EmergenciesCGA_EDNCT03786250
Comprehensive Geriatric Assessment in an Emergency Department
An observational study of Emergencies and Aging, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency Departments (ED), higher hospital admissions and more risks for patients arising from the ED stay. The advantages of developing specific attention to frailty in ED have been highlighted. Read more about this study
- Who is it for?
- Ages 18 to 115 years
- Conditions the study is for
- Emergencies, Aging, Geriatric Assessment
- What is being tested?
- Geriatric Assessment
- Type of treatment
- Surgery or procedure
- How many people
- 450 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2018to 1 Dec 2019
- 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 18 to 115 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients older than 65 years, attended in ED during the study periode.
Who may be able to join
- All patients older than 65 years attended in the ED
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Mireia Puig, PhD, +34616335291, mpuigc@santpau.cat
About this study
Official title: Comprehensive Geriatric Assessment in Emergency Department. Impact on Health and Patient Flows
Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency Departments (ED), higher hospital admissions and more risks for patients arising from the ED stay. The advantages of developing specific attention to frailty in ED have been highlighted. The benefits of these approaches are related to patients but also to organizations. The aim is to present how a Program of Care for Frailty (PCF) in an ED impacts on patient health and flows.
Objective is to analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency Department (ED) and on patient flows Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult patients/year ED attendances (43%≥65 years). Two periods are compared: First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after) 01/04/2017 - 15/04/2017
Read the detailed description
Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency Departments (ED), higher hospital admissions and more risks for patients arising from the ED stay. The advantages of developing specific attention to frailty in ED have been highlighted. The benefits of these approaches are related to patients but also to organizations. The aim is to observe how a Program of Care for Frailty (PCF) in an ED impacts on patient health and flows.
Objective
- Analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency Department (ED).
- Analyze the impact on patient flows following the implementation of a Comprehensive Geriatric Assessment in the Emergency Department (ED).
Methods Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult patients/year ED attendances (43%≥65 years).
First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after) 01/04/2017 - 15/04/2017 Intervention: In the second period, the AGI was carried out by the emergency medical teams. It basically consists of care adapted to the special needs of geriatric patients, with systematic screening of delirium, delirium prevention, early treatment, pain management with scales adapted to chronicity, conciliation of medication to discharge from the emergency department, among others A comparison will be made of health outcomes and patient flows in ED: direct discharge, admission to emergency observation unit, admission to short stay unit, transfer to intermediate hospital, admission, admission to critical care area, death, time spent in the Emergency Department (ED) and in intermediate hospital, mortality during admission at one and six months, re-entry or reconsultation in the Emergency Department at 30 days and six months will be measured.
- Conditions
- Emergencies, Aging, Geriatric Assessment, Patient Discharge
- Being tested
- Geriatric Assessment
- Keywords
- Emergency department, Older, Frailty
- Medical subject headings
- Emergencies, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric AssessmentProcedure or surgery
Also called CGA
Systematic screening of delirium, prevention of delirium, early treatment, pain management with scales adapted to chronicity, conciliation of medication to emergency discharge, among others.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with delirium
Measured: From date of admission until discharge, assessed up to 30 days
Secondary outcomes (1)
Number of patients with pain correctly treated
Measured: From date of admission until discharge, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start1 Dec 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Mutuam Conviure
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786250
- Sponsor's protocol ID
- IIBSP-AGI-2017-14
- Acronym
- CGA_ED
- Status last verified
- Dec 2018
- First submitted
- 11 Dec 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment in Emergency Department. Impact on Health and Patient Flows
- ClinicalTrials.gov ID
- NCT03786250
- Acronym / sponsor ID
- CGA_ED / IIBSP-AGI-2017-14
- Conditions
- Emergencies, Aging, Geriatric Assessment, Patient Discharge
- Keywords
- Emergency department, Older, Frailty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Fundació Mutuam Conviure
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 26 Dec 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.
Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency Departments (ED), higher hospital admissions and more risks for patients arising from the ED stay. The advantages of developing specific attention to frailty in ED have been highlighted. The benefits of these approaches are related to patients but also to organizations. The aim is to present how a Program of Care for Frailty (PCF) in an ED impacts on patient health and flows.
Objective is to analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency Department (ED) and on patient flows Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult patients/year ED attendances (43%≥65 years). Two periods are compared: First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after) 01/04/2017 - 15/04/2017
Detailed description
Purpose Frailty and multi-morbidity have been associated with increased pressure on Emergency Departments (ED), higher hospital admissions and more risks for patients arising from the ED stay. The advantages of developing specific attention to frailty in ED have been highlighted. The benefits of these approaches are related to patients but also to organizations. The aim is to observe how a Program of Care for Frailty (PCF) in an ED impacts on patient health and flows.
Objective
- Analyze the clinical impact of Comprehensive Geriatric Care (CGA) in the Emergency Department (ED).
- Analyze the impact on patient flows following the implementation of a Comprehensive Geriatric Assessment in the Emergency Department (ED).
Methods Setting: A tertiary, teaching, 550-bed urban hospital, with 80,000 adult patients/year ED attendances (43%≥65 years).
First period (before CGA implantation) del 01/04/2016 - 15/04/2016 and second period (after) 01/04/2017 - 15/04/2017 Intervention: In the second period, the AGI was carried out by the emergency medical teams. It basically consists of care adapted to the special needs of geriatric patients, with systematic screening of delirium, delirium prevention, early treatment, pain management with scales adapted to chronicity, conciliation of medication to discharge from the emergency department, among others A comparison will be made of health outcomes and patient flows in ED: direct discharge, admission to emergency observation unit, admission to short stay unit, transfer to intermediate hospital, admission, admission to critical care area, death, time spent in the Emergency Department (ED) and in intermediate hospital, mortality during admission at one and six months, re-entry or reconsultation in the Emergency Department at 30 days and six months will be measured.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 115 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients older than 65 years, attended in ED during the study periode.
Key inclusion criteria (1 listed)
- All patients older than 65 years attended in the ED
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatric AssessmentAlso: CGASystematic screening of delirium, prevention of delirium, early treatment, pain management with scales adapted to chronicity, conciliation of medication to emergency discharge, among others. | Procedure or surgery | – |
Primary outcome
Number of patients with delirium
Time frame: From date of admission until discharge, assessed up to 30 days
1 secondary outcome
Number of patients with pain correctly treated
Time frame: From date of admission until discharge, assessed up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 Emergencies and Aging, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 1 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: status not confirmed, as of the sponsor's last update on 26 Dec 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with delirium (time frame: From date of admission until discharge, assessed up to 30 days). 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 26 Dec 2018.