The Family Perspectives Project Pilot 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).

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Respiratory Failure; Physician-Patient Relations; Family Support
• Intervention / Treatment: Behavioral: Family Perspective Program

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Modes, MD, MPP, MS; Phone Number: 310-423-9017; Email: matthew.modes@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Matthew Modes, MD, MPP, MS; Phone Number: 310-423-9017; Email: matthew.modes@cshs.org
      • Contact: Bryan Gonzalez; Phone Number: 310-248-6716; Email: bryan.gonzalez@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Behavioral: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of implementing the program for families of patients with acute respiratory failure.	The proportion of enrolled primary surrogate decision makers randomized to the program who receive all program components. The study will be declared "feasible" if at least 70% of primary surrogate decision makers receive all program components (meeting with ICU support counselors, ICU support counselors generating standardized reports, reports being reviewed by ICU care team members prior to meeting with families).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of collecting data from families	The proportion of enrolled primary surrogate decision makers completing all questionnaires (enrollment, after meetings with ICU care team, 1-month post-enrollment, and 6 months post-enrollment) in each arm.	6 months
Feasibility of collecting data from ICU support counselors	The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU support counselors.	6 months
Feasibility of collecting data from ICU care team members	The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU care team members (physicians, nurses, social workers) in each arm.	6 months
ICU support counselor perception of feasibility of implementing the program	Mean score on the validated 4-item Feasibility of Intervention Measure	6 months
ICU care team member perception of feasibility of implementing the program	Mean score on the validated 4-item Feasibility of Intervention Measure	6 months

Collaborators and Investigators

• Sponsor: Matthew Modes
• Collaborators: National Palliative Care Research Center
• Investigators: Principal Investigator: Matthew Modes, MD, MPP, MS, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: September 9, 2023
• First Submitted That Met QC Criteria: September 9, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Critical Illness
• Other Study ID Numbers: Study00002813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No