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
Qualifiers
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
Treatments tested in this trial
- EMPOWER
- Supportive Conversation
Treatment groups
172 Participants
are divided into 2 treatment groupsSponsors and collaborators
Weill Medical College of Cornell University
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Source ClinicalTrials.gov