Status:
RECRUITING
The Family Perspectives Project Pilot Trial
Lead Sponsor:
Matthew Modes
Collaborating Sponsors:
National Palliative Care Research Center
Conditions:
Respiratory Failure
Family Support
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 deter...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06039501
Start Date
October 13 2023
End Date
October 1 2026
Last Update
June 15 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048