Clinical trial NCT04652453: Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the ICU
Official title: Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the Intensive Care Unit (ACE-ICU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Syndrome
Keywords: Geriatrics
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-12-03
Enrollment: 83
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Pre-/Post-Intervention Design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Outcome 4 was updated 11/8/23.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Unable to provide informed consent and no proxy available
2. Advance directive of "comfort measures only" (CMO) or change to CMO anticipated during this hospital admission
3. Planned discharge to hospice
4. Primary language other than English
5. Tracheostomy with long-term ventilator dependence
6. Patients with non-family conservators (e.g. a lawyer serving as the conservator for the patient)
7. 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 \[the acute respiratory distress syndrome\])
8. COVID-19 positive
9. Already receiving OT in the ICU

Primary outcomes:
measure: Feasibility of Bundle Delivery
timeFrame: From ICU admission to hospital discharge, up to 30 days
measure: Acceptability of Bundle Delivery
timeFrame: From ICU admission to hospital discharge, up to 30 days
measure: Barriers and Facilitators to Bundle Implementation
timeFrame: From ICU admission to hospital discharge, up to 30 days
Secondary outcomes:
measure: Delirium Assessed Using Chart-based Delirium Identification Instrument for ICU (CHART-DEL-ICU)
timeFrame: during hospitalization, up to 128 days
measure: Mobility Level - Highest Level
timeFrame: From ICU admission to hospital discharge, up to 30 days
measure: Mobility Level - Level at Discharge
timeFrame: From ICU admission to hospital discharge, up to 30 days
measure: Muscle Strength
timeFrame: From ICU admission to hospital discharge, up to 30 days
measure: 30-day Functional Outcomes
timeFrame: 30 days after hospital discharge
measure: Number of Participants With Hospital Readmissions Within 30 Days
timeFrame: 30 days after hospital discharge
measure: Number of Participants That Reported Use and Perceived Benefit of Amplifying Device After Hospital Discharge
timeFrame: 30 days after hospital discharge
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Lauren Ferrante, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: