Addressing Palliative Care Needs Among Intensive Care Unit Family Members
Addressing Palliative Care Needs Among Intensive Care Unit Family Members
The quality of palliative care is highly variable for many patients treated in intensive care
 units (ICUs) and their family members. To address these challenges, the investigators will
 test the impact of a mobile app designed to help families navigate ICU-based palliative care
 vs. usual care. The investigators hypothesize that the intervention will reduce
 patient/family member unmet palliative care needs and improve the quality of clinical-family
 communication in racially/ethnically diverse populations.
The quality of palliative care is highly variable in an intensive care unit (ICU) setting.
 These markers of poor quality are even more common among Black patients and families than
 among Whites. To address these challenges, the investigators developed a mobile app that
 allows families to both give and receive information relevant to palliative care and for ICU
 clinicians to visualize patient/family data and therefore better support them.

 To determine the effect of this intervention,the investigators propose to conduct a
 randomized clinical trial (RCT) comparing the intervention to usual care to address four
 specific aims: (1) Using a cluster randomized clinical trial, determine the effect of the
 intervention vs usual care on unmet needs [as measured by the NEST scale], psychological
 distress symptoms [as measured by the PHQ-9, GAD-7, and PTSS scales], and patient-centered
 care [as measured by the IPC scale]; (2) Determine the impact of the intervention on unmet
 needs and patient-centered care based across different racial groups; and (3) Explore family
 member and clinician experiences with intervention using mixed methods to understand
 mechanisms within unique case contexts [exploratory aim]. The investigators hypothesize that
 compared to usual care, ICUconnect will reduce family members' unmet needs, reduce family
 member psychological distress, increase the patient-centeredness care, and reduce hospital
 length of stay overall--though the magnitude of effect will be greater among Blacks compared
 to Whites.
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.