The Family Perspectives Project Pilot Trial
Launched by MATTHEW MODES · Sep 9, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The Family Perspectives Project Pilot Trial is a research study aimed at improving communication and emotional support for families of critically ill patients, particularly those experiencing respiratory failure. The trial will involve 70 patients who are receiving intensive care, along with their primary decision-makers, such as family members or close friends. Participants will take part in activities like completing questionnaires, meeting with support counselors and medical teams, and possibly having their discussions recorded for research purposes. The goal is to see if this program is helpful and acceptable to families during a challenging time.
To be eligible for the study, patients must be 18 years or older, admitted to the medical intensive care unit (MICU) at Cedars-Sinai Medical Center, and expected to need mechanical ventilation for a certain period. Their designated decision-makers must also be 18 or older and proficient in English. This study is currently recruiting participants, and it welcomes people of all genders. By participating, families can share their experiences and help improve the support offered to others facing similar situations in the future.
Gender
ALL
Eligibility criteria
- 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:
- • None
About Matthew Modes
Matthew Modes is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative study designs and rigorous scientific methodologies. With a focus on developing novel therapies and enhancing existing treatments, the organization prioritizes patient safety and ethical conduct in all research endeavors. Leveraging a network of experienced professionals and cutting-edge technology, Matthew Modes aims to facilitate efficient trial processes, ensuring timely delivery of meaningful results that contribute to the broader medical community and improve healthcare practices.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Patients applied
Trial Officials
Matthew Modes, MD, MPP, MS
Principal Investigator
Cedars-Sinai Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported