Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT03276559
Eligibility Criteria:
Inclusion criteria for stakeholders:
1. Bereaved family caregivers of patients treated in the ICU identified by referring clinicians and through support groups, clinics, and word of mouth
2. 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:
1. 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
2. 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
3. Surrogate decision-makers must speak English
4. 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:
1. Patients (\>18 years) who during the course of their current hospital stay were admitted to an ICU/step-down unit
2. 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
3. Surrogate decision-makers must speak English
4. 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).
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:
1. Patients below the age of 18 who have spent at least 3 days in a pediatric intensive care unit
2. 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
3. Surrogate decision-makers must speak English
Inclusion criteria for adult open trial COVID-19 participants:
1. Patients (\>18 years) who during the course of their current hospital stay were admitted to an ICU/step-down unit
2. 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
3. Surrogate decision-makers must speak English
4. 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).
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03276559
Study Brief:
Protocol Section:
NCT03276559