Achievement and quality measure attainment in patients hospitalized with atrial fibrillation: Results from The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) registry.

BACKGROUND: The Get With The Guidelines - Atrial Fibrillation (GWTG-AFIB) Registry uses achievement and quality measures to improve the care of patients with atrial fibrillation (AF). We sought to evaluate overall and site-level variation in attainment of these measures among sites participating in the GWTG-AFIB Registry. METHODS: From the GWTG-AFIB registry, we included patients with AF admitted between 1/3/2013 and 6/30/2019. We described patient-level attainment and variation in attainment across sites of 6 achievement measures with 1) defect-free scores (percent of patients with all eligible measures attained), and 2) composite opportunity scores (percent of all eligible patient measures attained). We also described attainment of 11 quality measures at the patient-level. RESULTS: Among 80,951 patients hospitalized for AF (age 70±13 years, 47.0% female; CHA2DS2-VASc 3.6±1.8) at 132 sites. Site-level defect-free scores ranged from 4.7% to 85.8% (25th, 50th, 75th percentile: 32.7%, 52.1%, 64.4%). Composite opportunity scores ranged from 39.4% to 97.5% (25th, 50th, 75th: 68.1%, 80.3%, 87.1%). Attainment was notably low for the following quality measures: 1) aldosterone antagonist prescription when ejection fraction ≤35% (29% of those eligible); and 2) avoidance of antiplatelet therapy with OAC in patients without coronary/peripheral artery disease (81% of those eligible). CONCLUSIONS: Despite high overall attainment of care measures across GWTG-AFIB registry sites, large site variation was present with meaningful opportunities to improve AF care beyond OAC prescription, including but not limited to prescription of aldosterone antagonists in those with AF and systolic dysfunction and avoidance of non-indicated adjunctive antiplatelet therapy.

Outcomes of Endovascular Therapy in Patients With Prestroke Mobility Impairment.

Background and Purpose: Patients with prestroke mobility impairment (PSMI) were excluded from endovascular clinical trials. There are limited data regarding safety and outcomes of endovascular thrombectomy in this population. We used a large, national data set (Get With The Guidelines­Stroke) to evaluate the safety and outcomes of endovascular thrombectomy in patients with PSMI. Methods: We included patients who underwent endovascular thrombectomy in the Get With The Guidelines­Stroke registry between 2015 and 2019. PSMI was defined as the inability to ambulate independently. Generalized estimating equations for logistic regression models were used to evaluate the association between PSMI and outcomes. Results: Of 56 762 patients treated with endovascular thrombectomy, 2919 (5.14%) had PSMI. PSMI was not associated with symptomatic intracranial hemorrhage (6.0% versus 5.4%; P=0.979). In-hospital death or discharge to hospice occurred in 32.3% of patients with PSMI versus 17.5% without PSMI (adjusted odds ratio, 1.45 [1.32­1.58]). Conclusions: While procedural adverse outcomes were no higher in patients with PSMI, further study is necessary to determine clinical benefit in this population.

Disease Burden Following Non-Cardioembolic Minor Ischemic Stroke or High-Risk TIA: A GWTG-Stroke Study.

BACKGROUND: Limited real-world data are available on outcomes following non-cardioembolic minor ischemic stroke (IS) or high-risk transient ischemic attack (TIA), particularly in the United States (US). We examined outcomes and Medicare payments following any severity IS or TIA as well as the subgroup with minor IS or high-risk TIA. METHODS: Medicare beneficiaries >65 years were identified using US nationwide Get with the Guidelines (GWTG)-Stroke Registry linked to Medicare claims data. The cohort consisted of patients enrolled in Medicare fee-for-service plan, hospitalized with non-cardioembolic IS or TIA between 2011 and 2014, segmenting a subgroup with minor IS (National Institute of Health Stroke Scale [NIHSS] ≤5) or high-risk TIA (ABCD2-score ≥6) compatible with the THALES clinical trial population. Outcomes included functional status at discharge, clinical outcomes (all-cause mortality, ischemic stroke, and hemorrhagic stroke, individually and as a composite), hospitalizations, and population average inpatient Medicare payments following non-cardioembolic IS or TIA. RESULTS: The THALES-compatible cohort included 62,518 patients from 1471 hospitals. At discharge, 37.0% were unable to ambulate without assistance, and 96.2% were prescribed antiplatelet therapy. Cumulative incidences at 30 days, 90 days, and 1 year for the composite outcome were 3.7%, 7.6%, and 17.2% and 2.4%, 4.0%, and 7.3% for subsequent stroke. The mean Medicare payment for the index hospitalization was $7951. The cumulative all-cause inpatient Medicare spending per patient (with or without any subsequent admission) at 30 days and 1 year from discharge was $1451 and $8105, respectively. CONCLUSIONS: The burden of illness for minor IS/high-risk TIA patients indicates an important unmet need. Improved therapeutic options may offer a significant impact on both patient outcomes and Medicare spending.

