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Not yet recruiting NCT06681376

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

No phase Interventional Emergency Department Patient Comfort

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comfort menu and cart.
Who it may be relevant to
Registry conditions: Emergency Department Patient, Comfort. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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 60 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.

Interventions

  • 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 k

Primary outcome measures

  • Experience of older patients treated in the ED [Time frame: Baseline assessment during ED stay]
Secondary outcome measures (4)
  • Experience of medical and multidisciplinary staff involved in caring for older patients treated in the ED [Time frame: 3 months pre- and post-intervention, concurrent with patient inclusion]
  • Institutional satisfaction indicators [Time frame: 30 days]
  • Caregiver anxiety and depression [Time frame: Baseline assessment during ED stay]
  • Caregiver burden [Time frame: Baseline assessment during ED stay]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Brazil · 1 center
  • Hospital Sírio Libanês — São Paulo

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. PMID 41343524

Identifiers

NCT: NCT06681376 · AVAP-NG 3776

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