Background: Adults hospitalized for cardiovascular events are at high risk for post-discharge mortality. Hospital-based screening of health-related psychosocial risk factors is now prioritized by the Joint Commission and the National Quality Forum to achieve equitable, high-quality care. We tested our hypothesis that key patient-reported psychosocial and behavioral measures could predict post-hospitalization mortality in a cohort of adults hospitalized for a cardiovascular event. Methods: This was a prospective cohort of adults hospitalized at Vanderbilt University Medical Center. Validated patient-reported measures of health literacy, social support, disease self-management, and socioeconomic status were used as predictors of interest. Cox survival analyses of mortality were conducted over a median 3.5-year follow-up (range: 1.25 ? 5.5 years). Results: Among 2,977 adults, 1,874 (63%) were hospitalized for acute coronary syndrome and 1,103 (37%) were hospitalized for acute decompensated heart failure; 60% were male; and the mean age was 53 years. After adjusting for demographic, clinical, and other psychosocial factors, mortality risk was greatest among patients who reported being unable to work due to disability (Hazard Ratio (HR) 2.36, 95% Confidence Interval (CI): 1.73-3.21), who were retired (HR 2.14, 95% CI 1.60-2.87), and who reported unemployment (HR 1.99, 95% CI 1.30-3.06) as compared to those who were employed. Patient-reported measures of disease self-management, perceived health competence and exercise frequency, were also associated with mortality risk after full covariate adjustment (HR 0.86, 95% CI 0.73-1.00 per four-point increase), (HR 0.86, 95% CI 0.77-0.96 per three-day change), respectively. Conclusions: Patient-reported measures of employment status independently predict post-discharge mortality after a cardiac hospitalization. Measure of disease self-management also have prognostic modest utility. Hospital-based screening of psychosocial risk is increasingly prioritized in legislative policy. Incorporating brief, valid measures of employment status and disease self-management factors may help target patients for psychosocial, financial, and rehabilitative resources during post-discharge transitions of care.

ImportanceThe effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain.ObjectiveTo assess the effectiveness of fluvoxamine, 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19.Design, Setting, and ParticipantsThe ACTIV-6 platform randomized clinical trial aims to evaluate repurposed medications for mild to moderate COVID-19. Between August 25, 2022, and January 20, 2023, a total of 1175 participants were enrolled at 103 US sites for evaluating fluvoxamine; participants were 30 years or older with confirmed SARS-CoV-2 infection and at least 2 acute COVID-19 symptoms for 7 days or less.InterventionsParticipants were randomized to receive fluvoxamine, 50 mg twice daily on day 1 followed by 100 mg twice daily for 12 additional days (n = 601), or placebo (n = 607).Main Outcomes and MeasuresThe primary outcome was time to sustained recovery (defined as at least 3 consecutive days without symptoms). Secondary outcomes included time to death; time to hospitalization or death; a composite of hospitalization, urgent care visit, emergency department visit, or death; COVID-19 clinical progression scale score; and difference in mean time unwell. Follow-up occurred through day 28.ResultsAmong 1208 participants who were randomized and received the study drug, the median (IQR) age was 50 (40-60) years, 65.8% were women, 45.5% identified as Hispanic/Latino, and 76.8% reported receiving at least 2 doses of a SARS-CoV-2 vaccine. Among 589 participants who received fluvoxamine and 586 who received placebo included in the primary analysis, differences in time to sustained recovery were not observed (adjusted hazard ratio [HR], 0.99 [95% credible interval, 0.89-1.09]; P for efficacy = .40]). Additionally, unadjusted median time to sustained recovery was 10 (95% CI, 10-11) days in both the intervention and placebo groups. No deaths were reported. Thirty-five participants reported health care use events (a priori defined as death, hospitalization, or emergency department/urgent care visit): 14 in the fluvoxamine group compared with 21 in the placebo group (HR, 0.69 [95% credible interval, 0.27-1.21]; P for efficacy = .86) There were 7 serious adverse events in 6 participants (2 with fluvoxamine and 4 with placebo) but no deaths.Conclusions and RelevanceAmong outpatients with mild to moderate COVID-19, treatment with fluvoxamine does not reduce duration of COVID-19 symptoms.Trial RegistrationClinicalTrials.gov Identifier: NCT04885530

BACKGROUND:Disease-modifying therapy (DMT) delays disease progression and improves quality of life for patients with multiple sclerosis (MS), but adherence to DMT is often suboptimal. Vanderbilt Specialty Pharmacy (VSP) embeds pharmacists within an outpatient MS clinic to provide medication management and address barriers to adherence.OBJECTIVE:We evaluated rates and predictors of adherence to DMT among patients with MS at an integrated specialty pharmacy.METHODS:We included patients with MS who filled ≥3 DMT prescriptions from VSP during the study period. Adherence was defined as medication possession ratio (MPR) or proportion of days covered (PDC) ≥0.8. Reasons for nonadherence were collected from pharmacy claims and electronic medical records.RESULTS:The study included 653 patients. Average MPR and PDC were 0.93 and 0.94, respectively. Eighty-eight percent of patients achieved MPR ≥0.8; 89% achieved PDC ≥0.8. Using financial assistance and having $0 out-of-pocket cost were associated with higher odds of achieving MPR and PDC ≥0.8 (P < .05). Of the 12% of patients who were nonadherent, most were unreachable for refills.CONCLUSIONS:Ensuring financial assistance and low out-of-pocket costs are associated with high adherence to DMT within an integrated specialty clinic, but more work is needed to address adherence in unreachable patients.

Barriers remain in the hepatitis C virus (HCV) cascade of care (CoC), limiting the overall impact of direct acting antivirals. This study examines movement between the stages of the HCV CoC and identifies reasons why patients and specific patient populations fail to advance through care in a real world population. We performed a single-center, ambispective cohort study of patients receiving care in an outpatient infectious diseases clinic between October 2015 and September 2016. Patients were followed from treatment referral through sustained virologic response. Univariate and multivariate analyses were performed to identify factors related to completion of each step of the CoC. Of 187 patients meeting inclusion criteria, 120 (64%) completed an evaluation for HCV treatment, 119 (64%) were prescribed treatment, 114 (61%) were approved for treatment, 113 (60%) initiated treatment, 107 (57%) completed treatment, and 100 (53%) achieved a sustained virologic response. In univariate and multivariate analyses, patients with Medicaid insurance were less likely to complete an evaluation and were less likely to be approved for treatment. Treatment completion and SVR rates are much improved from historical CoC reports. However, linkage to care following referral continues to be a formidable challenge for the HCV CoC in the DAA era. Ongoing efforts should focus on linkage to care to capitalize on DAA treatment advances and improving access for patients with Medicaid insurance.

Medication nonadherence increases the risk of hospitalization and poor outcomes, particularly among patients with cardiovascular disease. The purpose of this study was to examine characteristics associated with medication nonadherence among adults hospitalized for cardiovascular disease. Patients in the Vanderbilt Inpatient Cohort Study who were admitted for acute coronary syndrome or heart failure completed validated assessments of self-reported medication adherence (the Adherence to Refills and Medications Scale), demographic characteristics, health literacy, numeracy, social support, depressive symptoms, and health competence. We modeled the independent predictors of nonadherence before hospitalization, standardizing estimated effects by each predictor's interquartile range. Among 1,967 patients studied, 70.7% indicated at least some degree of medication nonadherence leading up to their hospitalization. Adherence was significantly lower among patients with lower health literacy (0.18-point change in adherence score per interquartile range change in health literacy), lower numeracy (0.28), lower health competence (0.30), and more depressive symptoms (0.52) and those of younger age, of non-White race, of male gender, or with less social support. Medication nonadherence in the period before hospitalization is more prevalent among patients with lower health literacy, numeracy, or other intervenable psychosocial factors. Addressing these factors in a coordinated care model may reduce hospitalization rates.

Objectives Increased clinician workload is associated with medical errors and patient harm. The Quality and Workload Assessment Tool (QWAT) measures anticipated (pre-case) and perceived (post-case) clinical workload during actual surgical procedures using ratings of individual and team case difficulty from every operating room (OR) team member. The purpose of this study was to examine the QWAT ratings of OR clinicians who were not present in the OR but who read vignettes compiled from actual case documentation to assess interrater reliability and agreement with ratings made by clinicians involved in the actual cases. Methods Thirty-six OR clinicians (13 anesthesia providers, 11 surgeons, and 12 nurses) used the QWAT to rate 6 cases varying from easy to moderately difficult based on actual ratings made by clinicians involved with the cases. Cases were presented and rated in random order. Before rating anticipated individual and team difficulty, the raters read prepared clinical vignettes containing case synopses and much of the same written case information that was available to the actual clinicians before the onset of each case. Then, before rating perceived individual and team difficulty, they read part 2 of the vignette consisting of detailed role-specific intraoperative data regarding the anesthetic and surgical course, unusual events, and other relevant contextual factors. Results Surgeons had higher interrater reliability on the QWAT than did OR nurses or anesthesia providers. For the anticipated individual and team workload ratings, there were no statistically significant differences between the actual ratings and the ratings obtained from the vignettes. There were differences for the 3 provider types in perceived individual workload for the median difficulty cases and in the perceived team workload for the median and more difficult cases. Conclusions The case difficulty items on the QWAT seem to be sufficiently reliable and valid to be used in other studies of anticipated and perceived clinical workload of surgeons. Perhaps because of the limitations of the clinical documentation shown to anesthesia providers and OR nurses in the current vignette study, more evidence needs to be gathered to demonstrate the criterion-related validity of the QWAT difficulty items for assessing the workload of nonsurgeon OR clinicians.

Objective: Understanding variations in size and pattern of development of angiotensin II (Ang II)-induced abdominal aortic aneurysms (AAA) may inform translational research strategies. Thus, we sought insight into the temporal evolution of AAA in apolipoprotein (apo) E-/- mice.Approach: A cohort of mice underwent a 4-week pump-mediated infusion of saline (n = 23) or 1500 ng/kg/min of Ang II (n = 85) and AAA development was tracked via in vivo ultrasound imaging. We adjusted for hemodynamic covariates in the regression models for AAA occurrence in relation to time.Results: The overall effect of time was statistically significant (p<0.001). Compared to day 7 of AngII infusion, there was no decrease in the log odds of AAA occurrence by day 14 (-0.234, p = 0.65), but compared to day 21 and 28, the log odds decreased by 9.07 (p<0.001) and 2.35 (p = 0.04), respectively. Hemodynamic parameters were not predictive of change in aortic diameter (Delta) (SBP, p = 0.66; DBP, p = 0.66). Mean total cholesterol (TC) was higher among mice with large versus small AAA (601 vs. 422 mg/ml, p<0.0001), and the difference was due to LDL. AngII exposure was associated with 0.43 mm (95% CI, 0.27 to 0.61, p<0.0001) increase in aortic diameter; and a 100 mg/dl increase in mean final cholesterol level was associated with a 12% (95% CI, 5.68 to 18.23, p<0.0001) increase in aortic diameter. Baseline cholesterol was not associated with change in aortic diameter (p = 0.86).Conclusions: These are the first formal estimates of a consistent pattern of Ang II-induced AAA development. The odds of AAA occurrence diminish after the second week of Ang II infusion, and TC is independently associated with AAA size.

BackgroundVasa vasorum (VV) vessels are critical in the genesis of atherosclerosis. Therefore, we assessed measures of carotid VV, intima–media thickness (CIMT), and patient risk factors in a primary prevention population.MethodsWe used multivariable linear models to evaluate the relationship between baseline covariates and a measure of carotid VV (VV ratio) and CIMT among 324 diabetics and 141 nondiabetics.ResultsMedian CIMT (in mm) and VV ratio among nondiabetics were 0.82 ± 0.22 and 0.80 ± 0.19, respectively, and 1.06 ± 0.19 and 1.21 ± 0.26 among diabetics (P < 0.0001). Diabetes was associated with 36% (95% CI: 24.3–48.0, P < 0.001) higher VV ratio whereas a unit change in BMI was associated with ≈1% (95% CI: 0.5–1.4, P < 0.001) change in VV ratio. A 10‐year increase in age was associated with 4% (95% CI: 1–7, P = 0.005) higher CIMT. Each 10 mmHg increase in mean systolic blood pressure was associated with 2% (95% CI: 1–4, P = 0.003) higher CIMT whereas diabetes conferred 31% (95% CI: 19.1–42.1, P < 0.001) higher CIMT. Female sex was associated with a 9% (95% CI: −12.9 to −4.1, P < 0.001) lower CIMT. Low density lipoprotein (LDL) cholesterol, blood pressure, and CIMT were not significantly associated with VV ratio.ConclusionIn this cohort of patients with low CIMT, VV ratio, and CIMT were distinctly unrelated, but each independently associated with diabetes. VV ratio and CIMT relationships warrant further investigation in large‐scale studies and across a spectrum of atherosclerostic states.

Background Understanding the pattern of development of abdominal aortic aneurysms (AAA) may help optimize translational research strategies. Thus we sought mechanistic insight on the pattern of AAA evolution in apolipoprotein E -/- mice. Methods Fifty-nine mice underwent a 4-week pump-mediated infusion of saline (controls; n=13) or 1500 ng/kg/min of AngII (n=46), and AAA development was tracked via in vivo serial ultrasound imaging. We adjusted for hemodynamic covariates in the mixed logistic regression model for AAA occurrence in relation to time. Results The incidence of intact AAA in AngII infused mice was 59% (27/46) of which 55.6% (15/27) were small AAA and 44.4% were large AAA (1.2-1.5 vs. >1.5x baseline diameter, respectively). The incidence of rupture was 22% (10/46). All large aneurysms and most ruptures occurred within the first week of AngII exposure. Subsequent aneurysms were small and evolved in the second week of AngII infusion. The overall effect of time was statistically significant (p<0.001) (Figure). When compared to day 7 of the study period, there was no decrease in the log odds of AAA occurrence by day 14 (-0.234, p = 0.65). However, compared to 21 and 28 days into AngII infusion, the log odds of an AAA occurrence decreased by -9.07 (p< 0.001) and -2.35 (p= 0.04), respectively (Figure). Conclusions These are the first formal estimates of the odds of AAA occurrence vis-à-vis time in the context of a consistent pattern of AAA development in this mouse model of AngII-induced AAA. They occur in the first (large AAA) and second (small AAA) weeks of AngII infusion, and the odds of occurrence diminish thereafter. These findings provide guidance for experimental strategies.

Background Although hyperlipidemia is known to augment the incidence of abdominal aortic aneurysms (AAA) in the AngII-induced model of apolipoprotein E -/- mice, its relationship to AAA size is unknown. Therefore, we evaluated the relationship between total cholesterol concentration (TC) and change (delta) in aortic diameter. Methods TC was measured in 36 male mice that underwent a 4-week infusion period with saline (n=9) or AngII (1500 ng/kg/min; n=27), along with serial measurements of pulse rate (PR), and pulse (PP), mean arterial (MAP), systolic (SBP) and diastolic (DBP) pressure. A linear mixed effect model was used to assess the relationship between all hemodynamic parameters and delta. Nonparametric and linear regression methods were used to evaluate TC in relation to delta. Results TC did not differ between AngII and control mice (Figure, bottom left) (p=0.18). The burden of atherosclerosis was greater among AngII-exposed mice versus control, but did not differ by presence or size of AAA (Figure, bottom right). None of the hemodynamic parameters were predictive of delta (SBP, p = 0.66; DBP, p = 0.66; MAP, p = 0.55; PP, p = 0.66; and PR, p = 0.39). Mean TC was higher among mice with large versus small AAA (552.6 vs. 393.5 mg/ ml, p<0.05; Figure, top right). The nonparametric smoothing line (Figure, top left) suggests a first order relationship between delta and TC (p for trend < 0.001). AngII (ß = 0.48, p < 0.001) and TC (ß = 0.0015, p = 0.003) were independent predictors in the linear model for delta. Conclusions Our findings suggest that TC is incrementally associated with AAA size. These findings may have potential clinical relevance for risk assessment in AAA patients. Figure

BACKGROUND:Collaborative and toolkit approaches have gained traction for improving quality in health care.OBJECTIVE:To determine if a quality improvement virtual collaborative intervention would perform better than a toolkit-only approach at preventing central line-associated bloodstream infections (CLABSIs) and ventilator-associated pneumonias (VAPs).DESIGN AND SETTING:Cluster randomized trial with the Intensive Care Units (ICUs) of 60 hospitals assigned to the Toolkit (n=29) or Virtual Collaborative (n=31) group from January 2006 through September 2007.MEASUREMENT:CLABSI and VAP rates. Follow-up survey on improvement interventions, toolkit utilization, and strategies for implementing improvement.RESULTS:A total of 83% of the Collaborative ICUs implemented all CLABSI interventions compared to 64% of those in the Toolkit group (P = 0.13), implemented daily catheter reviews more often (P = 0.04), and began this intervention sooner (P < 0.01). Eighty-six percent of the Collaborative group implemented the VAP bundle compared to 64% of the Toolkit group (P = 0.06). The CLABSI rate was 2.42 infections per 1000 catheter days at baseline and 2.73 at 18 months (P = 0.59). The VAP rate was 3.97 per 1000 ventilator days at baseline and 4.61 at 18 months (P = 0.50). Neither group improved outcomes over time; there was no differential performance between the 2 groups for either CLABSI rates (P = 0.71) or VAP rates (P = 0.80).CONCLUSION:The intensive collaborative approach outpaced the simpler toolkit approach in changing processes of care, but neither approach improved outcomes. Incorporating quality improvement methods, such as ICU checklists, into routine care processes is complex, highly context-dependent, and may take longer than 18 months to achieve.

Context Bureaucratic organisational culture is less favourable to quality improvement, whereas organisations with group (teamwork) culture are better aligned for quality improvement. Objective To determine if an organisational group culture shows better alignment with patient safety climate. Design Cross-sectional administration of questionnaires. Setting 40 Hospital Corporation of America hospitals. Participants 1406 nurses, ancillary staff, allied staff and physicians. Main outcome measures Competing Values Measure of Organisational Culture, Safety Attitudes Questionnaire (SAQ), Safety Climate Survey (SCSc) and Information and Analysis (IA). Results The Cronbach alpha was 0.81 for the group culture scale and 0.72 for the hierarchical culture scale. Group culture was positively correlated with SAQ and its subscales (from correlation coefficient r=0.44 to 0.55, except situational recognition), ScSc (r=0.47) and IA (r=0.33). Hierarchical culture was negatively correlated with the SAQ scales, SCSc and IA. Among the 40 hospitals, 37.5% had a hierarchical dominant culture, 37.5% a dominant group culture and 25% a balanced culture. Group culture hospitals had significantly higher safety climate scores than hierarchical culture hospitals. The magnitude of these relationships was not affected after adjusting for provider job type and hospital characteristics. Conclusions Hospitals vary in organisational culture, and the type of culture relates to the safety climate within the hospital. In combination with prior studies, these results suggest that a healthcare organisation's culture is a critical factor in the development of its patient safety climate and in the successful implementation of quality improvement initiatives.