Intensive Care Unit SyndromeACE-ICUNCT04652453
Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the ICU
A study testing Geriatrics Bundle in people with Intensive Care Unit Syndrome, run by Yale University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- Geriatrics Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 22 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the Intensive Care Unit (ACE-ICU)
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.
Read the detailed description
Outcome 4 was updated 11/8/23.
- Conditions
- Intensive Care Unit Syndrome
- Being tested
- Geriatrics Bundle
- Keywords
- Geriatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatrics BundleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Geriatrics Bundle |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: From ICU admission to hospital discharge, up to 30 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start19 Jan 2021
- Primary completion22 Dec 2021
- Study completion22 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pre-/Post-Intervention Design
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Lauren Ferrante, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652453
- Sponsor's protocol ID
- 2000029410
- Other IDs
- P30AG021342
- Acronym
- ACE-ICU
- Status last verified
- Feb 2024
- First submitted
- 26 Nov 2020
- Last updated
- 16 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the Intensive Care Unit (ACE-ICU)
- ClinicalTrials.gov ID
- NCT04652453
- Acronym / sponsor ID
- ACE-ICU / 2000029410
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- Geriatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 22 Dec 2021 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Posted 1 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pre-/Post-Intervention Design
| Arm | Type | Receives |
|---|---|---|
| Post-Intervention Group (Geriatrics Bundle) | Experimental | Other: Geriatrics BundleEnrolled 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geriatrics BundleEnrolled 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. | Other | Post-Intervention Group (Geriatrics Bundle) |
Primary outcome
Feasibility of Bundle Delivery
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Delirium Assessed Using Chart-based Delirium Identification Instrument for ICU (CHART-DEL-ICU)
Time frame: during hospitalization, up to 128 days
Mobility Level - Highest Level
Time frame: From ICU admission to hospital discharge, up to 30 days
Mobility Level - Level at Discharge
Time frame: From ICU admission to hospital discharge, up to 30 days
Muscle Strength
Time frame: From ICU admission to hospital discharge, up to 30 days
30-day Functional Outcomes
Time frame: 30 days after hospital discharge
Number of Participants With Hospital Readmissions Within 30 Days
Time frame: 30 days after hospital discharge
Number of Participants That Reported Use and Perceived Benefit of Amplifying Device After Hospital Discharge
Time frame: 30 days after hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Ferrante, MD, MHS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatrics Bundle in people with Intensive Care Unit Syndrome, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Bundle Delivery (time frame: From ICU admission to hospital discharge, up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.