<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/NCT03276559</url>
  </required_header>
  <id_info>
    <org_study_id>1610017622</org_study_id>
    <secondary_id>R21CA218313</secondary_id>
    <nct_id>NCT03276559</nct_id>
  </id_info>
  <brief_title>Enhancing &amp; Mobilizing the POtential for Wellness &amp; Emotional Resilience Among Surrogate Decision-Makers of ICU Patients</brief_title>
  <acronym>EMPOWER</acronym>
  <official_title>Enhancing &amp; Mobilizing the POtential for Wellness &amp; Emotional Resilience Among Surrogate Decision-Makers of ICU Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New York Hospital Queens</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intensive Care Units (ICU) are stressful places where life-and-death medical decisions are&#xD;
      made and patients' surrogate decision-makers are exposed to potentially traumatic&#xD;
      experiences. As the number of life-prolonging procedures administered to the patient rises,&#xD;
      the patient's quality of life falls. Thus, interventions to improve the quality of life and&#xD;
      care of ICU patients are needed.&#xD;
&#xD;
      EMPOWER is a cognitive-behavioral, acceptance-based intervention for patient surrogate&#xD;
      decision-makers to reduce experiential avoidance of unpleasant thoughts and feelings related&#xD;
      to thinking about patient death. By reducing surrogate's experiential avoidance, EMPOWER&#xD;
      removes a barrier to advance care planning. EMPOWER aims to improve patient quality of life&#xD;
      through enhancing value-directed end-of-life care while also empowering surrogates to cope&#xD;
      with a loved one's potential impending death and adjust following the patient's ICU death or&#xD;
      discharge. Specifically, investigators aim to:&#xD;
&#xD;
        -  1: Develop EMPOWER for surrogate decision-makers of critically ill patients who are at&#xD;
           risk of becoming incapacitated or are currently unable to communicate in the ICU. Key&#xD;
           informants, including bereaved ICU patient caregivers and clinicians, will be asked to&#xD;
           evaluate the EMPOWER intervention manual to increase its potential tolerability,&#xD;
           acceptability and efficacy.&#xD;
&#xD;
        -  2: Determine feasibility, tolerability, acceptability, and preliminary effects of&#xD;
           EMPOWER on surrogate mental health.&#xD;
&#xD;
        -  3: Estimate the effects of EMPOWER on patient outcomes in the months following the ICU&#xD;
           admission.&#xD;
&#xD;
      Hypothesis 1: Surrogate decision-makers who receive EMPOWER will have significantly lower&#xD;
      levels of peritraumatic distress when compared to usual care condition at post intervention&#xD;
      assessment (T2).&#xD;
&#xD;
      Hypothesis 2: Patients whose surrogates receive EMPOWER will have more value-concordant care,&#xD;
      better quality of life, and better quality of death.&#xD;
&#xD;
      EMPOWER was first evaluated though a single site open trial (n=10). All 10 participants in&#xD;
      the open trial phase received EMPOWER. Feedback from clinicians, bereaved stakeholders and&#xD;
      results from the open trial were then used to refine the intervention and launch a&#xD;
      multi-center randomized controlled trial to examine clinical superiority of EMPOWER to&#xD;
      enhanced usual care. In order to adapt to restrictions in ICU visitation and meet the needs&#xD;
      of family caregivers impacted by the COVID-19 pandemic, we then launched a second single arm&#xD;
      open trial and paused recruitment for the RCT. All participants recruited during the open&#xD;
      trial COVID-19 phase received EMPOWER. Beginning in August 2021, we resumed the RCT portion&#xD;
      of the trial to meet the initial recruitment goals of the study (total n of RCT &amp; COVID-19&#xD;
      open trial=60).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aggressive care in Intensive Care Units (ICUs) has been shown to impair the quality of life&#xD;
      of patients with advanced cancer and to increase the risk of Posttraumatic Stress Disorder&#xD;
      (PTSD) among the family and friends who serve as informal caregivers. Although ICU stays are&#xD;
      established indicators of low quality end-of-life (EoL) cancer care, a large, growing number&#xD;
      of cancer patients - over 1 in 4 -- are being admitted to the ICU in the last month of life.&#xD;
      Even within the ICU, investigators find that as the number of life-prolonging procedures&#xD;
      administered to the patient rises, the patient's quality of life falls. Thus, interventions&#xD;
      to reduce the suffering and to improve the quality of life and care of ICU cancer patients&#xD;
      are needed.&#xD;
&#xD;
      As described above, suffering is not confined to the patient. Informal caregivers of cancer&#xD;
      patients in the ICU also suffer. In our &quot;Severity of Suffering&quot; (SoS) study, which examined&#xD;
      dying cancer patients' quality of life in the ICU, nurses indicated that 53% of the patients'&#xD;
      caregivers were acutely distressed. The nurses also reported that 43% of the patient's&#xD;
      caregivers had unrealistic expectations for the patient's recovery and that 41% insisted that&#xD;
      the patient receive futile, burdensome care (e.g., resuscitation). Over 85% of these patients&#xD;
      were unable to communicate, which resulted in the need for grieving, potentially traumatized&#xD;
      caregivers to serve as the patient's surrogate decision-maker and make life-and-death&#xD;
      decisions for a critically ill, uncommunicative patient. Additionally, caregivers of patients&#xD;
      who die in the ICU are also at elevated risk of posttraumatic stress disorder (PTSD) in the&#xD;
      months that follow the potentially traumatic ICU &quot;exposures&quot;. These findings indicate a&#xD;
      compelling need to address the varying mental health needs of informal caregivers and&#xD;
      surrogate decision-makers of patients in the ICU from admission to after discharge, as well&#xD;
      as to provide them with resources to clarify and inform the decision-making process regarding&#xD;
      care for patients who are unable to communicate.&#xD;
&#xD;
      To address these needs, we have developed and will refine and evaluate EMPOWER, a mental&#xD;
      health intervention for surrogate decision-makers of ICU patients who are at risk of becoming&#xD;
      incapacitated or are currently unable to make medical decisions. Delivered by a trained&#xD;
      mental health professional in the ICU setting, EMPOWER is a cognitive-behavioral,&#xD;
      acceptance-based intervention designed to reduce &quot;experiential avoidance&quot; of unpleasant&#xD;
      thoughts and feelings related to thinking about the patient's death and to provide active&#xD;
      strategies for coping with peritraumatic distress and anticipatory grief. Additionally, by&#xD;
      reducing surrogates' experiential avoidance, EMPOWER removes a barrier to advanced care&#xD;
      planning and promotes the receipt of EoL care consistent with patient values. In this way,&#xD;
      EMPOWER aims to facilitate EoL care that enhances patient quality of life while also&#xD;
      empowering surrogates to cope with a loved one's potential impending death and adjust&#xD;
      following the patient's ICU death or discharge.&#xD;
&#xD;
