Mobile App-Based Mindfulness Intervention for Addressing Psychological Distress Among Survivors of Hospitalization for COVID-19 Infection.

BACKGROUND: Psychological distress symptoms are present and persistent among many patients who survive a critical illness like COVID-19. RESEARCH QUESTION: Could a self-directed mobile app-delivered mindfulness intervention be feasibly and rapidly implemented within a clinical trials network to reduce distress symptoms? STUDY DESIGN AND METHODS: A randomized clinical trial was conducted between January 2021 and May 2022 at 29 US sites and included survivors of hospitalization due to COVID-19-related illness with elevated symptoms of depression at discharge. Participants were randomized to intervention or usual care control. The intervention consisted of four themed weeks of daily audio, video, and text content. All study procedures were virtual. The primary outcome was depression symptoms assessed with the Patient Health Questionnaire 9 at 3 months. Secondary outcomes included anxiety (Generalized Anxiety Disorder 7-item scale), quality of life (EQ-5D), and adherence. We used general linear models to estimate treatment arm differences in outcomes over time. RESULTS: Among 56 randomized participants (mean age ± SD, 51.0 ± 13.2 years; 38 female [67.9%]; 14 Black participants [25%]), 45 (intervention: n = 23 [79%]; control: n = 22 [81%]) were retained at 6 months. There was no difference in mean improvement between intervention and control participants at 3 months in Patient Health Questionnaire 9 (-0.5 vs 0.1), Generalized Anxiety Disorder 7-item scale (-0.3 vs 0.1), or EQ-5D (-0.03 vs 0.02) scores, respectively; 6-month results were similar. Only 15 participants (51.7%) initiated the intervention, whereas the mean number ± SD of the 56 prescribed intervention activities completed was 12.0 ± 15.2. Regulatory approvals delayed trial initiation by nearly a year. INTERPRETATION: Among survivors of COVID-19 hospitalization with elevated psychological distress symptoms, a self-directed mobile app-based mindfulness intervention had poor adherence. Future psychological distress interventions mobilized at broad scale should focus efforts on patient engagement and regulatory simplification to enhance success. TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT04581200; URL: www.clinicaltrials.gov.

Provider-Documented Anxiety in the ICU: Prevalence, Risk Factors, and Associated Patient Outcomes.

PURPOSE: To determine the prevalence of provider-documented anxiety in critically ill patients, associated risk factors, and related patient outcomes. METHOD: Chart review of 100 randomly sampled, adult patients, with a length of stay ≥48 hours in a medical or trauma/surgical intensive care unit (ICU). Provider-documented anxiety was identified based on a comprehensive retrospective chart review of the ICU stay, searching for any acute episode of anxiety (e.g., documented words related to anxiety, panic, and/or distress). RESULTS: Of 100 patients, 45% (95% confidence interval: 35%-55%) had documented anxiety, with similar prevalence in medical vs. trauma/surgical ICU. Patients with documented anxiety more frequently had history of anxiety (22% vs. 4%, p = .004) and substance abuse (40% vs. 22%, p = .048). In the ICU, they had greater severity of illness (median (IQR) Acute Physiology Score 16(13,21) vs. 13(8,19), p = .018), screened positive for delirium at least once during ICU stay, (62% vs. 31%, p = .002), benzodiazepines and antipsychotics use (87% vs. 58%, p = .002; 33% vs. 13%, p = .013, respectively), and mental health consultation (31% vs. 18%, p = .132). These patients also had longer ICU and hospital lengths of stay (6(4,11) vs. 4(3,6), p<.001 and 18(10,30) vs. 10(6,16) days, p<.001, respectively) and less frequent discharge back to home (27% vs. 44%, p = .079). CONCLUSIONS: Documented anxiety, occurring in almost half of ICU patients with length of stay ≥48 hours, was associated with a history of anxiety and/or substance abuse, and greater ICU severity of illness, delirium, psychiatric medications, and length of stay. Increased awareness along with more standardized protocols for assessment of anxiety in the ICU, as well as greater evaluation of non-pharmacological treatments for anxiety symptoms in the ICU are warranted.

Fluid management in ARDS: an evaluation of current practice and the association between early diuretic use and hospital mortality.

BACKGROUND: Acute respiratory distress syndrome (ARDS) and volume overload are associated with increased hospital mortality. Evidence supports conservative fluid management in ARDS, but whether current practice reflects the implementation of that evidence has not been described. This study reports the variability in contemporary fluid management for ICU patients with ARDS. We compared routine care to trial protocols and analyzed whether more conservative management with diuretic medications in contemporary, usual care is associated with outcomes. METHODS: We performed a retrospective cohort study in nine ICUs at two academic hospitals during 2016 and 2017. We included 234 adult patients with ARDS in an ICU at least 3 days after meeting moderate-severe ARDS criteria (PaO2:FIO2 ≤ 150). The primary exposure was any diuretic use in 48 to 72 h after meeting ARDS criteria. The primary outcome was hospital mortality. Unadjusted statistical analyses and multivariable logistic regression were used. RESULTS: In 48-72 h after meeting ARDS criteria, 116 patients (50%) received a diuretic. In-hospital mortality was lower in the group that received diuretics than in the group that did not (14% vs 25%; p = 0.025). At ARDS onset, both groups had similar Sequential Organ Failure Assessment scores and ICU fluid balances. During the first 48 h after ARDS, the diuretic group received less crystalloid fluid than the no diuretic group (median [inter-quartile range]: 1.2 L [0.2-2.8] vs 2.4 L [1.2-5.0]; p < 0.001), but both groups received more fluid from medications and nutrition than from crystalloid. At 48 h, the prevalence of volume overload (ICU fluid balance >10% of body weight) in each group was 16% and 25%(p = 0.09), respectively. During 48-72 h after ARDS, the overall prevalence of shock was 44% and similar across both groups. Central venous pressure was recorded in only 18% of patients. Adjusting for confounders, early diuretic use was independently associated with lower hospital mortality (AOR 0.46, 95%CI [0.22, 0.96]). CONCLUSIONS: In this sample of ARDS patients, volume overload was common, and early diuretic use was independently associated with lower hospital mortality. These findings support the importance of fluid management in ARDS and suggest opportunities for further study and implementation of conservative fluid strategies into usual care.

Low tidal volume ventilation use remains low in patients with acute respiratory distress syndrome at a single center.

PURPOSE: Low tidal volume ventilation (LTVV) reduces mortality in acute respiratory distress syndrome (ARDS) patients. Understanding local barriers to LTVV use at a former ARDS Network hospital may provide new insight to improve LTVV implementation. METHODS: A cohort of 214 randomly selected adults met the Berlin definition of ARDS at Harborview Medical Center between 2008 and 2012. The primary outcome was the receipt of LTVV (tidal volume of ≤6.5mL/kg predicted body weight) within 48h of ARDS onset. We constructed a multivariable logistic regression model to identify factors associated with the outcome. RESULTS: Only 27% of patients received tidal volumes of ≤6.5mL/kg PBW within 48h of ARDS onset. Increasing plateau pressure (OR 1.11; 95% CI 1.03 to 1.19; p-value<0.01) was positively associated with LTVV use while increasing PaO2:FIO2 ratio was negatively associated (OR 0.75; 95% CI 0.57 to 0.98; p-value 0.03). Physicians documented an ARDS diagnosis in only 21% of the cohort. Neither patient height nor gender was associated with LTVV use. CONCLUSIONS: Most ARDS patients did not receive LTVV despite implementation of a protocol. ARDS was also recognized in a minority of patients, suggesting an opportunity for improvement of care.

Development and Validation of a Mortality Prediction Model for Patients Receiving 14 Days of Mechanical Ventilation.

OBJECTIVES: The existing risk prediction model for patients requiring prolonged mechanical ventilation is not applicable until after 21 days of mechanical ventilation. We sought to develop and validate a mortality prediction model for patients earlier in the ICU course using data from day 14 of mechanical ventilation. DESIGN: Multicenter retrospective cohort study. SETTING: Forty medical centers across the United States. PATIENTS: Adult patients receiving at least 14 days of mechanical ventilation. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Predictor variables were measured on day 14 of mechanical ventilation in the development cohort and included in a logistic regression model with 1-year mortality as the outcome. Variables were sequentially eliminated to develop the ProVent 14 model. This model was then generated in the validation cohort. A simplified prognostic scoring rule (ProVent 14 Score) using categorical variables was created in the development cohort and then tested in the validation cohort. Model discrimination was assessed by the area under the receiver operator characteristic curve. Four hundred ninety-one patients and 245 patients were included in the development and validation cohorts, respectively. The most parsimonious model included age, platelet count, requirement for vasopressors, requirement for hemodialysis, and nontrauma admission. The area under the receiver operator characteristic curve for the ProVent 14 model using continuous variables was 0.80 (95% CI, 0.76-0.83) in the development cohort and 0.78 (95% CI, 0.72-0.83) in the validation cohort. The ProVent 14 Score categorized age at 50 and 65 years old and platelet count at 100×10(9)/L and had similar discrimination as the ProVent 14 model in both cohorts. CONCLUSION: Using clinical variables available on day 14 of mechanical ventilation, the ProVent 14 model can identify patients receiving prolonged mechanical ventilation with a high risk of mortality within 1 year.

Red blood cell transfusion is associated with decreased in-hospital muscle strength among critically ill patients requiring mechanical ventilation.

PURPOSE: Red blood cell (RBC) transfusion is linked to poor functional recovery after surgery and trauma. To investigate one potential mechanism, we examined the association between RBC transfusion and muscle strength in a cohort of critically ill patients. METHODS: We performed a secondary analysis of 124 critically ill, mechanically ventilated patients enrolled in 2 prospective cohort studies where muscle strength testing was performed at a median of 12 days after mechanical ventilation onset. We examined the association between RBC transfusion and dynamometry handgrip strength using multivariable linear regression, adjusting for study site, age, sex, Acute Physiology and Chronic Health Evaluation, Sequential Organ Failure Assessment score, days from hospital admission to examination, and steroid use. Secondary outcomes included systematic manual muscle strength and intensive care unit-acquired paresis. RESULTS: Among 124 subjects, 73 (59%) received RBC transfusion in the 30 days before examination. In adjusted analyses, RBC transfusion was significantly associated with weaker handgrip (adjusted mean difference, -9.9 kg; 95% confidence interval, -16.6 to -3.2; P < .01) and proximal manual muscle strength (adjusted mean difference in Medical Research Council score, -0.5; 95% confidence interval, -0.7 to -0.2; P < .01) but not intensive care unit-acquired paresis. CONCLUSIONS: Red blood cell transfusion was associated with decreased muscle strength in this cohort of critically ill patients after adjusting for illness severity and organ dysfunction. Further studies are needed to validate these results and probe mechanisms.

Post-discharge insomnia symptoms are associated with quality of life impairment among survivors of acute lung injury.

INTRODUCTION: Sleep disturbance is common during critical illness, yet little is known about its prevalence or role in post-discharge quality of life among high-risk acute lung injury (ALI) patients. METHODS: In a prospective cohort of 61 mechanically ventilated ALI patients, we examined the association between insomnia symptoms and quality of life six months after discharge. Subjects completed surveys rating quality of life (MOS SF-36), post-traumatic stress disorder (PCL), and depression (PHQ-9). Using an individual item from the PCL, we defined insomnia symptoms as moderate or greater trouble falling or staying asleep in the past month. We performed multivariable linear regression to examine the association between insomnia symptoms and SF-36 physical and mental component summary scores, adjusting for PTSD and depression. RESULTS: Forty subjects (85% of eligible) completed six-month questionnaires; 20 (50%) met criteria for insomnia symptoms. After adjustment for PTSD and depression, insomnia symptoms remained significantly associated with worse physical component summary scores (adjusted mean difference=-8.8; 95% CI: -15.0, -2.5; P<0.01). CONCLUSIONS: Post-discharge insomnia symptoms were common and significantly associated with physical quality of life impairment among six-month ALI survivors, even after adjustment for PTSD and depression symptoms. Further studies are needed to validate these results and to characterize sleep disturbance after ALI using sleep-specific metrics.

