<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/NCT04476914</url>
  </required_header>
  <id_info>
    <org_study_id>20-1021</org_study_id>
    <nct_id>NCT04476914</nct_id>
  </id_info>
  <brief_title>Stress Related Disorders in Family Members of COVID-19 Patients Admitted to the ICU</brief_title>
  <official_title>Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tulane University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>South Shore Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Evergreen Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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>
      Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by severe acute&#xD;
      respiratory syndrome coronavirus 2 (SARS-CoV-2). This syndrome has been associated with high&#xD;
      mortality, estimated to be about 1.7% of all infected in the US, though in those who develop&#xD;
      acute respiratory distress syndrome (ARDS) in the context of the infection, mortality rates&#xD;
      appear to be much higher, perhaps up to 70%. To avoid transmission of the virus, patient&#xD;
      isolation has become the standard of care, with many hospitals eliminating visitors of any&#xD;
      type, and particularly eliminating visitation to patients infected with COVID-19. These&#xD;
      necessary, but restrictive, measures add stress to the ICU and particularly to the family&#xD;
      members who are not only left with fear, but also many unanswered questions. In contrast to&#xD;
      the Society of Critical Care Guidelines (SCCM) which recommend family engagement in the ICU&#xD;
      and recent data from this study team which suggests engaging families in end-of-life&#xD;
      situations reduces symptoms of Post-Traumatic Stress Disorder (PTSD) in family members,&#xD;
      family members are now unable to say good-bye and unable to provide support to their&#xD;
      loved-one throughout the process of the patients' ICU stay. The study hypothesizes is that&#xD;
      these restrictive visiting regulations will increase rates of Post-intensive care syndrome-&#xD;
      family (PICS-F) which includes symptoms of PTSD, depression, and anxiety and aim to evaluate&#xD;
      for factors that either exacerbate these symptoms or protect from them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study aims to define the prevalence of PICS-F in the study population 3-4 months after&#xD;
      ICU admission of patient, specifically symptoms of PTSD as the primary outcome, and symptoms&#xD;
      of depression and anxiety as secondary outcomes. The study hypothesizes prevalence will be&#xD;
      higher than seen in other studies.&#xD;
&#xD;
      An additional aim is to identify predisposing or mitigating exposures for PICS-F. The study&#xD;
      hypothesizes that increased psychological symptoms will be associated less exposure to&#xD;
      virtual patient visits (tablet/video conferencing), higher number of patient comorbidities&#xD;
      (using the Charleston comorbidity index), preexisting family member psychological conditions.&#xD;
&#xD;
      The study also plans to evaluate the association between family perception of quality of&#xD;
      communication or decision-making using items from the validated Family Satisfaction in the&#xD;
      ICU (FS-ICU) and psychological symptoms. The study hypothesizes that the quality of&#xD;
      communication and decision-making will be associated with lower psychological symptoms.&#xD;
&#xD;
      Finally, the plan is to, using qualitative methods, explore and describe family members'&#xD;
      stress, experiences with communication with healthcare providers and their satisfaction with&#xD;
      ICU care while being physically distant from their loved ones. The aim is to use qualitative&#xD;
      findings about family members' experiences to contextualize and explain results differences&#xD;
      in stress, satisfaction and communication quality between low vs high PICS-F scores.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Actual">June 15, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Symptoms of Post-Traumatic Stress Disorder (PTSD)</measure>
    <time_frame>90-120 days after admission of patient to the ICU</time_frame>
    <description>Using Impact of Events Scale-Revised-6 , family members will be screened for symptoms of PTSD. Scale returns scores of 0-24, with higher scores indicating more likely to have symptoms of PTSD</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptoms of Anxiety</measure>
    <time_frame>90-120 days after admission of patient to the ICU</time_frame>
    <description>Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of anxiety. The HADS anxiety scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of Depression</measure>
    <time_frame>90-120 days after admission of patient to the ICU</time_frame>
    <description>Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of Depression. The HADS depression scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Satisfaction with Communication and Decision Making</measure>
    <time_frame>90-120 days after admission of patient to the ICU</time_frame>
    <description>Using preselected questions from the Family Satisfaction in the ICU-27 questionnaire, we will survey families to evaluate their satisfaction with communication and decision making. Higher scores will indicate more satisfication</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">330</enrollment>
  <condition>Respiratory Failure</condition>
  <condition>SARS-CoV 2</condition>
  <condition>Corona Virus Infection</condition>
  <condition>Post Intensive Care Unit Syndrome</condition>
  <condition>Family Members</condition>
  <condition>Post Traumatic Stress Disorder</condition>
  <condition>Anxiety</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Family Member</arm_group_label>
    <description>Family members of ICU patients admitted with respiratory failure from COVID-19</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will be consenting family members of COVID-19 positive patients who&#xD;
        are admitted to the intensive care unit with respiratory failure&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Family members of COVID-19 positive patients admitted to the Intensive Care Unit with&#xD;
             respiratory failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Family members will be excluded if they: are under 18 or unable to complete the&#xD;
