The Family Perspectives Project Pilot Trial

NCT ID: NCT06039501

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-13
• Study Completion Date: 2026-10-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Family Perspective Program

Intervention Type: BEHAVIORAL

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

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.

• Individuals 18 years old or older.
• Individuals who work as hospital chaplains in the MICU.

• Individuals 18 years old or older.
• Individuals who work as critical care physicians in the MICU (fellow or attending).

• Individuals 18 years old or older.
• Individuals who work as bedside nurses in the MICU.

• Individuals 18 years old or older.
• Individuals work as social workers in the MICU.

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.

o Not proficient in English language. (Rationale: materials and intervention are not adapted in other languages.)

o None

o None

o None

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Palliative Care Research Center

OTHER

Sponsor Role: collaborator

Matthew Modes

OTHER

Sponsor Role: lead

Responsible Party

Matthew Modes

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Matthew Modes, MD, MPP, MS

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew Modes, MD, MPP, MS

Role: CONTACT

matthew.modes@cshs.org

310-423-9017

Facility Contacts

Matthew Modes, MD, MPP, MS

Role: primary

matthew.modes@cshs.org

310-423-9017

Bryan Gonzalez

Role: backup

bryan.gonzalez@cshs.org

310-248-6716

Other Identifiers

Study00002813

Identifier Type: -

Identifier Source: org_study_id