Addressing Palliative Care Needs Among Intensive Care Unit Family Members (ICUconnect)
Critical Illness, Family Members, Psychological Distress
About this trial
This is an interventional supportive care trial for Critical Illness focused on measuring critical illness, palliative care, mobile app, psychological distress, depression, anxiety, informal caregiver
Eligibility Criteria
PATIENTS
Inclusion Criteria:
- ≥18 years of age
- Receive mechanical ventilation in a study ICU for ≥48 hours under care of a study ICU physician
Exclusion Criteria (pre-consent):
- Decisional capacity
- Death expected within 24 hours
- Admission to an ICU at the index hospital >14 days
- Comfort care or withdrawal of treatment planned
- Imprisoned
- Extubated and possess decisional capacity prior to informed consent
- Died before T2 survey complete
- No known family or surrogate
- Care assumed by a non-study ICU attending after consent by patient/family but before T1
- Care assumed by non-study ICU attending <3 days after T1 but before T2
- Study ICU attending physicians from different groups (i.e., intervention or control) caring for patient change <3 days after T1 completed by family
Exclusion Criteria (post-consent):
- Patient regains decision making capacity before T2
- Patient dies before T2
FAMILY MEMBER
Inclusion Criteria:
- ≥18 years of age
- Self-described as the individual (related or unrelated) who provides the most support and with whom the patient has a significant relationship (per definition of 'family' described in the Society of Critical Care Medicine 2016 Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU)
Exclusion Criteria (pre-consent):
- Lack a knowledge of English such that the potential participant is not confident that they could complete study tasks (app viewing, surveys)
- Imprisoned
- Unable to complete surveys for any reason
- Describe their race as neither White nor Black*
Describe their ethnicity as Hispanic*
- Note that this study explicitly targets issues of racial disparities in healthcare, particularly of Black / African-Americans. Hispanics are excluded because of the pervasive nature of US residents' general belief that 'Hispanic' is a racial category.
Exclusion criteria (post-consent):
- If the assigned randomized ICU attending physician either leaves ICU service or is replaced by a non-participating ICU physician <= 2 calendar days after family member completes T1 survey
- Low need burden (NEST score <15)*
ICU PHYSICIANS
Inclusion Criteria:
- ≥18 years of age
- Attending physician in a study ICU
Exclusion Criteria:
- None
*The NEST score cutoff was changed on June 26, 2019. At this point, 3 patients had been randomized. This change was based on our review of data (NEST + psychological distress symptoms) from a parallel cohort study of >50 family members of ICU patients who met nearly identical eligibility criteria as for the ICUconnect trial. This was a larger cohort than the pilot study on which we based the NEST cutoff.
Sites / Locations
- Duke University
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Mobile app group
Usual care
Clinicians and family members will receive access to versions of the needs-focused mobile app that differ in content.
Usual ICU care