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

NCT ID: NCT04652453

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2021-12-22

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.

Detailed Description

Outcome 4 was updated 11/8/23.

Conditions

Intensive Care Unit Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Geriatrics Bundle

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Ferrante, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale-New Haven Hospital

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30AG021342

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000029410

Identifier Type: -

Identifier Source: org_study_id