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CompletedNCT03276559EMPOWERUpdated Aug 20, 2024Results posted

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

An interventional study of EMPOWER and Enhanced Usual Care in Critical Illness and Communication Disabilities, sponsored by Weill Medical College of Cornell University. Completed at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-20.

Primary conditionCritical Illness(the registry's first term)UnverifiedIs this wrong?Critical Illness is a broad heading, used only when no more specific condition is named. No better condition is named, so the registry's term is kept.

Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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).

Read the detailed description

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.

02

Conditions studied

  • Critical Illness
  • Communication Disabilities

Browse trials for

Keywords

  • critically ill
  • ICU
  • uncommunicative
  • caregivers
  • surrogate
  • decision-making
03

In context

Critical Illness Unverified

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's enrollment of 63 is below the median of 90 across 926 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.

Browse Weill Medical College of Cornell University studies →

Compared within Critical Illness, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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

Inclusion criteria 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 Scale19 items (either anxiety item score>5).

Inclusion criteria for adult pilot RCT participants:

  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 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 or by self-report of the surrogate
  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.

Inclusion criteria child pilot RCT/COVID-19 Open Trial participants:

  1. Patients below the age of 18 who have spent at least 3 days in a pediatric intensive care unit
  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 or by self-report of the surrogate, or are parents of the patient
  3. Surrogate decision-makers must speak English

Inclusion criteria for adult open trial COVID-19 participants:

  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 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 all arms:

Patients and surrogate decision-makers who do not meet the eligibility criteria or surrogate decision-makers who endorse suicidal ideation in the past month based on responses to the Columbia Suicide Severity Rating Scale.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
63 participants (actual)

Study arms

  • Experimental
    Randomized controlled trial 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

  • Placebo comparator
    Randomized controlled trial 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

  • Experimental
    Open trial COVID-19 phase arm

    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.

    Behavioral: EMPOWER

Interventions

  • BehavioralEMPOWER

    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.

  • OtherEnhanced 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.

06

What researchers measure

Primary outcomes

  1. Change in Peritraumatic Distress Inventory

    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.

    Time frame: At baseline (T1) and in the week following the intervention (T2)

Secondary outcomes

  1. Change in Anticipatory Grief

    Anticipatory grief for patients who are not deceased, as measured by the Prolonged Grief-12, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (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.

    Time frame: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).

  2. Change in Experiential Avoidance

    Symptoms of experiential avoidance, as measured by the Brief Experiential Avoidance Questionnaire, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (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.

    Time frame: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).

  3. Change in Post-Traumatic Stress Disorder

    Symptoms of post-traumatic stress disorder, as measured by the Impact of Events Scale-Revised, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (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.

    Time frame: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).

Other outcomes

  1. Change in Anxiety

    Symptoms of anxiety, as measured by the state scale of the State-Trait Anxiety Scale, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (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.

    Time frame: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).

  2. Change in Depression

    Symptoms of depression, as measured by the Patient Health Questionnaire - 9 , will be compared between groups at baseline (T1), one month and three months from baseline (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.

    Time frame: At baseline (T1), one month and three months from baseline (T3 and T4).

  3. Change in Decision Regret

    Decision regret, as measured by the Decision Regret Scale, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4). The decision regret scale is a five-item measure, on a scale from 1-5. Total scores will be added up, and higher scores represent greater decision regret. Lower scores represent less decision regret. The maximum score is 25 and the minimum score is 5.

    Time frame: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).

07

Results

Posted Aug 20, 2024
Limitations and caveats
A caveat to the statistical analyses performed for this trial is that the original proposal assumed that there would be an "interventionist bias" for which we would need to adjust using approaches such as Hierarchical Linear Modeling (HLM). This resulted in a deviation from the original proposed use of HLM because there was no need to correct for clustering within interventionists.

Participant flow

T1 Assessment
Participant flow — T1 Assessment
MilestoneRandomized Controlled Trial EMPOWER ArmRandomized Controlled Trial Enhanced Usual Care ArmOpen Trial COVID-19 Phase ArmT1 Assessment
Started00063
Completed00063
Not completed0000
Randomization
Participant flow — Randomization
MilestoneRandomized Controlled Trial EMPOWER ArmRandomized Controlled Trial Enhanced Usual Care ArmOpen Trial COVID-19 Phase ArmT1 Assessment
Started10700
Completed5500
Not completed5200
EMPOWER Only
Participant flow — EMPOWER Only
MilestoneRandomized Controlled Trial EMPOWER ArmRandomized Controlled Trial Enhanced Usual Care ArmOpen Trial COVID-19 Phase ArmT1 Assessment
Started00230
Completed00140
Not completed0090
Randomization
Participant flow — Randomization
MilestoneRandomized Controlled Trial EMPOWER ArmRandomized Controlled Trial Enhanced Usual Care ArmOpen Trial COVID-19 Phase ArmT1 Assessment
Started101000
Completed5600
Not completed5400

Outcome measures

PrimaryChange in Peritraumatic Distress Inventory

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.

