The Family Perspectives Project Pilot Trial for Respiratory Failure

This study, called The Family Perspectives Project Pilot Trial, is testing a program to improve how families of critically ill patients communicate with doctors and nurses, and to offer emotional support. The program involves regular meetings between families and a trained ICU (Intensive Care Unit) support counselor. We want to see if this program can be successfully put into practice, if families find it helpful, and what their experiences are like. You might be able to join if you are an adult patient (18 or older) at Cedars-Sinai Medical Center's MICU (Medical Intensive Care Unit) with acute respiratory failure (meaning you've been on a breathing machine for over 24 hours). The study aims to enroll 70 patients and their primary family decision-makers. The current status of the study is unclear.

Study design
This is a pilot randomized trial, meaning participants are assigned by chance to different groups, and it plans to include 70 participants. The study is interventional, testing a behavioral program.
What's involved
You would complete questionnaires, have meetings with ICU support counselors and care teams, and potentially have optional audio recordings of meetings and interviews.
Compensation
Not stated in the trial record.
Follow-up
The feasibility of the program will be measured at 6 months.

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NCT06039501

The Family Perspectives Project Pilot Trial

Recruiting
NAAges 18+Interventional
Matthew Modes
~70 participants
Updated 2025-06-15 on ClinicalTrials.gov
What's tested:Family Perspective Program

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of implementing the program for families of patients with acute respiratory failure.
Measured over 6 months
Respiratory Failure
Family Support
Physician-Patient Relations
Critical Illness
1 sites across 1 states
California1
  • Matthew Modes, MD, MPP, MS · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

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Eligibility criteria

Inclusion

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).
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.
Individuals 18 years old or older.
Individuals who work as hospital chaplains in the MICU.
Individuals 18 years old or older.
Individuals who work as critical care physicians in the MICU (fellow or attending).
Individuals 18 years old or older.
Individuals who work as bedside nurses in the MICU.
Individuals 18 years old or older.
Individuals work as social workers in the MICU.

Exclusion

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.
None
  • Feasibility of implementing the program for families of patients with acute respiratory failure.6 months

    The proportion of enrolled primary surrogate decision makers randomized to the program who receive all program components. The study will be declared "feasible" if at least 70% of primary surrogate decision makers receive all program components (meeting with ICU support counselors, ICU support counselors generating standardized reports, reports being reviewed by ICU care team members prior to meeting with families).