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

December 13, 2023 updated by: Weill Medical College of Cornell University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

172

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Not yet recruiting
        • University of Miami
        • Contact:
          • Wendy Lichtenthal, Ph.D.
          • Phone Number: 305-243-8983
          • Email: wgl31@miami.edu
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Rosario Costas-Muñiz
          • Phone Number: 646-888-8062
        • Principal Investigator:
          • Rosario Costas-Muñiz, PhD
      • New York, New York, United States, 10065
        • Recruiting
        • NewYork-Presbyterian Weill Cornell Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Holly G Prigerson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMPOWER arm

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

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.
Placebo Comparator: Supportive Conversation arm

The Supportive Conversation (SC) arm includes a supportive, empathic encounter without specific skill-building for approximately the same amount of time as EMPOWER.

Subjects who meet eligibility criteria will receive up to 4 sequential assessments before and after SC within 3 months conducted in person and by phone.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Prolonged Grief Disorder
Time Frame: from baseline through twelve-month follow-up
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
Change of Post-Traumatic Stress Disorder
Time Frame: From baseline through twelve-month follow-up
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
Change of Anticipatory Grief
Time Frame: from baseline through twelve-month follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Depression
Time Frame: From baseline through twelve-month follow-up
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
Change of Regret
Time Frame: From baseline through twelve-month follow-up
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
Change of Peritraumatic Distress
Time Frame: 1 week following the intervention through twelve-month follow-up .
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 .
Change of Anxiety
Time Frame: From baseline through twelve-month follow-up
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Dissociation
Time Frame: From baseline to the 1 week following the intervention
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
Change of Distress Tolerance
Time Frame: From baseline through twelve-month follow-up
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
Change of Surrogate's Quality of Life
Time Frame: From the 1 week following the intervention through twelve-month follow-up
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
Satisfaction with Critical Care
Time Frame: At the three-month follow-up
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
Patient's Symptoms
Time Frame: At baseline
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
Change of Patient's Quality of Death
Time Frame: From one-month to twelve-month follow-up
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
Change of General Physical and General Mental Health
Time Frame: From baseline through twelve-month follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Holly Prigerson, PhD, Weill Medical College of Cornell University
  • Principal Investigator: Wendy Lichtenthal, PhD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Estimated)

December 11, 2027

Study Completion (Estimated)

December 11, 2027

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 19, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-09023929
  • R01NR019831 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All participant data, including self-report measures and qualitative interviews, will be shared to qualified investigators under a Data Use Agreement in de-identifiable form. Data will be made available upon approval of PIs and will be used solely for research purposes.

IPD Sharing Time Frame

Data will become available once the study's specific aims will be published and will be destroyed once analyses are completed.

IPD Sharing Access Criteria

Accessing data requires making a formal request at the appropriate time and the PIs and investigative team will review the request. If approved, the data analyst from our Cornell Center for Research on End-of-Life Care will make a de-identifiable dataset to address the analyses in the request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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