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 @ 11:21 PM
Ignite Modification Date:
2025-12-24 @ 11:21 PM
NCT ID:
NCT06588556
Eligibility Criteria:
Inclusion Criteria:
Patients (who are not interviewed but whose characteristics prompt enrollment of family members)
1. Adult aged ≥18 years
2. Managed in an adult medical, cardiac, trauma, surgical, or neurological ICU
3. Serious acute illness associated with a need for invasive mechanical ventilation
4. ICU team expect patient to require mechanical ventilation for 2 or more days
Family members
1. Adult aged ≥18 years
2. Family member: self-described as the individual (related or unrelated) who provides the most support and with whom the eligible patient has a significant relationship (Society of Critical Care Medicine definition of family; Davidson J, et al. Crit Care Med, 45:103-128; 2017)
ICU clinicians
1. Adult aged ≥18 years
2. ICU clinician: ICU attending caring for the eligible patient on the day of family member informed consent
Exclusion Criteria:
Patients
1. Death or full comfort care plan expected within 24 hours by ICU attending or fellow physician Rationale: measurable intervention effect unlikely
2. Palliative care consultative team and/or palliative care specialists are currently involved in the patient's care.
Rationale: this would dilute the intervention's effect.
3. ICU length of stay \>4 days during current ICU admission. Rationale: this would dilute intervention effect by widening the timeframe of family-clinician interactions and limiting standardization.
6\. Imprisoned person. Rationale: this is a vulnerable population.
Family members
1. Low palliative care need burden (i.e., NEST scale score \<15) at baseline. Rationale: if there are very low baseline needs, the intervention cannot impact the primary outcome measure (i.e., NEST).
2. Lack of English or Spanish fluency, operationalized as need for a translator to understand medical forms or participate in medical discussions.
Rationale: the app has not been translated into other languages; also, many outcome measures aren't validated in languages other than English and Spanish.
3. Endorsement of suicidal ideation (i.e., PHQ-9 suicidality item) at the time of baseline data collection.
Rationale: this indicates a serious level of distress that will require professional assistance beyond that provided by the intervention (or control).
4. Patient regains decisional capacity after informed consent but before the first family meeting. Rationale: as in our past ICU-based studies, this circumstance (the entry of the patient as a decision maker), would substantially change the nature of the interactions of family members and clinicians.
5. The ICU clinician changes from a consented clinician to a non-consented clinician before the first family meeting. Rationale: in this circumstance the intervention cannot be fully deployed.
ICU clinicians None
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06588556
Study Brief:
Protocol Section:
NCT06588556