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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06006000

Acronym

LANTERN

Enrollment

350

Registered

2023-08-23

Start date

2024-01-25

Completion date

2028-10-01

Last updated

2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Illness, Critical

Keywords

Geriatrics, Older Adults

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Contacts

CONTACTNicole Bouranis, PhD

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

PRINCIPAL_INVESTIGATORLauren Ferrante, MD, MHS

Yale University

Outcome results