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 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.