Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30AG021342 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Outcome 4 was updated 11/8/23.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | Experimental | 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. |
|
| Pre-Intervention Group (Control) | No Intervention | Participants in the control arm will be enrolled prior to implementation of the geriatrics bundle to gather preliminary data about the secondary outcomes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geriatrics Bundle | Other | 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. |
| 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 |
| 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
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lauren Ferrante, MD, MHS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States |
Not provided
72 participants and 11 providers
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Providers | Providers were surveyed for the acceptability outcome only. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Not collected for providers |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only participants in the geriatric bundle were eligible. | Posted | Count of Participants | Participants | From ICU admission to hospital discharge, up to 30 days |
|
up to 30 days after hospital discharge
Adverse events were not tracked for providers as it was not part of the study protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Ferrante, MD, MHS | Department of Internal Medicine: Yale School of Medicine | (203) 785-3207 | lauren.ferrante@yale.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2021 | Dec 20, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 15, 2021 | Feb 13, 2024 | ICF_001.pdf |
Not provided
Pre-/Post-Intervention Design
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | Providers | 11 Providers were surveyed for the acceptability outcome only. Demographics were not collected for the providers. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Not collected for providers | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Not collected for providers | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Highest level of education completed | Not collected for providers | Count of Participants | Participants |
|
| Medicaid recipient | Not collected for providers | Count of Participants | Participants |
|
| Marital status | Not collected for providers | Count of Participants | Participants |
|
| Lives alone | Not collected for providers | Count of Participants | Participants |
|
| Respondent | Not collected for providers | Count of Participants | Participants |
|
| Comorbidity count | range, 0-10 | Not collected for providers | Median | Inter-Quartile Range | count of comorbidities |
|
| Presence of functional disability in any of the 15 activities | The 15 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 score indicates greater disability. | Not collected for providers | Count of Participants | Participants |
|
| Hearing impairment | Not collected for providers | Count of Participants | Participants |
|
| Vision impairment | Not collected for providers | Count of Participants | Participants |
|
| Fall prior to hospitalization | Not collected for providers | Count of Participants | Participants |
|
| Disability in month prior to hospitalization | Number of functional activities participant experienced disability (range, 0-15), median (IQR) | Not collected for providers | Median | Inter-Quartile Range | number of activities |
|
| Hospitalization in the 6 months prior to admission | Not collected for providers | Count of Participants | Participants |
|
| History of tobacco use | current or former | Not collected for providers | Count of Participants | Participants |
|
| Clinical Frailty Scale, range 1-7 | Clinical Frailty Scale (CFS), which measures frailty. The range of scores is 1-7, where a higher score indicates higher frailty (a worse outcome). | Not collected for providers | Mean | Standard Deviation | score on a scale |
|
| Muscle strength at baseline, range 0-60 mean (SD) | Medical Research Council Sum Score (MRC-SS). Strength in each of 6 muscle groups bilaterally is assessed. Each muscle group is scored from 0 (no visible or palpable contraction) to 5 (normal power). If the maneuver was not attempted for a given muscle group, it was assigned a score of zero.The indvidual scores are then summed to make a total score (range, 0-60). Lower scores indicate less strength. There were 13 participants missing the entire MRC-SS assessment in the intervention group and 1 missing in the control group at baseline. | Not collected for providers | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
| 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). | 11 providers | Posted | Count of Participants | Participants | From ICU admission to hospital discharge, up to 30 days |
|
|
|
| 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. | Numbers represented here are the number of themes derived from interviews. | Posted | Number | themes | From ICU admission to hospital discharge, up to 30 days |
|
|
|
| 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
| Only patients that proceeded to hospital discharge within 30 days. | Posted | Count of Participants | Participants | during hospitalization, up to 128 days |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | From ICU admission to hospital discharge, up to 30 days |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | From ICU admission to hospital discharge, up to 30 days |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | From ICU admission to hospital discharge, up to 30 days |
|
|
|
| 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. | Only participants with data were analyzed. | Posted | Median | Inter-Quartile Range | count of activities | 30 days after hospital discharge |
|
|
|
| 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. | Only participants eligible for readmission were assessed. | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| 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. | Out of 7 participants that completed the interview. Amplifying device was only provided to the intervention group and not the control group. | Posted | Count of Participants | Participants | 30 days after hospital discharge |
|
|
|
| 8 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 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. | 2 | 22 | 0 | 22 | 0 | 22 |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Pharmacy Component: Facilitators |
|
| Hearing Amplifier Component: Barriers |
|
| Hearing Amplifier Component: Facilitators |
|