跳至主要内容
临床试验/NCT06681376
NCT06681376尚未招募不适用

Enhancing the Emergency Department Experience for Older Adults: Study Protocol for the Implementation of a Comfort Menu and Cart

Hospital Sirio-Libanes2 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
264
试验地点
2
主要终点
Experience of older patients treated in the ED

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

A research assistant, blinded to the initial assessment and ED care details, will conduct a phone interview 30 days (± 2 days) post-initial assessment.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Pre-intervention

No Intervention

Usual ED care

Post-intervention

Experimental

Comfort menu and cart implemented

干预措施: Comfort menu and cart (Other)

结局指标

主要结局

Experience of older patients treated in the ED

时间窗: Baseline assessment during ED stay

Likert scale and brief questionnaire adapted from previous studies

次要结局

  • Experience of medical and multidisciplinary staff involved in caring for older patients treated in the ED(3 months pre- and post-intervention, concurrent with patient inclusion)
  • Institutional satisfaction indicators(30 days)
  • Caregiver anxiety and depression(Baseline assessment during ED stay)
  • Caregiver burden(Baseline assessment during ED stay)

研究者

发起方
Hospital Sirio-Libanes
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pedro Kallas Curiati

Principal Investigator

Hospital Sirio-Libanes

研究点 (2)

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