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

Critical Illness Clinical Trial

— LANTERN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06006000
• Other study ID #: 2000034943
• Secondary ID: 1R01AG079916-01A
• Status: Recruiting
• Start date: January 25, 2024
• Est. completion date: October 2028

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: Nicole Bouranis, PhD
• Phone: +1 (203) 737-1731
• Email: nicole.bouranis[@]yale.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: October 2028
• Est. primary completion date: October 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Illness, Critical

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of hospital readmissions	Number of hospital readmissions monthly up to 6 months.	monthly up to 6 months
Primary	Number of deaths	Number of deaths each month up to 6 months.	monthly up to 6 months
Primary	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	Functional non-recovery	Not returning to the pre-ICU functional baseline within the follow-up period	monthly up to 6 months