<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/NCT03808350</url>
  </required_header>
  <id_info>
    <org_study_id>1050086</org_study_id>
    <nct_id>NCT03808350</nct_id>
  </id_info>
  <brief_title>Family Procedural Presence</brief_title>
  <official_title>Stress and Engagement Surrounding ICU Procedures Among Patients, Families and Clinicians</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Intermountain Health Care, Inc.</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>
      This study seeks to determine the effect of a quality improvement policy regarding allowing&#xD;
      family members to remain in a patient's room during ICU procedures. The investigators&#xD;
      hypothesized that our change in policy to invite family members to remain during procedures&#xD;
      will improve patient &amp; family engagement and improve long term psychological outcomes after&#xD;
      an ICU admission. The study also seeks to determine if inviting family members to remain in a&#xD;
      patient's room during ICU procedures will not increase clinician stress.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a research study about the effect of a quality improvement policy change regarding&#xD;
      family presence at ICU procedures on family and patient engagement, psychological outcomes&#xD;
      and stress levels in clinicians. In the study, ICU patients, their family members and ICU&#xD;
      clinicians will be surveyed regarding these outcomes, with some surveys obtained prior to a&#xD;
      policy change and a second set during a second time period after policy change. The patients&#xD;
      and family members will be asked survey questions after the procedure and 3 months later.&#xD;
      This study will also evaluate the change in clinician stress related to this policy change,&#xD;
      and clinicians will also answer survey questions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 14, 2016</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Family members and patients will be told the study is being done to understand engagement, but will not be told about the main intervention</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient &amp; Family Member Engagement</measure>
    <time_frame>Time of ICU procedure to 48 hours afterwards</time_frame>
    <description>Engagement, as measured by the collaboRATE survey, administered to patients &amp; family members within 48 hours after a procedure in the ICU</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient &amp; Family Member Stress</measure>
    <time_frame>Time of ICU procedure to 48 hours afterwards</time_frame>
    <description>Perceived stress of patient &amp; family members, assessed within 48 hours after a procedure in the ICU by the Perceived Stress Scale-4 (PSS-4), measured on a scale from 0 to 16 with high numbers indicating increased level of perceived stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinician Stress</measure>
    <time_frame>Time of ICU procedure to 48 hours afterwards</time_frame>
    <description>Clinician stress, as assessed within 48 hours after a procedure in ICU by the visual analog scale, measured on a scale from 1-100 with 100 indicating higher levels of clinician stress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedural Complication Rate</measure>
    <time_frame>Through 7 days after the ICU procedure</time_frame>
    <description>Complications associated with procedures, including infections associated with central lines</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trainee Satisfaction with Procedure Education</measure>
    <time_frame>Time of ICU procedure to 24 hours afterwards</time_frame>
    <description>Satisfaction with the education experience among trainees performing procedures, as assessed within 24 hours by a Likert scale from 1-5 with 5 indicating increased satisfaction with education experience and 1 indicating dissatisfaction with education experience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient &amp; Family Member Anxiety &amp; Depression</measure>
    <time_frame>3 months after ICU procedure</time_frame>
    <description>Anxiety and depression for patients &amp; family members, assessed at 3 months after the ICU procedure by the Hospital Anxiety and Depression Scale (HADS), measured from 0 to 42 with higher scores indicating more likelihood of anxiety or depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient &amp; Family Member PTSD</measure>
    <time_frame>3 months after ICU procedure</time_frame>
    <description>PTSD for patients &amp; family members, assessed at 3 months after the ICU procedure by the Impact of Event Scale Revised (IES-R), measured from 4 to 88 with a score over 33 indicating likely presence of PTSD.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Patient and Family Engagement</condition>
  <arm_group>
    <arm_group_label>Families Excluded From Presence at Procedures</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Families not invited to remain for ICU procedures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Families Invited to Be Present at Procedures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Families invited to remain for ICU procedures</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Families Invited to Be Present at Procedures</intervention_name>
    <description>Family members will be invited (but not required) to remain in the ICU room during procedures, if patients agree</description>
    <arm_group_label>Families Invited to Be Present at Procedures</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo/Control</intervention_name>
    <description>Family members will not be invited to remain in the ICU room</description>
    <arm_group_label>Families Excluded From Presence at Procedures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old or older&#xD;
&#xD;
          -  Able to read &amp; speak English&#xD;
&#xD;
          -  Family member of a patient or a patient that has undergone one of these procedures at&#xD;
             any point during the ICU stay (if the procedure occurs from Sunday at 8 am to Friday&#xD;
             at 12 pm): intubation, central line placement, arterial line placement, bronchoscopy,&#xD;
             thoracentesis, chest tube placement, paracentesis and lumbar puncture&#xD;
&#xD;
          -  Physician (both attending physicians and trainees) and nurses who work in the ICU&#xD;
             during the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients for whom no family member can be identified&#xD;
&#xD;
          -  Non-English speaking individuals&#xD;
&#xD;
          -  Children (&lt;18 years of age)&#xD;
&#xD;
          -  Participants with dementia, psychiatric disorder with psychosis, schizophrenia or&#xD;
             known cognitive dysfunction (established from chart review, report and/or score&#xD;
             greater than or equal to 3 on IQ Code screening).&#xD;
&#xD;
          -  Provider who does not want to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah J Beesley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Health Care, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>April 11, 2022</last_update_submitted>
  <last_update_submitted_qc>April 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Intermountain Health Care, Inc.</investigator_affiliation>
    <investigator_full_name>Sarah Beesley</investigator_full_name>
    <investigator_title>Pulmonologist - Shock Trauma ICU</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Completely deidentified data may potentially be available to other researchers upon request</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03808350
org study id: 1050086
nct id: NCT03808350
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to determine the effect of a quality improvement policy regarding allowing
      family members to remain in a patient's room during ICU procedures. The investigators
      hypothesized that our change in policy to invite family members to remain during procedures
      will improve patient & family engagement and improve long term psychological outcomes after
      an ICU admission. The study also seeks to determine if inviting family members to remain in a
      patient's room during ICU procedures will not increase clinician stress.
This is a research study about the effect of a quality improvement policy change regarding
      family presence at ICU procedures on family and patient engagement, psychological outcomes
      and stress levels in clinicians. In the study, ICU patients, their family members and ICU
      clinicians will be surveyed regarding these outcomes, with some surveys obtained prior to a
      policy change and a second set during a second time period after policy change. The patients
      and family members will be asked survey questions after the procedure and 3 months later.
      This study will also evaluate the change in clinician stress related to this policy change,
      and clinicians will also answer survey questions.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: Single (Participant)
masking description: Family members and patients will be told the study is being done to understand engagement, but will not be told about the main intervention
measure: Patient & Family Member Engagement
time frame: Time of ICU procedure to 48 hours afterwards
description: Engagement, as measured by the collaboRATE survey, administered to patients & family members within 48 hours after a procedure in the ICU
measure: Patient & Family Member Stress
time frame: Time of ICU procedure to 48 hours afterwards
description: Perceived stress of patient & family members, assessed within 48 hours after a procedure in the ICU by the Perceived Stress Scale-4 (PSS-4), measured on a scale from 0 to 16 with high numbers indicating increased level of perceived stress.
measure: Clinician Stress
time frame: Time of ICU procedure to 48 hours afterwards
description: Clinician stress, as assessed within 48 hours after a procedure in ICU by the visual analog scale, measured on a scale from 1-100 with 100 indicating higher levels of clinician stress.
measure: Procedural Complication Rate
time frame: Through 7 days after the ICU procedure
description: Complications associated with procedures, including infections associated with central lines
measure: Trainee Satisfaction with Procedure Education
time frame: Time of ICU procedure to 24 hours afterwards
description: Satisfaction with the education experience among trainees performing procedures, as assessed within 24 hours by a Likert scale from 1-5 with 5 indicating increased satisfaction with education experience and 1 indicating dissatisfaction with education experience.
measure: Patient & Family Member Anxiety & Depression
time frame: 3 months after ICU procedure
description: Anxiety and depression for patients & family members, assessed at 3 months after the ICU procedure by the Hospital Anxiety and Depression Scale (HADS), measured from 0 to 42 with higher scores indicating more likelihood of anxiety or depression.
measure: Patient & Family Member PTSD
time frame: 3 months after ICU procedure
description: PTSD for patients & family members, assessed at 3 months after the ICU procedure by the Impact of Event Scale Revised (IES-R), measured from 4 to 88 with a score over 33 indicating likely presence of PTSD.
arm group label: Families Excluded From Presence at Procedures
arm group type: Placebo Comparator
description: Families not invited to remain for ICU procedures
arm group label: Families Invited to Be Present at Procedures
arm group type: Active Comparator
description: Families invited to remain for ICU procedures
intervention type: Procedure
intervention name: Families Invited to Be Present at Procedures
description: Family members will be invited (but not required) to remain in the ICU room during procedures, if patients agree
arm group label: Families Invited to Be Present at Procedures
intervention type: Other
intervention name: Placebo/Control
description: Family members will not be invited to remain in the ICU room
arm group label: Families Excluded From Presence at Procedures
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sarah J Beesley, MD
role: Principal Investigator
affiliation: Intermountain Health Care, Inc.
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Intermountain Health Care, Inc.
investigator full name: Sarah Beesley
investigator title: Pulmonologist - Shock Trauma ICU
sharing ipd: Undecided
ipd description: Completely deidentified data may potentially be available to other researchers upon request