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

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 unable to
communicate their EoL care preferences. 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 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 the larger, efficacy
randomized controlled trial (RCT). Our study will consist of a preliminary open trial (n =
10) followed by a parallel-arm RCT (n = 60) comparing EMPOWER to usual care. In total, we
will enroll 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. Patients will be comatose or sedated on a ventilator or otherwise
will not be able to communicate or decide on the treatment planning. Research staff will
contact ICU physicians and/or fellows in person or by email regularly 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 trial.
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-baseline (Time point 3, T3), and 3-months post-baseline (Time point 4, T4).
Surrogates will be assigned to either control (usual care) or intervention group using block
randomization. Approximately 20 ICU clinicians who are working with the patients and
surrogate decision-makers will also be surveyed about their perceptions of the effects of
EMPOWER.

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. Exploratory outcomes are differences in reported symptoms of anxiety,
depression, and decision regret at one-month (T3) and three-month (T4) follow up. 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.

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 and pilot RCT participants:

1. Patients (>21 years) in the ICU/step-down units who cannot communicate and decide on
treatments and whose ICU physicians or fellows would not be surprised if the patient
did not survive more than 3 months

2. Informal caregivers 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 record

3. Informal caregivers must speak English

4. Informal caregivers must either meet the threshold for a high degree of emotional
dependence (BDS score >8) on the patient or significant anxiety on the McGill Quality
of Life Scale items (either anxiety item score >5).

5. ICU attendings whose patients are enrolled in the study

Exclusion Criteria:

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