<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/NCT03833375</url>
  </required_header>
  <id_info>
    <org_study_id>H00004724/H00015764</org_study_id>
    <secondary_id>5K23HD080971</secondary_id>
    <nct_id>NCT03833375</nct_id>
  </id_info>
  <brief_title>Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients</brief_title>
  <official_title>Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Massachusetts, Worcester</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>
      Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral&#xD;
      hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and&#xD;
      disability in adults in the U.S. Due to concerns for a poor long-term quality of life,&#xD;
      withdrawal of mechanical ventilation and supportive medical care with transition to comfort&#xD;
      care is the most common cause of death in SABI, but occurs at a highly variable rate (for&#xD;
      example in Traumatic Brain Injury (TBI) 45-89%). Decision aids (DAs) are shared&#xD;
      decision-making tools which have been successfully implemented and validated for many other&#xD;
      diseases to assist difficult decision making. The investigators have developed a pilot DA for&#xD;
      goals-of-care decisions for surrogates of SABI patients. This was developed through&#xD;
      qualitative research using semi-structured interviews in surrogate decision makers of TBI&#xD;
      patients and physicians. The investigators now propose to pilot-test a DA for surrogates of&#xD;
      SABI patients in a feasibility trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral&#xD;
      hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and&#xD;
      disability in adults in the U.S, accounting for more than 200,000 of the acute brain&#xD;
      injury-related deaths in the U.S. annually. Patients with SABI are critically ill and most&#xD;
      commonly require mechanical ventilation and supportive medical care with artificial nutrition&#xD;
      to ensure survival. However, due to concerns for a poor long-term quality of life, withdrawal&#xD;
      of mechanical ventilation and supportive medical care with transition to comfort care is by&#xD;
      far the most common cause of death in SABI but occurs at a highly variable rate (for example&#xD;
      in TBI 45-90%) at different trauma centers. Shared decision making is a collaborative process&#xD;
      that enhances patients' and surrogates' understanding about prognosis, encourages them to&#xD;
      actively weigh the risks and benefits of a treatment, and to match them to patient&#xD;
      preferences, thereby decreasing decisional conflict and improving decision quality and health&#xD;
      related outcomes. Decision aids (DAs) are shared decision-making tools which have been&#xD;
      successfully implemented and validated for many other diseases to assist difficult decision&#xD;
      making. No DA currently exists for goals-of-care decisions in SABI. Such a patient- and&#xD;
      family-centered DA has the potential to improve decision-making for SABI patients by ensuring&#xD;
      proxies receive consistent, evidence-based prognostication while also addressing patients'&#xD;
      preferences and values. The investigators have developed a pilot DA for goals of care&#xD;
      decisions by surrogates of SABI patients using qualitative research using semi-structured&#xD;
      interviews in surrogate decision makers of TBI patients and physicians, followed by an&#xD;
      iterative feedback process with feedback by surrogates, physicians, and other stakeholders&#xD;
      (ICU nurses). The investigators now propose to pilot-test a DA for surrogates of SABI&#xD;
      patients in a feasibility trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 11, 2018</start_date>
  <completion_date type="Actual">March 9, 2020</completion_date>
  <primary_completion_date type="Actual">December 2, 2019</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>
    <intervention_model_description>Open-label, usual-care-controlled feasibility trial comparing decision aid intervention prior to the goals-of-care family meeting to standard of care (no intervention prior to family meeting).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment</measure>
    <time_frame>From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.</time_frame>
    <description>Consent rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Participation</measure>
    <time_frame>1-36 hours after family meeting</time_frame>
    <description>Proportion of participants who read decision aid and completed worksheet</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention</measure>
    <time_frame>3 months</time_frame>
    <description>Number of participants who complete follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinician-surrogate concordance scale score</measure>
    <time_frame>Baseline and 1-36 hours after family meeting</time_frame>
    <description>measures prognostic concordance between ICU clinicians and surrogates. Participants from both groups will independently estimate numerically a SABI patient's 6-month survival and return to independence. Concordance is calculated as the absolute value of the difference in prognosis between the surrogate and the clinician, and, therefore, can range from 0 (no concordance) to 100 (full concordance).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decision Self-Efficacy Scale</measure>
    <time_frame>1-36 hours after family meeting</time_frame>
