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

NCT04652453 | Completed Results

• 2 other identifiers: 2000029410P30AG021342
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Syndrome

Keywords

Geriatrics

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• Delirium Assessed Using Chart-based Delirium Identification Instrument for ICU (CHART-DEL-ICU)

  during hospitalization, up to 128 days

• Mobility Level - Highest Level

  From ICU admission to hospital discharge, up to 30 days

• Mobility Level - Level at Discharge

  From ICU admission to hospital discharge, up to 30 days

• Muscle Strength

  From ICU admission to hospital discharge, up to 30 days

• 30-day Functional Outcomes

  30 days after hospital discharge

Study Arms (2)

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.

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.

Interventions

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.

Post-Intervention Group (Geriatrics Bundle)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Results Point of Contact

• Title: Lauren Ferrante, MD, MHS
• Organization: Department of Internal Medicine: Yale School of Medicine

lauren.ferrante@yale.edu

(203) 785-3207

Study Officials

• Lauren Ferrante, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre-/Post-Intervention Design

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 3, 2020
• Study Start: January 19, 2021
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: February 16, 2024
• Results First Posted: March 1, 2023

Record last verified: 2024-02

Locations

US (1)