search
Back to results

The Family Perspectives Project Pilot Trial

Primary Purpose

Respiratory Failure, Family Support, Physician-Patient Relations

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family Perspective Program
Sponsored by
Matthew Modes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Family Perspective Program

    Usual Care

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.
    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.
    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.
    ICU support counselor perception of feasibility of implementing the program
    Mean score on the validated 4-item Feasibility of Intervention Measure
    ICU care team member perception of feasibility of implementing the program
    Mean score on the validated 4-item Feasibility of Intervention Measure

    Full Information

    First Posted
    September 9, 2023
    Last Updated
    September 9, 2023
    Sponsor
    Matthew Modes
    Collaborators
    Icahn School of Medicine at Mount Sinai
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06039501
    Brief Title
    The Family Perspectives Project Pilot Trial
    Official Title
    The Family Perspectives Project Pilot Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Matthew Modes
    Collaborators
    Icahn School of Medicine at Mount Sinai

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Respiratory Failure, Family Support, Physician-Patient Relations, Critical Illness

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Family Perspective Program
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Family Perspective Program
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Feasibility of implementing the program for families of patients with acute respiratory failure.
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Feasibility of collecting data from families
    Description
    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
    Title
    Feasibility of collecting data from ICU support counselors
    Description
    The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU support counselors.
    Time Frame
    6 months
    Title
    Feasibility of collecting data from ICU care team members
    Description
    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
    Title
    ICU support counselor perception of feasibility of implementing the program
    Description
    Mean score on the validated 4-item Feasibility of Intervention Measure
    Time Frame
    6 months
    Title
    ICU care team member perception of feasibility of implementing the program
    Description
    Mean score on the validated 4-item Feasibility of Intervention Measure
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Matthew Modes, MD, MPP, MS
    Phone
    310-423-9017
    Email
    matthew.modes@cshs.org

    12. IPD Sharing Statement

    Learn more about this trial

    The Family Perspectives Project Pilot Trial

    We'll reach out to this number within 24 hrs