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Item The AURORA Study: A Longitudinal, Multimodal Library of Brain Biology and Function after Traumatic Stress Exposure(Springer Nature, 2020-02) McLean, Samuel A.; Ressler, Kerry; Koenen, Karestan Chase; Neylan, Thomas; Germine, Laura; Jovanovic, Tanja; Clifford, Gari D.; Zeng, Donglin; An, Xinming; Linnstaedt, Sarah; Beaudoin, Francesca; House, Stacey; Bollen, Kenneth A.; Musey, Paul; Hendry, Phyllis; Jones, Christopher W.; Lewandowski, Christopher; Swor, Robert; Datner, Elizabeth; Mohiuddin, Kamran; Stevens, Jennifer S.; Storrow, Alan; Kurz, Michael Christopher; McGrath, Meghan E.; Fermann, Gregory J.; Hudak, Lauren A.; Gentile, Nina; Chang, Anna Marie; Peak, David A.; Pascual, Jose L.; Seamon, Mark J.; Sergot, Paulina; Peacock, W. Frank; Diercks, Deborah; Sanchez, Leon D.; Rathlev, Niels; Domeier, Robert; Haran, John Patrick; Pearson, Claire; Murty, Vishnu P.; Insel, Thomas R.; Dagum, Paul; Onnela, Jukka-Pekka; Bruce, Steven E.; Gaynes, Bradley N.; Joormann, Jutta; Miller, Mark W.; Pietrzak, Robert H.; Buysse, Daniel J.; Pizzagalli, Diego A.; Rauch, Scott L.; Harte, Steven E.; Young, Larry J.; Barch, Deanna M.; Lebois, Lauren A. M.; van Rooij, Sanne J. H.; Luna, Beatriz; Smoller, Jordan W.; Dougherty, Robert F.; Pace, Thaddeus W. W.; Binder, Elisabeth; Sheridan, John F.; Elliott, James M.; Basu, Archana; Fromer, Menachem; Parlikar, Tushar; Zaslavsky, Alan M.; Kessler, Ronald; Emergency Medicine, School of MedicineAdverse posttraumatic neuropsychiatric sequelae (APNS) are common among civilian trauma survivors and military veterans. These APNS, as traditionally classified, include posttraumatic stress, postconcussion syndrome, depression, and regional or widespread pain. Traditional classifications have come to hamper scientific progress because they artificially fragment APNS into siloed, syndromic diagnoses unmoored to discrete components of brain functioning and studied in isolation. These limitations in classification and ontology slow the discovery of pathophysiologic mechanisms, biobehavioral markers, risk prediction tools, and preventive/treatment interventions. Progress in overcoming these limitations has been challenging because such progress would require studies that both evaluate a broad spectrum of posttraumatic sequelae (to overcome fragmentation) and also perform in-depth biobehavioral evaluation (to index sequelae to domains of brain function). This article summarizes the methods of the Advancing Understanding of RecOvery afteR traumA (AURORA) Study. AURORA conducts a large-scale (n = 5000 target sample) in-depth assessment of APNS development using a state-of-the-art battery of self-report, neurocognitive, physiologic, digital phenotyping, psychophysical, neuroimaging, and genomic assessments, beginning in the early aftermath of trauma and continuing for 1 year. The goals of AURORA are to achieve improved phenotypes, prediction tools, and understanding of molecular mechanisms to inform the future development and testing of preventive and treatment interventions.Item Clinical and Research Considerations for Patients with Hypertensive Acute Heart Failure(Elsevier, 2016-08) Collins, Sean P.; Levy, Phillip D.; Martindale, Jennifer L.; Dunlap, Mark E.; Storrow, Alan B.; Pang, Peter S.; Sawyer, Douglas B.; Fermann, Gregory J.; Lenihan, Daniel J.; Peacock, W. Frank; Albert, Nancy M.; Hollander, Judd E.; Lindenfeld, JoAnn M.; Teerlink, John R.; Felker, G. Michael; Fonarow, Gregg C.; Butler, Javed; Department of Emergency Medicine, IU School of MedicineManagement approaches for patients in the emergency department (ED) who present with acute heart failure (AHF) have largely focused on intravenous diuretics. Yet, the primary pathophysiologic derangement underlying AHF in many patients is not solely volume overload. Patients with hypertensive AHF (H-AHF) represent a clinical phenotype with distinct pathophysiologic mechanisms that result in elevated ventricular filling pressures. To optimize treatment response and minimize adverse events in this subgroup, we propose that clinical management be tailored to a conceptual model of disease based on these mechanisms. This consensus statement reviews the relevant pathophysiology, clinical characteristics, approach to therapy, and considerations for clinical trials in ED patients with H-AHF.Item Design and Rationale of a Randomized Trial of a Care Transition Strategy in Patients With Acute Heart Failure Discharged From the Emergency Department: GUIDED-HF (Get With the Guidelines in Emergency Department Patients With Heart Failure).(American Heart Association, 2017-02) Fermann, Gregory J.; Levy, Phillip D.; Pang, Peter; Butler, Javed; Ayaz, S. Imran; Char, Douglas; Dunn, Pat; Jenkins, Cathy A.; Kampe, Christy; Khan, Yosef; Kumar, Vijaya A.; Lindenfeld, JoAnn; Liu, Dandan; Miller, Karen; Peacock, W. Frank; Rizk, Samaa; Robichaux, Chad; Rothman, Russell L.; Schrock, Jon; Singer, Adam; Sterling, Sarah A.; Storrow, Alan B.; Walsh, Cheryl; Wilburn, John; Collins, Sean P.; Emergency Medicine, School of MedicineGUIDED-HF (Get With the Guidelines in Emergency Department Patients With Heart Failure) is a multicenter randomized trial of a patient-centered transitional care intervention in patients with acute heart failure (AHF) who are discharged either directly from the emergency department (ED) or after a brief period of ED-based observation. To optimize care and reduce ED and hospital revisits, there has been significant emphasis on improving transitions at the time of hospital discharge for patients with HF. Such efforts have been almost exclusively directed at hospitalized patients; individuals with AHF who are discharged from the ED or ED-based observation are not included in these transitional care initiatives. Patients with AHF discharged directly from the ED or after a brief period of ED-based observation are randomly assigned to our transition GUIDED-HF strategy or standard ED discharge. Patients in the GUIDED arm receive a tailored discharge plan via the study team, based on their identified barriers to outpatient management and associated guideline-based interventions. This plan includes conducting a home visit soon after ED discharge combined with close outpatient follow-up and subsequent coaching calls to improve postdischarge care and avoid subsequent ED revisits and inpatient admissions. Up to 700 patients at 11 sites will be enrolled over 3 years of the study. GUIDED-HF will test a novel approach to AHF management strategy that includes tailored transitional care for patients discharged from the ED or ED-based observation. If successful, this program may significantly alter the current paradigm of AHF patient care.Item Design and rationale of the high-sensitivity Troponin T Rules Out Acute Cardiac Insufficiency Trial(Dove Press, 2017-05-18) Hunter, Benton R.; Collins, Sean P.; Fermann, Gregory J.; Levy, Phillip D.; Shen, Changyu; Ayaz, Syed Imran; Cole, Mette L.; Miller, Karen F.; Soliman, Adam A.; Pang, Peter S.; Emergency Medicine, School of MedicineBACKGROUND: Acute heart failure (AHF) is a common presentation in the Emergency Department (ED), and most patients are admitted to the hospital. Identification of patients with AHF who have a low risk of adverse events and are suitable for discharge from the ED is difficult, and an objective tool would be useful. METHODS: The highly sensitive Troponin T Rules Out Acute Cardiac Insufficiency Trial (TACIT) will enroll ED patients being treated for AHF. Patients will undergo standard ED evaluation and treatment. High-sensitivity troponin T (hsTnT) will be drawn at the time of enrollment and 3 hours after the initial draw. The initial hsTnT draw will be no more than 3 hours after initiation of therapy for AHF (vasodilator, loop diuretic, noninvasive ventilation). Treating clinicians will be blinded to hsTnT results. We will assess whether hsTnT, as a single measurement or in series, can accurately predict patients at low risk of short-term adverse events. CONCLUSION: TACIT will explore the value of hsTnT measurements in isolation, or in combination with other markers of disease severity, for the identification of ED patients with AHF who are at low risk of short-term adverse events.Item Effect of a Self-care Intervention on 90-Day Outcomes in Patients With Acute Heart Failure Discharged From the Emergency Department: A Randomized Clinical Trial(American Medical Association, 2021) Collins, Sean P.; Liu, Dandan; Jenkins, Cathy A.; Storrow, Alan B.; Levy, Phillip D.; Pang, Peter S.; Chang, Anna Marie; Char, Douglas; Diercks, Deborah J.; Fermann, Gregory J.; Han, Jin H.; Hiestand, Brian; Hogan, Christopher; Kampe, Christina J.; Khan, Yosef; Lee, Sangil; Lindenfeld, JoAnn; Martindale, Jennifer; McNaughton, Candace D.; Miller, Karen F.; Miller-Reilly, Carolyn; Moser, Kelly; Peacock, W. Frank; Robichaux, Chad; Rothman, Russell; Schrock, Jon; Self, Wesley H.; Singer, Adam J.; Sterling, Sarah A.; Ward, Michael J.; Walsh, Cheryl; Butler, Javed; Emergency Medicine, School of MedicineImportance: Up to 20% of patients who present to the emergency department (ED) with acute heart failure (AHF) are discharged without hospitalization. Compared with rates in hospitalized patients, readmission and mortality are worse for ED patients. Objective: To assess the impact of a self-care intervention on 90-day outcomes in patients with AHF who are discharged from the ED. Design, setting, and participants: Get With the Guidelines in Emergency Department Patients With Heart Failure was an unblinded, parallel-group, multicenter randomized trial. Patients were randomized 1:1 to usual care vs a tailored self-care intervention. Patients with AHF discharged after ED-based management at 15 geographically diverse EDs were included. The trial was conducted from October 28, 2015, to September 5, 2019. Interventions: Home visit within 7 days of discharge and twice-monthly telephone-based self-care coaching for 3 months. Main outcomes and measures: The primary outcome was a global rank of cardiovascular death, HF-related events (unscheduled clinic visit due to HF, ED revisit, or hospitalization), and changes in the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score (SS) at 90 days. Key secondary outcomes included the global rank outcome at 30 days and changes in the KCCQ-12 SS score at 30 and 90 days. Intention-to-treat analysis was performed for the primary, secondary, and safety outcomes. Per-protocol analysis was conducted including patients who completed a home visit and had scheduled outpatient follow-up in the intervention arm. Results: Owing to slow enrollment, 479 of a planned 700 patients were randomized: 235 to the intervention arm and 244 to the usual care arm. The median age was 63.0 years (interquartile range, 54.7-70.2), 302 patients (63%) were African American, 305 patients (64%) were men, and 178 patients (37%) had a previous ejection fraction greater than 50%. There was no significant difference in the primary outcome between patients in the intervention vs usual care arm (hazard ratio [HR], 0.89; 95% CI, 0.73-1.10; P = .28). At day 30, patients in the intervention arm had significantly better global rank (HR, 0.80; 95% CI, 0.64-0.99; P = .04) and a 5.5-point higher KCCQ-12 SS (95% CI, 1.3-9.7; P = .01), while at day 90, the KCCQ-12 SS was 2.7 points higher (95% CI, -1.9 to 7.2; P = .25). Conclusions and relevance: The self-care intervention did not improve the primary global rank outcome at 90 days in this trial. However, benefit was observed in the global rank and KCCQ-12 SS at 30 days, suggesting that an early benefit of a tailored self-care program initiated at an ED visit for AHF was not sustained through 90 days.Item Feasibility of Serial 6-min Walk Tests in Patients with Acute Heart Failure(MDPI, 2017-09-11) Collins, Sean P.; Thorn, Michael; Nowak, Richard M.; Levy, Phillip D.; Fermann, Gregory J.; Hiestand, Brian C.; Cowart, Tillman Douglas; Venuti, Robert P.; Hiatt, William R.; Foo, ShiYin; Pang, Peter S.; Emergency Medicine, School of MedicineBackground: Functional status assessment is common in many cardiovascular diseases but it has undergone limited study in the setting of acute heart failure (AHF). Accordingly, we performed a pilot study of the feasibility of the six-minute walk test (6MWT) at the emergency department (ED) presentation and through the hospitalization in patients with AHF. Methods and Results: From November 2014 to February 2015, we conducted a multicenter, observational study of ED patients, aged 18–85 years, whose primary ED admission diagnosis was AHF. Other criteria for enrollment included a left ventricular ejection fraction ≤40%, systolic blood pressure between 90 and 170 mmHg, and verbal confirmation that the patient was able to walk >30 m at the baseline, prior to ED presentation. Study teams were uniformly trained to administer a 6MWT. Patients underwent a baseline 6MWT within 24 h of ED presentation (Day 1) and follow-up 6MWTs at 24 (Day 2), 48 (Day 3), and 120 h (Day 5). A total of 46 patients (65.2% male, 73.9% African American) had a day one mean walk distance of 137.3 ± 78 m, day 2 of 170.9 ± 100 m, and day 3 of 180.8 ± 98 m. The 6MWT demonstrated good reproducibility, as the distance walked on the first 6MWT on Day 3 was similar to the distance on the repeated 6MWT the same day. Conclusions: Our pilot study demonstrates the feasibility of the 6MWT as a functional status endpoint in AHF patients. A larger study in a more demographically diverse cohort of patients is necessary to confirm its utility and association with 30-day heart failure (HF) events.Item Improvement in Kansas City Cardiomyopathy Questionnaire Scores After a Self-Care Intervention in Patients With Acute Heart Failure Discharged From the Emergency Department(American Heart Association, 2021) Stubblefield, William B.; Jenkins, Cathy A.; Liu, Dandan; Storrow, Alan B.; Spertus, John A.; Pang, Peter S.; Levy, Phillip D.; Butler, Javed; Chang, Anna Marie; Char, Douglas; Diercks, Deborah B.; Fermann, Gregory J.; Han, Jin H.; Hiestand, Brian C.; Hogan, Christopher J.; Khan, Yosef; Lee, Sangil; Lindenfeld, JoAnn M.; McNaughton, Candace D.; Miller, Karen; Peacock, W. Frank; Schrock, Jon W.; Self, Wesley H.; Singer, Adam J.; Sterling, Sarah A.; Collins, Sean P.; Emergency Medicine, School of MedicineBackground: We conducted a secondary analysis of changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 over 30 days in a randomized trial of self-care coaching versus structured usual care in patients with acute heart failure who were discharged from the emergency department. Methods: Patients in 15 emergency departments completed the KCCQ-12 at emergency department discharge and at 30 days. We compared change in KCCQ-12 scores between the intervention and usual care arms, adjusted for enrollment KCCQ-12 and demographic characteristics. We used linear regression to describe changes in KCCQ-12 summary scores and logistic regression to characterize clinically meaningful KCCQ-12 subdomain changes at 30 days. Results: There were 350 patients with both enrollment and 30-day KCCQ summary scores available; 166 allocated to usual care and 184 to the intervention arm. Median age was 64 years (interquartile range, 55-70), 37% were female participants, 63% were Black, median KCCQ-12 summary score at enrollment was 47 (interquartile range, 33-64). Self-care coaching resulted in significantly greater improvement in health status compared with structured usual care (5.4-point greater improvement, 95% CI, 1.12-9.68; P=0.01). Improvements in health status in the intervention arm were driven by improvements within the symptom frequency (adjusted odds ratio, 1.62 [95% CI, 1.01-2.59]) and quality of life (adjusted odds ratio, 2.39 [95% CI, 1.46-3.90]) subdomains. Conclusions: In this secondary analysis, patients with acute heart failure who received a tailored, self-care intervention after emergency department discharge had clinically significant improvements in health status at 30 days compared with structured usual care largely due to improvements within the symptom frequency and quality of life subdomains of the KCCQ-12.Item TACIT (High Sensitivity Troponin T Rules Out Acute Cardiac Insufficiency Trial)(American Heart Association, 2019-07-10) Pang, Peter S.; Fermann, Gregory J.; Hunter, Benton R.; Levy, Phillip D.; Lane, Kathleen A.; Li, Xiaochun; Cole, Mette; Collins, Sean P.; Emergency Medicine, School of MedicineBackground Identifying low-risk acute heart failure (AHF) patients safe for discharge from the emergency department (ED) is a major unmet need. Methods A prospective, observational, multi-center pilot study targeting lower risk AHF patients to determine whether high sensitivity troponin T (hsTnT) identifies ED AHF patients at low risk for re-hospitalization and mortality. hsTnT was drawn at baseline and 3 hours. Phone follow up occurred at 30 and 90 days. The primary endpoint: composite of all-cause mortality, re-hospitalization, and ED visits at 90 days (changed from 30 days due to lack of mortality events), analyzed using logistic regression. Secondary endpoints: 30 and 90-day all-cause mortality. hsTnT values less than the 99th%ile were defined as ‘low’ hsTnT. Results Out of 527 enrolled patients, 499 comprised the initial analysis set. Of these, 332 had both 0 and 3-hour hsTnT drawn, of whom 319 completed 30 day follow up. The average age was 62, 60% male, and 57% Black. Median hsTnT was 26.4ng/L (IQR 15.1–44.3). There were 99 (21%) 30-day composite events, 13 (2.7%) deaths at 30 days and 25 deaths (8.2%) at 90 days. Serial hsTnT values below the 99th%ile were not associated with a lower risk for the 90-day primary composite endpoint (OR 0.79 (95% CI 0.42–1.50) p=0.4736). However, no