Electronic alerts for ambulatory patients with atrial fibrillation not prescribed anticoagulation: A randomized, controlled trial (AF-ALERT2).

BACKGROUND: Despite widely available risk stratification tools, safe and effective anticoagulants, and guideline recommendations, anticoagulation for stroke prevention in atrial fibrillation (AF) is under-prescribed in ambulatory patients. To assess the impact of alert-based computerized decision support (CDS) on anticoagulation prescription in ambulatory patients with AF and high-risk for stroke, we conducted this randomized controlled trial. METHODS: Patients with AF and CHA2DS2-VASc score ≥ 2 who were not prescribed anticoagulation and had a clinic visit at Brigham and Women's Hospital were enrolled. Patients were randomly allocated, according to Attending Physician of record, to intervention (alert-based CDS) versus control (no notification). The primary efficacy outcome was the frequency of anticoagulant prescription. RESULTS: The CDS tool assigned 395 and 403 patients to the alert and control groups, respectively. Alert patients were more likely to be prescribed anticoagulation within 48 h of the clinic visit (15.4 % vs. 7.7 %, p < 0.001) and at 90 days (17.2 % vs. 9.9 %, p < 0.01). Direct oral anticoagulants were the predominantly prescribed form of anticoagulation. No significant differences were observed in stroke, TIA, or systemic embolic events (0 % vs. 0.8 %, p = 0.09), symptomatic VTE (0.5 % vs. 1 %, p = 0.43), all-cause mortality (2 % vs. 0.7 %, p = 0.12), or major adverse cardiovascular events (2.8 % vs. 2.5 %, p = 0.79) at 90 days. CONCLUSIONS: An alert-based CDS strategy increased a primary efficacy outcome of anticoagulation in clinic patients with AF and high-risk for stroke who were not receiving anticoagulation at the time of the office visit. The study was likely underpowered to assess an impact on clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier- NCT02958943.

Extended-Duration Low-Intensity Apixaban to Prevent Recurrence in Patients with Provoked Venous Thromboembolism and Enduring Risk Factors: Rationale and Design of the HI-PRO Trial.

Patients with acute venous thromboembolism (VTE) in the setting of transient provoking factors are typically treated with short-term anticoagulation. However, the risk of recurrence may be increased in the presence of enduring risk factors. In such patients, the optimal duration of treatment remains uncertain. HI-PRO is a single-center, double-blind randomized trial. Patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) following a major provoking factor, including major surgery or major trauma, who completed at least 3 months of standard-dose therapeutic anticoagulation and have at least one enduring risk factor (such as obesity or heart failure) will be considered for inclusion. Patients will be randomized to apixaban 2.5 mg twice daily or placebo for 12 months. The primary efficacy outcome will be symptomatic recurrent VTE-a composite of DVT and/or PE at 12 months after randomization. Secondary efficacy outcomes include a composite of death due to cardiovascular causes, nonfatal myocardial infarction, stroke or systemic embolism, major adverse limb events, or coronary or peripheral ischemia requiring revascularization at 12 months, and individual components of these outcomes. The primary safety outcome is major bleeding according to the International Society on Thrombosis and Haemostasis definition. The study plans to enroll 600 patients (300 per arm) to have 80% power for detecting a 75% relative risk reduction in the primary outcome. Active recruitment began in March 2021. HI-PRO will provide clinically meaningful data on whether patients with provoked VTE and enduring risk factors have fewer adverse clinical outcomes if prescribed low-intensity extended-duration anticoagulation.

Unique Patient-Reported Hospital Safety Concerns With Online Tool: MySafeCare.

BACKGROUND: Hospitalized patients and their care partners have valuable and unique perspectives of the medical care they receive. Direct and real-time reporting of patients' safety concerns, though limited in the acute care setting, could provide opportunities to improve patient care. METHODS: We implemented the MySafeCare (MSC) application on six acute care units for 18 months as part of a patient-centered health information technology intervention to promote engagement and safety in the acute care setting. The web-based application allowed hospitalized patients to submit safety concerns anonymously and in real time. We describe characteristics of patient submissions including their categorizations. We evaluated rates of submissions to MSC and compared them with rates of submissions to the Patient Family Relations department at the hospital. In addition, we performed thematic analysis of narrative concerns submitted to the application. RESULTS: We received 46 submissions to MSC and 33% of concerns received were anonymous. The overall rate of submissions was 0.6 submissions per 1000 patient-days and was considerably lower than the rate of submissions to the Patient Family Relations during the same period (4.1 per 1000 patient-days). Identified themes of narrative concerns included unmet care needs and preferences, inadequate communication, and concerns about safety of care. CONCLUSIONS: Although the submission rate to the application was low, MSC captured important content directly from hospitalized patients or their care partners. A web-based patient safety reporting tool for patients should be studied further to understand patient and care partner use and willingness to engage, as well as potential effects on patient safety outcomes.

Impact of Atrial Fibrillation on In-Hospital Mortality and Stroke in Acute Aortic Syndromes.

