Clinical trial NCT06788210: Geriatric Team in ED: Effects on Rate of Hospitalization and on Community Health Management of Elderly (GerED-21)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comparative Effectiveness Research
Keywords: Elderly patients &amp;amp;gt;= 75 years
Geriatric Team
CGA
Emergency room
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 624
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Change the ED hospitalization rate in the intervention arm compared with the control arm
timeFrame: Discharge from ED at baseline access
Secondary outcomes:
measure: Change in rate of new accesses in the ED and hospital admission
timeFrame: 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
measure: Change in rate of mortality
timeFrame: 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
measure: Change in rate of loss of autonomy
timeFrame: 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
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Maria L Lunardelli, MD
role: PRINCIPAL_INVESTIGATOR
References: