NCT06039501 The Family Perspectives Project Pilot Trial
| NCT ID | NCT06039501 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Matthew Modes |
| Condition | Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-10-13 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2023-10-13 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Matthew Modes, MD, MPP, MS
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT06039501 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06039501 currently recruiting?
Yes, NCT06039501 is actively recruiting participants. Contact the research team at matthew.modes@cshs.org for enrollment information.
Where is the NCT06039501 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06039501 clinical trial?
NCT06039501 is sponsored by Matthew Modes. The principal investigator is Matthew Modes, MD, MPP, MS at Cedars-Sinai Medical Center. The trial plans to enroll 70 participants.