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

Keywords

• Geriatrics

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Study arms

• Experimental
  Post-Intervention Group (Geriatrics Bundle)

  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

• No intervention
  Pre-Intervention Group (Control)

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

Interventions

• OtherGeriatrics Bundle

  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.

Primary outcomes

1. 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.

   Time frame: From ICU admission to hospital discharge, up to 30 days

2. 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).

   Time frame: From ICU admission to hospital discharge, up to 30 days

3. 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.

   Time frame: From ICU admission to hospital discharge, up to 30 days

Secondary outcomes

1. 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 1. Definite (85%+) 2. Probable (60-85%) 3. Possible (40-60%) 4. Uncertain (10-40%) 5. 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.

   Time frame: during hospitalization, up to 128 days

2. 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.

   Time frame: From ICU admission to hospital discharge, up to 30 days

3. 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.

   Time frame: From ICU admission to hospital discharge, up to 30 days

4. 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.

   Time frame: From ICU admission to hospital discharge, up to 30 days

5. 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.

   Time frame: 30 days after hospital discharge

6. 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.

   Time frame: 30 days after hospital discharge

7. 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.

   Time frame: 30 days after hospital discharge

Baseline characteristics

11 further baseline measures are reported on the registry.

Study documents

• Protocol and statistical analysis plan · Apr 7, 2021
• Informed consent form · Jan 15, 2021

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