[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06039501":3,"trial-entities:NCT06039501":113,"trial-summary:NCT06039501":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":13,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":35,"secondary_outcomes":40,"sex":55,"minimum_age":56,"maximum_age":16,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":83,"locations":86,"central_contacts":106,"overall_officials":108,"references":111,"see_also_links":112},"NCT06039501","Study00002813","The Family Perspectives Project Pilot Trial","RECRUITING","2026-10","2025-06","2025-06-15","2023-10-13","Matthew Modes","OTHER",false,"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.\n\nThe 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).\n\nStudy 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).",null,[18,19,20,21],"Respiratory Failure","Family Support","Physician-Patient Relations","Critical Illness",[],"INTERVENTIONAL",[25],"NA",{"count":27,"type":28},70,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"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\u002For 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.",[32],[36],{"measure":37,"description":38,"timeFrame":39},"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",[41,44,47,50,53],{"measure":42,"description":43,"timeFrame":39},"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.",{"measure":45,"description":46,"timeFrame":39},"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.",{"measure":48,"description":49,"timeFrame":39},"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.",{"measure":51,"description":52,"timeFrame":39},"ICU support counselor perception of feasibility of implementing the program","Mean score on the validated 4-item Feasibility of Intervention Measure",{"measure":54,"description":52,"timeFrame":39},"ICU care team member perception of feasibility of implementing the program","ALL","18 Years",true,{"inclusion":59,"exclusion":71,"raw_text":82},[60,61,62,63,64,65,66,60,67,60,68,60,69,60,70],"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).","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 who work as hospital chaplains in the MICU.","Individuals who work as critical care physicians in the MICU (fellow or attending).","Individuals who work as bedside nurses in the MICU.","Individuals work as social workers in the MICU.",[72,73,74,75,76,77,78,79,80,81],"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.","None","Inclusion Criteria:\n\n* Patient inclusion criteria:\n\n  * Individuals 18 years old or older.\n  * Individuals admitted to the medical intensive care unit (MICU) at Cedars-Sinai Medical Center.\n  * Individuals with acute respiratory failure, defined as \\>24 hours of invasive mechanical ventilation.\n  * Individuals who received invasive mechanical ventilation within 24 hours of admission to the MICU.\n  * Individuals expected to need invasive mechanical ventilation for \\>72 hours total, as determined by the patient's intensivist physician (fellow or attending).\n* Primary surrogate decision maker inclusion criteria:\n\n  o Individuals 18 years old or older.\n  * Individual who self-identifies as the most responsible for making decisions for the enrolled patient (can be either family member or close friend).\n  * Proficiency in English language.\n* ICU support counselor inclusion criteria:\n\n  * Individuals 18 years old or older.\n  * Individuals who work as hospital chaplains in the MICU.\n* Physician (intensivist) inclusion criteria:\n\n  * Individuals 18 years old or older.\n  * Individuals who work as critical care physicians in the MICU (fellow or attending).\n* Nurse inclusion criteria:\n\n  * Individuals 18 years old or older.\n  * Individuals who work as bedside nurses in the MICU.\n* Social worker inclusion criteria:\n\n  * Individuals 18 years old or older.\n  * Individuals work as social workers in the MICU.\n\nExclusion Criteria:\n\n* Patient exclusion criteria:\n\n  o Any records flagged \"break the glass\" or \"research opt out.\"\n\n  o Individuals expected to die within 24 hours of potential enrollment, as determined by the patient's intensivist physician (fellow or attending).\n\n  o Individuals on comfort care protocol or with clear preference for comfort care, as determined by the patient's intensivist physician (fellow or attending).\n  * Individuals who are chronically dependent on a ventilator prior to admission.\n  * Individuals with acute on chronic neuromuscular disease-related respiratory failure (e.g., Guillain Barre, Muscular Dystrophy, Myasthenia Gravis, etc.).\n  * Individuals imminently awaiting organ transplant, as determined by the patient's intensivist physician (fellow or attending).\n  * Individuals with decisional capacity, as determined by the patient's intensivist physician (fellow or attending).\n  * Individuals who are unrepresented (i.e., patient has no surrogate decision maker).\n  * Individuals whose potential enrolled family member (primary surrogate decision maker) is not proficient in English.\n  * Individuals whose attending physician is the PI on this study at the time of potential enrollment.\n  * Individuals who are cared for by intensivist physicians (fellow and attending) who do not agree to participate in the study.\n  * 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.\n* Primary surrogate decision maker exclusion criteria:\n\n  o Not proficient in English language. (Rationale: materials and intervention are not adapted in other languages.)\n* ICU support counselor exclusion criteria:\n\n  o None\n* Physician (intensivist) exclusion criteria:\n\n  o None\n* Nurse exclusion criteria:\n\n  o None\n* Social worker exclusion criteria:\n\n  * None",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"status":7,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":103},"Cedars-Sinai Medical Center","Los Angeles","California","90048","United States",[94,99],{"name":95,"role":96,"phone":97,"email":98},"Matthew Modes, MD, MPP, MS","CONTACT","310-423-9017","matthew.modes@cshs.org",{"name":100,"role":96,"phone":101,"email":102},"Bryan Gonzalez","310-248-6716","bryan.gonzalez@cshs.org",{"lat":104,"lon":105},34.05223,-118.24368,[107],{"name":95,"role":96,"phone":97,"email":98},[109],{"name":95,"affiliation":88,"role":110},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":114,"biomarkers":115},[21,18],[],{"nct_id":4,"found":57,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is a pilot randomized trial, meaning participants are assigned by chance to different groups, and it plans to include 70 participants. The study is interventional, testing a behavioral program.","completed","The Family Perspectives Project Pilot Trial for Respiratory Failure","This study, called The Family Perspectives Project Pilot Trial, is testing a program to improve how families of critically ill patients communicate with doctors and nurses, and to offer emotional support. The program involves regular meetings between families and a trained ICU (Intensive Care Unit) support counselor. We want to see if this program can be successfully put into practice, if families find it helpful, and what their experiences are like. You might be able to join if you are an adult patient (18 or older) at Cedars-Sinai Medical Center's MICU (Medical Intensive Care Unit) with acute respiratory failure (meaning you've been on a breathing machine for over 24 hours). The study aims to enroll 70 patients and their primary family decision-makers. The current status of the study is unclear.","The feasibility of the program will be measured at 6 months.",130,"You would complete questionnaires, have meetings with ICU support counselors and care teams, and potentially have optional audio recordings of meetings and interviews.","Not stated in the trial record.",[],"v2"]