      This study is designed to obtain information on its feasibility, tolerability, acceptability,&#xD;
      and preliminary effect size estimates to inform the planning of a larger, efficacy randomized&#xD;
      controlled trial (RCT). In order to develop the RCT, the first 10 surrogate decision-makers&#xD;
      were enrolled in an open trial to receive EMPOWER. In addition, during the manual refinement&#xD;
      phase, up to 15 stakeholders (bereaved caregivers of ICU patients) were interviewed after&#xD;
      reviewing the EMPOWER intervention manual. We then began a pilot RCT, randomizing surrogate&#xD;
      decision-makers to receive either EMPOWER or enhanced usual care using a block-randomization&#xD;
      strategy to determine condition assignment. In light of restrictions on recruitment and&#xD;
      increased needs of surrogates during the COVID-19 pandemic, we paused the RCT portion of this&#xD;
      trial and we recruited for a second open trial only administering EMPOWER. 60&#xD;
      surrogate-patient dyads were enrolled between the RCT and COVID-19 open trial. In August&#xD;
      2021, we resumed the RCT trial of the study. We resumed in person recruitment and&#xD;
      randomization of participants to EMPOWER or EUC. Including the first open trial, we will&#xD;
      enroll a total of 70 surrogate decision-makers of 70 current patients from the intensive care&#xD;
      units at New York Presbyterian-Weill Cornell, New York Presbyterian-Queens, and Memorial&#xD;
      Sloan Kettering Cancer Center. Research staff will regularly contact ICU physicians in person&#xD;
      or by email and/or screen patient charts to identify eligible candidates based on the&#xD;
      inclusion criteria.&#xD;
&#xD;
      Surrogates will be consented and screened. Those who score above 5 on either item measuring&#xD;
      anxiety in the McGill Quality of Life Scale, or with a summed score of at least 8 on the&#xD;
      first two items of the Partner Dependency Scale (PDS) will be randomized to receive EMPOWER&#xD;
      or usual care in the RCT, or solely assigned to receive the intervention in the pilot trials.&#xD;
      Surrogates will be assessed pre-intervention/baseline (Time point 1, T1), post-intervention&#xD;
      (within a week of the surrogate's completion of the baseline assessment) (Time point 2, T2),&#xD;
      1-month post-T2 (Time point 3, T3), and 3-months post-T2(Time point 4, T4). Surrogates will&#xD;
      be assigned to either control (usual care) or intervention group using block randomization in&#xD;
      the RCT, and solely to EMPOWER in open trials.&#xD;
&#xD;
      EMPOWER is based on well-established cognitive-behavioral techniques that aim to promote the&#xD;
      expression and understanding of a person's emotional reactions. The EMPOWER interventionist&#xD;
      will be compassionate and attempt to teach subjects tools for remaining present-focused,&#xD;
      validate participants' experience, explore participants' loved ones' and participants' own&#xD;
      wishes, values and decision challenges, increase subjects acceptance and sense of permission&#xD;
      to experience challenging emotions, and prepare participants for future distressing&#xD;
      situations. Enhanced usual care will consist of a surrogate's interactions with social&#xD;
      support services in the ICU as documented in the patient's medical chart, referrals for&#xD;
      current site-specific resources for informal caregivers, and a packet providing general&#xD;
      information and tips on serving as an informal caregiver.&#xD;
&#xD;
      HLM modeling will determine differences between surrogates and patients assigned to EMPOWER&#xD;
      vs. enhanced usual care. The primary outcome is post-intervention (T2) differences on a&#xD;
      measure of peritraumatic distress. Secondary outcomes are differences on measures of&#xD;
      prolonged grief disorder, PTSD and experiential avoidance at one-month (T3) and three-month&#xD;
      (T4) follow up from T2. Exploratory outcomes for surrogates are differences in reported&#xD;
      symptoms of anxiety, depression, and decision regret at one-month (T3) and three-month (T4)&#xD;
      follow up from T2. Exploratory outcomes for patients are differences in surrogate-reported&#xD;
      quality of life, quality of death, and value concordant care. HLM models will include&#xD;
      covariates, either as fixed-effect or time-varying, if those variables are found to be&#xD;
      significantly statistically associated with both intervention assignment and the outcome&#xD;
      examined.&#xD;
&#xD;
      Following a review of the open trial pilot data and stakeholder feedback to evaluate our&#xD;
      intervention targets, assessments and the primary outcome in the RCT were revised to target&#xD;
      the effects of the EMPOWER intervention on peri (rather than post) traumatic stress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 12, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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 trial pilot and manual refinement phase followed by randomized controlled trial. Due to the COVID-19 pandemic, we included the open-trial COVID-19 phase to adjust to new circumstances. We resumed the randomized controlled trial once it was safe to do so.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peritraumatic Distress Inventory</measure>
    <time_frame>In the week following the intervention (T2)</time_frame>
    <description>Symptoms of peritraumatic distress, as measured by the Peritraumatic Distress Inventory (adapted to fit the ICU experience), will be compared between groups at post-intervention assessment (T2). The PDI consists of 13 likert-style items and total score can range from 0 to 52. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anticipatory Grief</measure>
    <time_frame>One month and three months from baseline (T3 and T4)</time_frame>
    <description>Anticipatory grief for patients who are not deceased, as measured by the Prolonged Grief-12, will be compared between groups at one-month and three-month follow up assessments (T3 and T4).The PG-12 consists of 12 items and total score can range from 0 to 57. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prolonged Grief Disorder</measure>
    <time_frame>One month and three months from baseline (T3 and T4)</time_frame>
    <description>Symptoms of prolonged grief disorder, as measured by the Prolonged Grief-13, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The PG-13 consists of 13 items and total score can range from 0 to 62. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experiential Avoidance</measure>
    <time_frame>One month and three months from baseline (T3 and T4)</time_frame>
    <description>Symptoms of experiential avoidance, as measured by the Brief Experiential Avoidance Questionnaire, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The BEAQ consists of 15 items and total score can range from 15 to 90. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Traumatic Stress Disorder</measure>
    <time_frame>One month and three months from baseline (T3 and T4)</time_frame>
    <description>Symptoms of post-traumatic stress disorder, as measured by the Impact of Events Scale-Revised, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The IES-R consists of 22 items and total score can range from 0 to 88. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Quality of Life</measure>
    <time_frame>From baseline assessment to three-month follow up</time_frame>
    <description>Logistic regression models will regress patient quality of life for EMPOWER vs. the enhanced usual care condition. Patient quality of life will be assessed using three previously validated items. Total score can range from 0 to 30. Higher total scores represent better caregiver-assessed patient quality of life. Higher scores represent better outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Quality of Death</measure>
    <time_frame>From baseline assessment to three-month follow up</time_frame>
    <description>For patients who die during the study period, logistic regression models will regress patient quality of death for EMPOWER vs. the enhanced usual care condition. Quality of Death will be measured using the Caregiver Evaluation of the Quality of End-of-Life Care (CEQUEL). Total score can range from 13 to 26. Higher total scores represent better caregiver-assessed patient quality of death. Higher total scores represent better outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Value-Concordant Care</measure>
    <time_frame>From baseline assessment to three-month follow up</time_frame>
    <description>Intensity of care (measured through indication of cardiopulmonary resuscitation, dialysis, mechanical ventilation, chemotherapy, parenteral nutrition, and palliative care in the medical record) will be matched with surrogate perceptions of patient treatment preferences to create a measure of value-concordant care.&#xD;
Logistic regression analyses will then model the effects of EMPOWER on the odds of patients' receipt of value-concordant care. Higher odds equal better outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Anxiety</measure>
    <time_frame>One month and three months from baseline (T3 and T4)</time_frame>
    <description>Symptoms of anxiety, as measured by the state scale of the State-Trait Anxiety Scale, will be compared between groups at one-month and three-month follow up assessments (T3 and T4).The STAI-Y state scale consists of 20 items and total score can range from 20 to 80. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Depression</measure>
    <time_frame>One month and three months from baseline (T3 and T4)</time_frame>
    <description>Symptoms of anxiety, as measured by the Patient Health Questionnaire - 9 , will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The PHQ-9 consists of 9 items and total score can range from 0 to 27. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.</description>
  </other_outcome>
  <other_outcome>
    <measure>Decision Regret</measure>
    <time_frame>One month and three months from baseline (T3 and T4)</time_frame>
    <description>Decision regret, as measured by the Decision Regret Scale, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The decision regret scale is a one-item likert-style measure. Total score can range from 1 to 10. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">98</enrollment>
  <condition>Critical Illness</condition>
  <condition>Communication Disabilities</condition>
  <arm_group>
    <arm_group_label>Randomized controlled trial EMPOWER arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The EMPOWER arm includes six 15 minute modules delivered in a 1-on-1 format with the same interventionist, and 2 boosters (approximately 45 minutes each) conducted by phone.&#xD;
Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the EMPOWER intervention within 3 months conducted in person and by phone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Randomized controlled trial Enhanced usual care arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The usual care arm indicates regular ICU support for informal caregivers (i.e. social work, chaplaincy) as recorded in the patient's medical record, a general information packet for informal caregivers, and a site-specific resource list.&#xD;
Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the usual care within 3 months conducted in person and by phone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open-trial phase arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The open-trial phase arm includes 10 participants who all received EMPOWER. Data from the open trial of 10 surrogate decision-makers will identify tactical and measurement issues involved in the delivery and outcomes measurements used in EMPOWER.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual refinement phase arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This phase involves obtaining feedback about the EMPOWER intervention manual using qualitative analysis from 15 stakeholders.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open trial COVID-19 phase arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The COVID-19 open trial phase arm did not include randomization or control arm. All participants received the EMPOWER intervention. Assessments will occur pre-intervention, immediately post-intervention, and then 1-month and 3-months from post-intervention assessment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>EMPOWER</intervention_name>
    <description>EMPOWER is a manualized treatment delivered based in cognitive behavioral and acceptance and commitment therapies delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psychoeducation, imaginal dialogue with the patient, and coping rehearsal techniques.&#xD;
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.</description>
    <arm_group_label>Open trial COVID-19 phase arm</arm_group_label>
    <arm_group_label>Open-trial phase arm</arm_group_label>
    <arm_group_label>Randomized controlled trial EMPOWER arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Usual Care</intervention_name>
    <description>Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.</description>
    <arm_group_label>Randomized controlled trial Enhanced usual care arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria for stakeholders:&#xD;
&#xD;
          1. Bereaved family caregivers of patients treated in the ICU identified by referring&#xD;
             clinicians and through support groups, clinics, and word of mouth&#xD;
&#xD;
          2. Clinicians with expertise in mental health care and/or critical care including but not&#xD;
             limited to nurses, nurse practitioners, social workers, psychologists, psychiatrists,&#xD;
             hospital chaplains, and physicians&#xD;
&#xD;
        Inclusion criteria for open trial participants:&#xD;
&#xD;
          1. Patients (&gt;21 years) who cannot communicate and decide on treatments, who during the&#xD;
             course of their current hospital stay were admitted to an ICU/step-down unit, and&#xD;
             whose ICU physicians or fellows would not be surprised if the patient did not survive&#xD;
             more than 3 months&#xD;
&#xD;
          2. Surrogate decision-makers whom ICU physicians or fellows indicate as the designated&#xD;
             health care proxy or decision-making patient surrogates, or who are listed as such in&#xD;
             the patient's medical charts&#xD;
&#xD;
          3. Surrogate decision-makers must speak English&#xD;
&#xD;
          4. Surrogate decision-makers must either meet the threshold for a high degree of&#xD;
             emotional dependence (PDS 18 score &gt;8) on the patient or on the McGill Quality of Life&#xD;
             Scale19 items (either anxiety item score&gt;5).&#xD;