    <description>is a validated scale that measures self-confidence in making an informed choice using a 5-point Likert scale ranging from 0 (not at all confident) to 4 (very confident).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decisional Conflict Scale</measure>
    <time_frame>1-36 hours after family meeting</time_frame>
    <description>is a validated scale that measures the personal perception of choosing an option and factors contributing to choice uncertainty. It is a 16-item, 5-item Likert scale with sub-scores for uncertainty, feeling informed, values clarity, decision support and effective decision-making. It ranges from 0 (strongly agree) to 4 (strongly disagree).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AIS/Intracerebral Hemorrhage (ICH)/Traumatic Brain Injury (TBI) knowledge test</measure>
    <time_frame>Baseline and 1-36 hours after family meeting</time_frame>
    <description>Medical knowledge about the goals-of-care decision in SABI will be assessed using the medical knowledge test, which was adapted to 17 questions about goals-of-care and SABI, all of which are addressed in the decision aid. The % correct will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>Baseline,1-36 hours after family meeting, and 3-months</time_frame>
    <description>is a 14-item, two-domain (depression, anxiety) instrument with reliability and validity among ICU surrogates, which is recommended by consensus guidelines for the prospective measurement of psychological distress among ICU surrogates. Each of the 14 questions are scored between 0 (not at all) and 3 (most of the time), and summed up for a total HADS score, which ranges from 0 to 42, with higher scores indicating worse symptoms. Total HADS 0-7 =normal, 8-10 borderline abnormal, 11-21=abnormal, indicating high anxiety and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Events Scale-revised</measure>
    <time_frame>Baseline,1-36 hours after family meeting, and 3-months</time_frame>
    <description>is a is a validated 15-item instrument, measuring post-traumatic stress disorder (PTSD) symptoms. Total score is the sum of all questions and ranges from 0 to 88, with higher scores indicating worse PTSD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Communications Scale</measure>
    <time_frame>1-36 hours after family meeting</time_frame>
    <description>is a is a validated 17-item patient-centered instrument widely used in the ICU to assess surrogates' satisfaction of clinician communication about treatments and understanding treatment decisions. It ranges between 0 (poor) to 10 (absolutely perfect). Total score is the sum of all questions and ranges from 0 to 100, with higher scores indicating better communication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Perceived Centeredness of Care Scale</measure>
    <time_frame>1-36 hours after family meeting</time_frame>
    <description>is a is a validated 14-item, 4-point Likert scale based test. Its version adapted to surrogates has shown responsiveness in a recent trial of a nurse-driven communication intervention for surrogates in the ICU. It ranges between 1 (very well) to 4 (not at all), and median score is calculated from all questions. Median scores range from 1 to 4, with lower scores indicating more patient- and family-centered care.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative duration of the goals-of-care family meetings</measure>
    <time_frame>1-36 hours after family meeting</time_frame>
    <description>Investigators will track the duration of each goals-of-care meeting. At the patient's ICU discharge, investigators will sum up the cumulative duration of all goals-of-care meetings [minutes].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total number of goals-of-care family meetings</measure>
    <time_frame>1-36 hours after family meeting</time_frame>
    <description>Investigators will sum up the total number of goals-of-care meetings at the patient's ICU discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's survival status</measure>
    <time_frame>3-months after goals of care decision</time_frame>
    <description>Investigators will record whether the patient is dead or alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's Glasgow Outcome Scale</measure>
    <time_frame>3-months after goals of care decision</time_frame>
    <description>The Glasgow Outcome Score (GOS) is a validated 5-point scale given to traumatic brain injury or other brain injury patients at some point in their recovery. It is a very general assessment of the general functioning of the person who suffered a head injury or other neurological injury. It ranges from 1-5 (higher scores indicating better functional status): 1=death, 2=Vegetative State, 3=Severely Disabled (conscious but the patient requires others for daily support due to disability), 4=Moderately Disabled (the patient is independent but disabled), 5=Good Recovery (the patient has resumed most normal activities but may have minor residual problems).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's modified Rankin Scale</measure>
    <time_frame>3-months after goals of care decision</time_frame>
    <description>is a validated scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It ranges from 0 (no symptoms at all) to 6 (death).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surrogate Decision Regret Scale</measure>
    <time_frame>3-months after goals of care decision</time_frame>
    <description>is a validated scale that measures distress or remorse after a health care decision with high internal consistency. It asks 5 questions and provides a 5-point Likert scale. It ranges between 1 (strongly agree) to 5 (strongly disagree).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Ischemic Stroke</condition>
  <condition>Intracerebral Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Usual Care (n=20)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control: general information about TBI from Center for Disease Control (CDC)/about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Decision Aid (n=20)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paper Decision aid (share decision making tool) with worksheet for surrogates</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision Aid</intervention_name>
    <description>Shared-decision making tool</description>
    <arm_group_label>Decision Aid (n=20)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age; no upper age limit&#xD;
&#xD;
          -  Documented health care proxy or legal next of kin of admitted SABI patient with&#xD;
             traumatic brain injury, intracerebral hemorrhage or acute ischemic stroke.&#xD;
&#xD;
          -  ≥3 days after insult (&quot;stabilization period&quot;); clinical team may ask study team to&#xD;
             wait longer if clinically indicated&#xD;
&#xD;
          -  SABI patient remains &quot;critically ill&quot; after 3 days defined as: either intubated and&#xD;
             mechanically ventilated, or unable to swallow, needing feeding tube beyond hospital&#xD;
             discharge (even if not intubated)&#xD;
&#xD;
          -  Surrogate is physically present in ICU to receive decision aid and participate in&#xD;
             planned family meeting in person (not over phone)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Devastating SABI near death&#xD;
&#xD;
          -  Patient will be extubated and pass swallow evaluation (as deemed by clinical team)&#xD;
&#xD;
          -  Surrogate is non-English speaking and no interpreter available to translate decision&#xD;
             aid (no available validated, translated decision aid version)&#xD;
&#xD;
          -  Surrogate is illiterate&#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>Dr. Susanne Muehlschlegel, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Massachusetts, Worcester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Medical School/Yale New Haven Medical Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Medical School</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Quinn T, Moskowitz J, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. What Families Need and Physicians Deliver: Contrasting Communication Preferences Between Surrogate Decision-Makers and Physicians During Outcome Prognostication in Critically Ill TBI Patients. Neurocrit Care. 2017 Oct;27(2):154-162. doi: 10.1007/s12028-017-0427-2.</citation>
    <PMID>28685395</PMID>
  </reference>
  <reference>
    <citation>Moskowitz J, Quinn T, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. Should We Use the IMPACT-Model for the Outcome Prognostication of TBI Patients? A Qualitative Study Assessing Physicians' Perceptions. MDM Policy Pract. 2018 Mar 26;3(1):2381468318757987. doi: 10.1177/2381468318757987. eCollection 2018 Jan-Jun.</citation>
    <PMID>30288437</PMID>
  </reference>
  <reference>
    <citation>Muehlschlegel S, Shutter L, Col N, Goldberg R. Decision Aids and Shared Decision-Making in Neurocritical Care: An Unmet Need in Our NeuroICUs. Neurocrit Care. 2015 Aug;23(1):127-30. doi: 10.1007/s12028-014-0097-2.</citation>
    <PMID>25561435</PMID>
  </reference>
  <reference>
    <citation>Cai X, Robinson J, Muehlschlegel S, White DB, Holloway RG, Sheth KN, Fraenkel L, Hwang DY. Patient Preferences and Surrogate Decision Making in Neuroscience Intensive Care Units. Neurocrit Care. 2015 Aug;23(1):131-41. doi: 10.1007/s12028-015-0149-2.</citation>
    <PMID>25990137</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>June 16, 2020</last_update_submitted>
  <last_update_submitted_qc>June 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
    <investigator_full_name>Susanne Muehlschlegel</investigator_full_name>
    <investigator_title>Associate Professor of Neurocritical Care</investigator_title>
  </responsible_party>
  <keyword>TBI</keyword>
  <keyword>stroke</keyword>
  <keyword>ICH</keyword>
  <keyword>AIS</keyword>
  <keyword>decision aid</keyword>
  <keyword>shared decision making</keyword>
  <keyword>neurocritical care</keyword>
  <keyword>SABI</keyword>
  <keyword>surrogate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Ischemic Stroke</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Cerebral Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03833375
org study id: H00004724/H00015764
secondary id: 5K23HD080971
nct id: NCT03833375
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral
      hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and
      disability in adults in the U.S. Due to concerns for a poor long-term quality of life,
      withdrawal of mechanical ventilation and supportive medical care with transition to comfort
      care is the most common cause of death in SABI, but occurs at a highly variable rate (for
      example in Traumatic Brain Injury (TBI) 45-89%). Decision aids (DAs) are shared
      decision-making tools which have been successfully implemented and validated for many other
      diseases to assist difficult decision making. The investigators have developed a pilot DA for
      goals-of-care decisions for surrogates of SABI patients. This was developed through
      qualitative research using semi-structured interviews in surrogate decision makers of TBI
      patients and physicians. The investigators now propose to pilot-test a DA for surrogates of
      SABI patients in a feasibility trial.
