Enhancing communication and support for families of critically ill patients

The Family Perspectives Project Pilot Trial

This study is testing a new program to see if it can help families of critically ill patients in the ICU communicate better and feel more supported during a tough time.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT06039501 on ClinicalTrials.gov

What this trial studies

This pilot trial aims to evaluate a program designed to improve communication and emotional support for families of patients experiencing acute respiratory failure in the ICU. The study will involve 70 critically ill patients and their primary surrogate decision makers, as well as ICU support counselors and care teams. Participants will engage in various activities including meetings with support counselors and physicians, and optional interviews to assess their experiences. The goal is to determine the feasibility and acceptability of the program.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old admitted to the MICU with acute respiratory failure requiring invasive mechanical ventilation.

Not a fit: Patients who are not critically ill or do not require invasive mechanical ventilation may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly improve the emotional well-being and support for families of critically ill patients.

How similar studies have performed: While similar approaches have been explored, this specific program is novel in its focus on family perspectives in the context of critical illness.

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

Where this trial is running

Los Angeles, California

• Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)

Study contacts

• Principal investigator: Matthew Modes, MD, MPP, MS — Cedars-Sinai Medical Center
• Study coordinator: Matthew Modes, MD, MPP, MS

Conditions: Respiratory Failure, Family Support, Physician-Patient Relations, Critical Illness