A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients

Intensive Care Units (ICUs) are stressful places fraught with grief for family members

who witness dying loved ones, often in pain, struggling to breathe and/or maintain

consciousness. Compounding their distress, family members are often thrust into the

position of patient "surrogate," needing to make life-and-death decisions on the

patient's behalf. Researchers have shown that end-of-life (EoL) decision-making is

undermined by grief, which interferes with acceptance of the patient's impending death

and leads to care choices that adversely affect patients' quality of care and death.1-3

These circumstances heighten surrogates' risk of meeting criteria for Prolonged Grief

Disorder (PGD), Posttraumatic Stress Disorder (PTSD), and decisional regret about the EoL

care that the patient received, each associated with poor bereavement outcomes.4-7 Nearly

60% of ICU surrogates report moderate to extreme grief; 34% report extreme levels of

peritraumatic stress symptoms.1

The coronavirus (COVID-19) pandemic has made an already bad situation worse. At the start

of the pandemic, social distancing policies forced millions of families to confront

obstacles to communication, medical decision-making, and care.8-10 Surrogates were left

struggling with severe pre-loss grief and peritraumatic stress -- intensely longing to be

near to the patient, confused about their roles, lonely, horrified, angry, disoriented

and emotionally numb.10,11 Now, as the Delta variant creates a new "wave" of mortality

and infection, bereaved family members may have remorse about vaccine refusal,12 feel

guilty for transmitting the virus to the patient, or regret decisions about EoL care.

With over 35 million cases and 600,000 deaths in the United States from COVID-19,13 the

need for psychosocial interventions to support surrogates in the ICU is clear.

Prior efforts to address the plight of family surrogates of critically ill patients have

proved disappointing14-20 - with one ICU intervention significantly increasing the

surrogate's severity of PTSD symptoms.14 A key limitation of these interventions is that

while they targeted psychological outcomes, they were not psychological interventions. To

address this, the investigators developed a brief, flexibly administered

cognitive-behavioral, acceptance-based psychological intervention called EMPOWER

(Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience).21,22 Our

pilot NIH-R21 (N=39) showed that EMPOWER had superior efficacy to enhanced usual care for

reducing symptoms of PGD (d=1.20) and PTSD (d=.99). Consistent with mediation, EMPOWER

reduced experiential avoidance (d=1.20); these reductions were correlated with PGD and

PTSD change scores (p<0.01). Large reductions in decisional regret (d=1.57) were

observed, with no notable differences by surrogate race or delivery format (telehealth

vs. in-person).

Investigators propose to conduct a Phase II mixed methods randomized controlled trial

(RCT) to further evaluate the efficacy of EMPOWER for reducing surrogate symptoms of PTSD

and PGD. Surrogates (N=172) will be randomized to EMPOWER (n=86) or a standardized

supportive conversation (SC; n=86). Effects of the intervention will be assessed via

measures administered pre-intervention (T1), immediately post-intervention (T2), and at 3

months (T3), and 12 months (T4) following the T2 assessment. Investigators will also

conduct semi-structured interviews with surrogates (n≈48) to probe intervention effects

on mental health and explore contextual factors (e.g., medical mistrust, visitation

restrictions) likely to affect surrogates during the pandemic.