Trial Outcomes & Findings for Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the ICU (NCT NCT04652453)
NCT ID: NCT04652453
Last Updated: 2024-02-16
Results Overview
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.
COMPLETED
NA
83 participants
From ICU admission to hospital discharge, up to 30 days
2024-02-16
Participant Flow
72 participants and 11 providers
Participant milestones
| Measure |
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.
|
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.
|
Providers
Providers were surveyed for the acceptability outcome only.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
22
|
11
|
|
Overall Study
COMPLETED
|
35
|
15
|
11
|
|
Overall Study
NOT COMPLETED
|
15
|
7
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
Providers
Providers were surveyed for the acceptability outcome only.
|
|---|---|---|---|
|
Overall Study
Death
|
8
|
2
|
0
|
|
Overall Study
Hospice
|
5
|
5
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
Baseline Characteristics
Not collected for providers
Baseline characteristics by cohort
| Measure |
Post-Intervention Group (Geriatrics Bundle)
n=50 Participants
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.
|
Pre-Intervention Group (Control)
n=22 Participants
Participants in the control arm will be enrolled prior to implementation of the geriatrics bundle to gather preliminary data about the secondary outcomes.
|
Providers
n=11 Participants
11 Providers were surveyed for the acceptability outcome only. Demographics were not collected for the providers.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
79.48 years
STANDARD_DEVIATION 7.11 • n=50 Participants • Not collected for providers
|
76.91 years
STANDARD_DEVIATION 8.09 • n=22 Participants • Not collected for providers
|
—
|
78.69 years
STANDARD_DEVIATION 7.46 • n=72 Participants • Not collected for providers
|
|
Sex: Female, Male
Female
|
23 Participants
n=50 Participants • Not collected for providers
|
12 Participants
n=22 Participants • Not collected for providers
|
—
|
35 Participants
n=72 Participants • Not collected for providers
|
|
Sex: Female, Male
Male
|
27 Participants
n=50 Participants • Not collected for providers
|
10 Participants
n=22 Participants • Not collected for providers
|
—
|
37 Participants
n=72 Participants • Not collected for providers
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
40 Participants
n=50 Participants • Not collected for providers
|
18 Participants
n=22 Participants • Not collected for providers
|
—
|
58 Participants
n=72 Participants • Not collected for providers
|
|
Race/Ethnicity, Customized
White, Hispanic
|
2 Participants
n=50 Participants • Not collected for providers
|
0 Participants
n=22 Participants • Not collected for providers
|
—
|
2 Participants
n=72 Participants • Not collected for providers
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
6 Participants
n=50 Participants • Not collected for providers
|
3 Participants
n=22 Participants • Not collected for providers
|
—
|
9 Participants
n=72 Participants • Not collected for providers
|
|
Race/Ethnicity, Customized
Black, Hispanic
|
0 Participants
n=50 Participants • Not collected for providers
|
0 Participants
n=22 Participants • Not collected for providers
|
—
|
0 Participants
n=72 Participants • Not collected for providers
|
|
Race/Ethnicity, Customized
Hispanic, race not reported
|
0 Participants
n=50 Participants • Not collected for providers
|
0 Participants
n=22 Participants • Not collected for providers
|
—
|
0 Participants
n=72 Participants • Not collected for providers
|
|
Race/Ethnicity, Customized
Non-Hispanic, race not reported
|
0 Participants
n=50 Participants • Not collected for providers
|
0 Participants
n=22 Participants • Not collected for providers
|
—
|
0 Participants
n=72 Participants • Not collected for providers
|
|
Race/Ethnicity, Customized
Asian, non-Hispanic
|
2 Participants
n=50 Participants • Not collected for providers
|
0 Participants
n=22 Participants • Not collected for providers
|
—
|
2 Participants
n=72 Participants • Not collected for providers
|
|
Race/Ethnicity, Customized
Unknown race and ethnicity
|
0 Participants
