Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06039501

The Family Perspectives Project Pilot Trial

Led by Matthew Modes · Updated on 2025-06-15

70

Participants Needed

1

Research Sites

154 weeks

Total Duration

On this page

Sponsors

M

Matthew Modes

Lead Sponsor

N

National Palliative Care Research Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

The Family Perspectives Project Pilot Trial

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18 years old or older.
  • Patient admitted to the medical intensive care unit (MICU) at Cedars-Sinai Medical Center.
  • Patient has acute respiratory failure with more than 24 hours of invasive mechanical ventilation.
  • Patient received invasive mechanical ventilation within 24 hours of MICU admission.
  • Patient expected to need invasive mechanical ventilation for more than 72 hours as determined by intensivist.
  • Primary surrogate decision maker is 18 years old or older.
  • Primary surrogate identifies as most responsible for decisions for the enrolled patient (family or close friend).
  • Primary surrogate is proficient in English.
  • ICU support counselors are 18 years old or older and work as hospital chaplains in the MICU.
  • Physicians are 18 years old or older and work as critical care physicians in the MICU (fellows or attendings).
  • Nurses are 18 years old or older and work as bedside nurses in the MICU.
  • Social workers are 18 years old or older and work as social workers in the MICU.
Not Eligible

You will not qualify if you...

  • Patient records flagged as "break the glass" or "research opt out".
  • Patient expected to die within 24 hours of potential enrollment as determined by intensivist.
  • Patient on comfort care protocol or with clear preference for comfort care as determined by intensivist.
  • Patient chronically dependent on a ventilator prior to admission.
  • Patient has acute on chronic neuromuscular disease-related respiratory failure (e.g., Guillain Barre, Muscular Dystrophy, Myasthenia Gravis).
  • Patient imminently awaiting organ transplant as determined by intensivist.
  • Patient has decisional capacity as determined by intensivist.
  • Patient is unrepresented with no surrogate decision maker.
  • Patient's primary surrogate decision maker is not proficient in English.
  • Patient's attending physician is the study principal investigator at time of enrollment.
  • Patient cared for by intensivist physicians who do not agree to participate.
  • Patient has a pre-existing relationship with a hospital chaplain who does not agree to participate.
  • Primary surrogate decision maker not proficient in English.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

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Research Team

M

Matthew Modes, MD, MPP, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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