Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients

NCT03276559 | Completed Results

• 2 other identifiers: 1610017622R21CA218313
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

Brief Summary

Intensive Care Units (ICU) are stressful places where life-and-death medical decisions are made and patients' surrogate decision-makers are exposed to potentially traumatic experiences. As the number of life-prolonging procedures administered to the patient rises, the patient's quality of life falls. Thus, interventions to improve the quality of life and care of ICU patients are needed. EMPOWER is a cognitive-behavioral, acceptance-based intervention for patient surrogate decision-makers to reduce experiential avoidance of unpleasant thoughts and feelings related to thinking about patient death. By reducing surrogate's experiential avoidance, EMPOWER removes a barrier to advance care planning. EMPOWER aims to improve patient quality of life through enhancing value-directed end-of-life care while also empowering surrogates to cope with a loved one's potential impending death and adjust following the patient's ICU death or discharge. Specifically, investigators aim to:

• 1: Develop EMPOWER for surrogate decision-makers of critically ill patients who are at risk of becoming incapacitated or are currently unable to communicate in the ICU. Key informants, including bereaved ICU patient caregivers and clinicians, will be asked to evaluate the EMPOWER intervention manual to increase its potential tolerability, acceptability and efficacy.
• 2: Determine feasibility, tolerability, acceptability, and preliminary effects of EMPOWER on surrogate mental health.
• 3: Estimate the effects of EMPOWER on patient outcomes in the months following the ICU admission. Hypothesis 1: Surrogate decision-makers who receive EMPOWER will have significantly lower levels of peritraumatic distress when compared to usual care condition at post intervention assessment (T2). Hypothesis 2: Patients whose surrogates receive EMPOWER will have more value-concordant care, better quality of life, and better quality of death. EMPOWER was first evaluated though a single site open trial (n=10). All 10 participants in the open trial phase received EMPOWER. Feedback from clinicians, bereaved stakeholders and results from the open trial were then used to refine the intervention and launch a multi-center randomized controlled trial to examine clinical superiority of EMPOWER to enhanced usual care. In order to adapt to restrictions in ICU visitation and meet the needs of family caregivers impacted by the COVID-19 pandemic, we then launched a second single arm open trial and paused recruitment for the RCT. All participants recruited during the open trial COVID-19 phase received EMPOWER. Beginning in August 2021, we resumed the RCT portion of the trial to meet the initial recruitment goals of the study (total n of RCT \& COVID-19 open trial=60).

Conditions

Critical Illness; Communication Disabilities

Keywords

critically ill; ICU; uncommunicative; caregivers; surrogate; decision-making

Outcome Measures

Primary Outcomes (1)

• Change in Peritraumatic Distress Inventory

  Symptoms of peritraumatic distress, as measured by the Peritraumatic Distress Inventory (adapted to fit the ICU experience), will be compared between groups at post-intervention assessment (T2). 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.

  At baseline (T1) and in the week following the intervention (T2)

Secondary Outcomes (3)

• Change in Anticipatory Grief

  At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).

• Change in Experiential Avoidance

  At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).

• Change in Post-Traumatic Stress Disorder

  At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).

Other Outcomes (3)

• Change in Anxiety

  At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).

• Change in Depression

  At baseline (T1), one month and three months from baseline (T3 and T4).

• Change in Decision Regret

  At baseline (T1) and in the week following the intervention (T2), one month and three months from baseline (T3 and T4).

Study Arms (3)

Randomized controlled trial EMPOWER arm

EXPERIMENTAL

The EMPOWER arm includes six 15 minute modules delivered in a 1-on-1 format with the same interventionist, and 2 boosters (approximately 45 minutes each) conducted by phone. Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the EMPOWER intervention within 3 months conducted in person and by phone.

Behavioral: EMPOWER

Randomized controlled trial Enhanced usual care arm

PLACEBO COMPARATOR

The usual care arm indicates regular ICU support for informal caregivers (i.e. social work, chaplaincy) as recorded in the patient's medical record, a general information packet for informal caregivers, and a site-specific resource list. Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the usual care within 3 months conducted in person and by phone.

Other: Enhanced Usual Care

Open trial COVID-19 phase arm

EXPERIMENTAL

The COVID-19 open trial phase arm did not include randomization or control arm. All participants received the EMPOWER intervention. Assessments will occur pre-intervention, immediately post-intervention, and then 1-month and 3-months from post-intervention assessment.

Behavioral: EMPOWER

Interventions

EMPOWER BEHAVIORAL

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.

Open trial COVID-19 phase arm; Randomized controlled trial EMPOWER arm

Enhanced Usual Care OTHER

Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.

Randomized controlled trial Enhanced usual care arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bereaved family caregivers of patients treated in the ICU identified by referring clinicians and through support groups, clinics, and word of mouth
• Clinicians with expertise in mental health care and/or critical care including but not limited to nurses, nurse practitioners, social workers, psychologists, psychiatrists, hospital chaplains, and physicians
• Patients (\>21 years) who cannot communicate and decide on treatments, who during the course of their current hospital stay were admitted to an ICU/step-down unit, and whose ICU physicians or fellows would not be surprised if the patient did not survive more than 3 months
• Surrogate decision-makers whom ICU physicians or fellows indicate as the designated health care proxy or decision-making patient surrogates, or who are listed as such in the patient's medical charts
• Surrogate decision-makers must speak English
• Surrogate decision-makers must either meet the threshold for a high degree of emotional dependence (PDS 18 score \>8) on the patient or on the McGill Quality of Life Scale19 items (either anxiety item score\>5).
• Patients (\>18 years) who during the course of their current hospital stay were admitted to an ICU/step-down unit
• Surrogate decision-makers whom ICU physicians or fellows 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 either meet the threshold for a high degree of emotional dependence (PDS 18 score \>8) on the patient or on the McGill Quality of Life Scale 19 items (either anxiety item score\>5).
• Surrogate decision-makers who do not meet criterion #4 but are identified by clinical staff as distressed and whom clinical staff believe would benefit from the intervention.
• Patients below the age of 18 who have spent at least 3 days in a pediatric intensive care unit
• Surrogate decision-makers whom ICU physicians or fellows 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, or are parents of the patient
• Surrogate decision-makers must speak English
• Patients (\>18 years) who during the course of their current hospital stay were admitted to an ICU/step-down unit

You may not qualify if:

• Patients and surrogate decision-makers who do not meet the eligibility criteria or surrogate decision-makers who endorse suicidal ideation in the past month based on responses to the Columbia Suicide Severity Rating Scale.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• New York Hospital Queens: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (3)

NewYork-Presbyterian Queens

Flushing, New York, 11355, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

NewYork-Presbyterian Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (22)

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• Gamez W, Chmielewski M, Kotov R, Ruggero C, Watson D. Development of a measure of experiential avoidance: the Multidimensional Experiential Avoidance Questionnaire. Psychol Assess. 2011 Sep;23(3):692-713. doi: 10.1037/a0023242.

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• Prigerson HG, Shear MK, Jacobs SC, Reynolds CF 3rd, Maciejewski PK, Davidson JR, Rosenheck R, Pilkonis PA, Wortman CB, Williams JB, Widiger TA, Frank E, Kupfer DJ, Zisook S. Consensus criteria for traumatic grief. A preliminary empirical test. Br J Psychiatry. 1999 Jan;174:67-73. doi: 10.1192/bjp.174.1.67.

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• Mack JW, Weeks JC, Wright AA, Block SD, Prigerson HG. End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol. 2010 Mar 1;28(7):1203-8. doi: 10.1200/JCO.2009.25.4672. Epub 2010 Feb 1.

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• Garrido MM, Prigerson HG. The end-of-life experience: modifiable predictors of caregivers' bereavement adjustment. Cancer. 2014 Mar 15;120(6):918-25. doi: 10.1002/cncr.28495. Epub 2013 Dec 2.

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• 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.

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• Kentish-Barnes N, Prigerson HG. Is this bereaved relative at risk of prolonged grief? Intensive Care Med. 2016 Aug;42(8):1279-81. doi: 10.1007/s00134-015-4182-6. Epub 2015 Dec 23. No abstract available.

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• Higgins PC, Garrido MM, Prigerson HG. Factors Predicting Bereaved Caregiver Perception of Quality of Care in the Final Week of Life: Implications for Health Care Providers. J Palliat Med. 2015 Oct;18(10):849-57. doi: 10.1089/jpm.2015.29001.hp. Epub 2015 Jul 17.

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MeSH Terms

Conditions

Critical Illness; Communication Disorders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

A caveat to the statistical analyses performed for this trial is that the original proposal assumed that there would be an "interventionist bias" for which we would need to adjust using approaches such as Hierarchical Linear Modeling (HLM). This resulted in a deviation from the original proposed use of HLM because there was no need to correct for clustering within interventionists.

Results Point of Contact

• Title: Hillary Winoker
• Organization: Weill Cornell Medicine

hiw4002@med.cornell.edu

646-962-7143

Study Officials

• Holly G Prigerson, Ph. D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open trial pilot and manual refinement phase followed by randomized controlled trial. Due to the COVID-19 pandemic, we included the open-trial COVID-19 phase to adjust to new circumstances. We resumed the randomized controlled trial once it was safe to do so.

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: September 8, 2017
• Study Start: July 12, 2017
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Locations

US (3)