Enhancing the Emergency Department Experience for Older Adults: Study Protocol for the Implementation of a Comfort Menu and Cart

NCT ID: NCT06681376

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2027-06-30

Brief Summary

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Introduction: The aging of the population is a global phenomenon, with projections indicating a significant increase in the proportion of individuals aged 65 years and older by 2050. This demographic shift requires adapting emergency department (ED) services to meet the specific demands of older patients, who often present with multiple comorbidities and face challenges such as sensory and cognitive difficulties. EDs, traditionally designed for acute illness and injury management, may not be adequately equipped to meet the unique needs of this vulnerable population. This can result in suboptimal patient experiences, prolonged ED stays, increased hospitalizations, and poorer outcomes.

Methods: This study protocol outlines a before-and-after study to evaluate the impact of implementing a comfort menu and cart on the experience and outcomes of older patients treated in the ED. The study will be conducted in the ED of Hospital Sírio-Libanês (HSL), a tertiary private hospital in São Paulo, Brazil. Patients aged 65 and older who presented to the ED will be eligible for inclusion. Participants will be recruited in two phases: pre-intervention and post-implementation of the comfort menu and cart. Data will be collected through patient and staff interviews, chart reviews, and a 30-day follow-up interview. Patient experience, staff experience, length of hospital stays, hospital costs, ED readmissions, falls, delirium incidence, quality of life, functional status, cognitive performance, and mortality will be assessed.

Ethics and dissemination: Ethical approval for this study has been granted by the Institutional Review Board of HSL. All participants, or their legal representatives for those with cognitive impairment, will provide written informed consent before any study procedures are initiated. The consent process has been designed keeping the study hypothesis blind by not revealing the outcomes that will be measured after the comfort cart intervention. The results will be shared with the academic community through peer-reviewed publications and presentations at relevant conferences to inform future clinical practice and research.

Expected Results: A positive impact of implementing the comfort menu and cart in the ED is expected on patient-centered outcomes. Improvements in the experience of older patients and medical and multidisciplinary staff are anticipated, and improvements in other exploratory outcomes, such as length of hospital stay, hospital costs, readmissions, falls, delirium incidence, quality of life, functionality, and cognitive performance, will be explored.

Detailed Description

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Conditions

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Emergency Department Patient Comfort

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study will utilize a quasi-experimental, before-and-after design.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
A research assistant, blinded to the initial assessment and ED care details, will conduct a phone interview 30 days (± 2 days) post-initial assessment.

Study Groups

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Pre-intervention

Usual ED care

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-intervention

Comfort menu and cart implemented

Group Type EXPERIMENTAL

Comfort menu and cart

Intervention Type OTHER

The comfort menu and cart will be implemented after the pre-intervention data collection phase is completed. The menu will list the items available on the cart and will be presented to eligible patients in printed or digital format (on a tablet). The cart will be placed in an easily accessible area within the ED. Approximated retail prices have been previously reported.

Comfort Cart Contents:

* Hot and cold packs;
* Extra blanket and pillow;
* Face towel;
* Gloves and hat;
* Personal hygiene kit;
* Items for distraction;
* Items to enhance communication.

Comfort Menu Options:

* Physiotherapy assessment;
* Conversation with chaplain, concierge, or social worker;
* List of resources for older adults needing community services;
* Home care assistance.

Interventions

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Comfort menu and cart

The comfort menu and cart will be implemented after the pre-intervention data collection phase is completed. The menu will list the items available on the cart and will be presented to eligible patients in printed or digital format (on a tablet). The cart will be placed in an easily accessible area within the ED. Approximated retail prices have been previously reported.

Comfort Cart Contents:

* Hot and cold packs;
* Extra blanket and pillow;
* Face towel;
* Gloves and hat;
* Personal hygiene kit;
* Items for distraction;
* Items to enhance communication.

Comfort Menu Options:

* Physiotherapy assessment;
* Conversation with chaplain, concierge, or social worker;
* List of resources for older adults needing community services;
* Home care assistance.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ED attendance at Hospital Sírio-Libanês (HSL), São Paulo, Brazil.
* Age ≥ 65 years.
* Capacity to consent and respond to the interview or the presence of a companion capable of doing so.

Exclusion Criteria

* Decline to participate in the study or use the comfort menu and cart.
* Absence of a companion able to consent to study participation and provide necessary information for patients with altered mental status or cognitive impairment.
* Decreased level of consciousness.
* Hemodynamic instability.
* Acute respiratory failure.
* Inability to be contacted by phone for the follow-up interview.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role collaborator

Hospital Sirio-Libanes

OTHER

Sponsor Role lead

Responsible Party

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Pedro Kallas Curiati

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pedro K Curiati, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital Sírio-Libanês

Locations

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Hospital Sírio Libanês

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Pedro K Curiati, M.D., Ph.D.

Role: CONTACT

0800 730 2211

Facility Contacts

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Pedro M Curiati, M.D., Ph.D.

Role: primary

+55 11 33945041

Other Identifiers

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AVAP-NG 3776

Identifier Type: -

Identifier Source: org_study_id

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