Fall PatientsOREGoNNCT03488615
Older falleRs : From Emergency to Geriatric Network
An observational study of Fall Patients, run by University Hospital, Angers at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Fall Patients
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2015to 1 Dec 2017
- 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
- Older adult
Study population: Patients are recruited during their passage to the Emergency Room of the University Hospital of Angers, France
Who may be able to join
- Age ≥ 75 years
- Reason for emergency consultation: fall or a related cause (fracture, head trauma, etc.)
Who cannot join
- No one
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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).
Read the 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.
- Conditions
- Fall Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of the proportion of serious fallers included in the geriatric pathway one year after passing the emergencies.
This outcome is assessed by the number of serious faller patients in the geriatric pathway.
Measured: 1 year
Secondary outcomes (5)
Measure of proportion of fallers admitted to emergencies.
This outcome is assessed by the number of fallers admitted to emergencies.
Measured: baseline
Measure of proportion of serious fallers admitted to emergencies.
This outcome is assessed by the number of serious fallers admitted to emergencies.
Measured: baseline
Number of severity criteria most commonly encountered in emergencies.
This outcome is assessed by the emergencies data.
Measured: baseline
Measure of the proportion of patients who fell again within one year of admission to ER.
This outcome is assessed by the number of patients who fell again within one year of admission to ER.
Measured: 1 year
Measure of the proportion of patients included in the geriatric pathway readmitted for fall to the ER in the following year.
This outcome is assessed by the number of patients included in the geriatric pathway readmitted for fall to the ER.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Oct 2015
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall PatientsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488615
- Sponsor's protocol ID
- 2017-05
- Acronym
- OREGoN
- Status last verified
- Jan 2018
- First submitted
- 26 Jan 2018
- Last updated
- 5 Apr 2018
- 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 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03488615
- Acronym / sponsor ID
- OREGoN / 2017-05
- Conditions
- Fall Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 5 Apr 2018 (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 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).
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients are recruited during their passage to the Emergency Room of the University Hospital of Angers, France
Key inclusion criteria (2 listed)
- Age ≥ 75 years
- Reason for emergency consultation: fall or a related cause (fracture, head trauma, etc.)
Key exclusion criteria (1 listed)
- No one
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
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.
5 secondary outcomes
Measure of proportion of fallers admitted to emergencies.
Time frame: baseline
Measure of proportion of serious fallers admitted to emergencies.
Time frame: baseline
Number of severity criteria most commonly encountered in emergencies.
Time frame: baseline
Measure of the proportion of patients who fell again within one year of admission to ER.
Time frame: 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
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 5 Apr 2018.
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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 Fall Patients, 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: finished, as of the sponsor's last update on 5 Apr 2018. 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?
Measure of the proportion of serious fallers included in the geriatric pathway one year after passing the emergencies. (time frame: 1 year). 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 5 Apr 2018.