Recruiting

Observational Study

Sponsor:

Matthew Modes

Code:

NCT06039501

Conditions

Respiratory Failure

Family Support

Physician-Patient Relations

Critical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Family Perspective Program

Study Details

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 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

Respiratory Failure

Family Support

Physician-Patient Relations

Critical Illness

Study ID

NCT06039501

Start date

Oct 13, 2023

Status verified date

Jun, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Family Perspective Program

Families of critically ill patients will receive a program designed to enhance equitable communication and emotional support.

Questionnaires will be completed by primary surrogate decision makers, ICU support counselors, and ICU care team members (physicians, nurses, social workers). Meetings between families and ICU support counselors will be audio recorded (optional). Meetings between families and ICU care teams will be audio recorded (optional). Interviews with participants will be completed (optional).

no intervention: Usual Care

Families of critically ill patients will receive usual care, which involves regular and routine meetings between families and the ICU care team.

Questionnaires will be completed by primary surrogate decision makers and ICU care team members (physicians, nurses, social workers). Meetings between families and ICU care teams will be audio recorded (optional). Interviews with participants will be completed (optional).

Interventions

Family Perspective Program

The program involves regular meetings between families and an ICU support counselor. The ICU support counselor is a trained expert in providing culturally competent emotional and/or spiritual support. The ICU support counselor will support families and also learn and summarize family perspectives in a standardized report. ICU care team members will be prompted to perspective take as they review reports prior to regular routine meetings between families and the ICU care team.

Primary outcome measure

  • Feasibility of implementing the program for families of patients with acute respiratory failure. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Matthew Modes, MD, MPP, MS

310-423-9017matthew.modes@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

More Information

Sponsor

Matthew Modes

Last update posted

Jun 15, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Matthew Modes on 2025-06-15.