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral
      hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and
      disability in adults in the U.S, accounting for more than 200,000 of the acute brain
      injury-related deaths in the U.S. annually. Patients with SABI are critically ill and most
      commonly require mechanical ventilation and supportive medical care with artificial nutrition
      to ensure survival. However, due to concerns for a poor long-term quality of life, withdrawal
      of mechanical ventilation and supportive medical care with transition to comfort care is by
      far the most common cause of death in SABI but occurs at a highly variable rate (for example
      in TBI 45-90%) at different trauma centers. Shared decision making is a collaborative process
      that enhances patients' and surrogates' understanding about prognosis, encourages them to
      actively weigh the risks and benefits of a treatment, and to match them to patient
      preferences, thereby decreasing decisional conflict and improving decision quality and health
      related outcomes. Decision aids (DAs) are shared decision-making tools which have been
      successfully implemented and validated for many other diseases to assist difficult decision
      making. No DA currently exists for goals-of-care decisions in SABI. Such a patient- and
      family-centered DA has the potential to improve decision-making for SABI patients by ensuring
      proxies receive consistent, evidence-based prognostication while also addressing patients'
      preferences and values. The investigators have developed a pilot DA for goals of care
      decisions by surrogates of SABI patients using qualitative research using semi-structured
      interviews in surrogate decision makers of TBI patients and physicians, followed by an
      iterative feedback process with feedback by surrogates, physicians, and other stakeholders
      (ICU nurses). The investigators now propose to pilot-test a DA for surrogates of SABI
      patients in a feasibility trial.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open-label, usual-care-controlled feasibility trial comparing decision aid intervention prior to the goals-of-care family meeting to standard of care (no intervention prior to family meeting).
primary purpose: Other
masking: None (Open Label)
measure: Recruitment
time frame: From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.
description: Consent rate
measure: Participation
time frame: 1-36 hours after family meeting
description: Proportion of participants who read decision aid and completed worksheet
measure: Retention
time frame: 3 months
description: Number of participants who complete follow-up
measure: Clinician-surrogate concordance scale score
time frame: Baseline and 1-36 hours after family meeting
description: measures prognostic concordance between ICU clinicians and surrogates. Participants from both groups will independently estimate numerically a SABI patient's 6-month survival and return to independence. Concordance is calculated as the absolute value of the difference in prognosis between the surrogate and the clinician, and, therefore, can range from 0 (no concordance) to 100 (full concordance).
measure: Decision Self-Efficacy Scale
time frame: 1-36 hours after family meeting
description: is a validated scale that measures self-confidence in making an informed choice using a 5-point Likert scale ranging from 0 (not at all confident) to 4 (very confident).
measure: Decisional Conflict Scale
time frame: 1-36 hours after family meeting
description: is a validated scale that measures the personal perception of choosing an option and factors contributing to choice uncertainty. It is a 16-item, 5-item Likert scale with sub-scores for uncertainty, feeling informed, values clarity, decision support and effective decision-making. It ranges from 0 (strongly agree) to 4 (strongly disagree).
measure: AIS/Intracerebral Hemorrhage (ICH)/Traumatic Brain Injury (TBI) knowledge test
time frame: Baseline and 1-36 hours after family meeting
description: Medical knowledge about the goals-of-care decision in SABI will be assessed using the medical knowledge test, which was adapted to 17 questions about goals-of-care and SABI, all of which are addressed in the decision aid. The % correct will be calculated.
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: Baseline,1-36 hours after family meeting, and 3-months
description: is a 14-item, two-domain (depression, anxiety) instrument with reliability and validity among ICU surrogates, which is recommended by consensus guidelines for the prospective measurement of psychological distress among ICU surrogates. Each of the 14 questions are scored between 0 (not at all) and 3 (most of the time), and summed up for a total HADS score, which ranges from 0 to 42, with higher scores indicating worse symptoms. Total HADS 0-7 =normal, 8-10 borderline abnormal, 11-21=abnormal, indicating high anxiety and depression.
measure: Impact of Events Scale-revised
time frame: Baseline,1-36 hours after family meeting, and 3-months
description: is a is a validated 15-item instrument, measuring post-traumatic stress disorder (PTSD) symptoms. Total score is the sum of all questions and ranges from 0 to 88, with higher scores indicating worse PTSD symptoms.
measure: Quality of Communications Scale
time frame: 1-36 hours after family meeting
description: is a is a validated 17-item patient-centered instrument widely used in the ICU to assess surrogates' satisfaction of clinician communication about treatments and understanding treatment decisions. It ranges between 0 (poor) to 10 (absolutely perfect). Total score is the sum of all questions and ranges from 0 to 100, with higher scores indicating better communication.
measure: Patient-Perceived Centeredness of Care Scale
time frame: 1-36 hours after family meeting
description: is a is a validated 14-item, 4-point Likert scale based test. Its version adapted to surrogates has shown responsiveness in a recent trial of a nurse-driven communication intervention for surrogates in the ICU. It ranges between 1 (very well) to 4 (not at all), and median score is calculated from all questions. Median scores range from 1 to 4, with lower scores indicating more patient- and family-centered care.
measure: Cumulative duration of the goals-of-care family meetings
time frame: 1-36 hours after family meeting
description: Investigators will track the duration of each goals-of-care meeting. At the patient's ICU discharge, investigators will sum up the cumulative duration of all goals-of-care meetings [minutes].
measure: Total number of goals-of-care family meetings
time frame: 1-36 hours after family meeting
description: Investigators will sum up the total number of goals-of-care meetings at the patient's ICU discharge.
measure: Patient's survival status
time frame: 3-months after goals of care decision
description: Investigators will record whether the patient is dead or alive.
measure: Patient's Glasgow Outcome Scale
time frame: 3-months after goals of care decision
description: The Glasgow Outcome Score (GOS) is a validated 5-point scale given to traumatic brain injury or other brain injury patients at some point in their recovery. It is a very general assessment of the general functioning of the person who suffered a head injury or other neurological injury. It ranges from 1-5 (higher scores indicating better functional status): 1=death, 2=Vegetative State, 3=Severely Disabled (conscious but the patient requires others for daily support due to disability), 4=Moderately Disabled (the patient is independent but disabled), 5=Good Recovery (the patient has resumed most normal activities but may have minor residual problems).
measure: Patient's modified Rankin Scale
time frame: 3-months after goals of care decision
description: is a validated scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It ranges from 0 (no symptoms at all) to 6 (death).
measure: Surrogate Decision Regret Scale
time frame: 3-months after goals of care decision
description: is a validated scale that measures distress or remorse after a health care decision with high internal consistency. It asks 5 questions and provides a 5-point Likert scale. It ranges between 1 (strongly agree) to 5 (strongly disagree).
arm group label: Usual Care (n=20)
arm group type: No Intervention
description: Control: general information about TBI from Center for Disease Control (CDC)/about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association
arm group label: Decision Aid (n=20)
arm group type: Experimental
description: Paper Decision aid (share decision making tool) with worksheet for surrogates
intervention type: Other
intervention name: Decision Aid
description: Shared-decision making tool
arm group label: Decision Aid (n=20)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr. Susanne Muehlschlegel, MD, MPH
role: Principal Investigator
affiliation: University of Massachusetts, Worcester
facility: 
facility: 
country: United States
citation: Quinn T, Moskowitz J, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. What Families Need and Physicians Deliver: Contrasting Communication Preferences Between Surrogate Decision-Makers and Physicians During Outcome Prognostication in Critically Ill TBI Patients. Neurocrit Care. 2017 Oct;27(2):154-162. doi: 10.1007/s12028-017-0427-2.
PMID: 28685395
citation: Moskowitz J, Quinn T, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. Should We Use the IMPACT-Model for the Outcome Prognostication of TBI Patients? A Qualitative Study Assessing Physicians' Perceptions. MDM Policy Pract. 2018 Mar 26;3(1):2381468318757987. doi: 10.1177/2381468318757987. eCollection 2018 Jan-Jun.
PMID: 30288437
citation: Muehlschlegel S, Shutter L, Col N, Goldberg R. Decision Aids and Shared Decision-Making in Neurocritical Care: An Unmet Need in Our NeuroICUs. Neurocrit Care. 2015 Aug;23(1):127-30. doi: 10.1007/s12028-014-0097-2.
PMID: 25561435
citation: Cai X, Robinson J, Muehlschlegel S, White DB, Holloway RG, Sheth KN, Fraenkel L, Hwang DY. Patient Preferences and Surrogate Decision Making in Neuroscience Intensive Care Units. Neurocrit Care. 2015 Aug;23(1):131-41. doi: 10.1007/s12028-015-0149-2.
PMID: 25990137
responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Worcester
investigator full name: Susanne Muehlschlegel
investigator title: Associate Professor of Neurocritical Care
mesh term: Brain Injuries
mesh term: Ischemic Stroke
mesh term: Brain Injuries, Traumatic
mesh term: Cerebral Hemorrhage
mesh term: Hemorrhage
mesh term: Wounds and Injuries
sharing ipd: No