NCT06039501 · Matthew Modes
The Family Perspectives Project Pilot Trial
What this study is about
The purpose of the study is to conduct a pilot randomly assigned 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.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient inclusion criteria:
- 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 inclusion criteria: 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 inclusion criteria:
- Individuals 18 years old or older.
- Individuals who work as hospital chaplains in the MICU.
- Physician (intensivist) inclusion criteria:
- Individuals 18 years old or older.
- Individuals who work as critical care physicians in the MICU (fellow or attending).
- Nurse inclusion criteria:
- Individuals 18 years old or older.
- Individuals who work as bedside nurses in the MICU.
- Social worker inclusion criteria:
- Individuals 18 years old or older.
- Individuals work as social workers in the MICU.
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.)
- ICU support counselor exclusion criteria: o None
- Physician (intensivist) exclusion criteria: o None
- Nurse exclusion criteria: o None
- Social worker exclusion criteria:
Where
- Los Angeles, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2025 · Source of record for eligibility and locations