Geriatric Team in ED: Effects on Rate of Hospitalization and on Community Health Management of Elderly (GerED-21)

NCT ID: NCT06788210

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 624 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2024-08-08

Brief 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. 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.

Conditions

Comparative Effectiveness Research

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

The Geriatric Emergency Team (GET) applied CGA to identify adult patients to safely discharge

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.

Group Type: EXPERIMENTAL

Multiprofessional Geriatric Emergency Team applied front-door CGA to identify patients who require inpatient care and those who can safely be discharged.

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥ 75 years
• Triage Risk Screening Tool (TRST) score ≥ 2
• Presence of signed informed consent

Exclusion Criteria

• 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)

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria L Lunardelli, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, , Italy

Countries

Italy

Other Identifiers

3665

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

GerED-21

Identifier Type: -

Identifier Source: org_study_id