Assessment of Clinical Palliative Care Trigger Status vs Actual Needs Among Critically Ill Patients and Their Family Members.

Importance: Palliative care consultations in intensive care units (ICUs) are increasingly prompted by clinical characteristics associated with mortality or resource utilization. However, it is not known whether these triggers reflect actual palliative care needs. Objective: To compare unmet needs by clinical palliative care trigger status (present vs absent). Design, Setting, and Participants: This prospective cohort study was conducted in 6 adult medical and surgical ICUs in academic and community hospitals in North Carolina between January 2019 and September 2020. Participants were consecutive patients receiving mechanical ventilation and their family members. Exposure: Presence of any of 9 common clinical palliative care triggers. Main Outcomes and Measures: The primary outcome was the Needs at the End-of-Life Screening Tool (NEST) score (range, 0-130, with higher scores reflecting greater need), which was completed after 3 days of ICU care. Trigger status performance in identifying serious need (NEST score ≥30) was assessed using sensitivity, specificity, positive and negative likelihood ratios, and C statistics. Results: Surveys were completed by 257 of 360 family members of patients (71.4% of the potentially eligible patient-family member dyads approached) with a median age of 54.0 years (IQR, 44-62 years); 197 family members (76.7%) were female, and 83 (32.3%) were Black. The median age of patients was 58.0 years (IQR, 46-68 years); 126 patients (49.0%) were female, and 88 (33.5%) were Black. There was no difference in median NEST score between participants with a trigger present (45%) and those with a trigger absent (55%) (21.0; IQR, 12.0-37.0 vs 22.5; IQR, 12.0-39.0; P = .52). Trigger presence was associated with poor sensitivity (45%; 95% CI, 34%-55%), specificity (55%; 95% CI, 48%-63%), positive likelihood ratio (1.0; 95% CI, 0.7-1.3), negative likelihood ratio (1.0; 95% CI, 0.8-1.2), and C statistic (0.50; 95% CI, 0.44-0.57). Conclusions and Relevance: In this cohort study, clinical palliative care trigger status was not associated with palliative care needs and no better than chance at identifying the most serious needs, which raises questions about an increasingly common clinical practice. Focusing care delivery on directly measured needs may represent a more person-centered alternative.

Improving racial disparities in unmet palliative care needs among intensive care unit family members with a needs-targeted app intervention: The ICUconnect randomized clinical trial.

INTRODUCTION: The technologies used to treat the millions who receive care in intensive care unit (ICUs) each year have steadily advanced. However, the quality of ICU-based communication has remained suboptimal, particularly concerning for Black patients and their family members. Therefore we developed a mobile app intervention for ICU clinicians and family members called ICUconnect that assists with delivering need-based care. OBJECTIVE: To describe the methods and early experiences of a clustered randomized clinical trial (RCT) being conducted to compare ICUconnect vs. usual care. METHODS AND ANALYSIS: The goal of this two-arm, parallel group clustered RCT is to determine the clinical impact of the ICUconnect intervention in improving outcomes overall and for each racial subgroup on reducing racial disparities in core palliative care outcomes over a 3-month follow up period. ICU attending physicians are randomized to either ICUconnect or usual care, with outcomes obtained from family members of ICU patients. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 3 days post-randomization. Secondary outcomes include goal concordance of care and interpersonal processes of care at 3 days post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use hierarchical linear models to compare outcomes between the ICUconnect and usual care arms within all participants and assess for differential intervention effects in Blacks and Whites by adding a patient-race interaction term. We hypothesize that both compared to usual care as well as among Blacks compared to Whites, ICUconnect will reduce unmet palliative care needs, psychological distress and healthcare resource utilization while improving goal concordance and interpersonal processes of care. In this manuscript, we also describe steps taken to adapt the ICUconnect intervention to the COVID-19 pandemic healthcare setting. ENROLLMENT STATUS: A total of 36 (90%) of 40 ICU physicians have been randomized and 83 (52%) of 160 patient-family dyads have been enrolled to date. Enrollment will continue until the end of 2021.

Operationalizing needs-focused palliative care for older adults in intensive care units: Design of and rationale for the PCplanner randomized clinical trial.

INTRODUCTION: The number of older adults who receive life support in an intensive care unit (ICU), now 2 million per year, is increasing while survival remains unchanged. Because the quality of ICU-based palliative care is highly variable, we developed a mobile app intervention that integrates into the electronic health records (EHR) system called PCplanner (Palliative Care planner) with the goal of improving collaborative primary and specialist palliative care delivery in ICU settings. OBJECTIVE: To describe the methods of a randomized clinical trial (RCT) being conducted to compare PCplanner vs. usual care. METHODS AND ANALYSIS: The goal of this two-arm, parallel group mixed methods RCT is to determine the clinical impact of the PCplanner intervention on outcomes of interest to patients, family members, clinicians, and policymakers over a 3-month follow up period. The primary outcome is change in unmet palliative care needs measured by the NEST instrument between baseline and 1 week post-randomization. Secondary outcomes include goal concordance of care, patient-centeredness of care, and quality of communication at 1 week post-randomization; length of stay; as well as symptoms of depression, anxiety, and post-traumatic stress disorder at 3 months post-randomization. We will use general linear models for repeated measures to compare outcomes across the main effects and interactions of the factors. We hypothesize that compared to usual care, PCplanner will have a greater impact on the quality of ICU-based palliative care delivery across domains of core palliative care needs, psychological distress, patient-centeredness, and healthcare resource utilization.

Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial.

INTRODUCTION: Although as many as 75% of the >2 million annual intensive care unit (ICU) survivors experience symptoms of psychological distress that persist for months to years, few therapies exist that target their symptoms and accommodate their unique needs. In response, we developed LIFT, a mobile app-based mindfulness intervention. LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1). OBJECTIVE: To describe the methods of a factorial experimental clinical trial (LIFT2) being conducted to aid in the development and implementation of the version of the LIFT intervention that is optimized across domains of effect, feasibility, scalability, and costs. METHODS AND ANALYSIS: The LIFT2 study is an optimization trial conceptualized as a component of a larger multiphase optimization strategy (MOST) project. The goal of LIFT2 is to use a 2 × 2 × 2 factorial experimental trial involving 152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose. The primary trial outcome is change in depression symptoms 1 month from randomization measured by the PHQ-9 instrument. Secondary outcomes include anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability; as well as themes assessed through qualitative analysis of semi-structured interviews with study participants conducted after follow up completion. We will use general linear models to compare outcomes across the main effects and interactions of the factors.