time Frame: 1 year
This outcome is assessed by the number of patients included in the geriatric pathway readmitted for fall to the ER.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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