&#xD;
        Inclusion criteria for adult pilot RCT participants:&#xD;
&#xD;
          1. Patients (&gt;18 years) who during the course of their current hospital stay were&#xD;
             admitted to an ICU/step-down unit&#xD;
&#xD;
          2. Surrogate decision-makers whom ICU physicians or fellows indicate as the designated&#xD;
             health care proxy or decision-making patient surrogates, or who are listed as such in&#xD;
             the patient's medical charts or by self-report of the surrogate&#xD;
&#xD;
          3. Surrogate decision-makers must speak English&#xD;
&#xD;
          4. Surrogate decision-makers must either meet the threshold for a high degree of&#xD;
             emotional dependence (PDS 18 score &gt;8) on the patient or on the McGill Quality of Life&#xD;
             Scale 19 items (either anxiety item score&gt;5).&#xD;
&#xD;
          5. Surrogate decision-makers who do not meet criterion #4 but are identified by clinical&#xD;
             staff as distressed and whom clinical staff believe would benefit from the&#xD;
             intervention.&#xD;
&#xD;
        Inclusion criteria child pilot RCT/COVID-19 Open Trial participants:&#xD;
&#xD;
          1. Patients below the age of 18 who have spent at least 3 days in a pediatric intensive&#xD;
             care unit&#xD;
&#xD;
          2. Surrogate decision-makers whom ICU physicians or fellows indicate as the designated&#xD;
             health care proxy or decision-making patient surrogates, or who are listed as such in&#xD;
             the patient's medical charts or by self-report of the surrogate, or are parents of the&#xD;
             patient&#xD;
&#xD;
          3. Surrogate decision-makers must speak English&#xD;
&#xD;
        Inclusion criteria for adult open trial COVID-19 participants:&#xD;
&#xD;
          1. Patients (&gt;18 years) who during the course of their current hospital stay were&#xD;
             admitted to an ICU/step-down unit&#xD;
&#xD;
          2. Surrogate decision-makers whom a member of the patient's care team indicate as the&#xD;
             designated health care proxy or decision-making patient surrogates, or who are listed&#xD;
             as such in the patient's medical charts&#xD;
&#xD;
          3. Surrogate decision-makers must speak English&#xD;
&#xD;
          4. Surrogate decision-makers must either meet the threshold for a high degree of&#xD;
             emotional dependence (PDS 18 score &gt;8) on the patient or on the McGill Quality of Life&#xD;
             Scale items (either anxiety item score&gt;5).&#xD;
&#xD;
          5. Surrogate decision-makers who do not meet criterion #4 but are identified by clinical&#xD;
             staff as distressed and whom clinical staff believe would benefit from the&#xD;
             intervention.&#xD;
&#xD;
        Exclusion criteria for all arms:&#xD;
&#xD;
        Patients and surrogate decision-makers who do not meet the eligibility criteria or&#xD;
        surrogate decision-makers who endorse suicidal ideation in the past month based on&#xD;
        responses to the Columbia Suicide Severity Rating Scale.&#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_official>
    <last_name>Holly G Prigerson, Ph. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hillary Winoker, B.A.</last_name>
    <phone>646 962 7143</phone>
    <email>hiw4002@med.cornell.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wendy Lichtenthal, Ph. D.</last_name>
    <phone>646-888-4812</phone>
    <email>lichtenw@mskcc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>NewYork-Presbyterian Queens</name>
      <address>
        <city>Flushing</city>
        <state>New York</state>
        <zip>11355</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wendy Lichtenthal, PhD</last_name>
      <phone>646-888-4812</phone>
    </contact>
    <investigator>
      <last_name>Wendy Lichtenthal, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NewYork-Presbyterian Weill Cornell Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://projectreporter.nih.gov/project_info_description.cfm?aid=8245810&amp;icde=35069156&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=</url>
    <description>Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient End-of-Life Outcomes, (PI: Curtis, J. R.)</description>
  </link>
  <link>
    <url>https://projectreporter.nih.gov/project_info_description.cfm?aid=7781300&amp;icde=35069273&amp;ddparam=&amp;ddvalue=&amp;ddsub=&amp;cr=1&amp;csb=default&amp;cs=ASC&amp;pball=</url>
    <description>Informing Decisions in Chronic Critical Illness: An RCT, (PIs: Nelson, J. E., Carson, S.)</description>
  </link>
  <reference>
    <citation>Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, Mitchell SL, Jackson VA, Block SD, Maciejewski PK, Prigerson HG. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008 Oct 8;300(14):1665-73. doi: 10.1001/jama.300.14.1665.</citation>
    <PMID>18840840</PMID>
  </reference>
  <reference>
    <citation>Zhang B, Nilsson ME, Prigerson HG. Factors important to patients' quality of life at the end of life. Arch Intern Med. 2012 Aug 13;172(15):1133-42. doi: 10.1001/archinternmed.2012.2364.</citation>
    <PMID>22777380</PMID>
  </reference>
  <reference>
    <citation>Gamez W, Chmielewski M, Kotov R, Ruggero C, Watson D. Development of a measure of experiential avoidance: the Multidimensional Experiential Avoidance Questionnaire. Psychol Assess. 2011 Sep;23(3):692-713. doi: 10.1037/a0023242.</citation>
    <PMID>21534697</PMID>
  </reference>
  <reference>
    <citation>Prigerson HG, Shear MK, Jacobs SC, Reynolds CF 3rd, Maciejewski PK, Davidson JR, Rosenheck R, Pilkonis PA, Wortman CB, Williams JB, Widiger TA, Frank E, Kupfer DJ, Zisook S. Consensus criteria for traumatic grief. A preliminary empirical test. Br J Psychiatry. 1999 Jan;174:67-73. doi: 10.1192/bjp.174.1.67.</citation>
    <PMID>10211154</PMID>
  </reference>
  <reference>
    <citation>Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol. 2010 Mar 1;28(7):1203-8. doi: 10.1200/JCO.2009.25.4672. Epub 2010 Feb 1.</citation>
    <PMID>20124172</PMID>
  </reference>
  <reference>
    <citation>Garrido MM, Prigerson HG. The end-of-life experience: modifiable predictors of caregivers' bereavement adjustment. Cancer. 2014 Mar 15;120(6):918-25. doi: 10.1002/cncr.28495. Epub 2013 Dec 2.</citation>
    <PMID>24301644</PMID>
  </reference>
  <reference>
    <citation>Wright AA, Keating NL, Balboni TA, Matulonis UA, Block SD, Prigerson HG. Place of death: correlations with quality of life of patients with cancer and predictors of bereaved caregivers' mental health. J Clin Oncol. 2010 Oct 10;28(29):4457-64. doi: 10.1200/JCO.2009.26.3863. Epub 2010 Sep 13.</citation>
    <PMID>20837950</PMID>
  </reference>
  <reference>
    <citation>Siegel MD, Hayes E, Vanderwerker LC, Loseth DB, Prigerson HG. Psychiatric illness in the next of kin of patients who die in the intensive care unit. Crit Care Med. 2008 Jun;36(6):1722-8. doi: 10.1097/CCM.0b013e318174da72.</citation>
    <PMID>18520637</PMID>
  </reference>
  <reference>
    <citation>Curtis JR, Back AL, Ford DW, Downey L, Shannon SE, Doorenbos AZ, Kross EK, Reinke LF, Feemster LC, Edlund B, Arnold RW, O'Connor K, Engelberg RA. Effect of communication skills training for residents and nurse practitioners on quality of communication with patients with serious illness: a randomized trial. JAMA. 2013 Dec 4;310(21):2271-81. doi: 10.1001/jama.2013.282081. Erratum In: JAMA. 2014 Apr 2;311(13):1360.</citation>
