Dataset Information

Immediate Discharge and Home Treatment With Rivaroxaban of Low-risk Venous Thromboembolism Diagnosed in Two U.S. Emergency Departments: A One-year Preplanned Analysis.

ABSTRACT: The study hypothesis was that a target-specific anticoagulant would allow successful home treatment of selected patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) diagnosed in two urban emergency departments (EDs).A protocol was established for treating low-risk DVT or PE patients with rivaroxaban and clinic, follow-up at both 2 to 5 weeks, and 3 to 6 months. Patients were determined to be low-risk by using a modified version of the Hestia criteria, supplemented by additional criteria for patients with active cancer. Acceptable outcome rates were defined as venous thromboembolism (VTE) recurrence ? 2.1% or bleeding ? 9.4% during treatment. VTE recurrence required positive imaging of any VTE. The International Society of Thrombosis and Hemostasis definition of major or clinically relevant nonmajor bleeding was used.From March 2013 through April 2014, a total of 106 patients were treated. Seventy-one (68%) had DVT, 30 (28%) had PE, and five (3%) had both, representing 51% of all DVTs and 27% of all PEs diagnosed in both EDs during the period of study. The 106 patients have been followed for a mean (±SD) of 389 (±111) days (range = 213 to 594 days). No patient had VTE recurrence, and no patient had a major or clinically relevant bleeding event while on therapy (none of the 106, 0%, 95% confidence interval [CI] = 0% to 3.4%). However, three patients 2.8% (95% CI = 1% to 8%) had recurrent DVT after cessation of therapy.Patients diagnosed with VTE and immediately discharged from the ED while treated with rivaroxaban had a low rate of VTE recurrence and bleeding.

SUBMITTER: Beam DM

PROVIDER: S-EPMC5034796 | biostudies-other | 2015 Jul

REPOSITORIES: biostudies-other

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Immediate Discharge and Home Treatment With Rivaroxaban of Low-risk Venous Thromboembolism Diagnosed in Two U.S. Emergency Departments: A One-year Preplanned Analysis.

Beam Daren M DM Kahler Zachary P ZP Kline Jeffrey A JA

Academic emergency medicine : official journal of the Society for Academic Emergency Medicine 20150625 7

<h4>Objectives</h4>The study hypothesis was that a target-specific anticoagulant would allow successful home treatment of selected patients with deep vein thrombosis (DVT) and pulmonary embolism (PE) diagnosed in two urban emergency departments (EDs).<h4>Methods</h4>A protocol was established for treating low-risk DVT or PE patients with rivaroxaban and clinic, follow-up at both 2 to 5 weeks, and 3 to 6 months. Patients were determined to be low-risk by using a modified version of the Hestia cri ...[more]

PMID: 26113241

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Project description:BackgroundThe objective was to test if low-risk emergency department patients with vitamin K antagonist (venous thromboembolism [VTE]; including venous thrombosis and pulmonary embolism [PE]) can be safely and effectively treated at home with direct acting oral (monotherapy) anticoagulation in a large-scale, real-world pragmatic effectiveness trial.MethodsThis was a single-arm trial, conducted from 2016 to 2019 in accordance with the Standards for Reporting Implementation Studies guideline in 33 emergency departments in the United States. Participants had newly diagnosed VTE with low risk of death based upon either the modified Hestia criteria, or physician judgment plus the simplified PE severity index score of zero, together with nonhigh bleeding risk were eligible. Patients had to be discharged within 24 hours of triage and treated with either apixaban or rivaroxaban. Effectiveness was defined by the primary efficacy and safety outcomes, image-proven recurrent VTE and bleeding requiring hospitalization >24 hours, respectively, with an upper limit of the 95% CI for the 30-day frequency of VTE recurrence below 2.0% for both outcomes.ResultsWe enrolled 1421 patients with complete outcomes data, including 903 with venous thrombosis and 518 with PE. The recurrent VTE requiring hospitalization occurred in 14/1421 (1.0% [95% CI, 0.5%-1.7%]), and bleeding requiring hospitalization occurred in 12/1421 (0.8% [0.4%-1.5%). The rate of severe bleeding using International Society for Thrombosis and Haemostasis criteria was 2/1421 (0.1% [0%-0.5%]). No patient died, and serious adverse events occurred in 2.5% of venous thrombosis patients and 2.3% of patients with PE. Medication nonadherence was reported by patients in 8.0% (6.6%-9.5%) and was associated with a risk ratio of 6.0 (2.3-15.2) for VTE recurrence. Among all patients diagnosed with VTE in the emergency department during the period of study, 18% of venous thrombosis patients and 10% of patients with PE were enrolled.ConclusionsMonotherapy treatment of low-risk patients with venous thrombosis or PE in the emergency department setting produced a low rate of bleeding and VTE recurrence, but may be underused. Patients with venous thrombosis and PE should undergo risk-stratification before home treatment. Improved patient adherence may reduce rate of recurrent VTE. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03404635.

Project description:IntroductionIn the USA, many emergency departments (EDs) have established protocols to treat patients with newly diagnosed deep vein thrombosis (DVT) as outpatients. Similar treatment of patients with pulmonary embolism (PE) has been proposed, but no large-scale study has been published to evaluate a comprehensive, integrated protocol that employs monotherapy anticoagulation to treat patients diagnosed with DVT and PE in the ED.Methods and analysisThis protocol describes the implementation of the Monotherapy Anticoagulation To expedite Home treatment of Venous ThromboEmbolism (MATH-VTE) study at 33 hospitals in the USA. The study was designed and executed to meet the requirements for the Standards for Reporting Implementation Studies guideline. The study was funded by investigator-initiated awards from industry, with Indiana University as the sponsor. The study principal investigator and study associates travelled to each site to provide on-site training. The protocol identically screens patients with both DVT or PE to determine low risk of death using either the modified Hestia criteria or physician judgement plus a negative result from the simplified PE severity index. Patients must be discharged from the ED within 24 hours of triage and treated with either apixaban or rivaroxaban. Overall effectiveness is based upon the primary efficacy and safety outcomes of recurrent VTE and bleeding requiring hospitalisation respectively. Target enrolment of 1300 patients was estimated with efficacy success defined as the upper limit of the 95% CI for the 30-day frequency of VTE recurrence below 2.0%. Thirty-three hospitals in 17 states were initiated in 2016-2017.Ethics and disseminationAll sites had Institutional Review Board approval. We anticipate completion of enrolment in June 2020; study data will be available after peer-reviewed publication. MATH-VTE will provide information from a large multicentre sample of US patients about the efficacy and safety of home treatment of VTE with monotherapy anticoagulation.

Project description:The objective of this study was to determine the clinical profile of and diagnostic and therapeutic approach to patients with venous thromboembolism (VTE) in Spanish Emergency Departments (EDs). Risk factors, adherence to clinical practice guidelines, and outcomes were also evaluated.Patients with VTE diagnosed in 53 Spanish EDs were prospectively and consecutively included. Demographic data, comorbidities, risk factors for VTE, index event characteristics, hemorrhagic risk, and mortality were evaluated. Adherence to clinical practice guidelines was assessed based on clinical probability scales, requests for determination of D-dimer, use of anticoagulant treatment before confirmation of diagnosis, and assessment of bleeding and prognostic risk. Recurrence, bleeding, and death during admission and at 30, 90, and 180 days after diagnosis in the EDs were recorded.From 549,840 ED visits made over a mean period of 40 days, 905 patients were diagnosed with VTE (incidence 1.6 diagnoses per 1000 visits). The final analysis included 801 patients, of whom 49.8% had pulmonary embolism. The most frequent risk factors for VTE were age (?70 years), obesity, and new immobility. Clinical probability, prognosis, and bleeding risk scales were recorded in only 7.6%, 7.5%, and 1% of cases, respectively. D-dimer was determined in 87.2% of patients with a high clinical probability of VTE, and treatment was initiated before confirmation in only 35.9% of these patients. In patients with pulmonary embolism, 31.3% had a low risk of VTE. Overall, 98.7% of patients with pulmonary embolism and 50.2% of patients with deep venous thrombosis were admitted. During follow-up, total bleeding was more frequent than recurrences: the rates of any bleeding event were 4.4%, 3.9%, 5.3%, and 3.5% at admission and at 30 and 90, and 180 days, respectively; the rates of VTE recurrence were 2.3%, 1.3%, 1.7%, and 0.6%, respectively. Mortality rates were 3.4%, 3.1%, 4.1%, and 2.6% during hospitalization and at 30, 90, and 180 days, respectively.VTE had a substantial impact on Spanish EDs. The clinical presentation and risk profile for the development of VTE in patients diagnosed in the EDs was similar to that recorded in previous studies. During follow-up, bleeding (overall) was more frequent than recurrences. Adherence to clinical practice guidelines could improve significantly.

Project description:BackgroundElectronic discharge communication tools (EDCTs) are increasingly common in pediatric emergency departments (EDs). These tools have been shown to improve patient-centered communication, support postdischarge care at home, and reduce unnecessary return visits to the ED.ObjectiveThis study aimed to map and assess the evidence base for EDCTs used in pediatric EDs according to their functionalities, intended purpose, implementation context features, and outcomes.MethodsA systematic review was conducted following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) procedures for identification, screening, and eligibility. A total of 7 databases (EBSCO, MEDLINE, CINAHL, PsycINFO, EMBASE Scopus, and Web of Science) were searched for studies published between 1989 and 2021. Studies evaluating discharge communication-related outcomes using electronic tools (eg, text messages, videos, and kiosks) in pediatric EDs were included. In all, 2 researchers independently assessed the eligibility. Extracted data related to study identification, methodology, settings and demographics, intervention features, outcome implementation features, and practice, policy, and research implications. The Mixed Method Appraisal Tool was used to assess methodological quality. The synthesis of results involved structured tabulation, vote counting, recoding into common metrics, inductive thematic analysis, descriptive statistics, and heat mapping.ResultsIn total, 231 full-text articles and abstracts were screened for review inclusion with 49 reports (representing 55 unique tools) included. In all, 70% (26/37) of the studies met at least three of five Mixed Method Appraisal Tool criteria. The most common EDCTs were videos, text messages, kiosks, and phone calls. The time required to use the tools ranged from 120 seconds to 80 minutes. The EDCTs were evaluated for numerous presenting conditions (eg, asthma, fracture, head injury, fever, and otitis media) that required a range of at-home care needs after the ED visit. The most frequently measured outcomes were knowledge acquisition, caregiver and patient beliefs and attitudes, and health service use. Unvalidated self-report measures were typically used for measurement. Health care provider satisfaction or system-level impacts were infrequently measured in studies. The directionality of primary outcomes pointed to positive effects for the primary measure (44/55, 80%) or no significant difference (10/55, 18%). Only one study reported negative findings, with an increase in return visits to the ED after receiving the intervention compared with the control group.ConclusionsThis review is the first to map the broad literature of EDCTs used in pediatric EDs. The findings suggest a promising evidence base, demonstrating that EDCTs have been successfully integrated across clinical contexts and deployed via diverse technological modalities. Although caregiver and patient satisfaction with EDCTs is high, future research should use robust trials using consistent measures of communication quality, clinician experience, cost-effectiveness, and health service use to accumulate evidence regarding these outcomes.Trial registrationPROSPERO CRD42020157500; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=157500.

Dataset Information

Immediate Discharge and Home Treatment With Rivaroxaban of Low-risk Venous Thromboembolism Diagnosed in Two U.S. Emergency Departments: A One-year Preplanned Analysis.

Publications

Immediate Discharge and Home Treatment With Rivaroxaban of Low-risk Venous Thromboembolism Diagnosed in Two U.S. Emergency Departments: A One-year Preplanned Analysis.

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