Time frame:
At baseline (T1) and in the week following the intervention (T2)
Reported as:
Mean · score on a scale
Change in Peritraumatic Distress Inventory
score on a scaleRandomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm CombinedRandomized Controlled Trial Enhanced Usual Care Arm
Pre-Intervention Time 114.6 (12.4 to 16.8)14.2 (10.2 to 18.3)
Post-Intervention Time 213.0 (9.9 to 16.0)14.4 (9.2 to 19.5)
SecondaryChange in Anticipatory Grief

Anticipatory grief for patients who are not deceased, as measured by the Prolonged Grief-12, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (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.

Time frame:
At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).
Reported as:
Mean · score on a scale
Change in Anticipatory Grief
score on a scaleRandomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm CombinedRandomized Controlled Trial Enhanced Usual Care Arm
Pre-Intervention Time 129.1 (26.4 to 31.8)24.8 (20.5 to 29.2)
Post-Intervention Time 225.7 (22.8 to 28.6)25.4 (20.9 to 29.0)
One Month Time 324.2 (22.1 to 26.4)26.5 (21.9 to 31.2)
Three Months Time 420.3 (17.8 to 22.9)23.0 (19.3 to 26.7)
SecondaryChange in Experiential Avoidance

Symptoms of experiential avoidance, as measured by the Brief Experiential Avoidance Questionnaire, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (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.

Time frame:
At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).
Reported as:
Mean · score on a scale
Change in Experiential Avoidance
score on a scaleRandomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm CombinedRandomized Controlled Trial Enhanced Usual Care Arm
Pre-Intervention (T1)44.7 (40.3 to 49.1)44.5 (40.2 to 48.9)
Post-Intervention (T2)42.2 (39.2 to 46.3)40.7 (34.7 to 46.7)
One Month Time (T3)43.3 (39.0 to 47.7)48.2 (43.2 to 53.3)
Three Months Time (T4)43.2 (39.0 to 47.4)48.2 (41.1 to 55.3)
SecondaryChange in Post-Traumatic Stress Disorder

Symptoms of post-traumatic stress disorder, as measured by the Impact of Events Scale-Revised, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (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.

Time frame:
At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).
Reported as:
Mean · score on a scale
Change in Post-Traumatic Stress Disorder
score on a scaleRandomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm CombinedRandomized Controlled Trial Enhanced Usual Care Arm
Pre-Intervention (T1)29.9 (25.2 to 34.5)24.6 (15.5 to 33.8)
Post-Intervention (T2)23.1 (17.7 to 28.5)25.8 (16.7 to 34.9)
One Month Time (T3)24.3 (18.3 to 30.2)29.8 (21.0 to 38.7)
Three Months Time (T4)16.0 (12.1 to 19.8)22.1 (14.5 to 29.6)
Other pre-specifiedChange in Anxiety

Symptoms of anxiety, as measured by the state scale of the State-Trait Anxiety Scale, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (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.

Time frame:
At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).
Reported as:
Mean · score on a scale
Change in Anxiety
score on a scaleRandomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm CombinedRandomized Controlled Trial Enhanced Usual Care Arm
Pre-Intervention Time 140.6 (38.3 to 42.9)38.8 (35.4 to 42.3)
Post-Intervention Time 237.0 (34.5 to 39.6)37.4 (33.4 to 41.3)
One Month Time (T3)36.2 (32.9 to 38.5)35.4 (32.1 to 38.7)
Three Month Time (T4)35.2 (32.3 to 38.1)32.2 (28.1 to 36.4)
Other pre-specifiedChange in Depression

Symptoms of depression, as measured by the Patient Health Questionnaire - 9 , will be compared between groups at baseline (T1), one month and three months from baseline (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.

Time frame:
At baseline (T1), one month and three months from baseline (T3 and T4).
Reported as:
Mean · score on a scale
Change in Depression
score on a scaleRandomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm CombinedRandomized Controlled Trial Enhanced Usual Care Arm
Pre-Intervention Time 18.9 (6.7 to 10.4)6.8 (4.3 to 9.2)
One Month Time 36.9 (5.9 to 12.5)9.2 (5.9 to 12.5)
Three Months Time 47.6 (5.6 to 9.6)8.2 (5.4 to 11.1)
Other pre-specifiedChange in Decision Regret

Decision regret, as measured by the Decision Regret Scale, will be compared between groups at baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4). The decision regret scale is a five-item measure, on a scale from 1-5. Total scores will be added up, and higher scores represent greater decision regret. Lower scores represent less decision regret. The maximum score is 25 and the minimum score is 5.

