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

NCT06681376 | Not Yet Recruiting

• 1 other identifier: AVAP-NG 3776
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emergency Department Patient; Comfort

Keywords

comfort cart; patient experience; older adult; emergency department

Outcome Measures

Primary Outcomes (1)

• Experience of older patients treated in the ED

  Likert scale and brief questionnaire adapted from previous studies

  Baseline assessment during ED stay

Secondary Outcomes (1)

• Experience of medical and multidisciplinary staff involved in caring for older patients treated in the ED

  3 months pre- and post-intervention, concurrent with patient inclusion

Other Outcomes (9)

• Length of hospital stay

  From the index ED admission to hospital discharge

• Hospital costs

  From the index ED admission to hospital discharge

• Readmissions

  30 days

Study Arms (2)

Pre-intervention

NO INTERVENTION

Usual ED care

Post-intervention

EXPERIMENTAL

Comfort menu and cart implemented

Other: Comfort menu and cart

Interventions

Comfort menu and cart 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.

Post-intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead
• Mayo Clinic: collaborator

Study Sites (1)

Hospital Sírio Libanês

São Paulo, São Paulo, 01308-050, Brazil

Location

Related Publications (1)

• Ferreira SA, Bellolio F, Bower SM, Penna LF, Marion MAL, Aliberti MR, Avelino-Silva TJ, Morinaga CV, Curiati PK. Enhancing the emergency department experience for older adults: Study protocol for the implementation of a comfort menu and cart. PLoS One. 2025 Dec 4;20(12):e0332773. doi: 10.1371/journal.pone.0332773. eCollection 2025.

  PMID: 41343524 DERIVED

MeSH Terms

Conditions

Emergencies

Interventions

Cocaine- and Amphetamine-Regulated Transcript Protein

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Pedro K Curiati, M.D., Ph.D.

  Hospital Sírio-Libanês

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

0800 730 2211; pedro.kcuriati@hsl.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research assistant, blinded to the initial assessment and ED care details, will conduct a phone interview 30 days (± 2 days) post-initial assessment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will utilize a quasi-experimental, before-and-after design.

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)