xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06039501</url>
    </required_header>
    <id_info>
      <org_study_id>Study00002813</org_study_id>
      <nct_id>NCT06039501</nct_id>
    </id_info>
    <brief_title>The Family Perspectives Project Pilot Trial</brief_title>
    <official_title>The Family Perspectives Project Pilot Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Matthew Modes</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Icahn School of Medicine at Mount Sinai</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cedars-Sinai Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of the study is to conduct a pilot randomized trial of a program designed to&#xD;
        enhance equitable communication and emotional support for families of critically ill patients&#xD;
        in order to determine feasibility, acceptability, and participant experience with the&#xD;
        program.&#xD;
  &#xD;
        The primary study procedures include: chart abstraction, questionnaires, meetings with ICU&#xD;
        support counselors, meetings with ICU physicians and care team, audio recordings of these&#xD;
        meetings (optional), and interviews with study participants (optional).&#xD;
  &#xD;
        Study participants include: 70 critically ill patients with acute respiratory failure&#xD;
        (enrolled with the consent of their Legally Authorized Representative) and their primary&#xD;
        surrogate decision makers as well as ICU support counselors and ICU care teams (physicians,&#xD;
        nurses, social workers).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of implementing the program for families of patients with acute respiratory failure.</measure>
      <time_frame>6 months</time_frame>
      <description>The proportion of enrolled primary surrogate decision makers randomized to the program who receive all program components. The study will be declared &quot;feasible&quot; 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).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Feasibility of collecting data from families</measure>
      <time_frame>6 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility of collecting data from ICU support counselors</measure>
      <time_frame>6 months</time_frame>
      <description>The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU support counselors.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility of collecting data from ICU care team members</measure>
      <time_frame>6 months</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU support counselor perception of feasibility of implementing the program</measure>
      <time_frame>6 months</time_frame>
      <description>Mean score on the validated 4-item Feasibility of Intervention Measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ICU care team member perception of feasibility of implementing the program</measure>
      <time_frame>6 months</time_frame>
      <description>Mean score on the validated 4-item Feasibility of Intervention Measure</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Respiratory Failure</condition>
    <condition>Family Support</condition>
    <condition>Physician-Patient Relations</condition>
    <condition>Critical Illness</condition>
    <arm_group>
      <arm_group_label>Family Perspective Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Families of critically ill patients will receive a program designed to enhance equitable communication and emotional support.&#xD;
  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).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Families of critically ill patients will receive usual care, which involves regular and routine meetings between families and the ICU care team.&#xD;
  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).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Family Perspective Program</intervention_name>
      <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.</description>
      <arm_group_label>Family Perspective Program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient inclusion criteria:&#xD;
  &#xD;
                 -  Individuals 18 years old or older.&#xD;
  &#xD;
                 -  Individuals admitted to the medical intensive care unit (MICU) at Cedars-Sinai&#xD;
                    Medical Center.&#xD;
  &#xD;
                 -  Individuals with acute respiratory failure, defined as &gt;24 hours of invasive&#xD;
                    mechanical ventilation.&#xD;
  &#xD;
                 -  Individuals who received invasive mechanical ventilation within 24 hours of&#xD;
                    admission to the MICU.&#xD;
  &#xD;
                 -  Individuals expected to need invasive mechanical ventilation for &gt;72 hours total,&#xD;
                    as determined by the patient's intensivist physician (fellow or attending).&#xD;
  &#xD;
            -  Primary surrogate decision maker inclusion criteria:&#xD;
  &#xD;
               o Individuals 18 years old or older.&#xD;
  &#xD;
                 -  Individual who self-identifies as the most responsible for making decisions for&#xD;
                    the enrolled patient (can be either family member or close friend).&#xD;
  &#xD;
                 -  Proficiency in English language.&#xD;
  &#xD;
            -  ICU support counselor inclusion criteria:&#xD;
  &#xD;
                 -  Individuals 18 years old or older.&#xD;
  &#xD;
                 -  Individuals who work as hospital chaplains in the MICU.&#xD;
  &#xD;
            -  Physician (intensivist) inclusion criteria:&#xD;
  &#xD;
                 -  Individuals 18 years old or older.&#xD;
  &#xD;