n=50 Participants • Not collected for providers
|
1 Participants
n=22 Participants • Not collected for providers
|
—
|
1 Participants
n=72 Participants • Not collected for providers
|
|
Region of Enrollment
United States
|
50 participants
n=50 Participants
|
22 participants
n=22 Participants
|
11 participants
n=11 Participants
|
83 participants
n=83 Participants
|
|
Highest level of education completed
Less than high school
|
9 Participants
n=50 Participants • Not collected for providers
|
3 Participants
n=22 Participants • Not collected for providers
|
—
|
12 Participants
n=72 Participants • Not collected for providers
|
|
Highest level of education completed
High school or equivalent
|
30 Participants
n=50 Participants • Not collected for providers
|
8 Participants
n=22 Participants • Not collected for providers
|
—
|
38 Participants
n=72 Participants • Not collected for providers
|
|
Highest level of education completed
2- or 4- year degree
|
6 Participants
n=50 Participants • Not collected for providers
|
8 Participants
n=22 Participants • Not collected for providers
|
—
|
14 Participants
n=72 Participants • Not collected for providers
|
|
Highest level of education completed
Graduate or post-graduate
|
4 Participants
n=50 Participants • Not collected for providers
|
6 Participants
n=22 Participants • Not collected for providers
|
—
|
10 Participants
n=72 Participants • Not collected for providers
|
|
Medicaid recipient
|
18 Participants
n=50 Participants • Not collected for providers
|
6 Participants
n=22 Participants • Not collected for providers
|
—
|
24 Participants
n=72 Participants • Not collected for providers
|
|
Marital status
Married or living with partner
|
21 Participants
n=50 Participants • Not collected for providers
|
13 Participants
n=22 Participants • Not collected for providers
|
—
|
34 Participants
n=72 Participants • Not collected for providers
|
|
Marital status
Single
|
3 Participants
n=50 Participants • Not collected for providers
|
2 Participants
n=22 Participants • Not collected for providers
|
—
|
5 Participants
n=72 Participants • Not collected for providers
|
|
Marital status
Divorced or separated
|
9 Participants
n=50 Participants • Not collected for providers
|
3 Participants
n=22 Participants • Not collected for providers
|
—
|
12 Participants
n=72 Participants • Not collected for providers
|
|
Marital status
Widowed
|
16 Participants
n=50 Participants • Not collected for providers
|
4 Participants
n=22 Participants • Not collected for providers
|
—
|
20 Participants
n=72 Participants • Not collected for providers
|
|
Marital status
Other
|
1 Participants
n=50 Participants • Not collected for providers
|
1 Participants
n=22 Participants • Not collected for providers
|
—
|
2 Participants
n=72 Participants • Not collected for providers
|
|
Lives alone
|
16 Participants
n=50 Participants • Not collected for providers
|
4 Participants
n=22 Participants • Not collected for providers
|
—
|
20 Participants
n=72 Participants • Not collected for providers
|
|
Respondent
Participant
|
34 Participants
n=50 Participants • Not collected for providers
|
19 Participants
n=22 Participants • Not collected for providers
|
—
|
53 Participants
n=72 Participants • Not collected for providers
|
|
Respondent
Proxy
|
16 Participants
n=50 Participants • Not collected for providers
|
3 Participants
n=22 Participants • Not collected for providers
|
—
|
19 Participants
n=72 Participants • Not collected for providers
|
|
Comorbidity count
|
3 count of comorbidities
n=50 Participants • Not collected for providers
|
3.5 count of comorbidities
n=22 Participants • Not collected for providers
|
—
|
3 count of comorbidities
n=72 Participants • Not collected for providers
|
|
Presence of functional disability in any of the 15 activities
|
37 Participants
n=50 Participants • Not collected for providers
|
16 Participants
n=22 Participants • Not collected for providers
|
—
|
53 Participants
n=72 Participants • Not collected for providers
|
|
Hearing impairment
|
27 Participants
n=50 Participants • Not collected for providers
|
11 Participants
n=22 Participants • Not collected for providers
|
—
|
38 Participants
n=72 Participants • Not collected for providers
|
|
Vision impairment
|
12 Participants
n=50 Participants • Not collected for providers
|
6 Participants
n=22 Participants • Not collected for providers
|
—
|
18 Participants
n=72 Participants • Not collected for providers
|
|
Fall prior to hospitalization
|
22 Participants
n=50 Participants • Not collected for providers
|
12 Participants
n=22 Participants • Not collected for providers
|
—
|
34 Participants
n=72 Participants • Not collected for providers
|
|
Disability in month prior to hospitalization
|
4 number of activities
n=50 Participants • Not collected for providers
|
2.5 number of activities
n=22 Participants • Not collected for providers
|
—
|
3 number of activities
n=72 Participants • Not collected for providers
|
|
Hospitalization in the 6 months prior to admission
|
33 Participants
n=50 Participants • Not collected for providers
|
10 Participants
n=22 Participants • Not collected for providers
|
—
|
43 Participants
n=72 Participants • Not collected for providers
|
|
History of tobacco use
|
32 Participants
n=50 Participants • Not collected for providers
|
15 Participants
n=22 Participants • Not collected for providers
|
—
|
47 Participants
n=72 Participants • Not collected for providers
|
|
Clinical Frailty Scale, range 1-7
|
4.87 score on a scale
STANDARD_DEVIATION 1.41 • n=50 Participants • Not collected for providers
|
4.52 score on a scale
STANDARD_DEVIATION 1.29 • n=22 Participants • Not collected for providers
|
—
|
4.76 score on a scale
STANDARD_DEVIATION 1.37 • n=72 Participants • Not collected for providers
|
|
Muscle strength at baseline, range 0-60 mean (SD)
|
46.4 units on a scale
STANDARD_DEVIATION 12.0 • n=50 Participants • Not collected for providers
|
44.0 units on a scale
STANDARD_DEVIATION 14.2 • n=22 Participants • Not collected for providers
|
—
|
45.6 units on a scale
STANDARD_DEVIATION 12.8 • n=72 Participants • Not collected for providers
|
PRIMARY outcome
Timeframe: From ICU admission to hospital discharge, up to 30 daysPopulation: Only participants in the geriatric bundle were eligible.
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.
Outcome measures
| Measure |
Post-Intervention Group (Geriatrics Bundle)
n=50 Participants
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.
|
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.
|
|---|---|---|
|
Feasibility of Bundle Delivery
|
50 Participants
|
—
|
PRIMARY outcome
Timeframe: From ICU admission to hospital discharge, up to 30 daysPopulation: 11 providers
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).
Outcome measures
| Measure |
Post-Intervention Group (Geriatrics Bundle)
n=11 Participants
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.
|
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.
|
|---|---|---|
|
Acceptability of Bundle Delivery
Strongly agree
|
5 Participants
|
—
|
|
Acceptability of Bundle Delivery
Agree
|
6 Participants
|
—
|
PRIMARY outcome
Timeframe: From ICU admission to hospital discharge, up to 30 daysPopulation: Numbers represented here are the number of themes derived from interviews.
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.
Outcome measures
| Measure |
Post-Intervention Group (Geriatrics Bundle)
n=50 Participants
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.
|
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.
|
|---|---|---|
|
Barriers and Facilitators to Bundle Implementation
Occupational Therapy Component: Barriers
|
7 themes
|
—
|
|
Barriers and Facilitators to Bundle Implementation
Occupational Therapy Component: Facilitators
|
3 themes
|
—
|
|
Barriers and Facilitators to Bundle Implementation
Pharmacy Component: Barriers
|
5 themes
|
—
|
|
Barriers and Facilitators to Bundle Implementation
Pharmacy Component: Facilitators
|
6 themes
|
—
|
|
Barriers and Facilitators to Bundle Implementation
Hearing Amplifier Component: Barriers
|
3 themes
|
—
|
|
Barriers and Facilitators to Bundle Implementation
Hearing Amplifier Component: Facilitators
|
2 themes
|
—
|
SECONDARY outcome
Timeframe: during hospitalization, up to 128 daysPopulation: Only patients that proceeded to hospital discharge within 30 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.
Outcome measures
| Measure |
Post-Intervention Group (Geriatrics Bundle)
n=41 Participants
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.
|
Pre-Intervention Group (Control)
n=20 Participants
Participants in the control arm will be enrolled prior to implementation of the geriatrics bundle to gather preliminary data about the secondary outcomes.
|
|---|---|---|
|
Delirium Assessed Using Chart-based Delirium Identification Instrument for ICU (CHART-DEL-ICU)
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From ICU admission to hospital discharge, up to 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Post-Intervention Group (Geriatrics Bundle)
n=48 Participants
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.
|
Pre-Intervention Group (Control)
n=21 Participants
Participants in the control arm will be enrolled prior to implementation of the geriatrics bundle to gather preliminary data about the secondary outcomes.
|
|---|---|---|
|
Mobility Level - Highest Level
|
4.44 score on a scale
Standard Deviation 1.13
|
4.38 score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: From ICU admission to hospital discharge, up to 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Post-Intervention Group (Geriatrics Bundle)
n=48 Participants
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.
|
Pre-Intervention Group (Control)
n=21 Participants
Participants in the control arm will be enrolled prior to implementation of the geriatrics bundle to gather preliminary data about the secondary outcomes.
|
|---|---|---|
|
Mobility Level - Level at Discharge
|
4.10 score on a scale
Standard Deviation 1.29
|
4.10 score on a scale
Standard Deviation 1.55
|
SECONDARY outcome
Timeframe: From ICU admission to hospital discharge, up to 30 daysPopulation: 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.
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.
Outcome measures
| Measure |
Post-Intervention Group (Geriatrics Bundle)
n=31 Participants
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.
|
Pre-Intervention Group (Control)
n=17 Participants
Participants in the control arm will be enrolled prior to implementation of the geriatrics bundle to gather preliminary data about the secondary outcomes.
|
|---|---|---|
|
Muscle Strength
|
50.2 score on a scale
Standard Deviation 9.0
|
49.6 score on a scale
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: 30 days after hospital dischargePopulation: Only participants with data were analyzed.
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.
Outcome measures
| Measure |
Post-Intervention Group (Geriatrics Bundle)
n=41 Participants
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.
|
Pre-Intervention Group (Control)
n=21 Participants
Participants in the control arm will be enrolled prior to implementation of the geriatrics bundle to gather preliminary data about the secondary outcomes.
|
|---|---|---|
|
30-day Functional Outcomes
|
5 count of activities
Interval 2.0 to 12.0
|
8 count of activities
Interval 4.0 to 12.0
|
SECONDARY outcome
Timeframe: 30 days after hospital dischargePopulation: Only participants eligible for readmission were assessed.
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.
Outcome measures
| Measure |
Post-Intervention Group (Geriatrics Bundle)
n=35 Participants
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.
|
Pre-Intervention Group (Control)
n=15 Participants
Participants in the control arm will be enrolled prior to implementation of the geriatrics bundle to gather preliminary data about the secondary outcomes.
|
|---|---|---|
|
Number of Participants With Hospital Readmissions Within 30 Days
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 days after hospital dischargePopulation: Out of 7 participants that completed the interview. Amplifying device was only provided to the intervention group and not the control group.
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.
Outcome measures
| Measure |
Post-Intervention Group (Geriatrics Bundle)
n=7 Participants
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.
|
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.
|
|---|---|---|
|
Number of Participants That Reported Use and Perceived Benefit of Amplifying Device After Hospital Discharge
Indicate Perceived benefits
|
6 Participants
|
—
|
|
Number of Participants That Reported Use and Perceived Benefit of Amplifying Device After Hospital Discharge
Did Not Indicate Perceived benefits
|
1 Participants
|
—
|
Adverse Events
Post-Intervention Group (Geriatrics Bundle)
Pre-Intervention Group (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lauren Ferrante, MD, MHS
Department of Internal Medicine: Yale School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place