             survey's due to language barriers&#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>
  <location>
    <facility>
      <name>Eastern Colorado Veterans Affairs Health Care System, University Of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Shore Medical Center</name>
      <address>
        <city>Weymouth</city>
        <state>Massachusetts</state>
        <zip>02910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Milstein and Allen Hospitals</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Hershey Milton S Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed on 3/30/2020</citation>
  </reference>
  <reference>
    <citation>Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.</citation>
    <PMID>32191259</PMID>
  </reference>
  <reference>
    <citation>Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.</citation>
    <PMID>27984278</PMID>
  </reference>
  <reference>
    <citation>Amass TH, Villa G, OMahony S, Badger JM, McFadden R, Walsh T, Caine T, McGuirl D, Palmisciano A, Yeow ME, De Gaudio R, Curtis JR, Levy MM. Family Care Rituals in the ICU to Reduce Symptoms of Post-Traumatic Stress Disorder in Family Members-A Multicenter, Multinational, Before-and-After Intervention Trial. Crit Care Med. 2020 Feb;48(2):176-184. doi: 10.1097/CCM.0000000000004113.</citation>
    <PMID>31939785</PMID>
  </reference>
  <reference>
    <citation>Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.</citation>
    <PMID>22080636</PMID>
  </reference>
  <reference>
    <citation>Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446. Erratum In: N Engl J Med. 2007 Jul 12;357(2):203.</citation>
    <PMID>17267907</PMID>
  </reference>
  <reference>
    <citation>Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.</citation>
    <PMID>15665319</PMID>
  </reference>
  <reference>
    <citation>Wall RJ, Engelberg RA, Downey L, Heyland DK, Curtis JR. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Crit Care Med. 2007 Jan;35(1):271-9. doi: 10.1097/01.CCM.0000251122.15053.50.</citation>
    <PMID>17133189</PMID>
  </reference>
  <reference>
    <citation>Sundin EC, Horowitz MJ. Horowitz's Impact of Event Scale evaluation of 20 years of use. Psychosom Med. 2003 Sep-Oct;65(5):870-6. doi: 10.1097/01.psy.0000084835.46074.f0.</citation>
    <PMID>14508034</PMID>
  </reference>
  <reference>
    <citation>Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.</citation>
    <PMID>6880820</PMID>
  </reference>
  <reference>
    <citation>Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.</citation>
    <PMID>11832252</PMID>
  </reference>
  <reference>
    <citation>Curtis JR, Treece PD, Nielsen EL, Gold J, Ciechanowski PS, Shannon SE, Khandelwal N, Young JP, Engelberg RA. Randomized Trial of Communication Facilitators to Reduce Family Distress and Intensity of End-of-Life Care. Am J Respir Crit Care Med. 2016 Jan 15;193(2):154-62. doi: 10.1164/rccm.201505-0900OC.</citation>
    <PMID>26378963</PMID>
  </reference>
  <reference>
    <citation>Carson SS, Cox CE, Wallenstein S, Hanson LC, Danis M, Tulsky JA, Chai E, Nelson JE. Effect of Palliative Care-Led Meetings for Families of Patients With Chronic Critical Illness: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):51-62. doi: 10.1001/jama.2016.8474. Erratum In: JAMA. 2017 May 23;317(20):2134.</citation>
    <PMID>27380343</PMID>
  </reference>
  <reference>
    <citation>White DB, Angus DC, Shields AM, Buddadhumaruk P, Pidro C, Paner C, Chaitin E, Chang CH, Pike F, Weissfeld L, Kahn JM, Darby JM, Kowinsky A, Martin S, Arnold RM; PARTNER Investigators. A Randomized Trial of a Family-Support Intervention in Intensive Care Units. N Engl J Med. 2018 Jun 21;378(25):2365-2375. doi: 10.1056/NEJMoa1802637. Epub 2018 May 23.</citation>
    <PMID>29791247</PMID>
  </reference>
  <reference>
    <citation>Van Scoy LJ, Chiarolanzio PJ, Kim C, Heyland DK. Development and initial evaluation of an online decision support tool for families of patients with critical illness: A multicenter pilot study. J Crit Care. 2017 Jun;39:18-24. doi: 10.1016/j.jcrc.2016.12.022. Epub 2017 Jan 19. No abstract available.</citation>
    <PMID>28131020</PMID>
  </reference>
  <reference>
    <citation>Heyland DK, Davidson J, Skrobik Y, des Ordons AR, Van Scoy LJ, Day AG, Vandall-Walker V, Marshall AP. Improving partnerships with family members of ICU patients: study protocol for a randomized controlled trial. Trials. 2018 Jan 4;19(1):3. doi: 10.1186/s13063-017-2379-4.</citation>
    <PMID>29301555</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 18, 2021</last_update_submitted>
  <last_update_submitted_qc>June 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT04476914
org study id: 20-1021
nct id: NCT04476914
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coronavirus disease 2019 (COVID-19) is a novel infectious disease caused by severe acute
      respiratory syndrome coronavirus 2 (SARS-CoV-2). This syndrome has been associated with high
      mortality, estimated to be about 1.7% of all infected in the US, though in those who develop
      acute respiratory distress syndrome (ARDS) in the context of the infection, mortality rates
      appear to be much higher, perhaps up to 70%. To avoid transmission of the virus, patient
      isolation has become the standard of care, with many hospitals eliminating visitors of any
      type, and particularly eliminating visitation to patients infected with COVID-19. These
      necessary, but restrictive, measures add stress to the ICU and particularly to the family
      members who are not only left with fear, but also many unanswered questions. In contrast to
      the Society of Critical Care Guidelines (SCCM) which recommend family engagement in the ICU
      and recent data from this study team which suggests engaging families in end-of-life
      situations reduces symptoms of Post-Traumatic Stress Disorder (PTSD) in family members,
      family members are now unable to say good-bye and unable to provide support to their
      loved-one throughout the process of the patients' ICU stay. The study hypothesizes is that
      these restrictive visiting regulations will increase rates of Post-intensive care syndrome-
      family (PICS-F) which includes symptoms of PTSD, depression, and anxiety and aim to evaluate
      for factors that either exacerbate these symptoms or protect from them.
The study aims to define the prevalence of PICS-F in the study population 3-4 months after
      ICU admission of patient, specifically symptoms of PTSD as the primary outcome, and symptoms
      of depression and anxiety as secondary outcomes. The study hypothesizes prevalence will be
      higher than seen in other studies.

      An additional aim is to identify predisposing or mitigating exposures for PICS-F. The study
      hypothesizes that increased psychological symptoms will be associated less exposure to
      virtual patient visits (tablet/video conferencing), higher number of patient comorbidities
      (using the Charleston comorbidity index), preexisting family member psychological conditions.

      The study also plans to evaluate the association between family perception of quality of
      communication or decision-making using items from the validated Family Satisfaction in the
      ICU (FS-ICU) and psychological symptoms. The study hypothesizes that the quality of
      communication and decision-making will be associated with lower psychological symptoms.

      Finally, the plan is to, using qualitative methods, explore and describe family members'
      stress, experiences with communication with healthcare providers and their satisfaction with
      ICU care while being physically distant from their loved ones. The aim is to use qualitative
      findings about family members' experiences to contextualize and explain results differences
      in stress, satisfaction and communication quality between low vs high PICS-F scores.
observational model: Cohort
time perspective: Prospective
measure: Symptoms of Post-Traumatic Stress Disorder (PTSD)
time frame: 90-120 days after admission of patient to the ICU
description: Using Impact of Events Scale-Revised-6 , family members will be screened for symptoms of PTSD. Scale returns scores of 0-24, with higher scores indicating more likely to have symptoms of PTSD
measure: Symptoms of Anxiety
time frame: 90-120 days after admission of patient to the ICU
description: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of anxiety. The HADS anxiety scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of anxiety
measure: Symptoms of Depression
time frame: 90-120 days after admission of patient to the ICU
description: Using the Hospital Anxiety and Depression Score, family members will be screened for symptoms of Depression. The HADS depression scale is scored between 0 and 21, with higher scores indicating more likely to have symptoms of depression
measure: Family Satisfaction with Communication and Decision Making
time frame: 90-120 days after admission of patient to the ICU
description: Using preselected questions from the Family Satisfaction in the ICU-27 questionnaire, we will survey families to evaluate their satisfaction with communication and decision making. Higher scores will indicate more satisfication
arm group label: Family Member
description: Family members of ICU patients admitted with respiratory failure from COVID-19
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html. Accessed on 3/30/2020
citation: Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
PMID: 32191259
citation: Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
PMID: 27984278
citation: Amass TH, Villa G, OMahony S, Badger JM, McFadden R, Walsh T, Caine T, McGuirl D, Palmisciano A, Yeow ME, De Gaudio R, Curtis JR, Levy MM. Family Care Rituals in the ICU to Reduce Symptoms of Post-Traumatic Stress Disorder in Family Members-A Multicenter, Multinational, Before-and-After Intervention Trial. Crit Care Med. 2020 Feb;48(2):176-184. doi: 10.1097/CCM.0000000000004113.
PMID: 31939785
citation: Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.
PMID: 22080636
citation: Lautrette A, Darmon M, Megarbane B, Joly LM, Chevret S, Adrie C, Barnoud D, Bleichner G, Bruel C, Choukroun G, Curtis JR, Fieux F, Galliot R, Garrouste-Orgeas M, Georges H, Goldgran-Toledano D, Jourdain M, Loubert G, Reignier J, Saidi F, Souweine B, Vincent F, Barnes NK, Pochard F, Schlemmer B, Azoulay E. A communication strategy and brochure for relatives of patients dying in the ICU. N Engl J Med. 2007 Feb 1;356(5):469-78. doi: 10.1056/NEJMoa063446. Erratum In: N Engl J Med. 2007 Jul 12;357(2):203.
PMID: 17267907
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responsible party type: Sponsor
mesh term: Coronavirus Infections
mesh term: Respiratory Insufficiency
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No