Comparative Effectiveness ResearchGerED-21NCT06788210
Geriatric Team in ED: Effects on Rate of Hospitalization and on Community Health Management of Elderly (GerED-21)
A study testing Multiprofessional Geriatric Emergency Team applied front-door CGA to identify patients who require inpatient care and those who can safely be discharged. in people with Comparative Effectiveness Research, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The Ger-ED Intervention study focuses on early assessment and intervention in the emergency department (ED) by a specialized geriatric team, which includes a geriatrician, a nurse with expertise in geriatrics and continuity of care from hospital to community and when necessary a social worker. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Comparative Effectiveness Research
- What is being tested?
- Multiprofessional Geriatric Emergency Team applied front-door CGA to identify patients who require inpatient care and those who can safely be discharged.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 624 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2023to 8 Aug 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients aged ≥ 75 years
- Triage Risk Screening Tool (TRST) score ≥ 2
- Presence of signed informed consent
Who cannot join
- Patients with acute pathology requiring immediate intervention (polytrauma, urgent surgery)
- Patients who need specific pathway (STEMI, Stroke, Hip Fracture, patients with highly contagious diseases, for example Sars Cov2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of the Geriatric Team in Facilitating the Emergency Department (ED) Workflow for Elderly Patients: Effects on Rate of Hospitalization and on Community Health Management: A Multicentric Randomized Controlled Intervention Study
The Ger-ED Intervention study focuses on early assessment and intervention in the emergency department (ED) by a specialized geriatric team, which includes a geriatrician, a nurse with expertise in geriatrics and continuity of care from hospital to community and when necessary a social worker. The intervention model is based on Comprehensive Geriatric Assessment (CGA) and aims to improve the management and care pathways for elderly patients. Through tailored responses, the team is expected to identify the appropriate setting for each patient and coordinate with community services to facilitate a safe return home when hospitalization is avoidable, and the risks outweigh the benefits.
The purpose of this study is to evaluate the impact of this dedicated ED multidisciplinary geriatric team intervention on the quality of care for elderly patients presenting at the ED, compared to usual care.
Read more
The study is a multicentric interventional randomized controlled trial involving cluster randomization, where calendar weeks are randomized rather than individual patients.
Study Design:
During the weeks designated as 'treatment', the multidisciplinary team will be present in the ED. They will recruit all eligible patients who meet the inclusion and exclusion criteria and provide consent to participate in the study, until the required weekly number is reached.
During the weeks designated as 'control', patients who meet the inclusion and exclusion criteria and provide consent will receive the usual care.
Read the detailed description
The GerED-21 study aims to introduce a multidisciplinary geriatric team model across three Northern Italian hospitals to reduce unnecessary hospitalizations among elderly emergency department (ED) patients. The Geriatric Emergency Team (GET) - comprising a geriatrician, a nurse specialized in transitional care, and a social worker - will conduct a front-door comprehensive geriatric assessment (CGA) to determine which patients require inpatient care and which can be safely discharged.
The study is planned for a 24-month duration. The first six months will focus on training team members, setting up a database, and arranging logistics within the EDs. The target population includes 624 patients aged 75 and older, admitted to the EDs of three hospitals: IRCCS AOU Policlinico di Sant'Orsola Bologna, Ospedale Maggiore AUSL Bologna, and Ospedale Maggiore AOU Parma, over 52 weeks following the start of the study at each site.
At various timepoints, data will be collected from patients, including:
Demographics: Age, sex, education level, housing status (home, sheltered facility, other hospital), cohabitation status (alone, with spouse, others), and primary caregiver.
Referral Details: Whether referred by an attending physician or direct access to the emergency room.
Multidimensional Assessment Data: Short Portable Mental Status Questionnaire (SPMSQ) , Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Charlson Comorbidity Index, Rockwood Frailty Index, Geriatric Depression Scale (GDS-5 item), and number of medications.
Delirium Screening: Using the 4AT tool. ED Presentation : Date and time of presentation, clinical diagnosis (reason/condition for ED visit and ICD-9 code at discharge), triage color code (1 red, 2 orange, 3 blue, 4 green, 5 white), 3 months following ED access (including intercurrent hospitalizations).
Patients' Follow-up: Follow-up will be conducted through phone calls and record linkage with administrative data at two timepoints: A- At 7 days post-ED discharge, data on new ED visits, hospital admissions, and corresponding diagnoses according to Canadian Emergency Department Information System (CEDIS) and discharge codes (ICD-9) will be collected. B- At 30 days and 3 months post-discharge of the index ED visit for all patients, data on new ED visits, hospitalizations, functional status (Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL), institutionalization, and mortality will be collected.
- Conditions
- Comparative Effectiveness Research
- Being tested
- Multiprofessional Geriatric Emergency Team applied front-door CGA to identify patients who require inpatient care and those who can safely be discharged.
- Keywords
- Elderly patients >= 75 years, Geriatric Team, CGA, Emergency room
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiprofessional Geriatric Emergency Team applied front-door CGA to identify patients who require inpatient care and those who can safely be discharged.Other
In comparison to the precedent studies, this project is characterised by some innovative aspects as regards to the design of intervention:
- the participation of both a geriatrician and a nurse expert in transitional care, with the consultancy of a social worker when needed, in the management of the elderly patient within ED, adds to the project a greater operational capacity of the multidimensional assessment (CGA) of planning the best care setting for the patient.
- The proposed CGA model is complete in the analysis of the different domains (social, clinical, functional, cognitive-affective) and achievable in this particular urgent setting.
- The program examines, unlike other studies, much more variables that can help to define the effectiveness of the intervention.
- The involvement in the network program of three main hospitals of the Emilia Romagna with a pool of elderly patients afferent to ED of about 20,000 elderly/year per hospital (2019 data prior of Sars Cov2 pandemic)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | During the weeks selected as 'control', patients who access and meet the inclusion and exclusion criteria will be asked for consent to participate in the study and will follow the usual care. An independent researcher will perform a Multidimensional assessment. |
| The Geriatric Emergency Team (GET) applied CGA to identify adult patients to safely discharge | Experimental | The Geriatric Emergency Team (GET), including a geriatrician, a nurse expert in transitional care, and a social worker, conducts a front-door Comprehensive Geriatric Assessment (CGA) to identify patients who require inpatient care and those who can safely be discharged. The multidimensional assessment includes the following instruments of evaluation: SPMSQ, ADL, IADL, Charlson Comorbidity Index, Rockwood Frailty Index, GCS-5 item, number of medications, and screening for delirium (4AT). The intervention consists of counseling and information, drug therapy optimization/deprescribing, planning referral to the Center for Diagnosis of Cognitive Disorders and Dementia, contact with the patient's general practitioner, physiotherapy and walking aid prescription, social worker referral, activation of home healthcare and assistance services, transfer to a community hospital/transitional care facility, and assessment for nursing home admission. Receives: Other: Multiprofessional Geriatric Emergency Team applied front-door CGA to identify patients who require inpatient care and those who can safely be discharged. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change the ED hospitalization rate in the intervention arm compared with the control arm
Expected result: >= 6% difference in hospitalization rate in patients receiving multidisciplinary evaluation compared to those following the standard care pathway.
Measue: Proportion of patients assigned by ED to Emergency Medicine or medical/surgical ward vs. those discharged to home, facility or nursing home.
Measured: Discharge from ED at baseline access
Secondary outcomes (3)
Change in rate of new accesses in the ED and hospital admission
Change in re-attendance rate at the ED within 7 and 30 days after the index access in elderly patients discharged Measure: Proportion of patients who needed a new ED visit for the same reason/condition
Measured: Patients participating in the study will also be asked for consent to be contacted by telephone at 7 days, 30 days and three months from access to the PS to carry out the follow-up with respect to secondary outcomes
Change in rate of mortality
Mortality rates at 30 and 90 days after index access to the ED in all patients.
Measure:% of deaths at 30 and at 90 days in all patients after index access to the ED
Measured: Patients participating in the study will also be asked for consent to be contacted by telephone at 7 days, 30 days and three months from access to the PS to carry out the follow-up with respect to secondary outcomes
Change in rate of loss of autonomy
Change in Activitiesof Daily Living (ADLs) score at 30 and 90 days after index access to the ED in all patients.
Measure: ADLs score (0-6) , where the higher score means better autonomy. Change in Instrumentale Activities of Daily Living (IADLs) score at 30 and 90 days after index access to the ED in all patients.
Measure :IADLs score (0-5) in males and (0-8) in females at 30 and 90 days after index access to the ED in all patients, where the higher score means better autonomy
Measured: Patients participating in the study will also be asked for consent to be contacted by telephone at 7 days, 30 days and three months from access to the PS to carry out the follow-up with respect to secondary outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start2 May 2023
- Primary completion2 May 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparative Effectiveness ResearchStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a multicentric interventional randomized controlled trial that involves cluster randomization, in which calendar weeks will be selected for treatment instead of patients.In the week selected as 'treatment,' the multidisciplinary team will be present in the ED and will recruit all patients who access, meet the inclusion and exclusion criteria, and provide consent to participate in the study until the required weekly number is reached. In the week selected as 'control,' patients who access and meet the inclusion and exclusion criteria will be asked for consent to participate in the study and will follow the usual care. The opulation of the study includes patients aged 75 years and older, with a Triage Risk Stratification Tool (TRST) ≥ 2, who provide consent to participate. Are excluded patients with acute pathology requiring immediate intervention in intensive areas (politrauma, urgent surgery) or who need specific pathways (Miocardial Infarction , stroke, hip fracture).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria L Lunardelli, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788210
- Sponsor's protocol ID
- GerED-21
- Other IDs
- 3665
- Acronym
- GerED-21
- Status last verified
- Nov 2024
- First submitted
- 6 Nov 2024
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Geriatric Team in Facilitating the Emergency Department (ED) Workflow for Elderly Patients: Effects on Rate of Hospitalization and on Community Health Management: A Multicentric Randomized Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT06788210
- Acronym / sponsor ID
- GerED-21 / GerED-21
- Conditions
- Comparative Effectiveness Research
- Keywords
- Elderly patients >= 75 years, Geriatric Team, CGA, Emergency room
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 23 Jan 2025 (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 Ger-ED Intervention study focuses on early assessment and intervention in the emergency department (ED) by a specialized geriatric team, which includes a geriatrician, a nurse with expertise in geriatrics and continuity of care from hospital to community and when necessary a social worker. The intervention model is based on Comprehensive Geriatric Assessment (CGA) and aims to improve the management and care pathways for elderly patients. Through tailored responses, the team is expected to identify the appropriate setting for each patient and coordinate with community services to facilitate a safe return home when hospitalization is avoidable, and the risks outweigh the benefits.
The purpose of this study is to evaluate the impact of this dedicated ED multidisciplinary geriatric team intervention on the quality of care for elderly patients presenting at the ED, compared to usual care.
The study is a multicentric interventional randomized controlled trial involving cluster randomization, where calendar weeks are randomized rather than individual patients.
Study Design:
During the weeks designated as 'treatment', the multidisciplinary team will be present in the ED. They will recruit all eligible patients who meet the inclusion and exclusion criteria and provide consent to participate in the study, until the required weekly number is reached.
During the weeks designated as 'control', patients who meet the inclusion and exclusion criteria and provide consent will receive the usual care.
Detailed description
The GerED-21 study aims to introduce a multidisciplinary geriatric team model across three Northern Italian hospitals to reduce unnecessary hospitalizations among elderly emergency department (ED) patients. The Geriatric Emergency Team (GET) - comprising a geriatrician, a nurse specialized in transitional care, and a social worker - will conduct a front-door comprehensive geriatric assessment (CGA) to determine which patients require inpatient care and which can be safely discharged.
The study is planned for a 24-month duration. The first six months will focus on training team members, setting up a database, and arranging logistics within the EDs. The target population includes 624 patients aged 75 and older, admitted to the EDs of three hospitals: IRCCS AOU Policlinico di Sant'Orsola Bologna, Ospedale Maggiore AUSL Bologna, and Ospedale Maggiore AOU Parma, over 52 weeks following the start of the study at each site.
At various timepoints, data will be collected from patients, including:
Demographics: Age, sex, education level, housing status (home, sheltered facility, other hospital), cohabitation status (alone, with spouse, others), and primary caregiver.
Referral Details: Whether referred by an attending physician or direct access to the emergency room.
Multidimensional Assessment Data: Short Portable Mental Status Questionnaire (SPMSQ) , Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Charlson Comorbidity Index, Rockwood Frailty Index, Geriatric Depression Scale (GDS-5 item), and number of medications.
Delirium Screening: Using the 4AT tool. ED Presentation : Date and time of presentation, clinical diagnosis (reason/condition for ED visit and ICD-9 code at discharge), triage color code (1 red, 2 orange, 3 blue, 4 green, 5 white), 3 months following ED access (including intercurrent hospitalizations).
