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

Yale University

Status: Completed

Conditions: Intensive Care Unit Syndrome

Treatments: Other: Geriatrics Bundle

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04652453

2000029410

P30AG021342 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Outcome 4 was updated 11/8/23.

Enrollment: 83 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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83 participants in 2 patient groups

Post-Intervention Group (Geriatrics Bundle)

Experimental group

Description:

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.

Treatment:

Other: Geriatrics Bundle

Pre-Intervention Group (Control)

No Intervention group

Description:

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