    <PMID>24302090</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>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>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>Orsillo SM, Batten SV. Acceptance and commitment therapy in the treatment of posttraumatic stress disorder. Behav Modif. 2005 Jan;29(1):95-129. doi: 10.1177/0145445504270876.</citation>
    <PMID>15557480</PMID>
  </reference>
  <reference>
    <citation>Kentish-Barnes N, Prigerson HG. Is this bereaved relative at risk of prolonged grief? Intensive Care Med. 2016 Aug;42(8):1279-81. doi: 10.1007/s00134-015-4182-6. Epub 2015 Dec 23. No abstract available.</citation>
    <PMID>26699916</PMID>
  </reference>
  <reference>
    <citation>Higgins PC, Garrido MM, Prigerson HG. Factors Predicting Bereaved Caregiver Perception of Quality of Care in the Final Week of Life: Implications for Health Care Providers. J Palliat Med. 2015 Oct;18(10):849-57. doi: 10.1089/jpm.2015.29001.hp. Epub 2015 Jul 17.</citation>
    <PMID>26186021</PMID>
  </reference>
  <reference>
    <citation>Mouthaan J, Sijbrandij M, de Vries GJ, Reitsma JB, van de Schoot R, Goslings JC, Luitse JS, Bakker FC, Gersons BP, Olff M. Internet-based early intervention to prevent posttraumatic stress disorder in injury patients: randomized controlled trial. J Med Internet Res. 2013 Aug 13;15(8):e165. doi: 10.2196/jmir.2460.</citation>
    <PMID>23942480</PMID>
  </reference>
  <reference>
    <citation>Gartlehner G, Forneris CA, Brownley KA, Gaynes BN, Sonis J, Coker-Schwimmer E, Jonas DE, Greenblatt A, Wilkins TM, Woodell CL, Lohr KN. Interventions for the Prevention of Posttraumatic Stress Disorder (PTSD) in Adults After Exposure to Psychological Trauma [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. Report No.: 13-EHC062-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK133344/</citation>
    <PMID>23658936</PMID>
  </reference>
  <reference>
    <citation>Bryant RA, Mastrodomenico J, Felmingham KL, Hopwood S, Kenny L, Kandris E, Cahill C, Creamer M. Treatment of acute stress disorder: a randomized controlled trial. Arch Gen Psychiatry. 2008 Jun;65(6):659-67. doi: 10.1001/archpsyc.65.6.659.</citation>
    <PMID>18519824</PMID>
  </reference>
  <reference>
    <citation>Andrews B, Brewin CR, Stewart L, Philpott R, Hejdenberg J. Comparison of immediate-onset and delayed-onset posttraumatic stress disorder in military veterans. J Abnorm Psychol. 2009 Nov;118(4):767-77. doi: 10.1037/a0017203.</citation>
    <PMID>19899846</PMID>
  </reference>
  <reference>
    <citation>Prigerson HG, Horowitz MJ, Jacobs SC, Parkes CM, Aslan M, Goodkin K, Raphael B, Marwit SJ, Wortman C, Neimeyer RA, Bonanno GA, Block SD, Kissane D, Boelen P, Maercker A, Litz BT, Johnson JG, First MB, Maciejewski PK. Prolonged grief disorder: Psychometric validation of criteria proposed for DSM-V and ICD-11. PLoS Med. 2009 Aug;6(8):e1000121. doi: 10.1371/journal.pmed.1000121. Epub 2009 Aug 4. Erratum In: PLoS Med. 2013 Dec;10(12). doi:10.1371/annotation/a1d91e0d-981f-4674-926c-0fbd2463b5ea. Bonanno, George [corrected to Bonanno, George A].</citation>
    <PMID>19652695</PMID>
  </reference>
  <reference>
    <citation>Tomarken A, Holland J, Schachter S, Vanderwerker L, Zuckerman E, Nelson C, Coups E, Ramirez PM, Prigerson H. Factors of complicated grief pre-death in caregivers of cancer patients. Psychooncology. 2008 Feb;17(2):105-11. doi: 10.1002/pon.1188.</citation>
    <PMID>17443644</PMID>
  </reference>
  <reference>
    <citation>Prigerson HG, Viola M, Brewin CR, Cox C, Ouyang D, Rogers M, Pan CX, Rabin S, Xu J, Vaughan S, Gordon-Elliot JS, Berlin D, Lief L, Lichtenthal WG. Enhancing &amp; Mobilizing the POtential for Wellness &amp; Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial. Trials. 2019 Jul 9;20(1):408. doi: 10.1186/s13063-019-3515-0.</citation>
    <PMID>31288829</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>critically ill</keyword>
  <keyword>ICU</keyword>
  <keyword>uncommunicative</keyword>
  <keyword>caregivers</keyword>
  <keyword>surrogate</keyword>
  <keyword>decision-making</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communication Disorders</mesh_term>
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <!-- 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/NCT03276559
org study id: 1610017622
secondary id: R21CA218313
nct id: NCT03276559
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Intensive Care Units (ICU) are stressful places where life-and-death medical decisions are
      made and patients' surrogate decision-makers are exposed to potentially traumatic
      experiences. As the number of life-prolonging procedures administered to the patient rises,
      the patient's quality of life falls. Thus, interventions to improve the quality of life and
      care of ICU patients are needed.

      EMPOWER is a cognitive-behavioral, acceptance-based intervention for patient surrogate
      decision-makers to reduce experiential avoidance of unpleasant thoughts and feelings related
      to thinking about patient death. By reducing surrogate's experiential avoidance, EMPOWER
      removes a barrier to advance care planning. EMPOWER aims to improve patient quality of life
      through enhancing value-directed end-of-life care while also empowering surrogates to cope
      with a loved one's potential impending death and adjust following the patient's ICU death or
      discharge. Specifically, investigators aim to:

        -  1: Develop EMPOWER for surrogate decision-makers of critically ill patients who are at
           risk of becoming incapacitated or are currently unable to communicate in the ICU. Key
           informants, including bereaved ICU patient caregivers and clinicians, will be asked to
           evaluate the EMPOWER intervention manual to increase its potential tolerability,
           acceptability and efficacy.

        -  2: Determine feasibility, tolerability, acceptability, and preliminary effects of
           EMPOWER on surrogate mental health.

        -  3: Estimate the effects of EMPOWER on patient outcomes in the months following the ICU
           admission.

      Hypothesis 1: Surrogate decision-makers who receive EMPOWER will have significantly lower
      levels of peritraumatic distress when compared to usual care condition at post intervention
      assessment (T2).

      Hypothesis 2: Patients whose surrogates receive EMPOWER will have more value-concordant care,
      better quality of life, and better quality of death.

      EMPOWER was first evaluated though a single site open trial (n=10). All 10 participants in
      the open trial phase received EMPOWER. Feedback from clinicians, bereaved stakeholders and
      results from the open trial were then used to refine the intervention and launch a
      multi-center randomized controlled trial to examine clinical superiority of EMPOWER to
      enhanced usual care. In order to adapt to restrictions in ICU visitation and meet the needs
      of family caregivers impacted by the COVID-19 pandemic, we then launched a second single arm
      open trial and paused recruitment for the RCT. All participants recruited during the open
      trial COVID-19 phase received EMPOWER. Beginning in August 2021, we resumed the RCT portion
      of the trial to meet the initial recruitment goals of the study (total n of RCT & COVID-19
      open trial=60).
Aggressive care in Intensive Care Units (ICUs) has been shown to impair the quality of life
      of patients with advanced cancer and to increase the risk of Posttraumatic Stress Disorder
      (PTSD) among the family and friends who serve as informal caregivers. Although ICU stays are
      established indicators of low quality end-of-life (EoL) cancer care, a large, growing number
      of cancer patients - over 1 in 4 -- are being admitted to the ICU in the last month of life.
      Even within the ICU, investigators find that as the number of life-prolonging procedures
      administered to the patient rises, the patient's quality of life falls. Thus, interventions
      to reduce the suffering and to improve the quality of life and care of ICU cancer patients
      are needed.

      As described above, suffering is not confined to the patient. Informal caregivers of cancer
      patients in the ICU also suffer. In our "Severity of Suffering" (SoS) study, which examined
      dying cancer patients' quality of life in the ICU, nurses indicated that 53% of the patients'
      caregivers were acutely distressed. The nurses also reported that 43% of the patient's
      caregivers had unrealistic expectations for the patient's recovery and that 41% insisted that
      the patient receive futile, burdensome care (e.g., resuscitation). Over 85% of these patients
      were unable to communicate, which resulted in the need for grieving, potentially traumatized
      caregivers to serve as the patient's surrogate decision-maker and make life-and-death
      decisions for a critically ill, uncommunicative patient. Additionally, caregivers of patients
      who die in the ICU are also at elevated risk of posttraumatic stress disorder (PTSD) in the
      months that follow the potentially traumatic ICU "exposures". These findings indicate a
      compelling need to address the varying mental health needs of informal caregivers and
      surrogate decision-makers of patients in the ICU from admission to after discharge, as well
      as to provide them with resources to clarify and inform the decision-making process regarding
      care for patients who are unable to communicate.

      To address these needs, we have developed and will refine and evaluate EMPOWER, a mental
      health intervention for surrogate decision-makers of ICU patients who are at risk of becoming
      incapacitated or are currently unable to make medical decisions. Delivered by a trained
      mental health professional in the ICU setting, EMPOWER is a cognitive-behavioral,
      acceptance-based intervention designed to reduce "experiential avoidance" of unpleasant
      thoughts and feelings related to thinking about the patient's death and to provide active
      strategies for coping with peritraumatic distress and anticipatory grief. Additionally, by
      reducing surrogates' experiential avoidance, EMPOWER removes a barrier to advanced care
      planning and promotes the receipt of EoL care consistent with patient values. In this way,
      EMPOWER aims to facilitate EoL care that enhances patient quality of life while also
      empowering surrogates to cope with a loved one's potential impending death and adjust
      following the patient's ICU death or discharge.

      This study is designed to obtain information on its feasibility, tolerability, acceptability,
      and preliminary effect size estimates to inform the planning of a larger, efficacy randomized
      controlled trial (RCT). In order to develop the RCT, the first 10 surrogate decision-makers
      were enrolled in an open trial to receive EMPOWER. In addition, during the manual refinement
      phase, up to 15 stakeholders (bereaved caregivers of ICU patients) were interviewed after
      reviewing the EMPOWER intervention manual. We then began a pilot RCT, randomizing surrogate
      decision-makers to receive either EMPOWER or enhanced usual care using a block-randomization
      strategy to determine condition assignment. In light of restrictions on recruitment and
      increased needs of surrogates during the COVID-19 pandemic, we paused the RCT portion of this
      trial and we recruited for a second open trial only administering EMPOWER. 60
      surrogate-patient dyads were enrolled between the RCT and COVID-19 open trial. In August
      2021, we resumed the RCT trial of the study. We resumed in person recruitment and
      randomization of participants to EMPOWER or EUC. Including the first open trial, we will
      enroll a total of 70 surrogate decision-makers of 70 current patients from the intensive care
      units at New York Presbyterian-Weill Cornell, New York Presbyterian-Queens, and Memorial
      Sloan Kettering Cancer Center. Research staff will regularly contact ICU physicians in person
      or by email and/or screen patient charts to identify eligible candidates based on the
      inclusion criteria.

      Surrogates will be consented and screened. Those who score above 5 on either item measuring
      anxiety in the McGill Quality of Life Scale, or with a summed score of at least 8 on the
      first two items of the Partner Dependency Scale (PDS) will be randomized to receive EMPOWER
      or usual care in the RCT, or solely assigned to receive the intervention in the pilot trials.
      Surrogates will be assessed pre-intervention/baseline (Time point 1, T1), post-intervention
      (within a week of the surrogate's completion of the baseline assessment) (Time point 2, T2),
      1-month post-T2 (Time point 3, T3), and 3-months post-T2(Time point 4, T4). Surrogates will
      be assigned to either control (usual care) or intervention group using block randomization in
      the RCT, and solely to EMPOWER in open trials.

      EMPOWER is based on well-established cognitive-behavioral techniques that aim to promote the
      expression and understanding of a person's emotional reactions. The EMPOWER interventionist
      will be compassionate and attempt to teach subjects tools for remaining present-focused,
      validate participants' experience, explore participants' loved ones' and participants' own
      wishes, values and decision challenges, increase subjects acceptance and sense of permission
      to experience challenging emotions, and prepare participants for future distressing
      situations. Enhanced usual care will consist of a surrogate's interactions with social
      support services in the ICU as documented in the patient's medical chart, referrals for
      current site-specific resources for informal caregivers, and a packet providing general
      information and tips on serving as an informal caregiver.

      HLM modeling will determine differences between surrogates and patients assigned to EMPOWER
      vs. enhanced usual care. The primary outcome is post-intervention (T2) differences on a
      measure of peritraumatic distress. Secondary outcomes are differences on measures of
      prolonged grief disorder, PTSD and experiential avoidance at one-month (T3) and three-month
      (T4) follow up from T2. Exploratory outcomes for surrogates are differences in reported
      symptoms of anxiety, depression, and decision regret at one-month (T3) and three-month (T4)
      follow up from T2. Exploratory outcomes for patients are differences in surrogate-reported
      quality of life, quality of death, and value concordant care. HLM models will include
      covariates, either as fixed-effect or time-varying, if those variables are found to be
      significantly statistically associated with both intervention assignment and the outcome
      examined.

