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NCT Number: NCT06681376

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 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sírio Libanês

São Paulo, 01308-050, Brazil

Location contact

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

PRINCIPAL_INVESTIGATOR

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

CONTACT

[email protected]

+55 11 33945041

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Experience of older patients treated in the ED

    Time frame: Baseline assessment during ED stay

    Likert scale and brief questionnaire adapted from previous studies

Secondary outcomes

  1. 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

    The interview will follow the standardization of the original comfort cart validation study, using a Likert scale.

  2. Institutional satisfaction indicators

    Time frame: 30 days

    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.

  3. Caregiver anxiety and depression

    Time frame: Baseline assessment during ED stay

    Assessed using the Hospital Anxiety and Depression Scale (HADS)

  4. Caregiver burden

    Time frame: Baseline assessment during ED stay

    Assessed using the Zarit Burden Interview

Other outcomes

  1. Length of hospital stay

    Time frame: From the index ED admission to hospital discharge

    Duration of the patient stay from ED admission to hospital discharge

  2. Hospital costs

    Time frame: From the index ED admission to hospital discharge

    All costs associated to patient care during the index ED visit and hospital stay

  3. Readmissions

    Time frame: 30 days

    Rate of ED and hospital readmissions after de index ED visit

  4. Falls

    Time frame: 30 days

    Rate of falls after hospital discharge

  5. Delirium incidence

    Time frame: 30 days

    Assessed using the Family Confusion Assessment Method (FAM-CAM)

  6. Quality of life

    Time frame: 30 days

    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.

  7. Functionality - Basic activities of daily living

    Time frame: 30 days

    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.

  8. Functionality - Instrumental activities of daily living

    Time frame: 30 days

    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.

  9. Cognitive performance

    Time frame: 30 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

0800 730 2211

Sponsors and collaborators

Lead sponsor

Hospital Sirio-Libanes

Other

Collaborators

  • Mayo Clinic

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 8, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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