Patients' Follow-up: Follow-up will be conducted through phone calls and record linkage with administrative data at two timepoints: A- At 7 days post-ED discharge, data on new ED visits, hospital admissions, and corresponding diagnoses according to Canadian Emergency Department Information System (CEDIS) and discharge codes (ICD-9) will be collected. B- At 30 days and 3 months post-discharge of the index ED visit for all patients, data on new ED visits, hospitalizations, functional status (Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL), institutionalization, and mortality will be collected.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a multicentric interventional randomized controlled trial that involves cluster randomization, in which calendar weeks will be selected for treatment instead of patients.In the week selected as 'treatment,' the multidisciplinary team will be present in the ED and will recruit all patients who access, meet the inclusion and exclusion criteria, and provide consent to participate in the study until the required weekly number is reached. In the week selected as 'control,' patients who access and meet the inclusion and exclusion criteria will be asked for consent to participate in the study and will follow the usual care. The opulation of the study includes patients aged 75 years and older, with a Triage Risk Stratification Tool (TRST) ≥ 2, who provide consent to participate. Are excluded patients with acute pathology requiring immediate intervention in intensive areas (politrauma, urgent surgery) or who need specific pathways (Miocardial Infarction , stroke, hip fracture).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –During the weeks selected as 'control', patients who access and meet the inclusion and exclusion criteria will be asked for consent to participate in the study and will follow the usual care. An independent researcher will perform a Multidimensional assessment. |
| The Geriatric Emergency Team (GET) applied CGA to identify adult patients to safely discharge | Experimental | Other: Multiprofessional Geriatric Emergency Team applied front-door CGA to identify patients who require inpatient care and those who can safely be discharged.The Geriatric Emergency Team (GET), including a geriatrician, a nurse expert in transitional care, and a social worker, conducts a front-door Comprehensive Geriatric Assessment (CGA) to identify patients who require inpatient care and those who can safely be discharged. The multidimensional assessment includes the following instruments of evaluation: SPMSQ, ADL, IADL, Charlson Comorbidity Index, Rockwood Frailty Index, GCS-5 item, number of medications, and screening for delirium (4AT). The intervention consists of counseling and information, drug therapy optimization/deprescribing, planning referral to the Center for Diagnosis of Cognitive Disorders and Dementia, contact with the patient's general practitioner, physiotherapy and walking aid prescription, social worker referral, activation of home healthcare and assistance services, transfer to a community hospital/transitional care facility, and assessment for nursing home admission. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients aged ≥ 75 years
- Triage Risk Screening Tool (TRST) score ≥ 2
- Presence of signed informed consent
Key exclusion criteria (2 listed)
- Patients with acute pathology requiring immediate intervention (polytrauma, urgent surgery)
- Patients who need specific pathway (STEMI, Stroke, Hip Fracture, patients with highly contagious diseases, for example Sars Cov2)
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 |
|---|---|---|
| Multiprofessional Geriatric Emergency Team applied front-door CGA to identify patients who require inpatient care and those who can safely be discharged.In comparison to the precedent studies, this project is characterised by some innovative aspects as regards to the design of intervention: 1. the participation of both a geriatrician and a nurse expert in transitional care, with the consultancy of a social worker when needed, in the management of the elderly patient within ED, adds to the project a greater operational capacity of the multidimensional assessment (CGA) of planning the best care setting for the patient. 2. The proposed CGA model is complete in the analysis of the different domains (social, clinical, functional, cognitive-affective) and achievable in this particular urgent setting. 3. The program examines, unlike other studies, much more variables that can help to define the effectiveness of the intervention. 4. The involvement in the network program of three main hospitals of the Emilia Romagna with a pool of elderly patients afferent to ED of about 20,000 elderly/year per hospital (2019 data prior of Sars Cov2 pandemic) | Other | The Geriatric Emergency Team (GET) applied CGA to identify adult patients to safely discharge |
Primary outcome
Change the ED hospitalization rate in the intervention arm compared with the control arm
Time frame: Discharge from ED at baseline access
Expected result: >= 6% difference in hospitalization rate in patients receiving multidisciplinary evaluation compared to those following the standard care pathway. Measue: Proportion of patients assigned by ED to Emergency Medicine or medical/surgical ward vs. those discharged to home, facility or nursing home.
3 secondary outcomes
Change in rate of new accesses in the ED and hospital admission
Time frame: Patients participating in the study will also be asked for consent to be contacted by telephone at 7 days, 30 days and three months from access to the PS to carry out the follow-up with respect to secondary outcomes
Change in rate of mortality
Time frame: Patients participating in the study will also be asked for consent to be contacted by telephone at 7 days, 30 days and three months from access to the PS to carry out the follow-up with respect to secondary outcomes
Change in rate of loss of autonomy
Time frame: Patients participating in the study will also be asked for consent to be contacted by telephone at 7 days, 30 days and three months from access to the PS to carry out the follow-up with respect to secondary outcomes
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 23 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Maria L Lunardelli, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiprofessional Geriatric Emergency Team applied front-door CGA to identify patients who require inpatient care and those who can safely be discharged. in people with Comparative Effectiveness Research, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 23 Jan 2025. 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 Italy. 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?
Change the ED hospitalization rate in the intervention arm compared with the control arm (time frame: Discharge from ED at baseline access). 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 23 Jan 2025.