N/A
N=83
Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the ICU
Intensive Care Unit Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04652453 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Feasibility of Bundle Delivery — 50 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Geriatrics Bundle (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Bundle Delivery |
50 | — |
| PRIMARY Acceptability of Bundle Delivery |
5; 6 | — |
| PRIMARY Barriers and Facilitators to Bundle Implementation |
7; 3; 5; 6; 3; 2 | — |
| SECONDARY Delirium Assessed Using Chart-based Delirium Identification Instrument for ICU (CHART-DEL-ICU) |
5; 7 | — |
| SECONDARY Mobility Level - Highest Level |
4.44; 4.38 | — |
| SECONDARY Mobility Level - Level at Discharge |
4.10; 4.10 | — |
| SECONDARY Muscle Strength |
50.2; 49.6 | — |
| SECONDARY 30-day Functional Outcomes |
5; 8 | — |
| SECONDARY Number of Participants With Hospital Readmissions Within 30 Days |
5; 3 | — |
| SECONDARY Number of Participants That Reported Use and Perceived Benefit of Amplifying Device After Hospital Discharge |
6; 1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04652453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.