RESUMEN
Rationale: Outpatients with interstitial lung disease often experience serious symptoms, yet infrequently receive palliative care. Objective: To determine the feasibility and clinical impact of a mobile application (PCplanner) in an outpatient setting. Methods: We conducted a pilot randomized controlled trial among adults with interstitial lung disease in a single-center academic clinic. Clinical outcomes included change in Needs at the End-of-Life Screening Tool (NEST) scale between baseline and 3 months as well as frequency of advance care planning discussions and referrals to palliative care services. Results: Observed feasibility outcomes were similar to targeted benchmarks including randomization rates (82.1% vs 80%) and retention (84.8% vs 80%). Mean NEST scores between the intervention and control group were 38.9 (SD, 18.9) vs 41.5 (SD, 20.5) at baseline, 34.6 (SD, 18.9) vs 33.6 (SD, 19.4) at 1 month after clinic visit, 40.5 (SD, 21.6) vs 35.3 (SD, 25.0) at 3 months after clinic visit. Changes in NEST scores between baseline and 3 months showed no difference in the primary outcome (P = 0.481, 95% CI [-8.45, 17.62]). Conclusion: Among patients with interstitial lung disease, a mobile app designed to focus patients and clinicians on palliative care principles demonstrated evidence of feasibility. Although changes in self-reported needs were similar between intervention and control groups, more patients in the intervention group updated their advance directives and code status compared to the control group. Clinical Trial Registration: Palliative Care Planner (PCplanner) NCT05095363. https://www.clinicaltrials.gov/study/NCT05095363.
RESUMEN
Importance: Unmet and racially disparate palliative care needs are common in intensive care unit (ICU) settings. Objective: To test the effect of a primary palliative care intervention vs usual care control both overall and by family member race. Design, Setting, and Participants: This cluster randomized clinical trial was conducted at 6 adult medical and surgical ICUs in 2 academic and community hospitals in North Carolina between April 2019 and May 2022 with physician-level randomization and sequential clusters of 2 Black patient-family member dyads and 2 White patient-family member dyads enrolled under each physician. Eligible participants included consecutive patients receiving mechanical ventilation, their family members, and their attending ICU physicians. Data analysis was conducted from June 2022 to May 2023. Intervention: A mobile application (ICUconnect) that displayed family-reported needs over time and provided ICU attending physicians with automated timeline-driven communication advice on how to address individual needs. Main Outcomes and Measures: The primary outcome was change in the family-reported Needs at the End-of-Life Screening Tool (NEST; range 0-130, with higher scores reflecting greater need) score between study days 1 and 3. Secondary outcomes included family-reported quality of communication and symptoms of depression, anxiety, and posttraumatic stress disorder at 3 months. Results: A total of 111 (51% of those approached) family members (mean [SD] age, 51 [15] years; 96 women [86%]; 15 men [14%]; 47 Black family members [42%]; 64 White family members [58%]) and 111 patients (mean [SD] age, 55 [16] years; 66 male patients [59%]; 45 Black patients [41%]; 65 White patients [59%]; 1 American Indian or Alaska Native patient [1%]) were enrolled under 37 physicians randomized to intervention (19 physicians and 55 patient-family member dyads) or control (18 physicians and 56 patient-family member dyads). Compared with control, there was greater improvement in NEST scores among intervention recipients between baseline and both day 3 (estimated mean difference, -6.6 points; 95% CI, -11.9 to -1.3 points; P = .01) and day 7 (estimated mean difference, -5.4 points; 95% CI, -10.7 to 0.0 points; P = .05). There were no treatment group differences at 3 months in psychological distress symptoms. White family members experienced a greater reduction in NEST scores compared with Black family members at day 3 (estimated mean difference, -12.5 points; 95% CI, -18.9 to -6.1 points; P < .001 vs estimated mean difference, -0.3 points; 95% CI, -9.3 to 8.8 points; P = .96) and day 7 (estimated mean difference, -9.5 points; 95% CI, -16.1 to -3.0 points; P = .005 vs estimated mean difference, -1.4 points; 95% CI, -10.7 to 7.8; P = .76). Conclusions and Relevance: In this study of ICU patients and family members, a primary palliative care intervention using a mobile application reduced unmet palliative care needs compared with usual care without an effect on psychological distress symptoms at 3 months; there was a greater intervention effect among White family members compared with Black family members. These findings suggest that a mobile application-based intervention is a promising primary palliative care intervention for ICU clinicians that directly addresses the limited supply of palliative care specialists. Trial Registration: ClinicalTrials.gov Identifier: NCT03506438.