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临床试验/NCT04652453
NCT04652453已完成不适用

Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the Intensive Care Unit (ACE-ICU)

Yale University1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2021年1月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
Feasibility of Bundle Delivery

研究概览

简要总结

Despite the known benefits of geriatric care models among hospitalized older adults outside the intensive care unit (ICU), few studies have addressed the needs of older adults in the ICU; for example, sensory impairment, functional decline, and de-prescribing of potentially inappropriate medications (PIMs) are rarely addressed in routine ICU practice. This pilot study will evaluate the feasibility, acceptability, and barriers to implementation of a geriatrics bundle (occupational therapy, assessment and treatment of hearing impairment, and de-prescribing PIMs) in the ICU.

详细描述

Outcome 4 was updated 11/8/23.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • •Age > 65 years
  • •Hospitalized in the Medical Intensive Care Unit (MICU) on the York Street campus of Yale-New Haven Hospital.
  • •Has not opted out of research

排除标准

  • •Unable to provide informed consent and no proxy available
  • •Advance directive of "comfort measures only" (CMO) or change to CMO anticipated during this hospital admission
  • •Planned discharge to hospice
  • •Primary language other than English
  • •Tracheostomy with long-term ventilator dependence
  • •Patients with non-family conservators (e.g. a lawyer serving as the conservator for the patient)
  • •Unable to participate in the OT and hearing impairment interventions due to cognitive status (e.g. advanced dementia, anoxic brain injury, vegetative state, etc) or the need for deep sedation (e.g. if treatment of the critical illness requires deep sedation and neuromuscular blockade, such as in severe ARDS [the acute respiratory distress syndrome])
  • •COVID-19 positive
  • •Already receiving OT in the ICU

研究组 & 干预措施

Pre-Intervention Group (Control)

No Intervention

Participants in the control arm will be enrolled prior to implementation of the geriatrics bundle to gather preliminary data about the secondary outcomes.

Post-Intervention Group (Geriatrics Bundle)

Experimental

Enrolled participants in the intervention arm will receive all 3 components of the geriatrics bundle: occupational therapy (in addition to physical therapy) upon enrollment in the ICU, a portable amplifying device upon enrollment in the ICU, and a de-prescribing intervention by the ICU pharmacist (in conjunction with the medical team) upon ICU-to-floor transfer.

干预措施: Geriatrics Bundle (Other)

结局指标

主要结局

Feasibility of Bundle Delivery

时间窗: From ICU admission to hospital discharge, up to 30 days

Feasibility of bundle delivery will be measured by review of electronic medical record (EMR) documentation of each bundle component and a daily-check in with the patient and team. We will determine the proportion of eligible patients receiving each component as well as delivery of the overall bundle. A feasibility threshold of 70% will be used for the individual bundle components, as well as the combined bundle.

Acceptability of Bundle Delivery

时间窗: From ICU admission to hospital discharge, up to 30 days

Acceptability of the bundle among providers will be assessed with a survey using a 5-point Likert scale (range 1-5, where 5 indicates that participants strongly agree the bundle is completely acceptable for use in its current form and are comfortable using it).

Barriers and Facilitators to Bundle Implementation

时间窗: From ICU admission to hospital discharge, up to 30 days

Barriers and facilitators to bundle implementation will be assessed using qualitative methods. Separate focus groups were conducted with members of each health care discipline. Focus groups were audio-recorded and transcribed. Content analysis was then used to identify barriers and facilitators to bundle implementation.

次要结局

  • Mobility Level - Level at Discharge(From ICU admission to hospital discharge, up to 30 days)
  • Muscle Strength(From ICU admission to hospital discharge, up to 30 days)
  • 30-day Functional Outcomes(30 days after hospital discharge)
  • Mobility Level - Highest Level(From ICU admission to hospital discharge, up to 30 days)
  • Delirium Assessed Using Chart-based Delirium Identification Instrument for ICU (CHART-DEL-ICU)(during hospitalization, up to 128 days)
  • Number of Participants With Hospital Readmissions Within 30 Days(30 days after hospital discharge)
  • Number of Participants That Reported Use and Perceived Benefit of Amplifying Device After Hospital Discharge(30 days after hospital discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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