Manual muscle strength testing of critically ill patients: feasibility and interobserver agreement.

INTRODUCTION: It has been proposed that intensive care unit (ICU)-acquired weakness (ICUAW) should be assessed using the sum of manual muscle strength test scores in 12 muscle groups (the sum score). This approach has been tested in patients with Guillain-Barré syndrome, yet little is known about the feasibility or test characteristics in other critically ill patients. We studied the feasibility and interobserver agreement of this sum score in a mixed cohort of critically ill and injured patients. METHODS: We enrolled patients requiring more than 3 days of mechanical ventilation. Two observers performed systematic strength assessments of each patient. The primary outcome measure was interobserver agreement of weakness as a binary outcome (ICUAW is sum score less than 48; "no ICUAW" is a sum score greater than or equal to 48) using the Cohen's kappa statistic. RESULTS: We identified 135 patients who met the inclusion criteria. Most were precluded from study participation by altered mental status or polytrauma. Thirty-four participants were enrolled, and 30 of these individuals completed assessments conducted by both observers. Six met the criteria for ICUAW recorded by at least one observer. The observers agreed on the diagnosis of ICUAW for 93% of participants (Cohen's kappa = 0.76; 95% confidence interval (CI), 0.44 to 1.0). Observer agreement was fair in the ICU (Cohen's kappa = 0.38), and agreement was perfect after ICU discharge (Cohen's kappa = 1.0). Absolute values of sum scores were similar between observers (intraclass correlation coefficient 0.83; 95% CI, 0.67 to 0.91), but they differed between observers by six points or more for 23% of the participants. CONCLUSIONS: Manual muscle testing (MMT) during critical illness was not possible for most patients because of coma, delirium and/or injury. Among patients who were able to participate in testing, we found that interobserver agreement regarding ICUAW was good, particularly when evaluated after ICU discharge. MMT is insufficient for early detection of ICU-acquired neuromuscular dysfunction in most patients and may be unreliable during critical illness.

Causes and timing of death in patients with ARDS.

BACKGROUND: Since the early 1980s, case fatality of patients with ARDS has decreased, and explanations are unclear. DESIGN AND METHODS: Using identical definitions of ARDS and organ failure, we analyzed consecutive cohorts of patients meeting syndrome criteria at our institution in 1982 (n = 46), 1990 (n = 112), 1994 (n = 99), and 1998 (n = 205) to determine causes and timing of death. RESULTS: Overall case fatality has decreased from 68% in 1981-1982 to a low of 29% in 1996, plateauing since the mid-1990s (p = 0.001 for trend). Sepsis syndrome with multiple organ failure remains the most common cause of death (30 to 50%), while respiratory failure causes a small percentage (13 to 19%) of deaths. The distribution of causes of death has not changed over time. There was no change in the timing of death during the study periods: 26 to 44% of deaths occurred early (< 72 h after ARDS onset), and 56 to 74% occurred late (> 72 h after ARDS onset). However, the increased survival over the past 2 decades is entirely accounted for by patients who present with trauma and other risk factors for their ARDS, while survival for those patients whose risk factor is sepsis has not changed. Additionally, withdrawal of life support in these patients is now occurring at our institution significantly more frequently than in the past, and median time until death has decreased in patients who have support withdrawn. CONCLUSIONS: While these results do not explain the overall case fatality decline in ARDS, they do indicate that sepsis syndrome remains the leading cause of death and suggest that future therapies to improve survival be targeted at reducing the complications of sepsis.