The Family Perspectives Project Pilot Trial (NCT06039501)
🩺 Plain-English Summary (8th-Grade Level)
The purpose of the study is to conduct a pilot randomized trial of a program designed to enhance equitable communication and emotional support for families of critically ill patients in order to determine feasibility, acceptability, and participant experience with the program. The primary study procedures include: chart abstraction, questionnaires, meetings with ICU support counselors, meetings with ICU physicians and care team, audio recordings of these meetings (optional), and interviews with study participants (optional). Study participants include: 70 critically ill patients with acute respiratory failure (enrolled with the consent of their Legally Authorized Representative) and their primary surrogate decision makers as well as ICU support counselors and ICU care teams (physicians, nurses, social workers).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (21 items) and avoid the listed exclusions (13 items).
Location: Cedars-Sinai Medical Center — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Patient exclusion criteria: o Any records flagged "break the glass" or "research opt out." o Individuals expected to die within 24 hours of potential enrollment, as determined by the patient's intensivist physician (fellow or attending). o Individuals on comfort care protocol or with clear preference for comfort care, as determined by the patient's intensivist physician (fellow or attending).
- Individuals who are chronically dependent on a ventilator prior to admission.
- Individuals with acute on chronic neuromuscular disease-related respiratory failure (e.g., Guillain Barre, Muscular Dystrophy, Myasthenia Gravis, etc.).
- Individuals imminently awaiting organ transplant, as determined by the patient's intensivist physician (fellow or attending).
- Individuals with decisional capacity, as determined by the patient's intensivist physician (fellow or attending).
- Individuals who are unrepresented (i.e., patient has no surrogate decision maker).
- Individuals whose potential enrolled family member (primary surrogate decision maker) is not proficient in English.
- Individuals whose attending physician is the PI on this study at the time of potential enrollment.
- Individuals who are cared for by intensivist physicians (fellow and attending) who do not agree to participate in the study.
- Individuals who have a pre-existing relationship with a hospital chaplain who does not agree to participate in the study, as determined by that chaplain.
- Primary surrogate decision maker exclusion criteria: o Not proficient in English language. (Rationale: materials and intervention are not adapted in other languages.)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Cedars-Sinai Medical Center — Los Angeles, California
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.