N/A
N=63
Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients
Critical Illness · Communication Disabilities
Bottom Line
View on ClinicalTrials.gov: NCT03276559 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Change in Peritraumatic Distress Inventory — 14.6; 14.2; 13.0; 14.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- EMPOWER (Behavioral); Enhanced Usual Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peritraumatic Distress Inventory |
14.6; 14.2; 13.0; 14.4 | — |
| SECONDARY Change in Anticipatory Grief |
29.1; 24.8; 25.7; 25.4; 24.2; 26.5 | — |
| SECONDARY Change in Experiential Avoidance |
44.7; 44.5; 42.2; 40.7; 43.3; 48.2 | — |
| SECONDARY Change in Post-Traumatic Stress Disorder |
29.9; 24.6; 23.1; 25.8; 24.3; 29.8 | — |
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).
Eligibility Criteria
Inclusion criteria for stakeholders:
- 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
Inclusion criteria for open trial participants:
- 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).
Inclusion criteria for adult pilot RCT participants:
- 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.
Inclusion criteria child pilot RCT/COVID-19 Open Trial participants:
- 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
Inclusion criteria for adult open trial COVID-19 participants:
- Patients (>18 years) who during the course of their current hospital stay were admitted to an ICU/step-down unit
- Surrogate decision-makers whom a member of the patient's care team 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 Scale 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.
Exclusion criteria for all arms:
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.
Data sourced from ClinicalTrials.gov (NCT03276559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.