Emergency Department PatientNCT06681376
Enhancing the Emergency Department Experience for Older Adults: Study Protocol for the Implementation of a Comfort Menu and Cart
A study testing Comfort menu and cart in people with Emergency Department Patient and Comfort, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Emergency Department Patient, Comfort
- What is being tested?
- Comfort menu and cart
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2026to 10 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital Sírio Libanês
São Paulo, São Paulo, 01308-050
Pedro M Curiati, M.D., Ph.D., +55 11 33945041, pedro.kcuriati@hsl.org.br
Pedro K Curiati, M.D., Ph.D.
About this study
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.
Read more
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.
- Conditions
- Emergency Department Patient, Comfort
- Being tested
- Comfort menu and cart
- Keywords
- comfort cart, patient experience, older adult, emergency department
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort menu and cartOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | Usual ED care |
| Post-intervention | Experimental | Comfort menu and cart implemented Receives: Other: Comfort menu and cart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of older patients treated in the ED
Likert scale and brief questionnaire adapted from previous studies
Measured: Baseline assessment during ED stay
Secondary outcomes (4)
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.
Measured: 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.
Measured: 30 days
Caregiver anxiety and depression
Assessed using the Hospital Anxiety and Depression Scale (HADS)
Measured: Baseline assessment during ED stay
Caregiver burden
Assessed using the Zarit Burden Interview
Measured: Baseline assessment during ED stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Aug 2026 (estimated)
- Primary completion10 Mar 2027 (estimated)
- Study completion10 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emergency Department PatientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This study will utilize a quasi-experimental, before-and-after design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Pedro Kallas Curiati, Hospital Sirio-Libanes
- Investigators
- Pedro K Curiati, M.D., Ph.D., Principal investigator, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681376
- Sponsor's protocol ID
- AVAP-NG 3776
- Status last verified
- Jun 2026
- First submitted
- 6 Nov 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient confidentiality
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.
PubMed 41343524
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Emergency Department Experience for Older Adults: Study Protocol for the Implementation of a Comfort Menu and Cart
- ClinicalTrials.gov ID
- NCT06681376
- Acronym / sponsor ID
- AVAP-NG 3776
- Conditions
- Emergency Department Patient, Comfort
- Keywords
- comfort cart, patient experience, older adult, emergency department
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 10 Mar 2027 (estimated)
- Study completion
- 10 Mar 2027 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will utilize a quasi-experimental, before-and-after design.
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –Usual ED care |
| Post-intervention | Experimental | Other: Comfort menu and cartComfort menu and cart implemented |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comfort menu and cartThe 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. | Other | Post-intervention |
Primary outcome
Experience of older patients treated in the ED
Time frame: Baseline assessment during ED stay
Likert scale and brief questionnaire adapted from previous studies
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Derived from this study: PubMed 41343524Ferreira 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.
- Individual participant dataSharing planned: No. Patient confidentiality
Related trials for Emergency Department Patient
RecruitingObservational study
Clinical Management and Outcomes After Lung Scintigraphy for Suspected Pulmonary Embolism in the Emergency Department
Pulmonary Embolism (Diagnosis)
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Recruiting
Adaptation and Testing of a Novel Text-based Tobacco Cessation and Education Intervention in Kenyan Emergency Department Patients
Tobacco Use, Tobacco Use Cessation
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
Not yet recruitingObservational study
Diaphragm Response in Elderly for Acute Monitoring
Acute Dyspnea, Acute Respiratory Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pedro K Curiati, M.D., Ph.D. principal investigator
Hospital Sirio-Libanes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comfort menu and cart in people with Emergency Department Patient and Comfort, run by Hospital Sirio-Libanes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pedro K Curiati, M.D., Ph.D. (0800 730 2211, pedro.kcuriati@hsl.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of older patients treated in the ED (time frame: Baseline assessment during ED stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06681376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.