About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Comfort menu and cart
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Experience of older patients treated in the ED
Likert scale and brief questionnaire adapted from previous studies
Secondary outcomes
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.
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.
Caregiver anxiety and depression
Assessed using the Hospital Anxiety and Depression Scale (HADS)
Caregiver burden
Assessed using the Zarit Burden Interview
Other outcomes
Length of hospital stay
Duration of the patient stay from ED admission to hospital discharge
Hospital costs
All costs associated to patient care during the index ED visit and hospital stay
Readmissions
Rate of ED and hospital readmissions after de index ED visit
Falls
Rate of falls after hospital discharge
Sponsors and contacts
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Hospital Sirio-Libanes
Lead sponsor
Mayo Clinic
Collaborator
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