The Comparing Options for Management: PAtient-centered REsults for Uterine Fibroids (COMPARE-UF) registry: rationale and design.

BACKGROUND: Uterine fibroids are common in premenopausal women, yet comparative effectiveness research on uterine fibroid treatments is rare. OBJECTIVE: The purpose of this study was to design and establish a uterine fibroid registry based in the United States to provide comparative effectiveness data regarding uterine fibroid treatment. STUDY DESIGN: We report here the design and initial recruitment for the Comparing Options for Management: Patient-centered REsults for Uterine Fibroids (COMPARE-UF) registry (Clinicaltrials.gov, NCT02260752), funded by the Agency for Healthcare Research and Quality in collaboration with the Patient-Centered Outcomes Research Institute. COMPARE-UF was designed to help answer critical questions about treatment options for women with symptomatic uterine fibroids. Women who undergo a procedure for uterine fibroids (hysterectomy, myomectomy [abdominal, hysteroscopic, vaginal, and laparoscopic/robotic], endometrial ablation, radiofrequency fibroid ablation, uterine artery embolization, magnetic resonance-guided focused ultrasound, or progestin-releasing intrauterine device insertion) at 1 of the COMPARE-UF sites are invited to participate in a prospective registry with 3 years follow up for postprocedural outcomes. Enrolled participants provide annual follow-up evaluation through an online portal or through traditional phone contact. A central data abstraction center provides information obtained from imaging, operative or procedural notes, and pathology reports. Women with uterine fibroids and other stakeholders are a key part of the COMPARE-UF registry and participate at all points from study design to dissemination of results. RESULTS: We built a network of 9 clinical sites across the United States with expertise in the care of women with uterine fibroids to capture geographic, racial, ethnic, and procedural diversity. Of the initial 2031 women who were enrolled in COMPARE-UF, 42% are self-identified as black or African American, and 40% are ≤40 years old, with 16% of participants <35 years old. Women who undergo myomectomy comprise the largest treatment group at 46% of all procedures, with laparoscopic or robotic myomectomy comprising the largest subset of myomectomies at 19% of all procedures. Hysterectomy is the second most common treatment within the registry at 38%. CONCLUSION: In response to priorities that were identified by our patient stakeholders, the initial aims within COMPARE-UF will address how different procedures that are used to treat uterine fibroids compare in terms of long-lasting symptom relief, potential for recurrence, medical complications, improvement in quality of life and sexual function, age at menopause, and fertility and pregnancy outcomes. COMPARE-UF will generate evidence on the comparative effectiveness of different procedural options for uterine fibroids and help patients and their caregivers make informed decisions that best meet an individual patient's short- and long-term preferences. Building on this infrastructure, the COMPARE-UF team of investigators and stakeholders, including patients, collaborate to identify future priorities for expanding the registry, such as assessing the efficacy of medical therapies for uterine fibroids. COMPARE-UF results will be disseminated directly to patients, providers, and other stakeholders by traditional academic pathways and by innovative methods that include a variety of social media platforms. Given demographic differences among women who undergo different uterine fibroid treatments, the assessment of comparative effectiveness for this disease through clinical trials will remain difficult. Therefore, this registry provides optimized evidence to help patients and their providers better understand the pros and cons of different treatment options so that they can make more informed decisions.

Association of Preceding Antithrombotic Treatment With Acute Ischemic Stroke Severity and In-Hospital Outcomes Among Patients With Atrial Fibrillation.

Importance: Antithrombotic therapies are known to prevent stroke for patients with atrial fibrillation (AF) but are often underused in community practice. Objectives: To examine the prevalence of patients with acute ischemic stroke with known history of AF who were not receiving guideline-recommended antithrombotic treatment before stroke and to determine the association of preceding antithrombotic therapy with stroke severity and in-hospital outcomes. Design, Setting, and Participants: Retrospective observational study of 94 474 patients with acute ischemic stroke and known history of AF admitted from October 2012 through March 2015 to 1622 hospitals participating in the Get With the Guidelines-Stroke program. Exposures: Antithrombotic therapy before stroke. Main Outcomes and Measures: Stroke severity as measured by the National Institutes of Health Stroke Scale (NIHSS; range of 0-42, with a higher score indicating greater stroke severity and a score ≥16 indicating moderate or severe stroke), and in-hospital mortality. Results: Of 94 474 patients (mean [SD] age, 79.9 [11.0] years; 57.0% women), 7176 (7.6%) were receiving therapeutic warfarin (international normalized ratio [INR] ≥2) and 8290 (8.8%) were receiving non-vitamin K antagonist oral anticoagulants (NOACs) preceding the stroke. A total of 79 008 patients (83.6%) were not receiving therapeutic anticoagulation; 12 751 (13.5%) had subtherapeutic warfarin anticoagulation (INR <2) at the time of stroke, 37 674 (39.9%) were receiving antiplatelet therapy only, and 28 583 (30.3%) were not receiving any antithrombotic treatment. Among 91 155 high-risk patients (prestroke CHA2DS2-VASc score ≥2), 76 071 (83.5%) were not receiving therapeutic warfarin or NOACs before stroke. The unadjusted rates of moderate or severe stroke were lower among patients receiving therapeutic warfarin (15.8% [95% CI, 14.8%-16.7%]) and NOACs (17.5% [95% CI, 16.6%-18.4%]) than among those receiving no antithrombotic therapy (27.1% [95% CI, 26.6%-27.7%]), antiplatelet therapy only (24.8% [95% CI, 24.3%-25.3%]), or subtherapeutic warfarin (25.8% [95% CI, 25.0%-26.6%]); unadjusted rates of in-hospital mortality also were lower for those receiving therapeutic warfarin (6.4% [95% CI, 5.8%-7.0%]) and NOACs (6.3% [95% CI, 5.7%-6.8%]) compared with those receiving no antithrombotic therapy (9.3% [95% CI, 8.9%-9.6%]), antiplatelet therapy only (8.1% [95% CI, 7.8%-8.3%]), or subtherapeutic warfarin (8.8% [95% CI, 8.3%-9.3%]). After adjusting for potential confounders, compared with no antithrombotic treatment, preceding use of therapeutic warfarin, NOACs, or antiplatelet therapy was associated with lower odds of moderate or severe stroke (adjusted odds ratio [95% CI], 0.56 [0.51-0.60], 0.65 [0.61-0.71], and 0.88 [0.84-0.92], respectively) and in-hospital mortality (adjusted odds ratio [95% CI], 0.75 [0.67-0.85], 0.79 [0.72-0.88], and 0.83 [0.78-0.88], respectively). Conclusions and Relevance: Among patients with atrial fibrillation who had experienced an acute ischemic stroke, inadequate therapeutic anticoagulation preceding the stroke was prevalent. Therapeutic anticoagulation was associated with lower odds of moderate or severe stroke and lower odds of in-hospital mortality.

Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research: Implementing the patient-driven research paradigm to aid decision making in stroke care.

BACKGROUND: Stroke is common and costly, annually depriving the lives and well-being of 800,000 Americans. Despite demonstrated efficacy in clinical trials, questions remain about the safety and clinical effectiveness of various treatment options given patient characteristics, conditions, preferences, and their desired outcomes. METHODS AND RESULTS: The Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) is a Patient-Centered Outcomes Research Institute-sponsored project designed to help patients, physicians, and other stakeholders make informed decisions regarding stroke care and improve outcomes through patient-centered comparative effectiveness research. The primary outcomes identified and prioritized by stroke patients are "home time" (time spent alive and outside a hospital) and major adverse cardiovascular events. With inputs from stroke patients themselves, a series of comparative safety and effectiveness analyses will be performed across 3 prioritized therapeutic areas identified as important by stroke survivors: oral anticoagulants, statin therapy, and antidepressants. We obtained data from Get With the Guidelines-Stroke linked with Medicare claims and follow-up telephone interviews. Our combined retrospective and prospective research strategy allows the evaluation of the safety and effectiveness of various treatment options and patient-centered longitudinal outcomes. To ensure the rapid translation of findings into clinical practice, results will be disseminated to stroke survivors, caregivers, and health care providers through traditional and social media, including an online decision aid tool. CONCLUSIONS: PROSPER is a patient-centered outcome research study guided by patients, caregivers, and the broader health care community. By addressing knowledge gaps in treatment uncertainties through comparative effectiveness research, PROSPER has the potential to improve decision making in stroke care and patient outcomes reflecting individual patient preferences, needs, and values.

Targeted versus standard feedback: results from a randomized quality improvement trial.

BACKGROUND: Quality improvement is central to improving the care of patients with cardiovascular disease; however, the optimum type of data feedback to support such efforts is unknown. METHODS: Over 26 months, 149 eligible Acute Coronary Treatment and Intervention Outcomes Network Registry-Get With The Guidelines hospitals were randomized to receive either standard (n = 76 control) or targeted (n = 73 intervention) performance feedback reports for acute myocardial infarction patient care. Each report summarized performance on identified metrics (providing hospitals with detailed data on their 3 lowest-performing quality metrics, relative to their peers). Intervention sites received 5 targeted feedback reports. Overall composite performance was compared between cohorts at end of study and as a change from baseline. RESULTS: Intervention (n = 60) and control (n = 64) hospitals that completed the study had similar baseline performance (median score 83.7% vs 84.2%). Over 26 months of follow-up, the change in overall composite score across hospitals was neutral (median 0.1% [interquartile range {IQR} -2.4% to 3.3%]). There was no difference in observed improvement in either the intervention (median -0.2% [IQR-2.6% to 3.3%]) or control (median 0.1% [IQR -2.2% to 3.4%]) hospitals. CONCLUSIONS: We were unable to demonstrate that targeted performance feedback reports lead to more rapid care improvements than standard reports. Future directions should explore the relationship between hospital self-selection of targeted metrics and the identification and promulgation of less common metrics--particularly those that reflect processes of care.

The impact of a statewide pre-hospital STEMI strategy to bypass hospitals without percutaneous coronary intervention capability on treatment times.

BACKGROUND: The ultimate treatment goal for ST-segment elevation myocardial infarction (STEMI) is rapid reperfusion via primary percutaneous intervention (PCI). North Carolina has adopted a statewide STEMI referral strategy that advises paramedics to bypass local hospitals and transport STEMI patients directly to a PCI-capable hospital, even if a non-PCI-capable hospital is closer. METHODS AND RESULTS: We assessed the adherence of emergency medical services to this STEMI protocol, as well as subsequent associations with patient treatment times and outcomes by linking data from the Acute Coronary Treatment and Intervention Outcomes Network Registry(®)-Get With the Guidelines(™) and a statewide emergency medical services data system from June 2008 to September 2010 for all patients with STEMI. Patients were divided into those (1) transported directly to a PCI hospital, thereby bypassing a closer non-PCI hospital and (2) first taken to a closer non-PCI center and later transferred to a PCI hospital. Among 6010 patients with STEMI, 1288 were eligible and included in our study cohort. Of these, 826 (64%) were transported directly to a PCI facility, whereas 462 (36%) were first taken to a non-PCI hospital and later transferred. In a multivariable model, increase in differential driving time and cardiac arrest were associated with a lesser likelihood of being taken directly to a PCI center, whereas a history of PCI was associated with a higher likelihood of being taken directly to a PCI center. Patients sent directly to a PCI center were more likely to have times between first medical contact and PCI within guideline recommendations. CONCLUSIONS: We found that patients who were sent directly to a PCI center had significantly shorter time to reperfusion.

Racial/Ethnic differences in process of care and outcomes among patients hospitalized with intracerebral hemorrhage.

BACKGROUND AND PURPOSE: Although racial/ethnic differences in care are pervasive in many areas of medicine, little is known whether intracerebral hemorrhage (ICH) care processes or outcomes differ by race/ethnicity. METHODS: We analyzed 123 623 patients with ICH (83 216 white, 22 147 black, 10 519 Hispanic, and 7741 Asian) hospitalized at 1199 Get With The Guidelines-Stroke hospitals between 2003 and 2012. Multivariable logistic regression with generalized estimating equation was used to evaluate the association among race, stroke performance measures, and in-hospital outcomes. RESULTS: Relative to white patients, black, Hispanic, and Asian patients were significantly younger, but more frequently had more severe stroke (median National Institutes of Health Stroke Scale, 9, 10, 10, and 11, respectively; P<0.001). After adjustment for both patient and hospital-level characteristics, black patients were more likely to receive deep venous thrombosis prophylaxis, rehabilitation assessment, dysphagia screening, and stroke education, but less likely to have door to computed tomographic time ≤25 minutes and smoking cessation counseling than whites. Both Hispanic and Asian patients had higher odds of dysphagia screening but lower odds of smoking cessation counseling. In-hospital all-cause mortality was lower for blacks (23.0%), Hispanics (22.8%), and Asians (25.3%) than for white patients (27.6%). After risk adjustment, all minority groups had lower odds of death, of receiving comfort measures only or of being discharged to hospice. In contrast, they were more likely to exceed the median length of stay when compared with white patients. CONCLUSIONS: Although individual quality indicators in ICH varied by race/ethnicity, black, Hispanic, and Asian patients with ICH had lower risk-adjusted in-hospital mortality than white patients with ICH.

Prehospital system delay in ST-segment elevation myocardial infarction care: a novel linkage of emergency medicine services and in hospital registry data.

BACKGROUND: Emergency medical services (EMS) are critical in the treatment of ST-segment elevation myocardial infarction (STEMI). Prehospital system delays are an important target for improving timely STEMI care, yet few limited data are available. METHODS: Using a deterministic approach, we merged EMS data from the North Carolina Pre-hospital Medical Information System (PreMIS) with data from the Reperfusion of Acute Myocardial Infarction in Carolina Emergency Departments-Emergency Response (RACE-ER) Project. Our sample included all patients with STEMI from June 2008 to October 2010 who arrived by EMS and who had primary percutaneous coronary intervention (PCI). Prehospital system delays were compared using both RACE-ER and PreMIS to examine agreement between the 2 data sources. RESULTS: Overall, 8,680 patients with STEMI in RACE-ER arrived at a PCI hospital by EMS; 21 RACE-ER hospitals and 178 corresponding EMS agencies across the state were represented. Of these, 6,010 (69%) patients were successfully linked with PreMIS. Linked and notlinked patients were similar. Overall, 2,696 patients were treated with PCI only and were taken directly to a PCI-capable hospital by EMS; 1,750 were transferred from a non-PCI facility. For those being transported directly to a PCI center, 53% reached the 90-minute target guideline goal. For those transferred from a non-PCI facility, 24% reached the 120-minute target goal for primary PCI. CONCLUSIONS: We successfully linked prehospital EMS data with in hospital clinical data. With this linked STEMI cohort, less than half of patients reach goals set by guidelines. Such a data source could be used for future research and quality improvement interventions.

Race-Ethnic Disparities in Rates of Declination of Thrombolysis for Stroke.

BACKGROUND AND OBJECTIVES: Prior regional or single-center studies have noted that 4% to 7% of eligible patients with acute ischemic stroke (AIS) decline IV tissue plasminogen activator (tPA). We sought to determine the prevalence of tPA declination in a nationwide registry of patients with AIS and to investigate differences in declination by race/ethnicity. METHODS: We used the Get With The Guidelines-Stroke registry to identify patients with AIS eligible for tPA and admitted to participating hospitals between January 1, 2016, and March 28, 2019. We compared patient demographics and admitting hospital characteristics between tPA-eligible patients who received and those who declined tPA. Using multivariable logistic regression, we determined patient and hospital factors associated with tPA declination. RESULTS: Among 177,115 tPA-eligible patients with AIS at 1,976 sites, 6,545 patients (3.7%) had tPA declination as the sole documented reason for not receiving tPA. Patients declining treatment were slightly older, were more likely to be female, arrived more often at off-hours and earlier after symptom onset, and were more likely to present to Primary Stroke Centers. Compared with non-Hispanic White, non-Hispanic Black race/ethnicity was independently associated with increased (adjusted odds ratio [aOR] 1.21, 95% CI 1.11-1.31), Asian race/ethnicity with decreased (aOR 0.72, 95% CI 0.58-0.88), and Hispanic ethnicity (any race) with similar odds of tPA declination (OR 0.98, 95% CI 0.86-1.13) in multivariable analysis. DISCUSSION: Although the overall prevalence of tPA declination is low, eligible non-Hispanic Black patients are more likely and Asian patients less likely to decline tPA than non-Hispanic White patients. Reducing rates of tPA declinations among non-Hispanic Black patients may be an opportunity to address disparities in stroke care.

Antiplatelet patterns and outcomes in patients with atrial fibrillation not prescribed an anticoagulant after stroke.

BACKGROUND: To determine association of discharge antiplatelet therapy prescription with 1-year outcomes among patients with AF admitted with acute ischemic stroke and discharged without oral anticoagulation. METHODS: In a retrospective cohort study from the Get With The Guidelines-Stroke registry, we identified all Medicare fee-for-service beneficiaries 65 years or older with AF or atrial flutter admitted with acute ischemic stroke and discharged without oral anticoagulation from April 2003 through December 2014, and we determined association of discharge antiplatelet therapy prescription with 1-year outcomes using Medicare claims data. Primary outcomes were 1-year mortality and composite endpoint of major adverse cardiovascular/neurologic/bleeding events (MACNBE). RESULTS: Of 64,228 subjects (median [interquartile range] age, 84 [78-89] years; 62.5% female), 54,621 (85.0%) were discharged with antiplatelet therapy, and 9607 (15.0%) were discharged with no antithrombotic therapy. The unadjusted rates of 1-year mortality were lower among patients receiving antiplatelet therapy (37.3%) than among those receiving no antithrombotic therapy (48.1%); unadjusted rates of MACNBE were lower for those receiving antiplatelet therapy (45.5%) compared with those receiving no antithrombotic therapy (55.2%). After adjusting for potential confounders, antiplatelet therapy prescription was associated with reduced 1-year mortality (adjusted hazard ratio [HR] 0.64, 95% confidence interval [CI] 0.62-0.66, P < .001) and MACNBE (adjusted HR 0.69, 95% CI 0.67-0.71, P < .001). CONCLUSIONS: Among Medicare beneficiaries with AF admitted for acute ischemic stroke but not discharged on oral anticoagulant therapy, antiplatelet therapy, compared with no antithrombotic therapy, was associated with reduced 1-year mortality and MACNBE.

Clinical Effectiveness of Direct Oral Anticoagulants vs Warfarin in Older Patients With Atrial Fibrillation and Ischemic Stroke: Findings From the Patient-Centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research (PROSPER) Study.

IMPORTANCE: Current guidelines recommend direct oral anticoagulants (DOACs) over warfarin for stroke prevention in patients with atrial fibrillation (AF) who are at high risk. Despite demonstrated efficacy in clinical trials, real-world data of DOACs vs warfarin for secondary prevention in patients with ischemic stroke are largely based on administrative claims or have not focused on patient-centered outcomes. OBJECTIVE: To examine the clinical effectiveness of DOACs (dabigatran, rivaroxaban, or apixaban) vs warfarin after ischemic stroke in patients with AF. DESIGN, SETTING, AND PARTICIPANTS: This cohort study included patients who were 65 years or older, had AF, were anticoagulation naive, and were discharged from 1041 Get With The Guidelines-Stroke-associated hospitals for acute ischemic stroke between October 2011 and December 2014. Data were linked to Medicare claims for long-term outcomes (up to December 2015). Analyses were completed in July 2018. EXPOSURES: DOACs vs warfarin prescription at discharge. MAIN OUTCOMES AND MEASURES: The primary outcomes were home time, a patient-centered measure defined as the total number of days free from death and institutional care after discharge, and major adverse cardiovascular events. A propensity score-overlap weighting method was used to account for differences in observed characteristics between groups. RESULTS: Of 11 662 survivors of acute ischemic stroke (median [interquartile range] age, 80 [74-86] years), 4041 (34.7%) were discharged with DOACs and 7621 with warfarin. Except for National Institutes of Health Stroke Scale scores (median [interquartile range], 4 [1-9] vs 5 [2-11]), baseline characteristics were similar between groups. Patients discharged with DOACs (vs warfarin) had more days at home (mean [SD], 287.2 [114.7] vs 263.0 [127.3] days; adjusted difference, 15.6 [99% CI, 9.0-22.1] days) during the first year postdischarge and were less likely to experience major adverse cardiovascular events (adjusted hazard ratio [aHR], 0.89 [99% CI, 0.83-0.96]). Also, in patients receiving DOACs, there were fewer deaths (aHR, 0.88 [95% CI, 0.82-0.95]; P < .001), all-cause readmissions (aHR, 0.93 [95% CI, 0.88-0.97]; P = .003), cardiovascular readmissions (aHR, 0.92 [95% CI, 0.86-0.99]; P = .02), hemorrhagic strokes (aHR, 0.69 [95% CI, 0.50-0.95]; P = .02), and hospitalizations with bleeding (aHR, 0.89 [95% CI, 0.81-0.97]; P = .009) but a higher risk of gastrointestinal bleeding (aHR, 1.14 [95% CI, 1.01-1.30]; P = .03). CONCLUSIONS AND RELEVANCE: In patients with acute ischemic stroke and AF, DOAC use at discharge was associated with better long-term outcomes relative to warfarin.

Potential unintended financial consequences of pay-for-performance on the quality of care for minority patients.

OBJECTIVES: The purpose of this study was to determine whether pay-for-performance (PFP) increases existing racial care disparities. BACKGROUND: Medicare's PFP program provides financial rewards to hospitals whose care performance ranks in the highest quintile relative to peers and reduces funding to hospitals that rank in the lowest quintile. Pay-for-performance is designed to improve care but may disproportionately penalize hospitals caring for large minority populations. METHODS: Using Medicare data, 3449 US hospitals were ranked by performance on PFP process measures for acute myocardial infarction (AMI), community-acquired pneumonia (CAP), and heart failure (HF). These rankings were compared with the percentage of African American (AA) patients in a center. We determined the eligibility for financial bonus (highest quintile ranking) or penalty (lowest quintile) among centers treating large AA populations (> or = 20%) versus not after adjusting for hospital facility (catheterization, percutaneous coronary intervention, surgery), academic status, number of hospital beds, location, patient volume, and region. RESULTS: The percentage of AA patients treated by a center was inversely associated with performance for AMI and CAP (P < .01) but not HF (P = .06). Relative to hospitals with < 20% AA, those with > or = 20% AA were less likely eligible for financial bonuses and more likely to face penalties: for AMI, adjusted odds ratio (OR) 0.7 (95% CI 0.5-1.0) and 1.8 (1.4-2.4), respectively; for CAP, OR 0.5 (95% CI 0.3-0.6) and 2.3 (1.8-2.9), respectively; for HF, OR 1.0 (95% CI 0.7-1.2) and 1.2 (0.9-1.5), respectively. CONCLUSIONS: Hospitals with large minority populations may be at financial risk under PFP. Thus, PFP may worsen existing racial care disparities.

Enoxaparin dosing and associated risk of in-hospital bleeding and death in patients with non ST-segment elevation acute coronary syndromes.

BACKGROUND: The efficacy of enoxaparin sodium in non-ST-segment elevation acute coronary syndromes is well established; however, concerns remain regarding bleeding risk. The extent to which bleeding risk is attributable to excess dosing of enoxaparin is unclear. METHODS: Using data from the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) National Quality Improvement Initiative, we determined the frequency of administration of excess (>10 mg above the recommended dose), lower-than-recommended (>10 mg below the recommended dose), and recommended doses of enoxaparin. We also determined unadjusted and adjusted risks of in-hospital major bleeding and death associated with excess and lower-than-recommended doses of enoxaparin. RESULTS: Of 10 687 patients, 2002 (18.7%) received an excess dose and 3116 (29.2%) received a lower-than-recommended dose of enoxaparin. Patients receiving excess doses were older (median age, 78 vs 66 years), smaller (median body mass index [calculated as weight in kilograms divided by height in meters squared], 26.2 vs 27.8), and more likely to be female (59.5% vs 38.2%) than patients receiving recommended doses (P < .001 for all). After adjustment for baseline characteristics, an excess dose was significantly associated with major bleeding (odds ratio, 1.43; 95% confidence interval [CI], 1.18-1.75) and death (odds ratio, 1.35; 95% CI, 1.03-1.77) compared with a recommended dose. A lower-than-recommended dose was not associated with major bleeding (odds ratio, 1.01; 95% CI, 0.84-1.21), but there was a trend toward higher mortality (odds ratio, 1.25; 95% CI, 0.93-1.68). CONCLUSIONS: Almost half the patients treated with enoxaparin did not receive a recommended dose and had worse outcomes, especially those receiving an excess dose. Improved adherence to the recommended dose could substantially improve the safety profile of enoxaparin.

Vaccination Trends in Patients With Heart Failure: Insights From Get With The Guidelines-Heart Failure.

OBJECTIVES: This study sought to evaluate and contribute to the limited data on U.S. hospital practice patterns with respect to respiratory vaccination in patients hospitalized with heart failure (HF). BACKGROUND: Respiratory infection is a major driver of morbidity in patients with HF, and many influenza and pneumococcal infections may be prevented by vaccination. METHODS: This study evaluated patients hospitalized at centers participating in the Get With The Guidelines-HF (GWTG-HF) registry from October 2012 to March 2017. The proportion of patients receiving vaccination was described for influenza and pneumococcal vaccination, respectively. The association of hospital-level vaccination rates with individual GWTG-HF performance measures and defect-free care was evaluated using multivariable modeling. RESULTS: This study evaluated 313,761 patients discharged from 392 hospitals during the study period. The proportion of patients receiving influenza vaccination was 68% overall and declined from 70% in 2012 to 2013 to 66% in 2016 to 2017 (p < 0.001), although this was not statistically significant after adjustment (odds ratio: 1.05 per flu season; 95% confidence interval [CI]: 0.94 to 1.18). The proportion of patients receiving pneumococcal vaccination was 66% overall and decreased over the study period from 71% in 2013 to 60% in 2016 (p < 0.001), remaining significant after adjustment (odds ratio: 0.75 per calendar year; 95% CI: 0.67 to 0.84). Hospitals with higher vaccination rates were more likely to discharge patients with higher performance on defect-free care and individual GWTG-HF performance measures (p < 0.001). In a subset of patients with linked Medicare claims, vaccinated patients had similar rates of 1-year all-cause mortality (adjusted hazard ratio: 0.96 [95% CI: 0.89 to 1.03] for influenza vaccination; adjusted hazard ratio: 0.95 [95% CI: 0.89 to 1.01] for pneumococcal vaccination) compared with those not vaccinated. CONCLUSIONS: Nearly 1 in 3 patients hospitalized with HF at participating hospitals were not vaccinated for influenza or pneumococcal pneumonia, and vaccination rates did not improve from 2012 to 2017. Hospitals that exhibited higher vaccination rates performed well with respect to other HF quality of care measures. Vaccination status was not associated with differences in clinical outcomes. Further randomized controlled data are needed to assess the relationship between vaccination and outcomes.

A framework for quality improvement: an analysis of factors responsible for improvement at hospitals participating in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) quality improvement initiative.

BACKGROUND: Hospitals are under increasing pressure to improve their quality of care. However, a key question remains: how can hospitals best design and implement successful quality improvement (QI) programs? Hospitals currently employ a variety of QI initiatives but have little empirical evidence on which to base their quality efforts. METHODS: We designed and applied a hospital cross-sectional survey to 212 hospitals participating in CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the American College of Cardiology/American Heart Association Guidelines), a voluntary QI initiative of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS). We factor analysis and an ordinary least squares regression model to determine the key hospital factors most associated with unexpected improvements in institutional QI in the treatment of NSTE ACS. RESULTS: From 2002 to 2004, the following factors had a significant association with unexpected increases in the 2004 QI in NSTE ACS treatment: the use of CRUSADE QI tools, clinical commitment to quality by a cardiology coadvocate, institutional financial commitment to quality, and barriers to QI related to resource availability and cultural resistance to change (all P < .10). Of these factors, optimal use of CRUSADE QI tools was associated with the highest absolute improvement in process adherence score relative to other factors. CONCLUSIONS: We identified several institutional factors associated with improved quality of care in the treatment of high-risk NSTE ACS. We hope that this evidence-based framework will help guide the development and implementation of future QI programs in order to improve the institutional quality of care for NSTE ACS.

