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.
