Mitigating Racial Disparities in Shared Decision Making in the Intensive Care Unit (NCT05710744) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Mitigating Racial Disparities in Shared Decision Making in the Intensive Care Unit
United States106 participantsStarted 2027-01-04
Plain-language summary
This is a non randomized pilot trial aimed to:
Test the feasibility of an intervention to support intensive care unit clinicians in conducting shared decision making conversations with families of patients with acute respiratory failure. The goal of this intervention is to mitigate racial disparities in shared decision making.
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.
Physician inclusion criterion:
\- ICU attending physician with at least 6 weeks of clinical service time in the 12 months preceding and following enrollment
Physician exclusion criterion:
\- Board certified in palliative care medicine
Patient inclusion criteria:
* Admitted to the ICU
* Being treated by a study physician currently and at least for the next 48 hours
* ≥ 18 years of age upon admission to hospital
* Mechanically ventilated ≥ 4 days
Patient exclusion criterion:
* Tracheostomy tube present or decision to pursue tracheostomy within next 7 days
* Has decision making capacity as assessed by medical team
* Extubation planned or death anticipated in next 24 hours
* Patients who are prisoners or are pregnant
* Awaiting organ transplantation during this hospitalization
* Acute respiratory failure due to progression of chronic neuromuscular disease
* No family decision maker available
Family member inclusion criteria:
* Identified by medical team as person most involved in medical decision making for the patient
* Confirmed to be patient's legally authorized representative
* Self-identifies as non-Hispanic, Black or White
* ≥ 18 years of age at time of consent
* Confirms conversational fluency 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
Intervention acceptability as measured by single Likert-scaled item completed by physicians
Timeframe: within 96 hours of signing study consent
2
Demand for the intervention measured by the proportion of physicians who viewed the intervention
Timeframe: within 96 hours of signing study consent
3
Fidelity to intervention measured by proportion of tip sheet phrases used by physicians
Timeframe: within 96 hours of signing study consent
4
Practicality as measured by proportion of screen eligible participants enrolled per month
Timeframe: through study completion, up to 1 year
5
Practicality as measured by time to complete physician or family surveys
Timeframe: within 96 hours of signing study consent
6
Practicality as measured by dropout rate from study