Recent trends in the care of patients with non-ST-segment elevation acute coronary syndromes: insights from the CRUSADE initiative.

BACKGROUND: The extent to which national health quality improvement initiatives have altered reported treatment gaps among patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) is unknown. We sought to determine recent trends in adherence to guideline-based therapies for NSTE ACS. METHODS: We evaluated the treatment of patients with high-risk (positive cardiac markers and/or ischemic ST-segment changes) NSTE ACS enrolled in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA (American College of Cardiology/American Heart Association) Guidelines (CRUSADE) Quality Improvement Initiative from 2002 through 2004 (a total of 113 595 patients over 11 calendar quarters). We analyzed adherence to guideline-recommended therapies, including medications used in the acute care period (<24 hours after presentation), invasive procedures, in-hospital outcomes, and discharge therapies and interventions. RESULTS: The use of each class I guideline recommendation, as well as overall adherence to the guidelines, improved significantly (P<.001) during the study period. In the acute care setting, the use of antiplatelet agents increased by 5% and beta-blockers by 12%; at hospital discharge, the use of antiplatelet agents increased by 3% and beta-blockers by 8%. Heparin use in the acute care period increased by 6%, largely owing to a 9% increase in the use of low-molecular-weight heparin. Use of glycoprotein IIb/IIIa inhibitors in the acute care period also increased by more than 13%. At discharge, clopidogrel use increased by 22%, lipid-lowering agents by 11%, and angiotensin-converting enzyme inhibitors by 5%. While adherence improved, many patients still failed to receive 100% indicated treatments at the end of the study period. CONCLUSIONS: During the 4 years since the initial release of the ACC/AHA guidelines for NSTE ACS, adherence to class I recommendations has significantly improved among hospitals participating in CRUSADE. Still, further improvements are needed for optimal implementation of the these guidelines.

Pay for performance, quality of care, and outcomes in acute myocardial infarction.

CONTEXT: Pay for performance has been promoted as a tool for improving quality of care. In 2003, the Centers for Medicare & Medicaid Services (CMS) launched the largest pay-for-performance pilot project to date in the United States, including indicators for acute myocardial infarction. OBJECTIVE: To determine if pay for performance was associated with either improved processes of care and outcomes or unintended consequences for acute myocardial infarction at hospitals participating in the CMS pilot project. DESIGN, SETTING, AND PARTICIPANTS: An observational, patient-level analysis of 105,383 patients with acute non-ST-segment elevation myocardial infarction enrolled in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association (ACC/AHA) Guidelines (CRUSADE) national quality-improvement initiative. Patients were treated between July 1, 2003, and June 30, 2006, at 54 hospitals in the CMS program and 446 control hospitals. MAIN OUTCOME MEASURES: The differences in the use of ACC/AHA class I guideline recommended therapies and in-hospital mortality between pay for performance and control hospitals. RESULTS: Among treatments subject to financial incentives, there was a slightly higher rate of improvement for 2 of 6 targeted therapies at pay-for-performance vs control hospitals (odds ratio [OR] comparing adherence scores from 2003 through 2006 at half-year intervals for aspirin at discharge, 1.31; 95% confidence interval [CI], 1.18-1.46 vs OR, 1.17; 95% CI, 1.12-1.21; P = .04) and for smoking cessation counseling (OR, 1.50; 95% CI, 1.29-1.73 vs OR, 1.28; 95% CI, 1.22-1.35; P = .05). There was no significant difference in a composite measure of the 6 CMS rewarded therapies between the 2 hospital groups (change in odds per half-year period of receiving CMS therapies: OR, 1.23; 95% CI, 1.15-1.30 vs OR, 1.17; 95% CI, 1.14-1.20; P = .16). For composite measures of acute myocardial infarction treatments not subject to incentives, rates of improvement were not significantly different (OR, 1.09; 95% CI, 1.05-1.14 vs OR, 1.08; 95% CI, 1.06-1.09; P = .49). Overall, there was no evidence that improvements in in-hospital mortality were incrementally greater at pay-for-performance sites (change in odds of in-hospital death per half-year period, 0.91; 95% CI, 0.84-0.99 vs 0.97; 95% CI, 0.94-0.99; P = .21). CONCLUSIONS: Among hospitals participating in a voluntary quality-improvement initiative, the pay-for-performance program was not associated with a significant incremental improvement in quality of care or outcomes for acute myocardial infarction. Conversely, we did not find evidence that pay for performance had an adverse association with improvement in processes of care that were not subject to financial incentives. Additional studies of pay for performance are needed to determine its optimal role in quality-improvement initiatives.