Status:
COMPLETED
Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience Among Surrogate Decision-Makers of ICU Patients
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
New York Hospital Queens
Memorial Sloan Kettering Cancer Center
Conditions:
Critical Illness
Communication Disabilities
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Aggressive care in Intensive Care Units (ICUs) has been shown to impair the quality of life of patients with advanced cancer and to increase the risk of Posttraumatic Stress Disorder (PTSD) among the ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03276559
Start Date
July 12 2017
End Date
May 22 2023
Last Update
August 20 2024
Active Locations (3)
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1
NewYork-Presbyterian Queens
Flushing, New York, United States, 11355
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
3
NewYork-Presbyterian Weill Cornell Medicine
New York, New York, United States, 10065