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

Recruiting

• Conditions: Critical Illness; Illness, Critical

• Registration Number: NCT06006000
• Lead Sponsor: Yale University

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.

Detailed Description

To identify unmet needs in multiple domains after return home from an ICU hospitalization, evaluate whether these unmet needs are associated with disability burden in the subsequent 6 months, and ascertain whether these associations are moderated by initial discharge destination (home or STR).

Study Timeline

• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-15
• Study First Posted: 2023-08-23
• Study Start: 2024-01-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-10
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability Count	monthly up to 6 months	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.
Number of hospital readmissions	monthly up to 6 months	Number of hospital readmissions monthly up to 6 months.
Number of deaths	monthly up to 6 months	Number of deaths each month up to 6 months.
Barriers and Facilitators to addressing unmet needs	month 6	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.

Secondary Outcome Measures

Name	Time	Method
Functional non-recovery	monthly up to 6 months	Not returning to the pre-ICU functional baseline within the follow-up period

Trial Locations

Locations (1)

Yale New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States