Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients (EMPOWER)
Critical Illness, Communication Disabilities
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring critically ill, ICU, uncommunicative, caregivers, surrogate, decision-making
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.
Sites / Locations
- NewYork-Presbyterian Queens
- Memorial Sloan Kettering Cancer CenterRecruiting
- NewYork-Presbyterian Weill Cornell Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Placebo Comparator
Experimental
No Intervention
Experimental
Randomized controlled trial EMPOWER arm
Randomized controlled trial Enhanced usual care arm
Open-trial phase arm
Manual refinement phase arm
Open trial COVID-19 phase 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.
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.
The open-trial phase arm includes 10 participants who all received EMPOWER. Data from the open trial of 10 surrogate decision-makers will identify tactical and measurement issues involved in the delivery and outcomes measurements used in EMPOWER.
This phase involves obtaining feedback about the EMPOWER intervention manual using qualitative analysis from 15 stakeholders.
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.