The Family Perspectives Project Pilot Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMatthew Modes
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Family Perspective Program
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Matthew Modes
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
National Palliative Care Research Center
Collaborator
Source ClinicalTrials.gov