BACKGROUND: Acute aortic syndromes may present with a number of cardiovascular complications, including atrial fibrillation. We assessed the prevalence of atrial fibrillation in patients presenting with acute aortic syndromes and evaluated atrial fibrillation's association with in-hospital mortality and stroke. METHODS: Consecutive patients with acute aortic syndromes admitted to a single tertiary care center from January 2015 to March 2020 were included. We identified patients with atrial fibrillation on the presenting electrocardiogram. RESULTS: A total of 309 patients with acute aortic syndromes were included in our analyses: 148 (48%) presented with Stanford type A and 161 (52%) with Stanford type B acute aortic syndromes. Twenty-seven (8.7%) patients had atrial fibrillation on the presenting electrocardiogram: 12 (44%) with type A and 15 (56%) with type B acute aortic syndromes. Patients with atrial fibrillation were older, more likely to be white, had a higher frequency of history of cancer, peripheral artery disease, cerebrovascular disease, and heart failure with preserved ejection fraction, compared with those without atrial fibrillation. Acute aortic syndromes patients with atrial fibrillation had higher frequencies of in-hospital mortality compared with those without atrial fibrillation (40.7% vs 12.4%, P < .0001). However, stroke frequencies did not differ between the 2 groups. CONCLUSION: In patients presenting with acute aortic syndromes and atrial fibrillation, we observed higher frequencies of in-hospital mortality, without differences in the frequencies of stroke.

Registry of Arterial and Venous Thromboembolic Complications in Patients With COVID-19.

BACKGROUND: Cardiovascular complications, including myocardial infarction, ischemic stroke, and pulmonary embolism, represent an important source of adverse outcomes in coronavirus disease-2019 (COVID-19). OBJECTIVES: To assess the frequency of arterial and venous thromboembolic disease, risk factors, prevention and management patterns, and outcomes in patients with COVID-19, the authors designed a multicenter, observational cohort study. METHODS: We analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through our Mass General Brigham integrated health network. The total cohort was analyzed by site of care: intensive care (n = 170); hospitalized nonintensive care (n = 229); and outpatient (n = 715). The primary study outcome was a composite of adjudicated major arterial or venous thromboembolism. RESULTS: Patients with COVID-19 were 22.3% Hispanic/Latinx and 44.2% non-White. Cardiovascular risk factors of hypertension (35.8%), hyperlipidemia (28.6%), and diabetes (18.0%) were common. Prophylactic anticoagulation was prescribed in 89.4% of patients with COVID-19 in the intensive care cohort and 84.7% of those in the hospitalized nonintensive care setting. Frequencies of major arterial or venous thromboembolism, major cardiovascular adverse events, and symptomatic venous thromboembolism were highest in the intensive care cohort (35.3%, 45.9%, and 27.0 %, respectively) followed by the hospitalized nonintensive care cohort (2.6%, 6.1%, and 2.2%, respectively) and the outpatient cohort (0% for all). CONCLUSIONS: Major arterial or venous thromboembolism, major adverse cardiovascular events, and symptomatic venous thromboembolism occurred with high frequency in patients with COVID-19, especially in the intensive care setting, despite a high utilization rate of thromboprophylaxis.

Acute Care Patient Portal Intervention: Portal Use and Patient Activation.

BACKGROUND: Patient-facing health information technology (HIT) tools, such as patient portals, are recognized as a potential mechanism to facilitate patient engagement and patient-centered care, yet the use of these tools remains limited in the hospital setting. Although research in this area is growing, it is unclear how the use of acute care patient portals might affect outcomes, such as patient activation. OBJECTIVE: The aim of this study was to describe the use of an acute care patient portal and investigate its association with patient and care partner activation in the hospital setting. METHODS: We implemented an acute care patient portal on 6 acute care units over an 18-month period. We investigated the characteristics of the users (patients and their care partners) of the patient portal, as well as their use of the portal. This included the number of visits to each page, the number of days used, the length of the user's access period, and the average percent of days used during the access period. Patient and care partner activation was assessed using the short form of the patient activation measure (PAM-13) and the caregiver patient activation measure (CG-PAM). Comparisons of the activation scores were performed using propensity weighting and robust weighted linear regression. RESULTS: Of the 2974 randomly sampled patients, 59.01% (1755/2974) agreed to use the acute care patient portal. Acute care patient portal enrollees were younger, less sick, less likely to have Medicare as their insurer, and more likely to use the Partners Healthcare enterprise ambulatory patient portal (Patient Gateway). The most used features of the acute care patient portal were the laboratory test results, care team information, and medication list. Most users accessed the portal between 1 to 4 days during their hospitalization, and the average number of days used (logged in at least once per day) was 1.8 days. On average, users accessed the portal 42.69% of the hospital days during which it was available. There was significant association with patient activation on the neurology service (P<.001) and medicine service (P=.01), after the introduction of HIT tools and the acute care patient portal, but not on the oncology service. CONCLUSIONS: Portal users most often accessed the portal to view their clinical information, though portal usage was limited to only the first few days of enrollment. We found an association between the use of the portal and HIT tools with improved levels of patient activation. These tools may help facilitate patient engagement and improve outcomes when fully utilized by patients and care partners. Future study should leverage usage metrics to describe portal use and assess the impact of HIT tools on specific outcome measures in the hospital setting.