Emergency Geriatric CareREGESANCT02712450
Tools Development for Geriatric Emergency Regulation
An observational study of Emergency Geriatric Care, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
According to surveys, 13% to 20% of the Service Médical d'Urgence (SAMU) centre 15 (French 911) calls concern elderly patients above 75 years of age. For these patients, the clinical pathway should be decided on the basis of the symptomatology described during the call, but also with the gathering of specific data… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Emergency Geriatric Care
- How many people
- 2,279 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Aug 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
- No healthy volunteers
- Older adult
Study population: Elderly patients calling SAMU
Who may be able to join
- Patient above 75 years olds
- Patient calling for a liberal regulation
- Patient calling between 8 a.m. and 6 p.m. from monday to friday
Who cannot join
- Patient calling for vital emergency (hospital regulation)
- Patient calling for inter-hospital transport
Trial locations and contacts
1 site in 1 country.
France1 site
Service Gériatrie - Hôpital Edouard Herriot, Hospices Civils de Lyon
Lyon, 69003
About this study
Official title: Tools Development for Geriatric Emergency Regulation at the Emergency Service Centre, in the Rhône Area
According to surveys, 13% to 20% of the Service Médical d'Urgence (SAMU) centre 15 (French 911) calls concern elderly patients above 75 years of age. For these patients, the clinical pathway should be decided on the basis of the symptomatology described during the call, but also with the gathering of specific data such as medical social and psychological evaluation. These items allow the regulating doctor to assess comorbidity, on-going treatment, psycho-cognitive status, previous hospitalisations, social situation, and patient expectations and needs.
However, data collected in order to assess the situation on the phone and take the orientation decision are mainly limited to the severity of clinical symptoms. Medical, psychological and social aspects are rarely gathered, for several reasons :
Read more
- Phone call shortness : emergency calls should be treated quickly
- Regulating doctors are not trained to take in account the specificities or geriatric patients in their decision making. Besides, they are not informed about alternatives to the hospital emergency department, such as "geriatric channel" system.
An observational study was performed in 2012 on 692 calls about elderly patients referred to the SAMU centre 15 during 7 days : 63% of these patients were transferred to an emergency department. Regardless of severe cases "hospital regulation", 55% of the least serious cases ("liberal regulation") were transferred to an emergency department.
Regulation is inadequate to elderly patients for whom 1) the situation assessment and the appropriate decision making require specific items that are not known by regulating doctors, 2) the medical care and the clinical pathway could be improved by the knowledge of on-field "geriatric channel", 3) the emergency department care is particularly long, 4) and could be pernicious to younger patients.
1920 patients will be recruited between January 2016 and August 2017, including a 6 months wash-out in order to train regulating doctors. This training will include geriatric patient's specificities, and geriatric channels. A 12% difference between the 2 groups (before and after the training) is expected, considering a 80% statistical power. The design is a time series experiment.
- Conditions
- Emergency Geriatric Care
- Keywords
- geriatric, emergency, clinical pathway, regulation, SAMU, training
- 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 |
|---|---|---|
| Control group | * Patients included from January 2016 to August 2016 * Before regulating doctors training course | |
| Experimental group | * Patients included from January 2017 to August 2017 * After regulating doctors training course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients sent to an emergency department
The training course efficiency (which contains specific regulation tools and emergency regulation doctors formation) will be assessed by evaluating the proportion of 75 years old patients and older sent to an emergency department after a liberal regulation.
Measured: 24 hours after patient's call
Secondary outcomes (7)
Duration of the hospital stay in emergency department
The training course efficiency on hospital stay duration will be assessed by evaluating the duration of the hospital stay in emergency department, after regulating doctor decision.
Measured: 7 days after patient's call
Occurence of non-programmed hospitalization in emergency department
The training course efficiency on non-programmed hospitalization in emergency department will be assessed by evaluating the occurence of these type of hospitalization one week after call regulation
Measured: 7 days after patient's call
Geriatric channel utilisation rate
Training course efficiency on the geriatric channel utilization by regulating doctors will be assessed using multiple parameters : geriatric hotline use, intra-hospital geriatric mobile team mobilisation, extra-hospital geriatric mobile team mobilisation, direct hospitalization in geriatric department
Measured: 24 hours after patient's call
Training course feasibility
Training course feasibility will be assessed using multiple parameters : regulation call duration, regulating doctor orientation respect, contact between regulating doctor and physician (GP, geriatric doctor, emergency doctor, geriatric channel)
Measured: 24 hours after patient's call
Medical cost for patient
Measured: 7 days after patient's call
Non medical cost for patient
Measured: 7 days after patient's call
Training course cost
Measured: 7 days after patient's call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency Geriatric CareStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712450
- Sponsor's protocol ID
- 69HCL14_0449
- Acronym
- REGESA
- Status last verified
- Feb 2018
- First submitted
- 16 Feb 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Foucaud A, Gilbert T, Vincent A, Jomard N, Comte B, Porthault S, Comte G, Theurey O, Gueugniaud PY, Bourelly L, Rabilloud M, Boutitie F, Douplat M, Tassa O, Haesebaert J, Termoz A, Schott AM. Evaluation of a training program for emergency medical service physician dispatchers to reduce emergency departments visits. J Am Geriatr Soc. 2023 Feb;71(2):484-495. doi: 10.1111/jgs.18101. Epub 2022 Nov 1.
PubMed 36317929
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tools Development for Geriatric Emergency Regulation at the Emergency Service Centre, in the Rhône Area
- ClinicalTrials.gov ID
- NCT02712450
- Acronym / sponsor ID
- REGESA / 69HCL14_0449
- Conditions
- Emergency Geriatric Care
- Keywords
- geriatric, emergency, clinical pathway, regulation, SAMU, training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,279 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 18 Mar 2016 (estimated)
- 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.
According to surveys, 13% to 20% of the Service Médical d'Urgence (SAMU) centre 15 (French 911) calls concern elderly patients above 75 years of age. For these patients, the clinical pathway should be decided on the basis of the symptomatology described during the call, but also with the gathering of specific data such as medical social and psychological evaluation. These items allow the regulating doctor to assess comorbidity, on-going treatment, psycho-cognitive status, previous hospitalisations, social situation, and patient expectations and needs.
However, data collected in order to assess the situation on the phone and take the orientation decision are mainly limited to the severity of clinical symptoms. Medical, psychological and social aspects are rarely gathered, for several reasons :
- Phone call shortness : emergency calls should be treated quickly
- Regulating doctors are not trained to take in account the specificities or geriatric patients in their decision making. Besides, they are not informed about alternatives to the hospital emergency department, such as "geriatric channel" system.
An observational study was performed in 2012 on 692 calls about elderly patients referred to the SAMU centre 15 during 7 days : 63% of these patients were transferred to an emergency department. Regardless of severe cases "hospital regulation", 55% of the least serious cases ("liberal regulation") were transferred to an emergency department.
Regulation is inadequate to elderly patients for whom 1) the situation assessment and the appropriate decision making require specific items that are not known by regulating doctors, 2) the medical care and the clinical pathway could be improved by the knowledge of on-field "geriatric channel", 3) the emergency department care is particularly long, 4) and could be pernicious to younger patients.
1920 patients will be recruited between January 2016 and August 2017, including a 6 months wash-out in order to train regulating doctors. This training will include geriatric patient's specificities, and geriatric channels. A 12% difference between the 2 groups (before and after the training) is expected, considering a 80% statistical power. The design is a time series experiment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –* Patients included from January 2016 to August 2016 * Before regulating doctors training course |
| Experimental group | – | –* Patients included from January 2017 to August 2017 * After regulating doctors training course |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients calling SAMU
Key inclusion criteria (3 listed)
- Patient above 75 years olds
- Patient calling for a liberal regulation
- Patient calling between 8 a.m. and 6 p.m. from monday to friday
Key exclusion criteria (2 listed)
- Patient calling for vital emergency (hospital regulation)
- Patient calling for inter-hospital transport
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
Proportion of patients sent to an emergency department
Time frame: 24 hours after patient's call
The training course efficiency (which contains specific regulation tools and emergency regulation doctors formation) will be assessed by evaluating the proportion of 75 years old patients and older sent to an emergency department after a liberal regulation.
7 secondary outcomes
Duration of the hospital stay in emergency department
Time frame: 7 days after patient's call
Occurence of non-programmed hospitalization in emergency department
Time frame: 7 days after patient's call
Geriatric channel utilisation rate
Time frame: 24 hours after patient's call
Training course feasibility
Time frame: 24 hours after patient's call
Medical cost for patient
Time frame: 7 days after patient's call
Non medical cost for patient
Time frame: 7 days after patient's call
Training course cost
Time frame: 7 days after patient's call
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 26 Feb 2018.
- Derived from this study: PubMed 36317929Foucaud A, Gilbert T, Vincent A, Jomard N, Comte B, Porthault S, Comte G, Theurey O, Gueugniaud PY, Bourelly L, Rabilloud M, Boutitie F, Douplat M, Tassa O, Haesebaert J, Termoz A, Schott AM. Evaluation of a training program for emergency medical service physician dispatchers to reduce emergency departments visits. J Am Geriatr Soc. 2023 Feb;71(2):484-495. doi: 10.1111/jgs.18101. Epub 2022 Nov 1.
- Individual participant dataSharing planned: No
Related trials for Emergency Geriatric Care
RecruitingObservational study
Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
Accidental Falls, Aged
Recruiting
Virtual Reality and Standard Care vs. Standard Care Alone for Acute MSK Pain in Geriatric ED Patients
Acute Musculoskeletal Pain
Active, not recruitingObservational study
Association of ICU Admission Time, Age Stratification, and Clinical Frailty Scale With 30-Day Mortality in Geriatric Oncology Patients
Cancer, Frailty
RecruitingObservational study
EndotyPIng PreHospitAl de Novo Acute hYpoxemic Respiratory Failure
Acute Hypoxemic Respiratory Failure, Acute Respiratory Distress Syndrome
RecruitingObservational study
Home-based Acute Care for Older Persons Initiated by the Emergency Medical and Ambulance Services - a Retrospective Observation of Effects on Healthcare Utilisation and Mortality
Aged, Home Care, Hospital-Based
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 Emergency Geriatric Care, run by Hospices Civils de Lyon 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 3 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 26 Feb 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?
Proportion of patients sent to an emergency department (time frame: 24 hours after patient's call). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02712450, which also lists 1 linked publication.
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 26 Feb 2018.