Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the ICU

Study Overview
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Brief Summary
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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
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Outcome 4 was updated 11/8/23.

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

Conditions
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Intensive Care Unit Syndrome

Intervention / Treatment
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* Other: Geriatrics Bundle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Pre-/Post-Intervention Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Post-Intervention Group (Geriatrics Bundle)<br>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. | Other: Geriatrics Bundle<br>* 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.<br>|
| No Intervention: Pre-Intervention Group (Control)<br>Participants in the control arm will be enrolled prior to implementation of the geriatrics bundle to gather preliminary data about the secondary outcomes. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Bundle Delivery | 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. | From ICU admission to hospital discharge, up to 30 days | 
| Acceptability of Bundle Delivery | 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). | From ICU admission to hospital discharge, up to 30 days | 
| Barriers and Facilitators to Bundle Implementation | 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. | From ICU admission to hospital discharge, up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium Assessed Using Chart-based Delirium Identification Instrument for ICU (CHART-DEL-ICU) | 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 Definite (85%+) Probable (60-85%) Possible (40-60%) Uncertain (10-40%) No evidence (< 10%) Delirium present during the hospitalization = definite, probable, or possible Delirium not present during the hospitalization = uncertain or no evidence Numbers represented here are participants with delirium. | during hospitalization, up to 128 days | 
| Mobility Level - Highest Level | 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. | From ICU admission to hospital discharge, up to 30 days | 
| Mobility Level - Level at Discharge | 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. | From ICU admission to hospital discharge, up to 30 days | 
| Muscle Strength | 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. | From ICU admission to hospital discharge, up to 30 days | 
| 30-day Functional Outcomes | 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. | 30 days after hospital discharge | 
| Number of Participants With Hospital Readmissions Within 30 Days | 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. | 30 days after hospital discharge | 
| Number of Participants That Reported Use and Perceived Benefit of Amplifying Device 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. | 30 days after hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geriatrics