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

Introduction: The aging of the population is a global phenomenon, with projections indicating a significant increase in the proportion of individuals aged 60 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Comfort; Emergency Department Patient
• Intervention / Treatment: Other: Comfort menu and cart

• Study Type: Interventional
• Enrollment (Estimated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedro K Curiati, M.D., Ph.D.; Phone Number: 0800 730 2211; Email: pedro.kcuriati@hsl.org.br

Study Locations

• Brazil
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01308-050
      • Hospital Sirio Libanes
      • Contact: Pedro M Curiati, M.D., Ph.D.; Phone Number: +55 11 33945041; Email: pedro.kcuriati@hsl.org.br
      • Principal Investigator: Pedro K Curiati, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-intervention; Usual ED care
Experimental: Post-intervention; Comfort menu and cart implemented	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience of older patients treated in the ED	Likert scale and brief questionnaire adapted from previous studies	Baseline assessment during ED stay

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience of medical and multidisciplinary staff involved in caring for older patients treated in the ED	The interview will follow the standardization of the original comfort cart validation study, using a Likert scale.	3 months pre- and post-intervention, concurrent with patient inclusion
Institutional satisfaction indicators	Transactional Net Promoter Score (NPS) and ombudsman manifestations classified as complaints, suggestions, or compliments. Transactional Net Promoter Score (tNPS) is a metric that measures customer loyalty immediately following a specific interaction (e.g., a purchase or support call) rather than the overall brand relationship. It operates on a scale of -100 to +100. Minimum Value (-100): Occurs if 100% of respondents are detractors (rated 0-6) and 0% are promoters (rated 9-10). This indicates severe issues and a high risk of churn. Maximum Value (+100): Occurs if 100% of respondents are promoters (rated 9-10) and 0% are detractors (rated 0-6). This indicates world-class, seamless customer experience.	30 days
Caregiver anxiety and depression	Assessed using the Hospital Anxiety and Depression Scale (HADS)	Baseline assessment during ED stay
Caregiver burden	Assessed using the Zarit Burden Interview	Baseline assessment during ED stay

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Duration of the patient stay from ED admission to hospital discharge	From the index ED admission to hospital discharge
Hospital costs	All costs associated to patient care during the index ED visit and hospital stay	From the index ED admission to hospital discharge
Readmissions	Rate of ED and hospital readmissions after de index ED visit	30 days
Falls	Rate of falls after hospital discharge	30 days
Delirium incidence	Assessed using the Family Confusion Assessment Method (FAM-CAM)	30 days
Quality of life	Assessed using the Euro Quality of Life Instrument - 5D. t encompasses five health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is classified into three levels: no problems (1 point), some problems (2 points), and extreme problems (3 points). Additionally, it includes a self-assessment of health on a visual analog scale (VAS), ranging from 0 (worst possible health) to 100 (best possible health), resulting in 243 out of 3125 distinct health states.	30 days
Functionality - Basic activities of daily living	Assessed using the Katz Index and Barthel Indexes. The Katz Index assesses self-care in Activities of Daily Living, with a score ranging from 0 (total independence) to 6 (total dependence). The Barthel Index measures functional independence in personal care and mobility, with a score from 0 to 100, classifying dependence from total to minimal.	30 days
Functionality - Instrumental activities of daily living	The Lawton and Brody scale assesses seven Instrumental Activities of Daily Living, with scores ranging from 9 to 27, classifying dependence from total to mild.	30 days
Cognitive performance	Assessed using the 10-Point Cognitive Screener. With a score ranging from 0 to 10, it classifies cognitive performance as normal (≥8), possible cognitive impairment (6-7), or probable cognitive impairment (0-5), with adjustments for education level.	30 days

Collaborators and Investigators

• Sponsor: Hospital Sirio-Libanes
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Pedro K Curiati, M.D., Ph.D., Hospital Sírio-Libanês

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): March 10, 2027

Study Registration Dates

• First Submitted: November 6, 2024
• First Submitted That Met QC Criteria: November 7, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: emergency department; patient experience; older adult; comfort cart
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Cocaine- and Amphetamine-Regulated Transcript Protein
• Other Study ID Numbers: AVAP-NG 3776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No