An interventional study of Comfort menu and cart in Emergency Department Patient and Comfort, sponsored by Hospital Sirio-Libanes. Not yet recruiting at 1 site in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Hospital Sirio-Libanes · Not applicable, Interventional, and Health services research
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.
Hospital Sirio-Libanes is the lead sponsor of 44 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Usual ED care
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.
Experience of older patients treated in the ED
Likert scale and brief questionnaire adapted from previous studies
Time frame: Baseline assessment during ED stay
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.
Time frame: 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.
Time frame: 30 days
Caregiver anxiety and depression
Assessed using the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline assessment during ED stay
Caregiver burden
Assessed using the Zarit Burden Interview
Time frame: Baseline assessment during ED stay
Length of hospital stay
Duration of the patient stay from ED admission to hospital discharge
Time frame: From the index ED admission to hospital discharge
Hospital costs
All costs associated to patient care during the index ED visit and hospital stay
Time frame: From the index ED admission to hospital discharge
Readmissions
Rate of ED and hospital readmissions after de index ED visit
Time frame: 30 days
Falls
Rate of falls after hospital discharge
Time frame: 30 days
Delirium incidence
Assessed using the Family Confusion Assessment Method (FAM-CAM)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days
Plan to share: No — Patient confidentiality
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Hospital Sirio-Libanes