Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06039501

The Family Perspectives Project Pilot Trial to Enhance Communication and Emotional Support for Families of Critically Ill Patients

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

70

Participants Needed

1

Research Sites

N/A

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

Researchers are evaluating a program aimed at improving fair communication and emotional support for families of critically ill patients with acute respiratory failure. This pilot randomized trial focuses on assessing how feasible and acceptable the program is, along with understanding participant experiences. The study involves critically ill patients on invasive mechanical ventilation and their primary surrogate decision makers, ICU support counselors, and ICU care teams including physicians, nurses, and social workers. The study compares two groups: one receiving the Family Perspective Program that includes regular meetings with trained ICU support counselors who provide culturally competent emotional and spiritual support and prepare reports summarizing family perspectives, and the other receiving usual care with standard meetings between families and the ICU care team. Both groups complete questionnaires, and meetings may be audio recorded and followed by optional interviews. Participants will be involved in chart reviews, questionnaires, meetings, and optional audio recordings and interviews. The study measures feasibility of implementing the program and collecting data from families, counselors, and care teams over six months. The research team monitors perceptions of the program's feasibility among ICU support counselors and care team members while participants receive regular support during their ICU stay.

CONDITIONS

Brief Title

The Family Perspectives Project Pilot Trial

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals 18 years old or older.
  • Admitted to the medical intensive care unit (MICU) at Cedars-Sinai Medical Center.
  • Diagnosed with acute respiratory failure requiring more than 24 hours of invasive mechanical ventilation.
  • Received invasive mechanical ventilation within 24 hours of MICU admission.
  • Expected to need invasive mechanical ventilation for more than 72 hours, as determined by the intensivist physician.
  • Primary surrogate decision makers 18 years or older who self-identify as responsible for patient decisions and are proficient in English.
  • ICU support counselors who work as hospital chaplains in the MICU.
  • Physicians (intensivists) working in the MICU.
  • Bedside nurses working in the MICU.
  • Social workers working in the MICU.
Not Eligible

You will not qualify if you...

  • Patient records flagged as "break the glass" or "research opt out."
  • Patients expected to die within 24 hours of potential enrollment.
  • Patients on or preferring comfort care protocols.
  • Patients chronically dependent on a ventilator before admission.
  • Patients with acute on chronic neuromuscular respiratory failure (e.g., Guillain Barre, Muscular Dystrophy).
  • Patients imminently awaiting organ transplant.
  • Patients with decisional capacity.
  • Patients without a surrogate decision maker.
  • Patients whose surrogate decision maker is not proficient in English.
  • Patients whose attending physician is the principal investigator on this study.
  • Patients cared for by intensivist physicians who do not agree to participate.
  • Patients with pre-existing relationships with hospital chaplains who do not agree to participate.
  • Surrogate decision makers not proficient in English.
  • No exclusion criteria for ICU support counselors, physicians, nurses, or social workers.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - Up to 6 months

Participants receive the Family Perspective Program, involving regular meetings between families and an ICU support counselor to enhance communication and emotional support. Families also have meetings with the ICU care team as part of usual care.

Regular meetings between families and ICU support counselors and ICU care teams during the ICU stay

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

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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