Clinical trial NCT03506438: Addressing Palliative Care Needs Among Intensive Care Unit Family Members
Official title: Addressing Palliative Care Needs Among Intensive Care Unit Family Members
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Family Members
Psychological Distress
Informal Caregivers
Palliative Care
Keywords: critical illness
palliative care
mobile app
psychological distress
depression
anxiety
informal caregiver
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2018-04-24
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Unit of randomization is the ICU attending physician. We anticipate 15-25 ICU physicians for intervention and 15-25 for control. Therefore each clinician will likely have 5-12 family members each.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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, psychological distress symptoms, and patient-centered care; (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

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.

Primary outcomes:
measure: Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
timeFrame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
Secondary outcomes:
measure: Patient Health Questionnaire 9-Item Scale (PHQ-9)
timeFrame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)
measure: Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)
measure: Post-Traumatic Stress Symptom (PTSS) Inventory
timeFrame: Time 1 (baseline) and Time 4 (3 months post-randomization)
measure: Number of Participants With Goal Concordant Care
timeFrame: Time 1 (baseline) and Time 2 (target ~3 days post-randomization)
measure: Post-randomization Hospital Length of Stay (Days)
timeFrame: Across the entire hospitalization after randomization (approximately 2 months)
measure: Post-randomization Intensive Care Unit Length of Stay (Days)
timeFrame: Across the entire hospitalization after randomization (approximately 2 months)
measure: Number of Participants Who Responded "Usually" or "Always" on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain
timeFrame: Baseline (at time of randomization) and ~3 days post-randomization
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Christopher Cox, MD'
role: PRINCIPAL_INVESTIGATOR
References: