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, 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
111
A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
Usual ICU care as per the standards of the ICU attending
Duke University
Durham, North Carolina, United States
Needs; Existential Concerns; Symptoms; and Therapeutic Interaction (NEST) Scale Total Score
A palliative care needs instrument that assesses palliative care needs across all 8 domains of palliative care quality. Scores on this 13-item instrument can range from 0 (no needs) to 130 (higher needs)
Time frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 3 (target ~1 week post-randomization)
Patient Health Questionnaire 9-Item Scale (PHQ-9)
A depression symptoms instrument. Scores range from 0 (no depression symptoms) to 27 (higher depression symptoms)
Time frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)
Generalized Anxiety Disorder 7-Item Scale (GAD-7)
An anxiety symptoms instrument. Scores range from 0 (no anxiety symptoms) to 21 (higher anxiety symptoms)
Time frame: Time 1 (baseline), Time 2 (target ~3 days post-randomization), and Time 4 (3 months post-randomization)
Post-Traumatic Stress Symptom (PTSS) Inventory
A post-traumatic stress disorder symptom instrument. Scores range from 10 (low PTSD symptoms) to 70 (higher PTSD symptoms)
Time frame: Time 1 (baseline) and Time 4 (3 months post-randomization)
Number of Participants With Goal Concordant Care
A measure of the alignment between patient values and treatments received. This is a dichotomous scale; care is either concordant or discordant.
Time frame: Time 1 (baseline) and Time 2 (target ~3 days post-randomization)
Post-randomization Hospital Length of Stay (Days)
Patient hospital length of stay measured in days post-randomization
Time frame: Across the entire hospitalization after randomization (approximately 2 months)
Post-randomization Intensive Care Unit Length of Stay (Days)
Patient intensive care unit length of stay post-randomization
Time frame: Across the entire hospitalization after randomization (approximately 2 months)
Number of Participants Who Responded "Usually" or "Always" on the Interpersonal Processes of Care 18-Item (IPC-18) Short Form Scale - Communication Domain
The IPC-18 is a measure of the interpersonal aspects of care. Interpersonal processes of care are the social-psychological aspects of the patient-physician interaction. These components of quality of care may help explain disparities in health between minority patients and their counterparts. The "elicited concerns, responded" scale within the Communication domain is used here. All items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.' A higher score indicates better processes.
Time frame: Baseline (at time of randomization) and ~3 days post-randomization
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