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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587517
• Other study ID #: 21-09023929
• Secondary ID: R01NR019831
• Status: Recruiting
• Phase: Phase 2
• Start date: October 11, 2022
• Est. completion date: December 11, 2027

Study information

• Verified date: December 2023
• Source: Weill Medical College of Cornell University
• Contact: Holly Prigerson, PhD
• Phone: 212-746-1374
• Email: hgp2001[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 172
• Est. completion date: December 11, 2027
• Est. primary completion date: December 11, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 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.

Exclusion Criteria:

• 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.
• 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.

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Grief
• Psychotherapy
• Trauma

Intervention

Behavioral:
• 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 the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	NewYork-Presbyterian Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

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* Note: There are 81 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of Dissociation	Symptoms of dissociation, as measured by the Peritraumatic Dissociative Experiences Questionnaire, will be compared between groups at baseline and the week following the intervention . The PDEQ consists of 10 items scored on a 5-point Likert scale. Scores range from 10 to 50, with higher scores representing greater symptoms of dissociation.	From baseline to the 1 week following the intervention
Other	Change of Distress Tolerance	Symptoms of distress tolerance, as measured by the Distress Tolerance Short Form Scale, will be compared between groups at baseline through the twelve-month follow-up . The DTS-SF consists of four 5-point Likert items measuring the individual's perceived ability to experience and endure negative psychological states.	From baseline through twelve-month follow-up
Other	Change of Surrogate's Quality of Life	Quality of life, as measured by Quality of Life/Death, will be compared between groups at the week following the intervention through the twelve-month follow-up . Scores range from 3 to 30, with lower scores representing better quality of life.	From the 1 week following the intervention through twelve-month follow-up
Other	Satisfaction with Critical Care	Satisfaction with critical care, as measured by Critical Care Family Satisfaction Survey, will be assessed at the three-month follow-up. The CCFSS-EMPOWER version consists of 12 items total, scored using a 1-5 Likert scale. Scores range from 12 to 60. Higher scores represent less satisfaction with care.	At the three-month follow-up
Other	Patient's Symptoms	Surrogate-perceived Patient Symptoms consists of two items on 10-point Likert scale that measure surrogate-perceived patient symptoms of patient pain and dyspnea. This assessment will be administered at baseline by the. Scores range from 1 to 10 each, with higher scores representing greater surrogate-perceived pain or dyspnea.	At baseline
Other	Change of Patient's Quality of Death	Quality of Death will be measured using the Caregiver Evaluation of the Quality of End-of-Life Care (CEQUEL). Total score can range from 13 to 26. Higher total scores represent better caregiver-assessed patient quality of death. Higher total scores represent better outcomes.	From one-month to twelve-month follow-up
Other	Change of General Physical and General Mental Health	PROMIS-GH consists of 10-items, with each utilizing a 7-day recall period. The initial 9-items make us of a 5-point scale, with 3 separate verbal anchors that ask patients to rate their health or abilities, indicate how often they are experiencing a phenomenon or how severe their symptomatic experience is. The final item asks patients to indicate their pain on a 0-10 numeric rating scale.	From baseline through twelve-month follow-up
Primary	Change of Prolonged Grief Disorder	Symptoms of prolonged grief disorder, as measured by the Prolonged Grief-13-Revised, will be compared between the week following the intervention, at one month follow-up and at twelve-month follow-up . The PG-13-R consists of 13 items and total score can range from 0 to 62. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.	from baseline through twelve-month follow-up
Primary	Change of Post-Traumatic Stress Disorder	Symptoms of post-traumatic stress disorder, as measured by the Impact of Events Scale-Revised, will be compared between groups at baseline through twelve-month follow up assessments . The IES-R consists of 22 items and total score can range from 0 to 88. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.	From baseline through twelve-month follow-up
Primary	Change of Anticipatory Grief	Symptoms of anticipatory grief, as measured by the PG-12-R, consists of 12 items using a 5-point Likert scale. Total scores range from 11 to 55, with higher scores representing greater anticipatory grief.	from baseline through twelve-month follow-up
Secondary	Change of Depression	Symptoms of depression, as measured by the Hospital Anxiety and Depression Scale (HADS), will be compared between groups at from baseline through twelve-month follow-up . HADS consists of 7 questions in their 14-item scale that assess depression. Higher scores indicate higher symptom burden. Lower scores represent a normal range.	From baseline through twelve-month follow-up
Secondary	Change of Regret	Regret, as measured by the Decision Regret Scale, will be compared between groups at baseline through twelve-month follow-up . The decision regret scale is a one-item likert-style measure. Total scores can range from 5 to 25. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.	From baseline through twelve-month follow-up
Secondary	Change of Peritraumatic Distress	Symptoms of peritraumatic distress, as measured by the Peritraumatic Distress Inventory (adapted to fi the ICU experience), will be compared between groups in the week following the intervention through the twelve-month-follow up . The PDI consists of 13 likert-style items and total score can range from 0 to 52. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.	1 week following the intervention through twelve-month follow-up .
Secondary	Change of Anxiety	Symptoms of anxiety, as measured by the Hospital Anxiety and Depression Scale (HADS), will be compared between groups at from baseline through twelve-month follow-up ). HADS consists of 7 questions in their 14-item scale that assess anxiety. Higher scores indicate higher symptom burden. Lower scores represent a normal range.	From baseline through twelve-month follow-up