A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 of patients who were admitted to the ICU or step-down unit during their current admission/stay, or within 1 month of discharge from their last admission/stay.
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.
Disqualifiers
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 and/or significant psychiatric or cognitive disturbance sufficient, in the investigator/study staff's judgment, to preclude completion of the assessment measures, interview or informed consent.
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.
Trial design
Design model
Parallel
Treatments tested in this trial
EMPOWER
BehavioralEMPOWER 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.
Supportive Conversation
Other interventionThe 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.
Treatment groups
172 Participants
are divided into 2 treatment groupsGroup A: EMPOWER armExperimental treatment 1 intervention
Group B: Supportive Conversation armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
from baseline through twelve-month follow-up2
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.
Time frame
From baseline through twelve-month follow-up3
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.
Time frame
from baseline through twelve-month follow-upSecondary outcomes
1
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.
Time frame
From baseline through twelve-month follow-up2
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.
Time frame
From baseline through twelve-month follow-up3
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.
Time frame
1 week following the intervention through twelve-month follow-up .4
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.
Time frame
From baseline through twelve-month follow-upOther outcomes
1
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.
Time frame
From baseline to the 1 week following the intervention2
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.
Time frame
From baseline through twelve-month follow-up3
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.
Time frame
From the 1 week following the intervention through twelve-month follow-up4
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.
Time frame
At the three-month follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov