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Clinical Trials/NCT06006000
NCT06006000
Recruiting
Not Applicable

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

Yale University1 site in 1 country650 target enrollmentJanuary 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Yale University
Enrollment
650
Locations
1
Primary Endpoint
Disability Count
Status
Recruiting
Last Updated
11 months ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 25, 2024
End Date
October 2028
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • PARTICIPANTS
  • Age ≥ 65 years
  • Survived an ICU admission of ≥2 days
  • 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.

Outcomes

Primary Outcomes

Disability Count

Time Frame: 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

Time Frame: monthly up to 6 months

Number of hospital readmissions monthly up to 6 months.

Number of deaths

Time Frame: monthly up to 6 months

Number of deaths each month up to 6 months.

Barriers and Facilitators to addressing unmet needs

Time Frame: 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 Outcomes

  • Functional non-recovery(monthly up to 6 months)

Study Sites (1)

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