Supporting Families in the ICU (NCT07228299) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Supporting Families in the ICU
United States64 participantsStarted 2026-06-01
Plain-language summary
The overarching goal of our work is to test the effect of high-quality spiritual care for ICU family surrogates on outcomes of psychological and spiritual well-being and medical decision making. Our team has developed an approach to high quality spiritual care intervention for ICU surrogates, called the Spiritual Care Assessment and Intervention (SCAI) framework, which is delivered by a chaplain interventionist to ICU surrogates.
Who can participate
Age range
18 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.
We will enroll patient/surrogate dyads.
Patients will be eligible if:
* They are age 18 or older at the time of screening.
* They are judged to lack decisional capacity based on either:
a Glasgow Coma Scale (GCS) score of 8 or less; or a GCS of 9-13 with at least one secondary criterion (intubation, sedation, delirium, or noted by clinicians to be unresponsive, comatose or unable to follow commands).
\* They have an eligible surrogate willing to participate.
Surrogates will be eligible if:
* They are age 18 or older,
* They are considered the legally authorized representative (LAR) based on prior appointment by the patient or each state's medical consent law.
Patient/surrogate dyads will be ineligible if:
\* They are unable to complete enrollment activities within 96 hours of admission to the ICU.
Patients will be ineligible if:
* They are being discharged from the ICU within 24 hours.
* They are intubated for surgery but expected to be extubated soon (typically within 24 hours).
* They are imminently dying or have a planned terminal wean.
Surrogates will be ineligible if:
\*They are unable to complete study procedures in English.
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
Effect of the intervention on surrogate anxiety (GAD-7)
Timeframe: Assessed at baseline and 6-8 weeks after the patient has discharged from the hospital