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

Overview

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.

Full Title of Study: “Feasibility, Acceptability, and Barriers to Implementation of a Geriatrics Bundle in the Intensive Care Unit (ACE-ICU)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 15, 2021

Interventions

  • Other: 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.

Arms, Groups and Cohorts

  • Experimental: Post-Intervention Group (Geriatrics Bundle)
    • Enrolled participants in the intervention arm will receive all 3 components of the geriatrics bundle: occupational therapy (in addition to physical therapy) upon enrollment in the ICU, a portable amplifying device upon enrollment in the ICU, and a de-prescribing intervention by the ICU pharmacist (in conjunction with the medical team) upon ICU-to-floor transfer.
  • No Intervention: Pre-Intervention Group (Control)
    • Participants in the control arm will be enrolled prior to implementation of the geriatrics bundle to gather preliminary data about the secondary outcomes.

Clinical Trial Outcome Measures

Primary Measures

  • 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 delivering the interventions will be assessed with a survey using a 5-point Likert scale (range 1-5, where 5 indicates that the bundle is completely acceptable for use in its current form).
  • 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.

Secondary Measures

  • Delirium
    • Time Frame: From ICU admission to hospital discharge, up to 30 days
    • Incident delirium and days of delirium will be determined by review of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) charting in the electronic medical record.
  • Mobility level
    • Time Frame: 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.
  • Muscle strength
    • Time Frame: 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.
  • 30-day functional outcomes
    • Time Frame: 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.
  • 30-day hospital readmissions
    • Time Frame: 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.
  • Use and perceived benefit of amplifying device after hospital discharge
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yale University
  • Collaborator
    • National Institute on Aging (NIA)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lauren Ferrante, MD, MHS, Principal Investigator, Yale University
  • Overall Contact(s)
    • Lauren Ferrante, MD, MHS, 203-737-1800, lauren.ferrante@yale.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.