Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
NCT ID:
NCT05019261
Eligibility Criteria:
INCLUSION
Patient
1. Age ≥18
2. Lack of decision-making capacity as determined by clinical examination by the attending physician or designee
3. Clinical indication of at least 40% risk of death or ≥40% chance of new, severe long-term functional impairment (needs assistance with ≥ 2 ADLs), as judged by the patient's attending physician or designee
Surrogate
1. The primary surrogate is determined by the patient's advance directive or, if no directive exists, by following the hierarchy of surrogates codified in state law.
2. Up to 3 additional surrogates
Clinician
1\. Patient's primary attending (or their designee)
EXCLUSION
Patient
1. Lack of a surrogate decision maker
2. Family not available for study
3. Imminent death (within 24 hours); goals of care are already "comfort measures only"; decision to withdraw life support has already been made
4. Currently participating in a competing research study that does not allow co-enrollment
5. Incarcerated or on an involuntary hold
6. Died prior to enrollment
7. Discharged prior to enrollment
8. Regained capacity prior to enrollment
9. Physician declined patient's participation
10. Physician and designee declined own participation
11. Patient does not meet inclusion criteria within 5 days of ICU admission
12. MD expects transfer orders will be written or the patient will be transferred within 36 hours of screening
13. Greater than 5 ICU days during the current hospitalization
Surrogate
1. Age \<18 years
2. Cannot read or understand English
3. Cannot complete questionnaires due to physical or cognitive limitations
4. Has no access to or cannot travel to access the internet
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05019261
Study Brief:
Protocol Section:
NCT05019261