Clinical trial NCT03276559: Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients
Official title: Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Communication Disabilities
Keywords: critically ill
ICU
uncommunicative
caregivers
surrogate
decision-making
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: New York Hospital Queens
name: Memorial Sloan Kettering Cancer Center
name: National Cancer Institute (NCI)
First posted: 2017-09-08
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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). 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).

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.

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.

Primary outcomes:
measure: Change in Peritraumatic Distress Inventory
timeFrame: At baseline (T1) and in the week following the intervention (T2)
Secondary outcomes:
measure: Change in Anticipatory Grief
timeFrame: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).
measure: Change in Experiential Avoidance
timeFrame: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).
measure: Change in Post-Traumatic Stress Disorder
timeFrame: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).
Other outcomes:
measure: Change in Anxiety
timeFrame: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).
measure: Change in Depression
timeFrame: At baseline (T1), one month and three months from baseline (T3 and T4).
measure: Change in Decision Regret
timeFrame: At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).
Locations:
city: Flushing
country: United States
facility: NewYork-Presbyterian Queens
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Holly G Prigerson, Ph. D.
role: PRINCIPAL_INVESTIGATOR
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