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

Sponsor
Yale University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06006000
Collaborator
National Institute on Aging (NIA) (NIH)
650
1
60
10.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    650 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness
    Anticipated Study Start Date :
    Oct 1, 2023
    Anticipated Primary Completion Date :
    Oct 1, 2028
    Anticipated Study Completion Date :
    Oct 1, 2028

    Arms and Interventions

    Arm Intervention/Treatment
    Older adults returning home post-ICU

    Community-dwelling older adults who return home (either directly or after a stay in short-term rehab (STR)) after an ICU hospitalization.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. Number of hospital readmissions [monthly up to 6 months]

      Number of hospital readmissions monthly up to 6 months.

    3. Number of deaths [monthly up to 6 months]

      Number of deaths each month up to 6 months.

    4. 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

    1. Functional non-recovery [monthly up to 6 months]

      Not returning to the pre-ICU functional baseline within the follow-up period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    CAREGIVERS

    • Primary language other than English

    • Is a paid caregiver

    • Unwilling to complete a qualitative interview

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale New Haven Hospital New Haven Connecticut United States 06520

    Sponsors and Collaborators

    • Yale University
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Lauren Ferrante, MD, MHS, Yale School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT06006000
    Other Study ID Numbers:
    • 2000034943
    • 1R01AG079916-01A1
    First Posted:
    Aug 23, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yale University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 23, 2023