Time frame:
At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).
Reported as:
Mean · score on a scale
Change in Decision Regret
score on a scaleRandomized Controlled Trial EMPOWER + Open Trial COVID-19 Phase Arm CombinedRandomized Controlled Trial Enhanced Usual Care Arm
Pre-Intervention Time 117.2 (10.3 to 24.1)19.4 (8.0 to 30.8)
Post-Intervention Time 220.5 (15.3 to 25.6)15.3 (5.7 to 24.9)
One Month Time 324.3 (19.1 to 29.5)18.5 (8.7 to 28.4)
Three Months Time 419.1 (14.2 to 23.9)22.6 (13.7 to 31.6)

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Randomized Controlled Trial EMPOWER Arm0/18 (0%)0/18 (0%)0/18 (0%)
Randomized Controlled Trial Enhanced Usual Care Arm0/17 (0%)0/17 (0%)0/17 (0%)
Open Trial COVID-19 Phase Arm0/25 (0%)0/25 (0%)0/25 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Randomized Controlled Trial EMPOWER ArmRandomized Controlled Trial Enhanced Usual Care ArmOpen Trial COVID-19 Phase ArmTotal
<=18 years0000
Between 18 and 65 years17132353
>=65 years1405
Age, Continuous
Age, Continuous(years)Randomized Controlled Trial EMPOWER ArmRandomized Controlled Trial Enhanced Usual Care ArmOpen Trial COVID-19 Phase ArmTotal
Mean43.635 ± 11.31351.413 ± 15.70542.091 ± 9.28245.303 ± 12.523
Sex: Female, Male
Sex: Female, Male(Participants)Randomized Controlled Trial EMPOWER ArmRandomized Controlled Trial Enhanced Usual Care ArmOpen Trial COVID-19 Phase ArmTotal
Female15131745
Male54615
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Randomized Controlled Trial EMPOWER ArmRandomized Controlled Trial Enhanced Usual Care ArmOpen Trial COVID-19 Phase ArmTotal
Hispanic or Latino54716
Not Hispanic or Latino14101539
Unknown or Not Reported1315
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Randomized Controlled Trial EMPOWER ArmRandomized Controlled Trial Enhanced Usual Care ArmOpen Trial COVID-19 Phase ArmTotal
American Indian or Alaska Native0000
Asian2215
Native Hawaiian or Other Pacific Islander1203
Black or African American32611
White129728
More than one race0000
Unknown or Not Reported22913
Region of Enrollment
Region of Enrollment(Participants)Randomized Controlled Trial EMPOWER ArmRandomized Controlled Trial Enhanced Usual Care ArmOpen Trial COVID-19 Phase ArmTotal
United States20172360
08

Study locations

3 sites
  • NewYork-Presbyterian Queens
    Flushing, New York 11355, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10021, United States
  • NewYork-Presbyterian Weill Cornell Medicine
    New York, New York 10065, United States
09

References and documents

Publications

  • 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. PubMed 18840840 ↗
  • 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. PubMed 22777380 ↗
  • 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. PubMed 21534697 ↗
  • 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. PubMed 10211154 ↗
  • 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. PubMed 20124172 ↗
  • 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. PubMed 24301644 ↗
  • 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. PubMed 20837950 ↗
  • 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. PubMed 18520637 ↗
  • 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. PubMed 24302090 ↗
  • 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. PubMed 17267907 ↗
  • 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. PubMed 27380343 ↗
  • 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. PubMed 15665319 ↗
  • 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. PubMed 15557480 ↗
  • 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. PubMed 26699916 ↗
  • 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. PubMed 26186021 ↗
  • 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. PubMed 23942480 ↗
  • 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/ PubMed 23658936 ↗
  • 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. PubMed 18519824 ↗
  • 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. PubMed 19899846 ↗
  • 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. PubMed 19652695 ↗
  • 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. PubMed 17443644 ↗
  • 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. PubMed 31288829 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03276559
Lead sponsor
Weill Medical College of Cornell University
Collaborators
New York Hospital Queens, Memorial Sloan Kettering Cancer Center, National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 8, 2017
Start date
Jul 12, 2017
Primary completion
May 22, 2023
Completion
May 22, 2023
Results posted
Aug 20, 2024
Last update
Aug 20, 2024

Study contacts

Holly G Prigerson, Ph. D.
principal investigator · Weill Medical College of Cornell University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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