Intensive Care Unit Syndrome
Conditions
Keywords
Geriatrics
Brief 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.
Detailed description
Outcome 4 was updated 11/8/23.
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.
Sponsors
National Institute on Aging (NIA)
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Pre-/Post-Intervention Design
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Bundle Delivery | 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. |
| Acceptability of Bundle Delivery | 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). |
| Barriers and Facilitators to Bundle Implementation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength | 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. |
| 30-day Functional Outcomes | 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. |
| Delirium Assessed Using Chart-based Delirium Identification Instrument for ICU (CHART-DEL-ICU) | 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 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. |
| Number of Participants That Reported Use and Perceived Benefit of Amplifying Device After Hospital Discharge | 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. |
| Number of Participants With Hospital Readmissions Within 30 Days | 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. |
| Mobility Level - Highest Level | 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. |
| Mobility Level - Level at Discharge | 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. |
Countries
United States
Participant flow
Recruitment details
72 participants and 11 providers
Participants by arm
| Arm | Count |
|---|---|
| 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.
Geriatrics 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. | 50 |
| 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. | 22 |
| Providers 11 Providers were surveyed for the acceptability outcome only. Demographics were not collected for the providers. | 11 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 8 | 2 | 0 |
| Overall Study | Hospice | 5 | 5 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Post-Intervention Group (Geriatrics Bundle) | Total | Pre-Intervention Group (Control) | Providers |
|---|---|---|---|---|
| Age, Continuous | 79.48 years STANDARD_DEVIATION 7.11 | 78.69 years STANDARD_DEVIATION 7.46 | 76.91 years STANDARD_DEVIATION 8.09 | — |
| Clinical Frailty Scale, range 1-7 | 4.87 score on a scale STANDARD_DEVIATION 1.41 | 4.76 score on a scale STANDARD_DEVIATION 1.37 | 4.52 score on a scale STANDARD_DEVIATION 1.29 | — |
| Comorbidity count | 3 count of comorbidities | 3 count of comorbidities | 3.5 count of comorbidities | — |
| Disability in month prior to hospitalization | 4 number of activities | 3 number of activities | 2.5 number of activities | — |
| Fall prior to hospitalization | 22 Participants | 34 Participants | 12 Participants | — |
| Hearing impairment | 27 Participants | 38 Participants | 11 Participants | — |
| Highest level of education completed 2- or 4- year degree | 6 Participants | 14 Participants | 8 Participants | — |
| Highest level of education completed Graduate or post-graduate | 4 Participants | 10 Participants | 6 Participants | — |
| Highest level of education completed High school or equivalent | 30 Participants | 38 Participants | 8 Participants | — |
| Highest level of education completed Less than high school | 9 Participants | 12 Participants | 3 Participants | — |
| History of tobacco use | 32 Participants | 47 Participants | 15 Participants | — |
| Hospitalization in the 6 months prior to admission | 33 Participants | 43 Participants | 10 Participants | — |
| Lives alone | 16 Participants | 20 Participants | 4 Participants | — |
| Marital status Divorced or separated | 9 Participants | 12 Participants | 3 Participants | — |
| Marital status Married or living with partner | 21 Participants | 34 Participants | 13 Participants | — |
| Marital status Other | 1 Participants | 2 Participants | 1 Participants | — |
| Marital status Single | 3 Participants | 5 Participants | 2 Participants | — |
| Marital status Widowed | 16 Participants | 20 Participants | 4 Participants | — |
| Medicaid recipient | 18 Participants | 24 Participants | 6 Participants | — |
| Muscle strength at baseline, range 0-60 mean (SD) | 46.4 units on a scale STANDARD_DEVIATION 12 | 45.6 units on a scale STANDARD_DEVIATION 12.8 | 44.0 units on a scale STANDARD_DEVIATION 14.2 | — |
| Presence of functional disability in any of the 15 activities | 37 Participants | 53 Participants | 16 Participants | — |
| Race/Ethnicity, Customized Asian, non-Hispanic | 2 Participants | 2 Participants | 0 Participants | — |
| Race/Ethnicity, Customized Black, Hispanic | 0 Participants | 0 Participants | 0 Participants | — |
| Race/Ethnicity, Customized Black, non-Hispanic | 6 Participants | 9 Participants | 3 Participants | — |
| Race/Ethnicity, Customized Hispanic, race not reported | 0 Participants | 0 Participants | 0 Participants | — |
| Race/Ethnicity, Customized Non-Hispanic, race not reported | 0 Participants | 0 Participants | 0 Participants | — |
| Race/Ethnicity, Customized Unknown race and ethnicity | 0 Participants | 1 Participants | 1 Participants | — |
| Race/Ethnicity, Customized White, Hispanic | 2 Participants | 2 Participants | 0 Participants | — |
| Race/Ethnicity, Customized White, Non-Hispanic | 40 Participants | 58 Participants | 18 Participants | — |
| Region of Enrollment United States | 50 participants | 83 participants | 22 participants | 11 participants |
| Respondent Participant | 34 Participants | 53 Participants | 19 Participants | — |
| Respondent Proxy | 16 Participants | 19 Participants | 3 Participants | — |
| Sex: Female, Male Female | 23 Participants | 35 Participants | 12 Participants | — |
| Sex: Female, Male Male | 27 Participants | 37 Participants | 10 Participants | — |
| Vision impairment | 12 Participants | 18 Participants | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 50 | 2 / 22 |
| other Total, other adverse events | 0 / 50 | 0 / 22 |
| serious Total, serious adverse events | 0 / 50 | 0 / 22 |
Outcome results
Primary
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
Population: 11 providers
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | Acceptability of Bundle Delivery | Strongly agree | 5 Participants |
| Post-Intervention Group (Geriatrics Bundle) | Acceptability of Bundle Delivery | Agree | 6 Participants |
Primary
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
Population: Numbers represented here are the number of themes derived from interviews.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | Barriers and Facilitators to Bundle Implementation | Occupational Therapy Component: Barriers | 7 themes |
| Post-Intervention Group (Geriatrics Bundle) | Barriers and Facilitators to Bundle Implementation | Occupational Therapy Component: Facilitators | 3 themes |
| Post-Intervention Group (Geriatrics Bundle) | Barriers and Facilitators to Bundle Implementation | Pharmacy Component: Barriers | 5 themes |
| Post-Intervention Group (Geriatrics Bundle) | Barriers and Facilitators to Bundle Implementation | Pharmacy Component: Facilitators | 6 themes |
| Post-Intervention Group (Geriatrics Bundle) | Barriers and Facilitators to Bundle Implementation | Hearing Amplifier Component: Barriers | 3 themes |
| Post-Intervention Group (Geriatrics Bundle) | Barriers and Facilitators to Bundle Implementation | Hearing Amplifier Component: Facilitators | 2 themes |
Primary
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
Population: Only participants in the geriatric bundle were eligible.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | Feasibility of Bundle Delivery | 50 Participants |
Secondary
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
Population: Only participants with data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | 30-day Functional Outcomes | 5 count of activities |
| Pre-Intervention Group (Control) | 30-day Functional Outcomes | 8 count of activities |
Secondary
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
Population: Only patients that proceeded to hospital discharge within 30 days.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | Delirium Assessed Using Chart-based Delirium Identification Instrument for ICU (CHART-DEL-ICU) | 5 Participants |
| Pre-Intervention Group (Control) | Delirium Assessed Using Chart-based Delirium Identification Instrument for ICU (CHART-DEL-ICU) | 7 Participants |
Secondary
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
Population: Only patients that were able to perform these tasks were analyzed, 2 participants in the geriatrics bundle and 1 participant in the control group were not able to be assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | Mobility Level - Highest Level | 4.44 score on a scale | Standard Deviation 1.13 |
| Pre-Intervention Group (Control) | Mobility Level - Highest Level | 4.38 score on a scale | Standard Deviation 1.28 |
Secondary
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
Population: Only patients that were able to perform these tasks were analyzed, 2 participants in the geriatrics bundle and 1 participant in the control group were not able to be assessed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | Mobility Level - Level at Discharge | 4.10 score on a scale | Standard Deviation 1.29 |
| Pre-Intervention Group (Control) | Mobility Level - Level at Discharge | 4.10 score on a scale | Standard Deviation 1.55 |
Secondary
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
Population: Only participants with data were analyzed; there were 19 participants in the geriatrics bundle group and 5 participants in the control group that were missing these scores at discharge.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | Muscle Strength | 50.2 score on a scale | Standard Deviation 9 |
| Pre-Intervention Group (Control) | Muscle Strength | 49.6 score on a scale | Standard Deviation 14 |
Secondary
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
Population: Out of 7 participants that completed the interview. Amplifying device was only provided to the intervention group and not the control group.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | Number of Participants That Reported Use and Perceived Benefit of Amplifying Device After Hospital Discharge | Indicate Perceived benefits | 6 Participants |
| Post-Intervention Group (Geriatrics Bundle) | Number of Participants That Reported Use and Perceived Benefit of Amplifying Device After Hospital Discharge | Did Not Indicate Perceived benefits | 1 Participants |
Secondary
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
Population: Only participants eligible for readmission were assessed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | Number of Participants With Hospital Readmissions Within 30 Days | 5 Participants |
| Pre-Intervention Group (Control) | Number of Participants With Hospital Readmissions Within 30 Days | 3 Participants |