Yale-New Haven Hospital
New Haven, Connecticut, 06510, United States
NCT Number: NCT04652453
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06510, United States
Outcome 4 was updated 11/8/23.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Enrolled participants in the intervention arm will receive all 3 bundle components: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: during hospitalization, up to 128 days
Incident delirium as measured by the Chart-based Delirium Identification Instrument for ICU (CHART-DEL-ICU). The CHART-DEL-ICU is a validated delirium detection tool for use in critically ill older adults. Charts were manually reviewed and assigned a level of confidence in the detection of delirium for the hospitalization:
Level of confidence in detection of delirium
Time frame: From ICU admission to hospital discharge, up to 30 days
Data about mobility level during hospitalization will be gathered from the physical therapy and occupational therapy flowsheets. This was scored on a scale of 0-6 with 6 being the highest level of mobility. Presented is the highest score by participants during the hospitalization period.
Time frame: From ICU admission to hospital discharge, up to 30 days
Data about mobility level during hospitalization will be gathered from the physical therapy and occupational therapy flowsheets. This was scored on a scale of 0-6 with 6 being the highest level of mobility. Presented is the participant score at discharge.
Time frame: From ICU admission to hospital discharge, up to 30 days
Manual muscle testing via the 6-point MRC system: Strength in each of 12 muscle groups is assessed via a 6-point system, in which a score of 0=no contraction, 1=flicker of a contraction, 2=active movement with gravity eliminated, 3=active movement against gravity, 4=active movement against gravity and resistance, 5= normal power. The highest possible score is 60, which would indicate maximum muscle strength.
Time frame: 30 days after hospital discharge
Participants will be asked whether they were independently able to complete a series of functional activities, including activities of daily living (ADLs), instrumental activities of daily living (IADLs), and mobility activity. Functional activities included seven basic activities of daily living (eating, dressing, bathing, toileting, grooming, getting in and out of a chair, walking around indoors); five instrumental activities of daily living (doing housework, going shopping, preparing a meal, taking medications, managing finances); and three mobility activities (walking a quarter of a mile, climbing stairs, and lifting or carrying heavy objects). A higher count of activities indicates less disability.
Time frame: 30 days after hospital discharge
Participants will be asked if they were readmitted to a hospital within 30 days of hospital. The electronic medical record will also be reviewed for readmissions.
Time frame: 30 days after hospital discharge
Participants will be asked whether they are still using the portable amplifying device after hospital discharge and whether they perceive benefit from its use. Presented are the qualitative responses summarized as frequencies.
Yale University
Other
Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the Intensive Care Unit (ACE-ICU)
Acronym: ACE-ICU
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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