deaths occurred in the low hsTnT group at 30 days with 1 death at 90 days. Conclusions hsTnT did not identify patients at low risk for the primary outcome of re-hospitalization, ED visits, and mortality at 90 days.Item Troponin is unrelated to outcomes in heart failure patients discharged from the emergency department(Wiley, 2022-04-09) Fermann, Gregory J.; Schrock, Jon W.; Levy, Phillip D.; Pang, Peter; Butler, Javed; Chang, Anna Marie; Char, Douglas; Diercks, Deborah; Han, Jin H.; Hiestand, Brian; Hogan, Chris; Jenkins, Cathy A.; Kampe, Christy; Khan, Yosef; Kumar, Vijaya A.; Lee, Sangil; Lindenfeld, JoAnn; Liu, Dandan; Miller, Karen F.; Peacock, W. Frank; Reilly, Carolyn M.; Robichaux, Chad; Rothman, Russell L.; Self, Wesley H.; Singer, Adam J.; Sterling, Sarah A.; Storrow, Alan B.; Stubblefield, William B.; Walsh, Cheryl; Wilburn, John; Collins, Sean P.; Emergency Medicine, School of MedicineBackground: Prior data has demonstrated increased mortality in hospitalized patients with acute heart failure (AHF) and troponin elevation. No data has specifically examined the prognostic significance of troponin elevation in patients with AHF discharged after emergency department (ED) management. Objective: Evaluate the relationship between troponin elevation and outcomes in patients with AHF who are treated and released from the ED. Methods: This was a secondary analysis of the Get with the Guidelines to Reduce Disparities in AHF Patients Discharged from the ED (GUIDED-HF) trial, a randomized, controlled trial of ED patients with AHF who were discharged. Patients with elevated conventional troponin not due to acute coronary syndrome (ACS) were included. Our primary outcome was a composite endpoint: time to 30-day cardiovascular death and/or heart failure-related events. Results: Of the 491 subjects included in the GUIDED-HF trial, 418 had troponin measured during the ED evaluation and 66 (16%) had troponin values above the 99th percentile. Median age was 63 years (interquartile range, 54-70), 62% (n = 261) were male, 63% (n = 265) were Black, and 16% (n = 67) experienced our primary outcome. There were no differences in our primary outcome between those with and without troponin elevation (12/66, 18.1% vs 55/352, 15.6%; P = 0.60). This effect was maintained regardless of assignment to usual care or the intervention arm. In multivariable regression analysis, there was no association between our primary outcome and elevated troponin (hazard ratio, 1.00; 95% confidence interval, 0.49-2.01, P = 0.994). Conclusion: If confirmed in a larger cohort, these findings may facilitate safe ED discharge for a group of patients with AHF without ACS when an elevated troponin is the primary reason for admission.Item What’s Next for Acute Heart Failure Research?(Wiley, 2017) Collins, Sean P.; Levy, Phillip D.; Fermann, Gregory J.; Givertz, Michael M.; Martindale, Jennifer M.; Pang, Peter S.; Storrow, Alan B.; Diercks, Deborah D.; Felker, G. Michael; Fonarow, Gregg C.; Lanfear, David J.; Lenihan, Daniel J.; Lindenfeld, JoAnn M.; Peacock, W. Frank; Sawyer, Douglas M.; Teerlink, John M.; Butler, Javed; Emergency Medicine, School of MedicineEach year over one million patients with acute heart failure (AHF) present to a United States emergency department (ED). The vast majority are hospitalized for further management. The length of stay and high postdischarge event rate in this cohort have changed little over the past decade. Therapeutic trials have failed to yield substantive improvement in postdischarge outcomes; subsequently, AHF care has changed little in the past 40 years. Prior research studies have been fragmented as either “inpatient” or “ED-based.” Recognizing the challenges in identification and enrollment of ED patients with AHF, and the lack of robust evidence to guide management, an AHF clinical trials network was developed. This network has demonstrated, through organized collaboration between cardiology and emergency medicine, that many of the hurdles in AHF research can be overcome. The development of a network that supports the collaboration of acute care and HF researchers, combined with the availability of federally funded infrastructure, will facilitate more efficient conduct of both explanatory and pragmatic trials in AHF. Yet many important questions remain, and in this document our group of emergency medicine and cardiology investigators have identified four high-priority research areas.