      Following a review of the open trial pilot data and stakeholder feedback to evaluate our
      intervention targets, assessments and the primary outcome in the RCT were revised to target
      the effects of the EMPOWER intervention on peri (rather than post) traumatic stress.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Open trial pilot and manual refinement phase followed by randomized controlled trial. Due to the COVID-19 pandemic, we included the open-trial COVID-19 phase to adjust to new circumstances. We resumed the randomized controlled trial once it was safe to do so.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Peritraumatic Distress Inventory
time frame: In the week following the intervention (T2)
description: Symptoms of peritraumatic distress, as measured by the Peritraumatic Distress Inventory (adapted to fit the ICU experience), will be compared between groups at post-intervention assessment (T2). The PDI consists of 13 likert-style items and total score can range from 0 to 52. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
measure: Anticipatory Grief
time frame: One month and three months from baseline (T3 and T4)
description: Anticipatory grief for patients who are not deceased, as measured by the Prolonged Grief-12, will be compared between groups at one-month and three-month follow up assessments (T3 and T4).The PG-12 consists of 12 items and total score can range from 0 to 57. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
measure: Prolonged Grief Disorder
time frame: One month and three months from baseline (T3 and T4)
description: Symptoms of prolonged grief disorder, as measured by the Prolonged Grief-13, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The PG-13 consists of 13 items and total score can range from 0 to 62. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
measure: Experiential Avoidance
time frame: One month and three months from baseline (T3 and T4)
description: Symptoms of experiential avoidance, as measured by the Brief Experiential Avoidance Questionnaire, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The BEAQ consists of 15 items and total score can range from 15 to 90. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
measure: Post-Traumatic Stress Disorder
time frame: One month and three months from baseline (T3 and T4)
description: Symptoms of post-traumatic stress disorder, as measured by the Impact of Events Scale-Revised, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The IES-R consists of 22 items and total score can range from 0 to 88. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
measure: Patient Quality of Life
time frame: From baseline assessment to three-month follow up
description: Logistic regression models will regress patient quality of life for EMPOWER vs. the enhanced usual care condition. Patient quality of life will be assessed using three previously validated items. Total score can range from 0 to 30. Higher total scores represent better caregiver-assessed patient quality of life. Higher scores represent better outcomes.
measure: Patient Quality of Death
time frame: From baseline assessment to three-month follow up
description: For patients who die during the study period, logistic regression models will regress patient quality of death for EMPOWER vs. the enhanced usual care condition. Quality of Death will be measured using the Caregiver Evaluation of the Quality of End-of-Life Care (CEQUEL). Total score can range from 13 to 26. Higher total scores represent better caregiver-assessed patient quality of death. Higher total scores represent better outcomes.
measure: Value-Concordant Care
time frame: From baseline assessment to three-month follow up
description: Intensity of care (measured through indication of cardiopulmonary resuscitation, dialysis, mechanical ventilation, chemotherapy, parenteral nutrition, and palliative care in the medical record) will be matched with surrogate perceptions of patient treatment preferences to create a measure of value-concordant care.
Logistic regression analyses will then model the effects of EMPOWER on the odds of patients' receipt of value-concordant care. Higher odds equal better outcomes.
measure: Anxiety
time frame: One month and three months from baseline (T3 and T4)
description: Symptoms of anxiety, as measured by the state scale of the State-Trait Anxiety Scale, will be compared between groups at one-month and three-month follow up assessments (T3 and T4).The STAI-Y state scale consists of 20 items and total score can range from 20 to 80. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
measure: Depression
time frame: One month and three months from baseline (T3 and T4)
description: Symptoms of anxiety, as measured by the Patient Health Questionnaire - 9 , will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The PHQ-9 consists of 9 items and total score can range from 0 to 27. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
measure: Decision Regret
time frame: One month and three months from baseline (T3 and T4)
description: Decision regret, as measured by the Decision Regret Scale, will be compared between groups at one-month and three-month follow up assessments (T3 and T4). The decision regret scale is a one-item likert-style measure. Total score can range from 1 to 10. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
arm group label: Randomized controlled trial EMPOWER arm
arm group type: Experimental
description: The EMPOWER arm includes six 15 minute modules delivered in a 1-on-1 format with the same interventionist, and 2 boosters (approximately 45 minutes each) conducted by phone.
Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the EMPOWER intervention within 3 months conducted in person and by phone.
arm group label: Randomized controlled trial Enhanced usual care arm
arm group type: Placebo Comparator
description: The usual care arm indicates regular ICU support for informal caregivers (i.e. social work, chaplaincy) as recorded in the patient's medical record, a general information packet for informal caregivers, and a site-specific resource list.
Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the usual care within 3 months conducted in person and by phone.
arm group label: Open-trial phase arm
arm group type: Experimental
description: The open-trial phase arm includes 10 participants who all received EMPOWER. Data from the open trial of 10 surrogate decision-makers will identify tactical and measurement issues involved in the delivery and outcomes measurements used in EMPOWER.
arm group label: Manual refinement phase arm
arm group type: No Intervention
description: This phase involves obtaining feedback about the EMPOWER intervention manual using qualitative analysis from 15 stakeholders.
arm group label: Open trial COVID-19 phase arm
arm group type: Experimental
description: The COVID-19 open trial phase arm did not include randomization or control arm. All participants received the EMPOWER intervention. Assessments will occur pre-intervention, immediately post-intervention, and then 1-month and 3-months from post-intervention assessment.
intervention type: Behavioral
intervention name: EMPOWER
description: EMPOWER is a manualized treatment delivered based in cognitive behavioral and acceptance and commitment therapies delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psychoeducation, imaginal dialogue with the patient, and coping rehearsal techniques.
The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.
arm group label: Open trial COVID-19 phase arm
arm group label: Open-trial phase arm
arm group label: Randomized controlled trial EMPOWER arm
intervention type: Other
intervention name: Enhanced Usual Care
description: Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.
arm group label: Randomized controlled trial Enhanced usual care arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Holly G Prigerson, Ph. D.
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Hillary Winoker, B.A.
phone: 646 962 7143
email: hiw4002@med.cornell.edu
last name: Wendy Lichtenthal, Ph. D.
phone: 646-888-4812
email: lichtenw@mskcc.org
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
country: United States
url: https://projectreporter.nih.gov/project_info_description.cfm?aid=8245810&icde=35069156&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball=
description: Randomized Trial of an Interdisciplinary Communication Intervention to Improve Patient End-of-Life Outcomes, (PI: Curtis, J. R.)
url: https://projectreporter.nih.gov/project_info_description.cfm?aid=7781300&icde=35069273&ddparam=&ddvalue=&ddsub=&cr=1&csb=default&cs=ASC&pball=
description: Informing Decisions in Chronic Critical Illness: An RCT, (PIs: Nelson, J. E., Carson, S.)
citation: Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, Mitchell SL, Jackson VA, Block SD, Maciejewski PK, Prigerson HG. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008 Oct 8;300(14):1665-73. doi: 10.1001/jama.300.14.1665.
PMID: 18840840
citation: Zhang B, Nilsson ME, Prigerson HG. Factors important to patients' quality of life at the end of life. Arch Intern Med. 2012 Aug 13;172(15):1133-42. doi: 10.1001/archinternmed.2012.2364.
