Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Location status: Recruiting
Location contact
Bryan Gonzalez
CONTACT
Matthew Modes, MD, MPP, MS
CONTACT
NCT Number: NCT06039501
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Los Angeles, California, 90048, United States
Location status: Recruiting
Bryan Gonzalez
CONTACT
Matthew Modes, MD, MPP, MS
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
o Individuals 18 years old or older.
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).
o Not proficient in English language. (Rationale: materials and intervention are not adapted in other languages.)
o None
o None
o None
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.
Time frame: 6 months
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).
Time frame: 6 months
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.
Time frame: 6 months
The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU support counselors.
Time frame: 6 months
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.
Time frame: 6 months
Mean score on the validated 4-item Feasibility of Intervention Measure
Time frame: 6 months
Mean score on the validated 4-item Feasibility of Intervention Measure
Contact information is provided by the study sponsor or research team.
Matthew Modes
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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