Clinical trial NCT06006000: Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness
Official title: Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Illness, Critical
Keywords: Geriatrics
Older Adults
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-08-23
Enrollment: 650
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Disability Count
timeFrame: monthly up to 6 months
measure: Number of hospital readmissions
timeFrame: monthly up to 6 months
measure: Number of deaths
timeFrame: monthly up to 6 months
measure: Barriers and Facilitators to addressing unmet needs
timeFrame: month 6
Secondary outcomes:
measure: Functional non-recovery
timeFrame: monthly up to 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Lauren Ferrante, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: