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Background The coping styles of the Sickness Insight in Coping Questionnaire (SICQ; positivism, redefinition, toughness, fighting spirit, nonacceptance) may affect the health and recovery of hospitalized critically ill patients. Research Question Do the SICQ coping styles of hospitalized critically ill patients relate to the patients health-related quality of life (HRQoL) and recovery? Study Design and Methods A prospective cohort study was conducted in a single university-affiliated Dutch hospital. Participants were critically ill adult patients admitted to a mixed medical-surgical ICU (start: n = 417; pre-ICU: n = 391; hospital discharge: n = 350; 3-month follow-up: n = 318; 6-month follow-up: n = 308; 12-month follow-up: n = 285). Coping was recorded with the SICQ pre-ICU and at discharge. HRQoL was measured with the SF-12 pre-ICU, at discharge, and 3, 6, and 12 months after discharge. Indicators of recovery were ICU and hospital length of stay, discharge disposition, and mortality. Correlation and regression analyses were used for data analysis. Results Positivism (r = 0.28-0.51), fighting spirit (r = 0.14-0.35), and redefinition (r = 0.12-0.23) associated significantly (P Interpretation SICQ coping is associated with long-term mental HRQoL, hospital length of stay, and hazard for death among hospitalized critically ill patients.

Rationale: Surrogate decision makers of patients with chronic critical illness (CCI) are at high risk for symptoms of post-traumatic stress disorder (PTSD). Whether patient health status following ...

Psychological distress symptoms are common among patients recently hospitalized with cardiorespiratory failure, yet there are few effective post-discharge therapies that are relevant to their experiences.To determine the feasibility and clinical impact of two different versions of a month-long self-guided mobile app-based coping skills program called Blueprint in comparison to usual care control.Patients hospitalized with a serious cardiopulmonary diagnoses were recruited from adult intensive care units and stepdown units at a large academic medical center. Participants with elevated psychological distress symptoms just after discharge were randomized in a 1:1:1 ratio to Blueprint with a therapist (BP/Therapist), Blueprint without a therapist (BP/No therapist), or usual care control (UC). All study procedures were conducted remotely. Blueprint is a self-guided, symptom-responsive, mobile app-based adaptive coping skills program with 4 themed weeks with different daily audio, video, and text content. Participants completed surveys via the app platform at baseline and both 1 and 3 months later. The primary outcome was feasibility. Additional outcomes included the Hospital Anxiety and Depression Scale (HADS) total score, the Post-Traumatic Stress Scale (PTSS), and a 100-point quality of life visual analog scale.Of 63 patients consented, 45 (71%) with elevated distress were randomized to BP/Therapist (n=16, 36%), BP/No therapist (n=14, 31%), and UC (n=15, 33%). Observed rates were similar to target feasibility benchmarks including consented patients who were randomized (71.4%), retention (75.6%), and intervention adherence (97% with weekly use). Estimated mean differences (95% CIs) at 1 month compared to baseline included: HADS total (BP/Therapist -3.8 [-6.7, -0.6], BP/No therapist -4.2 [-7.6, -0.0], UC -3.4 [-6.6, 0.2]), the PTSS (BP/Therapist -6.7 [-11.3, -2.1], BP/No therapist -9.1 [-14.4, -3.9], UC -4.2 [-10.8, 2.3]), and quality of life (BP/Therapist -4.5 [-14.3, 4.6], BP/No therapist 14.0 [-0.9, 29.0], UC 8.7 [-3.5, 20.9]).Among survivors of cardiorespiratory failure, a mobile app-based post-discharge coping skills training intervention demonstrated evidence of feasibility and clinical impact compared to usual care control. A larger trial is warranted to test the efficacy of this approach. Clinical trial registered with ClinicalTrials.gov (NCT04329702).

Background Patients with serious respiratory illness and their caregivers suffer considerable burdens and palliative care is a fundamental right for anyone who needs it However the overwhelming majority of patients do not receive timely palliative care before the end of life despite robust evidence for improved outcomes Goals This policy statement by the American Thoracic Society ATS and partnering societies advocates for improved integration of high quality palliative care early in the care continuum for patients with serious respiratory illness and their caregivers and provides clinicians and policymakers with a framework to accomplish this Methods An international and interprofessional expert committee including patients and caregivers achieved consensus across a diverse working group representing pulmonary critical care palliative care bioethics health law and policy geriatrics nursing physiotherapy social work pharmacy patient advocacy psychology and sociology Results The committee developed fundamental values principles and policy recommendations for integrating palliative care in serious respiratory illness care across seven domains 1 delivery models 2 comprehensive symptom assessment and management 3 advance care planning and goals of care discussions 4 caregiver support 5 health disparities 6 mass casualty events and emergency preparedness and 7 research priorities The recommendations encourage timely integration of palliative care promote innovative primary and secondary or specialist palliative care delivery models and advocate for research and policy initiatives to improve the availability and quality of palliative care for patients and their caregivers Conclusions This multisociety policy statement establishes a framework for early palliative care in serious respiratory illness and provides guidance for pulmonary critical care clinicians and policymakers for its proactive integration Copyright 2022 by the American Thoracic Society

ObjectiveThe objectives of this study were to develop and refine EMPOWER (Enhancing and Mobilizing the POtential for Wellness and Resilience), a brief manualized cognitive-behavioral, acceptance-based intervention for surrogate decision-makers of critically ill patients and to evaluate its preliminary feasibility, acceptability, and promise in improving surrogates’ mental health and patient outcomes.MethodPart 1 involved obtaining qualitative stakeholder feedback from 5 bereaved surrogates and 10 critical care and mental health clinicians. Stakeholders were provided with the manual and prompted for feedback on its content, format, and language. Feedback was organized and incorporated into the manual, which was then re-circulated until consensus. In Part 2, surrogates of critically ill patients admitted to an intensive care unit (ICU) reporting moderate anxiety or close attachment were enrolled in an open trial of EMPOWER. Surrogates completed six, 15–20 min modules, totaling 1.5–2 h. Surrogates were administered measures of peritraumatic distress, experiential avoidance, prolonged grief, distress tolerance, anxiety, and depression at pre-intervention, post-intervention, and at 1-month and 3-month follow-up assessments.ResultsPart 1 resulted in changes to the EMPOWER manual, including reducing jargon, improving navigability, making EMPOWER applicable for a range of illness scenarios, rearranging the modules, and adding further instructions and psychoeducation. Part 2 findings suggested that EMPOWER is feasible, with 100% of participants completing all modules. The acceptability of EMPOWER appeared strong, with high ratings of effectiveness and helpfulness (M= 8/10). Results showed immediate post-intervention improvements in anxiety (d= −0.41), peritraumatic distress (d= −0.24), and experiential avoidance (d= −0.23). At the 3-month follow-up assessments, surrogates exhibited improvements in prolonged grief symptoms (d= −0.94), depression (d= −0.23), anxiety (d= −0.29), and experiential avoidance (d= −0.30).Significance of resultsPreliminary data suggest that EMPOWER is feasible, acceptable, and associated with notable improvements in psychological symptoms among surrogates. Future research should examine EMPOWER with a larger sample in a randomized controlled trial.

Introduction Advanced directives (ADs) provide a framework from which families may understand patient’s wishes. However, end-of-life planning may not be prioritized by everyone. This analysis aimed to determine what populations have ADs and how they affected trauma outcomes. Methods Adult trauma patients recorded in the American College of Surgeons Trauma Quality Improvement Program (TQIP) from 2013-2015 were included. The primary outcome was presence of an AD. Secondary outcomes included mortality, length of stay (LOS), mechanical ventilation, ICU admission/LOS, withdrawal of life-sustaining measures, and discharge disposition. Multivariable logistic regression models were developed for outcomes. Results 44 705 patients were included in the analyses. Advanced directives were present in 1.79% of patients. The average age for patients with ADs was 77.8 ± 10.7. African American (odds ratio (OR) .53, confidence intervals [CI] .36-.79) and Asian (OR .22, CI .05-.91) patients were less likely to have ADs. Conversely, Medicaid (OR 1.70, CI 1.06-2.73) and Medicare (OR 1.65, CI 1.25-2.17) patients were more likely to have ADs as compared to those with private insurance. The presence of ADs was associated with increased hospital mortality (OR 2.84, CI 2.19-3.70), increased transition to comfort measures (OR 2.87, CI 2.08-3.95), and shorter LOS (CO −.74, CI −1.26-.22). Patients with ADs had an increased odds of hospice care (OR 4.24, CI 3.18-5.64). Conclusion Advanced directives at admission are uncommon, particularly among African Americans and Asians. The presence of ADs was associated with increased mortality, use of mechanical ventilation, admission to the ICU, withdrawal of life-sustaining measures, and hospice. Future research should target expansion of ADs among minority populations to alleviate disparities in end-of-life treatment.

Objective: To examine racial and ethnic differences in the utilization of 3 interventions (tracheostomy placement, gastrostomy tube placement, and hospice utilization) among patients with severe acute brain injury (SABI). Design: Retrospective cohort study. Setting: Data from the National Inpatient Sample, from 2002 to 2012. Patients: Adult patients with SABI defined as a primary diagnosis of stroke, traumatic brain injury, or post-cardiac arrest who received greater than 96 hours of mechanical ventilation. Exposure: Race/ethnicity, stratified into 5 categories (white, black, Hispanic, Asian, and other). Measurements and Main Results: Data from 86 246 patients were included in the cohort, with a mean (standard deviation) age of 60 (18) years. In multivariable analysis, compared to white patients, black patients had an 20% increased risk of tracheostomy utilization (relative risk [RR]: 1.20, 95% CI: 1.16-1.24, P < .001), Hispanic patients had a 10% increased risk (RR: 1.10, 95% CI: 1.06-1.14, P < .001), Asian patients had an 8% increased risk (RR: 1.08, 95% CI: 1.01-1.16, P = .02), and other race patients had an 10% increased risk (RR: 1.10, 95% CI: 1.04-1.16, P < .001). A similar relationship was observed for gastrostomy utilization. In multivariable analysis, compared to white patients, black patients had a 25% decreased risk of hospice discharge (RR: 0.75, 95% CI: 0.67-0.85, P < .001), Hispanic patients had a 20% decreased risk (RR: 0.80, 95% CI: 0.69-0.94, P < .01), and Asian patients had a 47% decreased risk (RR: 0.53, 95% CI: 0.39-0.73, P < .001). There was no observed relationship between race/ethnicity and in-hospital mortality. Conclusions: Minority race was associated with increased utilization of tracheostomy and gastrostomy, as well as decreased hospice utilization among patients with SABI. Further research is needed to better understand the mechanisms underlying these race-based differences in critical care.

Palliative care research is deeply challenging for many reasons, not the least of which is the conceptual and operational difficulty of measuring outcomes within a seriously ill population such as critically ill patients and their family members. This manuscript describes how Randy Curtis and his network of collaborators successfully confronted some of the most vexing outcomes measurement problems in the field, and by so doing, have enhanced clinical care and research alike. Beginning with a discussion of the clinical challenges of measurement in palliative care, we then discuss a selection of the novel measures developed by Randy and his collaborators and conclude with a look toward the future evolution of these concepts. Randy and his foundational work, including both successes as well as the occasional near miss, have enriched and advanced the field as well as (immeasurably) impacted the work of so many others—including this manuscript’s authors.

CONTEXT. Severe Acute Brain Injury (SABI) is neurologically devastating, and surrogates for these patients may struggle with particularly complex decisions due to substantial prognostic uncertainty. OBJECTIVES. To compare anxiety and depression symptoms over time between SABI surrogates and non-SABI surrogates for patients requiring prolonged mechanical ventilation (PMV). METHODS. We conducted a secondary analysis of the data from a multicenter randomized trial of a decision aid intervention for surrogates of adults experiencing PMV. Eligible patients were enrolled from medical, surgical, trauma, cardiac, and neurologic intensive care units (ICUs). ICU admitting diagnoses were used to identify patients experiencing SABI. We compared anxiety and depression symptoms as measured by the Hospital Anxiety and Depression Scale score 6 months after trial enrollment between surrogates of patients with SABI and surrogates of patients experiencing PMV for other reasons. RESULTS. Our analysis included 206 patients, 60 (29%) with SABI and 146 (71%) without SABI, and their primary surrogate decision makers. After adjusting for potential confounders including surrogate demographics, surrogate financial distress, patient severity of illness baseline GCS, and patient health status at 6 months, we found that surrogates of patients experiencing SABI had higher symptoms of anxiety and depression than surrogates of non-SABI patients (adjusted mean difference 3.6, 95% CI 1.2–6.0). CONCLUSION. Surrogates of PMV patients with SABI experience persistently elevated anxiety and depression symptoms over 6 months compared to surrogates of PMV patients without SABI. Further work is needed to understand contributors to prolonged distress in this higher risk population.

This cohort study assesses whether higher levels of family member–reported palliative care needs are observed among those whose critically ill loved ones meet a clinical palliative care trigger compared with those who do not meet such a trigger., Key Points Question Does clinical palliative care trigger status accurately identify individuals with the most serious unmet palliative care needs? Findings In this cohort study including 257 dyads (1 patient in an intensive care unit [ICU] and 1 family member of each patient), there was no significant difference in self-reported palliative care needs between those with and without a clinical trigger (median Needs at the End-of-Life Screening Tool scores, 21.0 vs 22.5). Clinical triggers’ 45% sensitivity and 55% specificity suggested that they were no better than chance at identifying serious needs. Meaning The findings suggest that using clinical trigger status to prompt palliative care consultation in ICU settings may be an inefficient use of this limited resource; incorporating direct measures of unmet need in care may be a promising alternative strategy., 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.

PURPOSE: To identify specific components of ICU clinician supportive care and communication that are associated with increased post-traumatic stress disorder (PTSD) symptoms for surrogate decision makers of patients with chronic critical illness (CCI). METHODS: We conducted a secondary analysis of data from a randomized controlled trial of palliative care-led meetings to provide information and support for CCI surrogates. The primary outcome for this secondary analysis was PTSD symptoms at 90 days, measured by the Impact of Event Scale-Revised (IES-R). Caregiver perceptions of clinician support and communication were assessed using a version of the After-Death Bereaved Family Member Interview (ADBFMI) instrument modified for use in non-bereaved in addition to bereaved caregivers. The association between ADBFMI items and IES-R score was analyzed using multiple linear regression. RESULTS: 90-day follow up was complete for 306 surrogates corresponding to 224 patients. 71% of surrogates were female and mean age was 51 years. Of the domains, negative perception of the patient’s physical comfort and emotional support was associated with the greatest increase in surrogate PTSD symptoms (beta coefficient 1.74, 95% CI 0.82 to 2.65). The three specific preselected items associated with increased surrogate PTSD symptoms were surrogate perception that clinicians did not listen to concerns (beta coefficient 10.7, 95% CI 3.6 to 17.9), failure of the physician to explain how the patient’s pain would be treated (beta coefficient 12.1, 95% CI 4.9 to 19.3), and lack of sufficient religious contact (beta coefficient 11.7, 95% CI 2 to 21.3). CONCLUSION: Modifiable deficits in ICU clinician support and communication were associated with increased PTSD symptoms among CCI surrogates.

ObjectiveBecause the heterogeneity of patients in intensive care units (ICUs) and family members represents a challenge to palliative care delivery, we aimed to determine if distinct phenotypes of palliative care needs exist.MethodsProspective cohort study conducted among family members of adult patients undergoing mechanical ventilation in six medical and surgical ICUs. The primary outcome was palliative care need measured by the Needs at the End-of-Life Screening Tool (NEST, range from 0 (no need) to 130 (highest need)) completed 3 days after ICU admission. We also assessed quality of communication, clinician–family relationship and patient centredness of care. Latent class analysis of the NEST’s 13 items was used to identify groups with similar patterns of serious palliative care needs.ResultsAmong 257 family members, latent class analysis yielded a four-class model including complex communication needs (n=26, 10%; median NEST score 68.0), family spiritual and cultural needs (n=21, 8%; 40.0) and patient and family stress needs (n=43, 31%; 31.0), as well as a fourth group with fewer serious needs (n=167, 65%; 14.0). Interclass differences existed in quality of communication (median range 4.0–10.0, pConclusionsFour novel phenotypes of palliative care need were identified among ICU family members with distinct differences in the severity of needs and perceived quality of the clinician–family interaction. Knowledge of need class may help to inform the development of more person-centred models of ICU-based palliative care.

Introduction Older adults are more vulnerable to opioid-associated morbidity. The purpose of this study was to determine the frequency and timing of acetaminophen and opioid use in the postoperative period. Methods Older adult trauma patients (≥65 years) with hip fractures requiring femur or hip fixation were reviewed (Premier Database 2008-2014). We examined rates of acetaminophen use on the day of surgery and prior to receipt of oral opioids. Mixed-effects linear regression models were used to examine the effects of an acetaminophen-first approach on opioid use the day prior to and on the day of discharge. Results Of the 192 768 patients, 81.6% were Caucasian; 74.0% were female; and the mean age was 82.0 years [± 7.0]. Only 16.8% (32 291) of patients received acetaminophen prior to being prescribed opioids. 27.4% (52 779) received an acetaminophen-opioid combination, and 9.2% (17 730) received opioids without acetaminophen first. Acetaminophen first was associated with reduced opioid use on the day prior to and on the day of discharge (3.52 parenteral morphine equivalent doses (PMEs) less [95% CI: 3.33, 3.70]; P < .0001). A statistically but not clinically significant reduction in length of stay was observed in the acetaminophen-first group. Conclusion Nearly 37% of older adult patients did not receive acetaminophen as first-line analgesia after hip surgery. Multimodal analgesia, including non-opioid medications as first-line, should be encouraged.

Background: ARICA (AdheRence to Inhaled Corticosteroids in Asthma) is a comprehensive inhaled corticosteroid (ICS) adherence intervention designed to remediate each patient's unique reason for not taking their ICS as prescribed. Objective: The primary objective was to evaluate the feasibility and acceptability of implementing ARICA in a health system. Methods: 29 Black adults who self-reported ICS nonadherence, had uncontrolled persistent asthma, and a Duke Primary Care provider visit within the past 3 years were randomly assigned to intervention (N=15) or control (N=14) in a waitlist randomized controlled pilot trial. Participants were assigned to 1-3 ARICA components based on adherence barriers selected by participants;including, an asthma selfmanagement program, financial assistance referral program, and/or objective feedback on asthma control. All participants received weekly texts and emails dispelling asthma myths. Activities were delivered virtually due to COVID-19. Primary outcomes were feasibility (e.g., process outcomes) and acceptability (e.g., patient exit interviews) measured at 12 weeks. Secondary asthma (e.g., ACT) and adherence outcomes (e.g., DOSEnonadherence) were measured. Results: Most participants were female (N=27, 93%), nonsmokers (N=26, 70%), poorly controlled with ACT

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.

Background The coping styles of the Sickness Insight in Coping Questionnaire (SICQ; positivism, redefinition, toughness, fighting spirit, nonacceptance) may affect the health and recovery of hospitalized critically ill patients. Research Question Do the SICQ coping styles of hospitalized critically ill patients relate to the patients health-related quality of life (HRQoL) and recovery? Study Design and Methods A prospective cohort study was conducted in a single university-affiliated Dutch hospital. Participants were critically ill adult patients admitted to a mixed medical-surgical ICU (start: n = 417; pre-ICU: n = 391; hospital discharge: n = 350; 3-month follow-up: n = 318; 6-month follow-up: n = 308; 12-month follow-up: n = 285). Coping was recorded with the SICQ pre-ICU and at discharge. HRQoL was measured with the SF-12 pre-ICU, at discharge, and 3, 6, and 12 months after discharge. Indicators of recovery were ICU and hospital length of stay, discharge disposition, and mortality. Correlation and regression analyses were used for data analysis. Results Positivism (r = 0.28-0.51), fighting spirit (r = 0.14-0.35), and redefinition (r = 0.12-0.23) associated significantly (P < .05) with mental HRQoL after discharge. Furthermore, positivism associated positively (P < .01) with physical HRQoL (r = 0.17-0.26) after discharge. Increase in positivism (r = 0.13), redefinition (r = 0.13), and toughness (r = 0.13) across the period of hospitalization associated positively (P ≤ .05) with mental HRQoL at discharge. Pre-ICU positivism associated with hospital length of stay (ρ = −.21, P ≤ .05) and hazard for death (HR = 0.57, P < .01) and had a unidirectional effect on mental HRQoL (β = .30, P < .001). Interpretation SICQ coping is associated with long-term mental HRQoL, hospital length of stay, and hazard for death among hospitalized critically ill patients., Graphical Abstract

This is a short tutorial on two key questions that pertain to cluster randomized trials (CRTs): 1) Should I perform a CRT? and 2) If so, how do I derive the sample size? In summary, a CRT is the best option when you “must” (e.g., the intervention can only be administered to a group) or you “should” (e.g., because of issues such as feasibility and contamination). CRTs are less statistically efficient and usually more logistically complex than individually randomized trials, and so reviewing the rationale for their use is critical. The most straightforward approach to the sample size calculation is to first perform the calculation as if the design were randomized at the level of the patient and then to inflate this sample size by multiplying by the “design effect”, which quantifies the degree to which responses within a cluster are similar to one another. Although trials with large numbers of small clusters are more statistically efficient than those with a few large clusters, trials with large clusters can be more feasible. Also, if results are to be compared across individual sites, then sufficient sample size will be required to attain adequate precision within each site. Sample size calculations should include sensitivity analyses, as inputs from the literature can lack precision. Collaborating with a statistician is essential. To illustrate these points, we describe an ongoing CRT testing a mobile-based app to systematically engage families of intensive care unit patients and help intensive care unit clinicians deliver needs-targeted palliative care.

Background: The experience of financial stress during and after critical illness for patients and their family is poorly understood. Objectives: Our objectives were to (1) explore common financial concerns, their contribution to emotional stress, and potential opportunities for interventions to reduce financial stress in patients with critical illness and their family members; and (2) confirm patient and family members' willingness to provide information on this topic. Design: Cross-sectional survey study. Setting/Subjects: Patients (18/24, response rate 75%) and their family members (32/58, response rate 55%) from two prior randomized trials at an urban, level 1 Trauma center. Results: Ten (56%) patients and 19 (70%) family members reported financial worries during an intensive care unit (ICU) stay; 70% of both groups reported financial worries post-ICU discharge. Thirty percent (3/10) of patients and 43% (10/23) of family members who were not asked about financial concerns by hospital staff wished that they had been asked. Both patients and family believed that it would have been helpful to have information about insurance coverage, interpreting hospital bills, and estimated out-of-pocket costs. Among patients, 47% favored receiving these services after the ICU stay (7/15), while 20% (3/15) preferred these services in the ICU; 73% of family members preferred receiving them during the ICU stay (22/30), while 27% (8/30) preferred these services after the ICU stay. Conclusion: Our findings suggest that the experience of financial stress and the worry it causes during and after critical illness are common and potentially modifiable with simple targeted interventions.

Patient-centered outcomes research (PCOR) represents a paradigm shift in research methods aimed to create the body of evidence that supports clinical practice and informs health care decisions. PCOR integrates patients and other key stakeholders including family members, policy makers, clinicians, and patient advocates and advocacy groups as research partners throughout all stages of the research process. The importance of PCOR has received increased recognition, yet there is little evidence available to help guide researchers interested in the design and conduct of PCOR. In May 2014, we convened a workshop to identify key issues related to designing, conducting, and disseminating findings from PCOR studies. Workshop participants included a diverse group of patients, patient advocates, clinicians (physicians, nurses, psychologists, and advanced practice providers), researchers, administrators, and funders within and beyond the pulmonary, critical care, and sleep medicine communities. Participants identified important issues and considerations to address when undertaking PCOR. In this report, we summarize the results of this workshop to inform members of the pulmonary, sleep, and critical care community interested in participating in PCOR. Key findings include the following: 1) requirements for research to be considered PCOR; 2) the potential significant impact of PCOR on patients, clinicians, and researchers; 3) guiding principles and practical strategies to form successful patient-centered research partnerships, conduct PCOR, and disseminate study results to a broad audience of stakeholders; 4) benefits and challenges of PCOR for researchers; and 5) resources available within the American Thoracic Society to help with the conduct of PCOR.

OBJECTIVE: Little is known about the experience of financial stress for patients who survive critical illness or their families. Our objective was to describe the prevalence of financial stress among critically ill patients and their families, identify clinical and demographic characteristics associated with this stress, and explore associations between financial stress and psychological distress. DESIGN: Secondary analysis of a randomized trial comparing a coping skills training program and an education program for patients surviving acute respiratory failure and their families. SETTING: Five geographically diverse hospitals. PARTICIPANTS: Patients (n=175) and their family members (n=85) completed surveys within 2 weeks of arrival home and 3 and 6 months after randomization. MEASUREMENTS AND MAIN RESULTS: We used regression analyses to assess associations between patient and family characteristics at baseline and financial stress at 3 and 6 months. We used path models and mediation analyses to explore relationships between financial stress, symptoms of anxiety and depression, and global mental health. Serious financial stress was high at both time points, and was highest at 6 months (42.5%) among patients and at 3 months (48.5%) among family members. Factors associated with financial stress included female sex, young children at home, and baseline financial discomfort. Experiencing financial stress had direct effects on symptoms of anxiety (β=0.260, p

Purpose: To evaluate whether a pharmacist-initiated electronic handoff tool can reduce the overall, and potentially inappropriate, hospital discharge prescribing rate of atypical antipsychotics (AAP) initiated in AAP-naive critically ill adults. Methods: This pre–post quality improvement study was initiated in 5 intensive care units (ICUs) at a large academic medical center. An electronic handoff tool (iVent) was utilized in the post-intervention period to enhance pharmacist communication at inpatient transitions of care. Results: Of the 358 included patients, the proportion of hospital survivors with an AAP initiated in the ICU receiving a hospital discharge prescription was not different between the pre- and post-intervention period (28.6% vs 22.2%, P = .12). The proportion of ICU survivors with an AAP continued at the time of ICU transfer to the floor was reduced post-intervention (78.7% vs 66.7%, P = .012). Additionally, the overall proportion of a patient’s hospitalization receiving an AAP was also reduced (50.4% vs 42.8%, P = .008). A multivariate logistic regression demonstrated thatutilization of the electronic handoff tool was not associated with a reduction in hospital discharge prescribing of an AAP (odds ratio [OR]: 0.97, 95% confidence interval [CI]: 0.57-1.65). Conclusions: A pharmacy-initiated electronic handoff tool may reduce the proportion of AAP-naive ICU survivors with an AAP continued at the time of ICU transfer. The handoff tool was not associated with a significant reduction in the discharge prescribing rates of AAPs for hospital survivors, but a clinically meaningful reduction was possibly achieved due to enhanced communication enabled by this tool.

The quality and patient-centeredness of intensive care unit (ICU)-based palliative care delivery is highly variable.To develop and pilot an app platform for clinicians and ICU patients and their family members that enhances the delivery of needs-targeted palliative care.In the development phase of the study, we developed an electronic health record (EHR) system-integrated mobile web app system prototype, PCplanner (Palliative Care Planner). PCplanner screens the EHR for ICU patients meeting any of five prompts (triggers) for palliative care consultation, allows families to report their unmet palliative care needs, and alerts clinicians to these needs. The evaluation phase included a prospective before/after study conducted at a large academic medical center. Two control populations were enrolled in the before period to serve as context for the intervention. First, 25 ICU patients who received palliative care consults served as patient-level controls. Second, 49 family members of ICU patients who received mechanical ventilation for at least 48 hours served as family-level controls. Afterward, 14 patients, 18 family members, and 10 clinicians participated in the intervention evaluation period. Family member outcomes measured at baseline and 4 days later included acceptability (Client Satisfaction Questionnaire [CSQ]), usability (Systems Usability Scale [SUS]), and palliative care needs, assessed with the adapted needs of social nature, existential concerns, symptoms, and therapeutic interaction (NEST) scale; the Patient-Centeredness of Care Scale (PCCS); and the Perceived Stress Scale (PSS). Patient outcomes included frequency of goal concordant treatment, hospital length of stay, and discharge disposition.Family members reported high PCplanner acceptability (mean CSQ, 14.1 [SD, 1.4]) and usability (mean SUS, 21.1 [SD, 1.7]). PCplanner family member recipients experienced a 12.7-unit reduction in NEST score compared with a 3.4-unit increase among controls (P = 0.002), as well as improved mean scores on the PCCS (6.6 [SD, 5.8]) and the PSS (-0.8 [SD, 1.9]). The frequency of goal-concordant treatment increased over the course of the intervention (n = 14 [SD, 79%] vs. n = 18 [SD, 100%]). Compared with palliative care controls, intervention patients received palliative care consultation sooner (3.9 [SD, 2.7] vs. 6.9 [SD, 7.1] mean days), had a shorter mean hospital length of stay (20.5 [SD, 9.1] vs. 22.3 [SD, 16.0] patient number), and received hospice care more frequently (5 [36%] vs. 5 [20%]), although these differences were not statistically significant.PCplanner represents an acceptable, usable, and clinically promising systems-based approach to delivering EHR-triggered, needs-targeted ICU-based palliative care within a standard clinical workflow. A clinical trial in a larger population is needed to evaluate its efficacy.

Many survivors of critical illness and their family members experience significant psychological distress after patient discharge.To compare the effects of a coping skills training (CST) program with an education program on patient and family psychological distress.In this five-center clinical trial, adult patients who received mechanical ventilation for more than 48 hours and one family member of each patient were randomized to six weekly CST telephone sessions plus access to a study website or a critical illness education program.The primary outcome was the patient Hospital Anxiety and Depression Scale (HADS) score at 3 months. Secondary outcomes included 3- and 6-month HADS subscales and the Impact of Events Scale-Revised. Among the 175 patients randomized to CST (n = 86) or education (n = 89), there was no significant difference between CST and education in either 3-month HADS scores (difference, 1.3; 95% confidence interval [CI], -0.9 to 3.4; P = 0.24) or secondary patient and family outcomes. In prespecified analyses, among patients with high baseline distress (n = 60), CST recipients had greater improvement in 6-month HADS score (difference, -4.6; 95% CI, -8.6 to -0.6; P = 0.02) than the education group. Among patients ventilated longer than 7 days (n = 47), education recipients had greater improvement in 3-month HADS score (difference, -4.0; 95% CI, -8.1 to -0.05; P = 0.047) than the CST group.CST did not improve psychological distress symptoms compared with an education program. However, CST improved symptoms of distress at 6 months among patients with high baseline distress, whereas the education program improved distress at 3 months among those ventilated for more than 7 days. Future efforts to address psychological distress among critical illness survivors should target high-risk populations. Clinical trial registered with www.clinicaltrials.gov (NCT01983254).

Information from clinicians about the expected course of the patient's illness is relevant and important for decision-making by surrogates for chronically critically ill patients on mechanical ventilation.To observe how surrogates of chronically critically ill patients respond to information about prognosis from palliative care clinicians.This was a qualitative analysis of a consecutive sample of audio-recorded meetings from a larger, multisite, randomized trial of structured informational and supportive meetings led by a palliative care physician and nurse practitioner for surrogates of patients in medical intensive care units with chronic critical illness (i.e., adults mechanically ventilated for ≥7 days and expected to remain ventilated and survive for ≥72 h).A total of 66 audio-recorded meetings involving 51 intervention group surrogates for 43 patients were analyzed using grounded theory. Six main categories of surrogate responses to prognostic information were identified: (1) receptivity, (2) deflection/rejection, (3) emotion, (4) characterization of patient, (5) consideration of surrogate role, and (6) mobilization of support. Surrogates responded in multiple and even antithetical ways, within and across meetings.Prognostic disclosure by skilled clinician communicators evokes a repertoire of responses from surrogates for the chronically critically ill. Recognition of these response patterns may help all clinicians better communicate their support to patients and families facing chronic critical illness and inform interventions to support surrogate decision-makers in intensive care units. Clinical trial registered with www.clinicaltrials.gov (NCT 01230099).

OBJECTIVE Addressing the quality gap in ICU-based palliative care is limited by uncertainty about acceptable models of collaborative specialist and generalist care. Therefore, we characterized the attitudes of physicians and nurses about palliative care delivery in an ICU environment. DESIGN Mixed-methods study. SETTING Medical and surgical ICUs at three large academic hospitals. PARTICIPANTS Three hundred three nurses, intensivists, and advanced practice providers. MEASUREMENTS AND MAIN RESULTS Clinicians completed written surveys that assessed attitudes about specialist palliative care presence and integration into the ICU setting, as well as acceptability of 23 published palliative care prompts (triggers) for specialist consultation. Most (n = 225; 75%) reported that palliative care consultation was underutilized. Prompting consideration of eligibility for specialist consultation by electronic health record searches for triggers was most preferred (n = 123; 41%); only 17 of them (6%) felt current processes were adequate. The most acceptable specialist triggers were metastatic malignancy, unrealistic goals of care, end of life decision making, and persistent organ failure. Advanced age, length of stay, and duration of life support were the least acceptable. Screening led by either specialists or ICU teams was equally preferred. Central themes derived from qualitative analysis of 65 written responses to open-ended items included concerns about the roles of physicians and nurses, implementation, and impact on ICU team-family relationships. CONCLUSIONS Integration of palliative care specialists in the ICU is broadly acceptable and desired. However, the most commonly used current triggers for prompting specialist consultation were among the least well accepted, while more favorable triggers are difficult to abstract from electronic health record systems. There is also disagreement about the role of ICU nurses in palliative care delivery. These findings provide important guidance to the development of collaborative care models for the ICU setting.

Introduction Although family members of incapacitated, critically ill patients often struggle in the role of surrogate decision maker, there are no low-cost, easily-scaled interventions to address this problem. Aim of the study To develop and pilot-test the Family Support Tool, an interactive, web-based tool to help individuals navigate the complexities of surrogate decision making in ICUs. Material and methods We used a mixed methods, user-centered process to create the Family Support Tool, including: 1) creation of a preliminary design by an expert panel; 2) engagement of a key stakeholder panel to iteratively refine the preliminary design; 3) user testing of a low-fidelity prototype of the tool by 6 former ICU surrogates; 4) creation of a web-based prototype; and 5) user testing of the web-based prototype with 14 surrogates and ICU physicians, including semi-structured interviews and quantitative measurement of usability, acceptability, and perceived effectiveness. Results The initial design contained a collection of videos and exercises designed to help individuals understand the surrogate's role and think through the patient's values and preferences. Based on family stakeholders' feedback about the emotional overwhelm they experience early in an ICU stay, we redesigned the tool to be viewed in sections, with the first section focused on decreasing surrogates' emotional distress, and later sections focused on helping surrogates prepare for family meetings. Surrogates actively making decisions in the ICU judged the final tool to be highly usable (mean summary score 83.5, correlating to 95th percentile when normalized to devices of its type), acceptable (mean 4.2 +/− 0.5 out of 5), and effective (mean 4.3 +/− 0.6 out of 5). All surrogates reported the tool helped them consider goals of care and all indicated they would recommend the tool to a friend. Conclusions We successfully developed a web-based tool to help individuals navigate the complexities of surrogate decision making in ICUs that has high potential for scalability. Surrogates judged the tool to be usable, acceptable, and effective. These data support proceeding to test the tool in a pilot randomized clinical trial.

Background Discharge against medical advice (AMA) is an important, yet understudied, aspect of health care—particularly in trauma populations. AMA discharges result in increased mortality, increased readmission rates, and higher health care costs. Objective The goal of this analysis was to determine what factors impact a patient's odds of leaving the hospital prior to treatment. Methods We performed a retrospective analysis of the National Trauma Data Bank on adult trauma patients (older than 14 years) from 2013 to 2015. Of the 1,770,570 patients with known disposition, excluding mortality, 24,191 patients (1.4%) left AMA. We ascertained patient characteristics including age, sex, race, ethnicity, insurance status, ETOH, drug use, geographic location, Injury Severity Score (ISS), injury mechanism, and anatomic injury location. Multivariate logistic regression models were used to determine which patient factors were associated with AMA status. Results Uninsured (odds ratio [OR] 2.72; 95% confidence interval [CI] 2.58–2.86) or Medicaid-insured (OR 2.50; 95% CI 2.37–2.63) trauma patients were significantly more likely to leave AMA than patients with private insurance. Compared to white patients, African-American patients (OR 1.06; 95% CI 1.02–1.11) were more likely, and Native-American (OR 0.62; 95% CI 0.52–0.75), Asian (OR 0.59; 95% CI 0.49–0.69), and Hispanic (OR 0.80; 95% CI 0.75–0.85) patients were less likely, to leave AMA when controlling for age, sex, ISS, and type of injury. Conclusions Insurance status, race, and ethnicity are associated with a patient's decision to leave AMA. Uninsured and Medicaid patients have more than twice the odds of leaving AMA. These findings demonstrate that racial and socioeconomic disparities are important targets for future efforts to reduce AMA rates and improve outcomes from blunt and penetrating trauma.

Background Critical illness increases the risk for poor mental health outcomes among both patients and their informal caregivers, especially their surrogate decision-makers. Surrogates who must make life-and-death medical decisions on behalf of incapacitated patients may experience additional distress. EMPOWER (Enhancing & Mobilizing the POtential for Wellness & Emotional Resilience) is a novel cognitive-behavioral, acceptance-based intervention delivered in the intensive care unit (ICU) setting to surrogate decision-makers designed to improve both patients’ quality of life and death and dying as well as surrogates’ mental health. Methods Clinician stakeholder and surrogate participant feedback (n = 15), as well as results from an open trial (n = 10), will be used to refine the intervention, which will then be evaluated through a multisite randomized controlled trial (RCT) (n = 60) to examine clinical superiority to usual care. Feasibility, tolerability, and acceptability of the intervention will be evaluated through self-report assessments. Hierarchical linear modeling will be used to adjust for clustering within interventionists to determine the effect of EMPOWER on surrogate differences in the primary outcome, peritraumatic stress. Secondary outcomes will include symptoms of post-traumatic stress disorder, prolonged grief disorder, and experiential avoidance. Exploratory outcomes will include symptoms of anxiety, depression, and decision regret, all measured at 1 and 3 months from post-intervention assessment. Linear regression models will examine the effects of assignment to EMPOWER versus the enhanced usual care group on patient quality of life or quality of death and intensity of care the patient received during the indexed ICU stay assessed at the time of the post-intervention assessment. Participant exit interviews will be conducted at the 3-month assessment time point and will be analyzed using qualitative thematic data analysis methods. Discussion The EMPOWER study is unique in its application of evidence-based psychotherapy targeting peritraumatic stress to improve patient and caregiver outcomes in the setting of critical illness. The experimental intervention will be strengthened through the input of a variety of ICU stakeholders, including behavioral health clinicians, physicians, bereaved informal caregivers, and open trial participants. Results of the RCT will be submitted for publication in a peer-reviewed journal and serve as preliminary data for a larger, multisite RCT grant application. Trial registration ClinicalTrials.gov, NCT03276559. Retrospectively registered on 8 September 2017. Electronic supplementary material The online version of this article (10.1186/s13063-019-3515-0) contains supplementary material, which is available to authorized users.

Objective:To provide clinicians with evidence-based strategies to optimize the support of the family of critically ill patients in the ICU.Methods:We used the Council of Medical Specialty Societies principles for the development of clinical guidelines as the framework for guideline development. We a

The goal of this article is to discuss approaches to discontinuing invasive mechanical ventilation in a general intensive care unit (ICU) population. It considers approaches in which the clinician expects patient survival, as well as those that do not. Additionally, approaches to acute and chronic critical illness are included.

Context Quality metrics for intensive care unit (ICU)-based palliative care have been proposed, but it is unknown how consultative palliative care can contribute to performance on these measures. Objectives Assess adherence to proposed quality metrics of ICU-based palliative care by palliative care specialists. Methods Surrogates for 9/14 patient-level quality metrics were assessed in all patients who received an initial palliative care specialist consult while in an ICU from 10/26/2012 to 1/16/2015 in the Global Palliative Care Quality Alliance, a nationwide palliative care quality registry. Results Two hundred fifty-four patients received an initial palliative care consultation in an ICU setting. Mean (SD) age was 67.5 (17.3) years, 52% were female. The most common reasons for consultation were symptom management (33%) and end-of-life transition (24%). Adherence to ICU quality metrics for palliative care was variable: clinicians documented presence or absence of advance directives in 36% of encounters, assessed pain in 52.0%, dyspnea in 50.8%, spiritual support in 62%, and reported an intervention for pain in 100% of patients with documented moderate to severe intensity pain. Conclusion Palliative care consultations in an ICU setting are characterized by variable adherence to candidate ICU palliative care quality metrics. Although symptom management was the most common reason for palliative care consultation, consultants infrequently documented symptom assessments. Palliative care consultants performed better in offering spiritual support and managing documented symptoms. These results highlight specific competencies of consultative palliative care that should be complimented by ICU teams to ensure high-quality comprehensive care for the critically ill.

To develop and evaluate a preliminary multifaceted model for coping among family members of patients who survive mechanical ventilation.In this multicenter cross-sectional survey, we interviewed family members of mechanically ventilated patients at the time of transfer from the ICU to the hospital ward. We constructed a theoretic model of coping that included characteristics attributable to family members, family-clinician rapport, and patients. We then explored relationships between coping factors and symptoms of psychological distress (anxiety, depression, and posttraumatic stress).Fifty-six family members of survivors of mechanical ventilation.Psychological distress measured by the Hospital Anxiety and Depression Scale and Posttraumatic Stress Scale. Optimism measured using the Life Orientation Test scale, resiliency by Conner-Davidson Resilience Scale, and social support using the Patient Reported Outcomes Measurement Information System inventory. Family members had moderate levels of psychological distress with median total Hospital Anxiety and Depression Scale equal to 14 (interquartile range, 5-20) and Posttraumatic Stress Scale equal to 22 (interquartile range, 15-31). Among family member characteristics, greater optimism (p = 0.001, Hospital Anxiety and Depression Scale; p = 0.010, Posttraumatic Stress Scale), resilience (p = 0.012, Hospital Anxiety and Depression Scale), and social support (p = 0.013, Hospital Anxiety and Depression Scale) were protective against psychological distress. On the contrary, characteristics of family-clinician rapport such as communication quality and presence of conflict did not have any associations with psychological distress.To our knowledge, this is the first study to explore coping as a multifaceted construct and its relationship with family psychological outcomes among survivors of mechanical ventilation. We found certain family characteristics of coping such as optimism, resilience, and social support to be associated with less psychological distress. Further research is warranted to identify potentially modifiable aspects of coping that might guide future interventions.

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.

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., Highlights • Intensive care unit (ICU) survivors experience psychological distress but have few therapies. • LIFT is a self-guided mobile app-based mindfulness intervention we developed for ICU survivors. • LIFT2 is a factorial experimental clinical trial using a multiphase optimization strategy (MOST). • LIFT2 tests the impact of 3 intervention factors on effect, feasibility, scalability, and costs.

Background Treatment decisions commonly have to be made in intensive care units (ICUs). These decisions are difficult for surrogate decision makers and often lead to decisional conflict, psychological distress, and treatments misaligned with patient preferences. Objective To determine whether a decision aid about prolonged mechanical ventilation improved prognostic concordance between surrogate decision makers and clinicians compared with a usual care control. Design Multicenter, parallel, randomized, clinical trial. (ClinicalTrials.gov: NCT01751061). Setting 13 medical and surgical ICUs at 5 hospitals. Participants Adult patients receiving prolonged mechanical ventilation and their surrogates, ICU physicians, and ICU nurses. Intervention A Web-based decision aid provided personalized prognostic estimates, explained treatment options, and interactively clarified patient values to inform a family meeting. The control group received information according to usual care practices followed by a family meeting. Measurements The primary outcome was improved concordance on 1-year survival estimates, measured with the clinician-surrogate concordance scale (range, 0 to 100 percentage points; higher scores indicate more discordance). Secondary and additional outcomes assessed the experiences of surrogates (psychological distress, decisional conflict, and quality of communication) and patients (length of stay and 6-month mortality). Outcomes assessors were blinded to group allocation. Results The study enrolled 277 patients, 416 surrogates, and 427 clinicians. Concordance improvement did not differ between intervention and control groups (mean difference in score change from baseline, -1.7 percentage points [95% CI, -8.3 to 4.8 percentage points]; P = 0.60). Surrogates' postintervention estimates of patients' 1-year prognoses did not differ between intervention and control groups (median, 86.0% [interquartile range {IQR}, 50.0%] vs. 92.5% [IQR, 47.0%]; P = 0.23) and were substantially more optimistic than results of a validated prediction model (median, 56.0% [IQR, 43.0%]) and physician estimates (median, 50.0% [IQR, 55.5%]). Eighty-two intervention surrogates (43%) favored a treatment option that was more aggressive than their report of patient preferences. Although intervention surrogates had greater reduction in decisional conflict than control surrogates (mean difference in change from baseline, 0.4 points [CI, 0.0 to 0.7 points]; P = 0.041), other surrogate and patient outcomes did not differ. Limitation Contamination among clinicians could have biased results toward the null hypothesis. Conclusion A decision aid about prolonged mechanical ventilation did not improve prognostic concordance between clinicians and surrogates, reduce psychological distress among surrogates, or alter clinical outcomes. Decision support in acute care settings may require greater individualized attention for both the cognitive and affective challenges of decision making. Primary funding source National Institutes of Health.

There is evidence that addressing the religious and spiritual needs of patients has positive effects on patient satisfaction and health care utilization. However, in the intensive care unit (ICU), chaplains are often consulted only at the very end of life, thereby leaving patients' spiritual needs unmet. This study looked at the views of 219 ICU clinicians on the role of chaplains. We found that all clinicians find chaplains helpful when a patient is dying or when the chaplain brings up religious or spiritual topics. Physicians find chaplains less helpful in other clinical scenarios such as challenging family meetings or when patients are recovering. Nurses are more likely to consult chaplains for a difficult family meeting or when patients are recovering from critical illness. Communication between clinicians and chaplains, both directly and indirectly through electronic health record notes, remains infrequent, highlighting the need for interventions aimed at improving multidisciplinary spiritual care.

Rationale: Chronically critically ill patients are often dependent on family members for surrogate decision-making, and these surrogates are at high risk for emotional distress. We hypothesized that patient- and surrogate-specific risk factors for surrogate post-traumatic stress disorder (PTSD) symptoms can be identified early in the course of chronic critical illness. Objectives: To identify risk factors for PTSD symptoms in surrogate decision-makers of chronically critically ill patients. Methods: We performed a secondary analysis of the database from a multicenter randomized trial of a communication intervention for chronic critical illness patients and surrogates. Variables preselected for plausible mechanism for increasing PTSD symptoms and identifiable by Day 10 of mechanical ventilation were included in the analysis for association with surrogate PTSD symptoms at 90 days, as measured by the Impact of Events Score–Revised (IES-R). Patient factors included demographics, insurance status, baseline functional status, chronic comorbidities, illness severity, and presence of advance directive. Surrogate variables included demographics, education level and employment, religion, relationship to patient, and Hospital Anxiety and Depression Scale score measured at enrollment. Multivariable linear regression models were then constructed for 26 potential risk factors, including biologically or mechanistically plausible confounders for each, with IES-R score as the outcome. All models were adjusted for multiple respondents, using a mixed model, considering the patients as a random factor. Results: Our analysis included 306 surrogates for 224 patients. A total of 49% of patients were female, and mean age was 59 years (95% confidence interval [CI], 56.4–60.7). A total of 71% of surrogates were female, and mean age was 51 years (95% CI, 49.3–52.4). After examining each potential risk factor in a separate multivariable model, only Day-10 surrogate Hospital Anxiety and Depression Scale score (β coefficient = 1.02; 95% CI, 0.73–1.30) and patient unresponsiveness (β coefficient = 8.39; 95% CI, 0.83–15.95) were associated with higher IES-R scores. Conclusions: Among surrogate decision-makers for chronically critically ill patients, high anxiety and depression scores and patient unresponsiveness on or near Day 10 of mechanical ventilation are risk factors for PTSD symptoms at 90 days.