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Recruiting NCT06006000

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

Observational Critical Illness Illness, Critical

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Critical Illness, Illness, Critical. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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).

Primary outcome measures

  • Disability Count [Time frame: monthly up to 6 months]
  • Number of hospital readmissions [Time frame: monthly up to 6 months]
  • Number of deaths [Time frame: monthly up to 6 months]
  • Barriers and Facilitators to addressing unmet needs [Time frame: month 6]
Secondary outcome measures (1)
  • Functional non-recovery [Time frame: monthly up to 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Yale New Haven Hospital — New Haven

Identifiers

NCT: NCT06006000 · 2000034943 · 1R01AG079916-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