Clinical trial NCT06681376: Enhancing the Emergency Department Experience for Older Adults: Study Protocol for the Implementation of a Comfort Menu and Cart
Official title: Enhancing the Emergency Department Experience for Older Adults: Study Protocol for the Implementation of a Comfort Menu and Cart
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emergency Department Patient
Comfort
Keywords: comfort cart
patient experience
older adult
emergency department
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2024-11-08
Enrollment: 264
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will utilize a quasi-experimental, before-and-after design.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Introduction: The aging of the population is a global phenomenon, with projections indicating a significant increase in the proportion of individuals aged 65 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.

Objective: 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.

Methods: The study will be conducted in the ED of Hospital Sírio-Libanês, a tertiary private hospital in São Paulo, Brazil. Patients aged 65 and older admitted to private ED rooms 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.

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: Inclusion Criteria:

* ED attendance at Hospital Sírio-Libanês (HSL), São Paulo, Brazil.
* Age ≥ 65 years.
* Accommodation in a private ED bed, regardless of the indication for hospitalization.
* Capacity to consent and respond to the interview or the presence of a companion capable of doing so.

Exclusion Criteria:

* Refusal 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.

Primary outcomes:
measure: Experience of older patients treated in the ED
timeFrame: Baseline assessment during ED stay
Secondary outcomes:
measure: Experience of medical and multidisciplinary staff involved in caring for older patients treated in the ED
timeFrame: 3 months pre- and post-intervention, concurrent with patient inclusion
Other outcomes:
measure: Length of hospital stay
timeFrame: From the index ED admission to hospital discharge
measure: Hospital costs
timeFrame: From the index ED admission to hospital discharge
measure: Readmissions
timeFrame: 30 days
measure: Falls
timeFrame: 30 days
measure: Delirium incidence
timeFrame: 30 days
measure: Quality of life
timeFrame: 30 days
measure: Functionality - Basic activities of daily living
timeFrame: 30 days
measure: Functionality - Instrumental activities of daily living
timeFrame: 30 days
measure: Cognitive performance
timeFrame: 30 days
Locations:
city: São Paulo
country: Brazil
facility: Hospital Sírio Libanês
Study officials:
affiliation: Hospital Sírio-Libanês
name: Pedro K Curiati, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: