BridgeMD
New treatment option for Respiratory Failure
Official title The Family Perspectives Project Pilot Trial
ClinicalTrials.gov ID: NCT06039501
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Patient
- Individuals 18 years old or older.
- Individuals admitted to the medical intensive care unit (MICU) at Cedars-Sinai Medical Center.
- Individuals with acute respiratory failure, defined as \>24 hours of invasive mechanical ventilation.
- Individuals who received invasive mechanical ventilation within 24 hours of admission to the MICU.
You likely can't join if
- Patient exclusion criteria: o Any records flagged "break the glass" or "research opt out." o Individuals expected to die within 24 hours of potential...
- 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...
- 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).
See the full eligibility criteria
- Patient
- Individuals 18 years old or older.
- Individuals admitted to the medical intensive care unit (MICU) at Cedars-Sinai Medical Center.
- Individuals with acute respiratory failure, defined as \>24 hours of invasive mechanical ventilation.
- Individuals who received invasive mechanical ventilation within 24 hours of admission to the MICU.
- Individuals expected to need invasive mechanical ventilation for \>72 hours total, as determined by the patient's intensivist physician (fellow or attending).
- Primary surrogate decision maker o Individuals 18 years old or older.
- Individual who self-identifies as the most responsible for making decisions for the enrolled patient (can be either family member or close friend).
- Proficiency in English language.
- ICU support counselor
- Individuals 18 years old or older.
- Individuals who work as hospital chaplains in the MICU.
- Physician (intensivist)
- Individuals 18 years old or older.
- Individuals who work as critical care physicians in the MICU (fellow or attending).
- Nurse
- Individuals 18 years old or older.
- Individuals who work as bedside nurses in the MICU.
- Social worker
- Individuals 18 years old or older.
- Individuals work as social workers in the MICU.
- 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...
- 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.)
- ICU support counselor exclusion criteria: o None
- Physician (intensivist) exclusion criteria: o None
- Nurse exclusion criteria: o None
- Social worker exclusion criteria:
- None
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.