Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness

NCT06006000 | Recruiting

• 2 other identifiers: 20000349431R01AG079916-01A1
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective longitudinal study that will evaluate the unmet needs of older adults (65 and older) who return home (either directly or after short-term rehab) after an ICU hospitalization, evaluate the association of these unmet needs with clinically relevant outcomes, and assess barriers and facilitators to addressing these unmet needs. The proposed research will inform the development and evaluation of a subsequent intervention to improve functional outcomes among older ICU survivors, in alignment with the NIH's mission to reduce disability.

Conditions

Critical Illness; Illness, Critical

Keywords

Geriatrics; Older Adults

Outcome Measures

Primary Outcomes (4)

• Disability Count

  Number of instances of disability during activities of daily living (ADLs), instrumental activities of daily living (IADLs), and mobility activity. Disability is defined as an inability to complete the task or the need for personal assistance to complete the task. The higher the count, the more disability.

  monthly up to 6 months

• Number of hospital readmissions

  Number of hospital readmissions monthly up to 6 months.

  monthly up to 6 months

• Number of deaths

  Number of deaths each month up to 6 months.

  monthly up to 6 months

• Barriers and Facilitators to addressing unmet needs

  Barriers and facilitators to addressing unmet needs will be assessed using qualitative interviews. A subgroup of participants will receive qualitative interviews conducted with members of the study team. Content analysis will then be used to identify barriers and facilitators to addressing unmet needs that will be informative when planning a future intervention.

  month 6

Secondary Outcomes (1)

• Functional non-recovery

  monthly up to 6 months

Study Arms (1)

Older adults returning home post-ICU

Community-dwelling older adults who return home (either directly or after a stay in short-term rehab (STR)) after an ICU hospitalization.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community-dwelling older adults who return home (either directly or after a stay in short-term rehab (STR)) after an ICU hospitalization.

You may qualify if:

• PARTICIPANTS
• Age ≥ 65 years
• Survived an ICU admission of ≥2 days
• CAREGIVERS
• Age ≥ 18 years
• Identified as caregiver of LANTERN participant who is an informal (unpaid) caregiver.

You may not qualify if:

• PARTICIPANTS
• Advance directive of comfort measures only (CMO) or a transition to hospice
• Planned discharge to a location other than home or Short-Term Rehab
• Tracheostomy with ventilator dependence
• Severe acute or prior neurologic injury (such as anoxic brain injury or acute, massive stroke)
• Advanced dementia
• ICU admission for monitoring only (e.g., antibiotic desensitization)
• Primary language other than English.
• Homelessness
• Active drug or alcohol use disorder.
• CAREGIVERS
• Primary language other than English
• Is a paid caregiver
• Unwilling to complete a qualitative interview

Sponsors & Collaborators

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

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lauren Ferrante, MD, MHS

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Bouranis, PhD

CONTACT

+1 (203) 737-1731; nicole.bouranis@yale.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 23, 2023
• Study Start: January 25, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)