                 -  Individuals who work as critical care physicians in the MICU (fellow or&#xD;
                    attending).&#xD;
  &#xD;
            -  Nurse inclusion criteria:&#xD;
  &#xD;
                 -  Individuals 18 years old or older.&#xD;
  &#xD;
                 -  Individuals who work as bedside nurses in the MICU.&#xD;
  &#xD;
            -  Social worker inclusion criteria:&#xD;
  &#xD;
                 -  Individuals 18 years old or older.&#xD;
  &#xD;
                 -  Individuals work as social workers in the MICU.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patient exclusion criteria:&#xD;
  &#xD;
               o Any records flagged &quot;break the glass&quot; or &quot;research opt out.&quot;&#xD;
  &#xD;
               o Individuals expected to die within 24 hours of potential enrollment, as determined&#xD;
               by the patient's intensivist physician (fellow or attending).&#xD;
  &#xD;
               o Individuals on comfort care protocol or with clear preference for comfort care, as&#xD;
               determined by the patient's intensivist physician (fellow or attending).&#xD;
  &#xD;
                 -  Individuals who are chronically dependent on a ventilator prior to admission.&#xD;
  &#xD;
                 -  Individuals with acute on chronic neuromuscular disease-related respiratory&#xD;
                    failure (e.g., Guillain Barre, Muscular Dystrophy, Myasthenia Gravis, etc.).&#xD;
  &#xD;
                 -  Individuals imminently awaiting organ transplant, as determined by the patient's&#xD;
                    intensivist physician (fellow or attending).&#xD;
  &#xD;
                 -  Individuals with decisional capacity, as determined by the patient's intensivist&#xD;
                    physician (fellow or attending).&#xD;
  &#xD;
                 -  Individuals who are unrepresented (i.e., patient has no surrogate decision&#xD;
                    maker).&#xD;
  &#xD;
                 -  Individuals whose potential enrolled family member (primary surrogate decision&#xD;
                    maker) is not proficient in English.&#xD;
  &#xD;
                 -  Individuals whose attending physician is the PI on this study at the time of&#xD;
                    potential enrollment.&#xD;
  &#xD;
                 -  Individuals who are cared for by intensivist physicians (fellow and attending)&#xD;
                    who do not agree to participate in the study.&#xD;
  &#xD;
                 -  Individuals who have a pre-existing relationship with a hospital chaplain who&#xD;
                    does not agree to participate in the study, as determined by that chaplain.&#xD;
  &#xD;
            -  Primary surrogate decision maker exclusion criteria:&#xD;
  &#xD;
               o Not proficient in English language. (Rationale: materials and intervention are not&#xD;
               adapted in other languages.)&#xD;
  &#xD;
            -  ICU support counselor exclusion criteria:&#xD;
  &#xD;
               o None&#xD;
  &#xD;
            -  Physician (intensivist) exclusion criteria:&#xD;
  &#xD;
               o None&#xD;
  &#xD;
            -  Nurse exclusion criteria:&#xD;
  &#xD;
               o None&#xD;
  &#xD;
            -  Social worker exclusion criteria:&#xD;
  &#xD;
                 -  None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Matthew Modes, MD, MPP, MS</last_name>
      <phone>310-423-9017</phone>
      <email>matthew.modes@cshs.org</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 9, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
      <investigator_full_name>Matthew Modes</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Insufficiency</mesh_term>
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06039501
  org study id: Study00002813
  nct id: NCT06039501
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Feasibility of implementing the program for families of patients with acute respiratory failure.
  time frame: 6 months
  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).
  measure: Feasibility of collecting data from families
  time frame: 6 months
  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.
  measure: Feasibility of collecting data from ICU support counselors
  time frame: 6 months
  description: The proportion of questionnaires (enrollment, after each meeting with a primary surrogate decision maker) completed by ICU support counselors.
  measure: Feasibility of collecting data from ICU care team members
  time frame: 6 months
  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.
  measure: ICU support counselor perception of feasibility of implementing the program
  time frame: 6 months
  description: Mean score on the validated 4-item Feasibility of Intervention Measure
  measure: ICU care team member perception of feasibility of implementing the program
  time frame: 6 months
  description: Mean score on the validated 4-item Feasibility of Intervention Measure
  arm group label: Family Perspective Program
  arm group type: Experimental
  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 group label: Usual Care
  arm group type: No Intervention
  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: Family Perspective Program
  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.
  arm group label: Family Perspective Program
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Matthew Modes, MD, MPP, MS
  phone: 310-423-9017
  email: matthew.modes@cshs.org
  responsible party type: Sponsor-Investigator
  investigator affiliation: Cedars-Sinai Medical Center
  investigator full name: Matthew Modes
  investigator title: Assistant Professor
  mesh term: Respiratory Insufficiency
  mesh term: Critical Illness