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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Illness, Critical

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 Type: Observational
• Enrollment (Estimated): 650

Contacts and Locations

• Study Contact: Name: Nicole Bouranis, PhD; Phone Number: +1 (203) 737-1731; Email: nicole.bouranis@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability Count	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.	monthly up to 6 months
Number of hospital readmissions	Number of hospital readmissions monthly up to 6 months.	monthly up to 6 months
Number of deaths	Number of deaths each month up to 6 months.	monthly up to 6 months
Barriers and Facilitators to addressing unmet needs	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.	month 6

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Lauren Ferrante, MD, MHS, Yale School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Older Adults; Geriatrics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 2000034943; 1R01AG079916-01A1 (U.S. NIH Grant/Contract: NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Deidentified data from this study will be available to investigators who sign a Data Use Agreement (DUA) executed between Yale University and the investigator's institution. The DUA requires the investigators to attest to (1) their commitment to using the data only for approved research purposes and not to identify any individual human participant; (2) their commitment to securing the data using appropriate computer technology; and (3) their commitment to destroying or returning the data after analyses are completed.

Data will not be available until all analyses are complete.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No