PMID: 22777380
citation: Gamez W, Chmielewski M, Kotov R, Ruggero C, Watson D. Development of a measure of experiential avoidance: the Multidimensional Experiential Avoidance Questionnaire. Psychol Assess. 2011 Sep;23(3):692-713. doi: 10.1037/a0023242.
PMID: 21534697
citation: Prigerson HG, Shear MK, Jacobs SC, Reynolds CF 3rd, Maciejewski PK, Davidson JR, Rosenheck R, Pilkonis PA, Wortman CB, Williams JB, Widiger TA, Frank E, Kupfer DJ, Zisook S. Consensus criteria for traumatic grief. A preliminary empirical test. Br J Psychiatry. 1999 Jan;174:67-73. doi: 10.1192/bjp.174.1.67.
PMID: 10211154
citation: Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol. 2010 Mar 1;28(7):1203-8. doi: 10.1200/JCO.2009.25.4672. Epub 2010 Feb 1.
PMID: 20124172
citation: Garrido MM, Prigerson HG. The end-of-life experience: modifiable predictors of caregivers' bereavement adjustment. Cancer. 2014 Mar 15;120(6):918-25. doi: 10.1002/cncr.28495. Epub 2013 Dec 2.
PMID: 24301644
citation: Wright AA, Keating NL, Balboni TA, Matulonis UA, Block SD, Prigerson HG. Place of death: correlations with quality of life of patients with cancer and predictors of bereaved caregivers' mental health. J Clin Oncol. 2010 Oct 10;28(29):4457-64. doi: 10.1200/JCO.2009.26.3863. Epub 2010 Sep 13.
PMID: 20837950
citation: Siegel MD, Hayes E, Vanderwerker LC, Loseth DB, Prigerson HG. Psychiatric illness in the next of kin of patients who die in the intensive care unit. Crit Care Med. 2008 Jun;36(6):1722-8. doi: 10.1097/CCM.0b013e318174da72.
PMID: 18520637
citation: Curtis JR, Back AL, Ford DW, Downey L, Shannon SE, Doorenbos AZ, Kross EK, Reinke LF, Feemster LC, Edlund B, Arnold RW, O'Connor K, Engelberg RA. Effect of communication skills training for residents and nurse practitioners on quality of communication with patients with serious illness: a randomized trial. JAMA. 2013 Dec 4;310(21):2271-81. doi: 10.1001/jama.2013.282081. Erratum In: JAMA. 2014 Apr 2;311(13):1360.
PMID: 24302090
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
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.
PMID: 27380343
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.
PMID: 15665319
citation: Orsillo SM, Batten SV. Acceptance and commitment therapy in the treatment of posttraumatic stress disorder. Behav Modif. 2005 Jan;29(1):95-129. doi: 10.1177/0145445504270876.
PMID: 15557480
citation: Kentish-Barnes N, Prigerson HG. Is this bereaved relative at risk of prolonged grief? Intensive Care Med. 2016 Aug;42(8):1279-81. doi: 10.1007/s00134-015-4182-6. Epub 2015 Dec 23. No abstract available.
PMID: 26699916
citation: Higgins PC, Garrido MM, Prigerson HG. Factors Predicting Bereaved Caregiver Perception of Quality of Care in the Final Week of Life: Implications for Health Care Providers. J Palliat Med. 2015 Oct;18(10):849-57. doi: 10.1089/jpm.2015.29001.hp. Epub 2015 Jul 17.
PMID: 26186021
citation: Mouthaan J, Sijbrandij M, de Vries GJ, Reitsma JB, van de Schoot R, Goslings JC, Luitse JS, Bakker FC, Gersons BP, Olff M. Internet-based early intervention to prevent posttraumatic stress disorder in injury patients: randomized controlled trial. J Med Internet Res. 2013 Aug 13;15(8):e165. doi: 10.2196/jmir.2460.
PMID: 23942480
citation: Gartlehner G, Forneris CA, Brownley KA, Gaynes BN, Sonis J, Coker-Schwimmer E, Jonas DE, Greenblatt A, Wilkins TM, Woodell CL, Lohr KN. Interventions for the Prevention of Posttraumatic Stress Disorder (PTSD) in Adults After Exposure to Psychological Trauma [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. Report No.: 13-EHC062-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK133344/
PMID: 23658936
citation: Bryant RA, Mastrodomenico J, Felmingham KL, Hopwood S, Kenny L, Kandris E, Cahill C, Creamer M. Treatment of acute stress disorder: a randomized controlled trial. Arch Gen Psychiatry. 2008 Jun;65(6):659-67. doi: 10.1001/archpsyc.65.6.659.
PMID: 18519824
citation: Andrews B, Brewin CR, Stewart L, Philpott R, Hejdenberg J. Comparison of immediate-onset and delayed-onset posttraumatic stress disorder in military veterans. J Abnorm Psychol. 2009 Nov;118(4):767-77. doi: 10.1037/a0017203.
PMID: 19899846
citation: Prigerson HG, Horowitz MJ, Jacobs SC, Parkes CM, Aslan M, Goodkin K, Raphael B, Marwit SJ, Wortman C, Neimeyer RA, Bonanno GA, Block SD, Kissane D, Boelen P, Maercker A, Litz BT, Johnson JG, First MB, Maciejewski PK. Prolonged grief disorder: Psychometric validation of criteria proposed for DSM-V and ICD-11. PLoS Med. 2009 Aug;6(8):e1000121. doi: 10.1371/journal.pmed.1000121. Epub 2009 Aug 4. Erratum In: PLoS Med. 2013 Dec;10(12). doi:10.1371/annotation/a1d91e0d-981f-4674-926c-0fbd2463b5ea. Bonanno, George [corrected to Bonanno, George A].
PMID: 19652695
citation: Tomarken A, Holland J, Schachter S, Vanderwerker L, Zuckerman E, Nelson C, Coups E, Ramirez PM, Prigerson H. Factors of complicated grief pre-death in caregivers of cancer patients. Psychooncology. 2008 Feb;17(2):105-11. doi: 10.1002/pon.1188.
PMID: 17443644
citation: Prigerson HG, Viola M, Brewin CR, Cox C, Ouyang D, Rogers M, Pan CX, Rabin S, Xu J, Vaughan S, Gordon-Elliot JS, Berlin D, Lief L, Lichtenthal WG. Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience (EMPOWER) among Surrogate Decision-Makers of ICU Patients: study protocol for a randomized controlled trial. Trials. 2019 Jul 9;20(1):408. doi: 10.1186/s13063-019-3515-0.
PMID: 31288829
responsible party type: Sponsor
mesh term: Communication Disorders
mesh term: Critical Illness