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

NCT06788210 | Completed DMC

• 2 other identifiers: GerED-213665
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

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.

Conditions

Comparative Effectiveness Research

Keywords

Elderly patients >= 75 years; Geriatric Team; CGA; Emergency room

Outcome Measures

Primary Outcomes (1)

• 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.

  Discharge from ED at baseline access

Secondary Outcomes (3)

• Change in rate of new accesses in the ED and hospital admission

  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

  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

  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

Study Arms (2)

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.

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

Interventions

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: 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)

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

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria L Lunardelli, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: January 23, 2025
• Study Start: May 2, 2023
• Primary Completion: May 2, 2024
• Study Completion: August 8, 2024
• Last Updated: January 23, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)