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
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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NOT_YET_RECRUITING
NA
264 participants
INTERVENTIONAL
2026-04-30
2027-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Pre-intervention
Usual ED care
No interventions assigned to this group
Post-intervention
Comfort menu and cart implemented
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 65 years.
* Capacity to consent and respond to the interview or the presence of a companion capable of doing so.
Exclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Hospital Sirio-Libanes
OTHER
Responsible Party
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Pedro Kallas Curiati
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AVAP-NG 3776
Identifier Type: -
Identifier Source: org_study_id
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