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

Обзор

Hypotheses 1a and 1b: Compared to Supportive Conversation arm, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patients' value-concordant care (secondary outcomes) at T1-T4. Hypothesis 2. Qualitative data will provide insights not captured by quantitative data. Hypothesis 3. Reductions in experiential avoidance will mediate reductions in grief and Post Traumatic Stress Disorder (PTSD) symptoms, highlighting it as important to target in future implementation.

Подробное описание

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.

Вмешательства

• Поведенческое EMPOWER
  EMPOWER is a manualized treatment delivered based in cognitive behavioral and acceptance and commitment therapies delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psychoeducation, imaginal dialogue with the patient, and coping rehearsal techniques. The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate th
• Другое Supportive Conversation
  The Supportive Conversation will match the time and attention offered through EMPOWER, so will be about 1.5-2 hours and will have two additional follow-up calls.

Первичные конечные точки

• Change of Prolonged Grief Disorder [Срок оценки: from baseline through twelve-month follow-up]
• Change of Post-Traumatic Stress Disorder [Срок оценки: From baseline through twelve-month follow-up]
• Change of Anticipatory Grief [Срок оценки: from baseline through twelve-month follow-up]

Вторичные конечные точки (4)

• Change of Depression [Срок оценки: From baseline through twelve-month follow-up]
• Change of Regret [Срок оценки: From baseline through twelve-month follow-up]
• Change of Peritraumatic Distress [Срок оценки: 1 week following the intervention through twelve-month follow-up .]
• Change of Anxiety [Срок оценки: From baseline through twelve-month follow-up]

Критерии участия

Критерии включения

• Patients who, during their hospital stay, have been admitted to the ICU and are near EoL, as indicated by a modified "surprise question" whereby physicians are asked to identify patients whom they do not expect to survive the next 12 months.
• Surrogate decision-makers of patients who were admitted to the ICU or step-down unit during their current admission/stay, or within 1 month of discharge from their last admission/stay.
• Surrogate decision-makers are 18 years or older.
• Surrogate decision-makers whom physicians or advance practice providers (i.e. physician assistants, nurse practitioners) 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.
• Surrogate decision-makers must speak English.
• Surrogate decision-makers must report "syndromal" levels of pre-loss grief (PG-12 score ≥ 25) or peritraumatic distress (PDI ≥ 23).
• Surrogate decision makers will need to reside in a state in which an interventionist is licensed or otherwise be able to comply with current telehealth regulations.
• Surrogate decision-makers will need to be willing to utilize a device (computer, tablet, phone) with internet.
• Surrogate decision-makers who are able and willing to provide an emergency contact.

Критерии исключения

• Patients and surrogate decision-makers who do not meet the eligibility criteria.
• Surrogate decision-makers who indicate the presence of cognitive impairment based on responses to the Ultra-Brief Confusion Assessment Method and/or significant psychiatric or cognitive disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent.
• Surrogate-decision makers who endorse suicidal ideation in the past month based on responses to the Columbia Suicide Severity Rating Scale.
• Surrogate-decision makers who are unable to access a functional device for videoconferencing and decline the offer to use a study loner device.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• University of Miami — Miami
• Memorial Sloan Kettering Cancer Center — New York
• NewYork-Presbyterian Weill Cornell Medicine — New York

Публикации

• Derry HM, Lief L, Schenck EJ, Berlin DA, Prigerson HG. Peritraumatic Stress among Caregivers of Patients in the Intensive Care Unit. Ann Am Thorac Soc. 2020 May;17(5):650-654. doi: 10.1513/AnnalsATS.201908-647RL. No abstract available. PMID 32068429
• Givens JL, Prigerson HG, Kiely DK, Shaffer ML, Mitchell SL. Grief among family members of nursing home residents with advanced dementia. Am J Geriatr Psychiatry. 2011 Jun;19(6):543-50. doi: 10.1097/JGP.0b013e31820dcbe0. PMID 21606897
• Maciejewski PK, Prigerson HG. Emotional numbness modifies the effect of end-of-life discussions on end-of-life care. J Pain Symptom Manage. 2013 May;45(5):841-7. doi: 10.1016/j.jpainsymman.2012.04.003. Epub 2012 Aug 25. PMID 22926093
• Siegel MD, Hayes E, Vanderwerker LC, Loseth DB, Prigerson HG. Psychiatric illness in the next of kin of patients who die in the intensive care unit. Crit Care Med. 2008 Jun;36(6):1722-8. doi: 10.1097/CCM.0b013e318174da72. PMID 18520637
• Wright AA, Keating NL, Balboni TA, Matulonis UA, Block SD, Prigerson HG. Place of death: correlations with quality of life of patients with cancer and predictors of bereaved caregivers' mental health. J Clin Oncol. 2010 Oct 10;28(29):4457-64. doi: 10.1200/JCO.2009.26.3863. Epub 2010 Sep 13. PMID 20837950
• Wright AA, Zhang B, Ray A, Mack JW, Trice E, Balboni T, Mitchell SL, Jackson VA, Block SD, Maciejewski PK, Prigerson HG. Associations between end-of-life discussions, patient mental health, medical care near death, and caregiver bereavement adjustment. JAMA. 2008 Oct 8;300(14):1665-73. doi: 10.1001/jama.300.14.1665. PMID 18840840
• Zhang B, Nilsson ME, Prigerson HG. Factors important to patients' quality of life at the end of life. Arch Intern Med. 2012 Aug 13;172(15):1133-42. doi: 10.1001/archinternmed.2012.2364. PMID 22777380
• Bronsther R. Visitor Restrictions During COVID-19 Pandemic May Impact Surrogate Medical Decision-Making. J Patient Exp. 2020 Aug;7(4):428-429. doi: 10.1177/2374373520938489. Epub 2020 Jun 30. No abstract available. PMID 33062852

Идентификаторы

NCT: NCT05587517 · 21-09023929 · R01NR019831

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