Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness (NCT06006000) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating the Unmet Needs of Older Adults to Promote Functional Recovery After a Critical Illness
United States350 participantsStarted 2024-01-25
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disability Count
Timeframe: monthly up to 6 months
2
Number of hospital readmissions
Timeframe: monthly up to 6 months
3
Number of deaths
Timeframe: monthly up to 6 months
4
Barriers and Facilitators to addressing unmet needs