Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients (EMPOWER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03276559
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : July 20, 2020
Sponsor:
Collaborators:
New York Hospital Queens
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

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). 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, a second single arm open trial is now occurring while the RCT recruitment is paused (total n of RCT & COVID-19 open trial=60).


Condition or disease Intervention/treatment Phase
Critical Illness Communication Disabilities Behavioral: EMPOWER Other: Enhanced Usual Care Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open trial pilot and stakeholder feedback followed by randomized controlled trial. Due to the COVID-19 pandemic, the RCT is now paused while a second open trial evaluating the EMPOWER intervention is underway.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Arm Intervention/treatment
Experimental: EMPOWER arm

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.

Behavioral: EMPOWER

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.


Placebo Comparator: Enhanced usual care arm

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.

Other: Enhanced Usual Care
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.




Primary Outcome Measures :
  1. Peritraumatic Distress Inventory [ Time Frame: In the week following the intervention (T2) ]
    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.


Secondary Outcome Measures :
  1. Anticipatory Grief [ Time Frame: One month and three months from baseline (T3 and T4) ]
    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.

  2. Prolonged Grief Disorder [ Time Frame: One month and three months from baseline (T3 and T4) ]
    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.

  3. Experiential Avoidance [ Time Frame: One month and three months from baseline (T3 and T4) ]
    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.

  4. Post-Traumatic Stress Disorder [ Time Frame: One month and three months from baseline (T3 and T4) ]
    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.


Other Outcome Measures:
  1. Patient Quality of Life [ Time Frame: From baseline assessment to three-month follow up ]
    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.

  2. Patient Quality of Death [ Time Frame: From baseline assessment to three-month follow up ]
    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.

  3. Value-Concordant Care [ Time Frame: From baseline assessment to three-month follow up ]

    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.


  4. Anxiety [ Time Frame: One month and three months from baseline (T3 and T4) ]
    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.

  5. Depression [ Time Frame: One month and three months from baseline (T3 and T4) ]
    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.

  6. Decision Regret [ Time Frame: One month and three months from baseline (T3 and T4) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For stakeholders:

  1. Bereaved family caregivers of patients treated in the ICU identified by referring clinicians and through support groups, clinics, and word of mouth
  2. Clinicians with expertise in mental health care and/or critical care including but not limited to nurses, nurse practitioners, social workers, psychologists, psychiatrists, hospital chaplains, and physicians

For open trial participants:

  1. Patients (>21 years) who cannot communicate and decide on treatments, who during the course of their current hospital stay were admitted to an ICU/step-down unit, and whose ICU physicians or fellows would not be surprised if the patient did not survive more than 3 months
  2. Surrogate decision-makers whom ICU physicians or fellows indicate as the designated health care proxy or decision-making patient surrogates, or who are listed as such in the patient's medical charts
  3. Surrogate decision-makers must speak English
  4. Surrogate decision-makers must either meet the threshold for a high degree of emotional dependence (PDS 18 score >8) on the patient or on the McGill Quality of Life Scale items (either anxiety item score>5).

For pilot RCT participants:

  1. Patients (>18 years) who during the course of their current hospital stay were admitted to an ICU/step-down unit, and whose ICU physicians or fellows would not be surprised if the patient did not survive more than 3 months
  2. Surrogate decision-makers whom ICU physicians or fellows indicate as the designated health care proxy or decision-making patient surrogates, or who are listed as such in the patient's medical charts
  3. Surrogate decision-makers must speak English
  4. Surrogate decision-makers must either meet the threshold for a high degree of emotional dependence (PDS 18 score >8) on the patient or on the McGill Quality of Life Scale 19 items (either anxiety item score>5).
  5. Surrogate decision-makers who do not meet criterion #4 but are identified by clinical staff as distressed and whom clinical staff believe would benefit from the intervention.

For COVID-19 Open Trial:

  1. Patients (>18 years) who during the course of their current hospital stay were admitted to an ICU/step-down unit
  2. Surrogate decision-makers whom a member of the patient's care team indicate as the designated health care proxy or decision-making patient surrogates, or who are listed as such in the patient's medical charts
  3. Surrogate decision-makers must speak English
  4. Surrogate decision-makers must either meet the threshold for a high degree of emotional dependence (PDS 18 score >8) on the patient or on the McGill Quality of Life Scale 19 items (either anxiety item score>5).
  5. Surrogate decision-makers who do not meet criterion #4 but are identified by clinical staff as distressed and whom clinical staff believe would benefit from the intervention.

Exclusion Criteria for open trials and RCT:

1. Patients and caregivers who do not meet the eligibility criteria or informal caregivers who endorse suicidal ideation in the past month based on responses to the Columbia Suicide Severity Rating Scale


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276559


Contacts
Layout table for location contacts
Contact: Martin Viola, M.A. 646 962 5045 mav4001@med.cornell.edu
Contact: Wendy Lichtenthal, Ph. D. 646-888-4812 lichtenw@mskcc.org

Locations
Layout table for location information
United States, New York
NewYork-Presbyterian Queens Completed
Flushing, New York, United States, 11355
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Wendy Lichtenthal, PhD    646-888-4812      
Principal Investigator: Wendy Lichtenthal, PhD         
NewYork-Presbyterian Weill Cornell Medicine Active, not recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
New York Hospital Queens
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Holly G Prigerson, Ph. D. Weill Cornell Medicine
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03276559    
Other Study ID Numbers: 1610017622
R21CA218313 ( U.S. NIH Grant/Contract )
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
critically ill
ICU
uncommunicative
caregivers
surrogate
decision-making
Additional relevant MeSH terms:
Layout table for MeSH terms
Communication Disorders
Critical Illness
Disease Attributes
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders