Dataset Information

Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial.

ABSTRACT:

Introduction

Current guidelines for patients presenting to the emergency department (ED) with chest pain without ST-segment elevation myocardial infarction (STEMI) on ECG are based on serial troponin measurements. A clinical tool able to identify very low-risk patients who could forgo a troponin test and low-risk patients requiring only one troponin measurement would be of great interest. To do so, the HEAR and HEART score, standing for history, ECG, age, risk factors±troponin were prospectively assessed, but not combined and implemented in clinical practice. The objective of the eCARE study is to assess the impact of implementing a diagnostic strategy based on a HEAR score <2 or a HEART score <4 (HEAR-T strategy) to rule out non-STEMI without or with a single troponin measurement in patients presenting to the ED with chest pain without obvious diagnosis after physical examination and an ECG.

Methods and analysis

Stepped-wedge cluster-randomised control trial in 10 EDs. Patients with non-traumatic chest pain and no formal diagnosis were included and followed for 30 days. In the interventional phase, the doctor will be asked not to perform a troponin test to look for an acute coronary if the HEAR score is <2 and not to perform an additional troponin test if the HEAR score is ≥2 and HEART score is <4. The main endpoint is the non-inferiority of the rates of major adverse cardiac events occurring between a patient's discharge and the 30-day follow-up against current recommended guidelines.

Ethics and dissemination

The study was approved by an institutional review board for all participating centres. If successful, the eCARE study will cover a gap in the evidence, proving that it is safe and efficient to rule out the hypothesis of an acute myocardial infarction in some selected very low-risk patients or based on a single troponin measurement in some low-risk patients.

Trial registration number

NCT04157790.

SUBMITTER: Moumneh T

PROVIDER: S-EPMC9730388 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial.

Moumneh Thomas T Penaloza Andrea A Charpentier Sandrine S Douillet Delphine D Prunier Fabrice F Riou Jérémie J Roy Pierre-Marie PM

BMJ open 20221206 12

<h4>Introduction</h4>Current guidelines for patients presenting to the emergency department (ED) with chest pain without ST-segment elevation myocardial infarction (STEMI) on ECG are based on serial troponin measurements. A clinical tool able to identify very low-risk patients who could forgo a troponin test and low-risk patients requiring only one troponin measurement would be of great interest. To do so, the HEAR and HEART score, standing for history, ECG, age, risk factors±troponin were prosp ...[more]

PMID: 36600358

Similar Datasets

Project description:BackgroundHigh-sensitivity cardiac troponin assays enable myocardial infarction to be ruled out earlier, but the safety and efficacy of this approach is uncertain. We investigated whether an early rule-out pathway is safe and effective for patients with suspected acute coronary syndrome.MethodsWe performed a stepped-wedge cluster randomized controlled trial in the emergency departments of 7 acute care hospitals in Scotland. Consecutive patients presenting with suspected acute coronary syndrome between December 2014 and December 2016 were included. Sites were randomized to implement an early rule-out pathway where myocardial infarction was excluded if high-sensitivity cardiac troponin I concentrations were <5 ng/L at presentation. During a previous validation phase, myocardial infarction was ruled out when troponin concentrations were <99th percentile at 6 to 12 hours after symptom onset. The coprimary outcome was length of stay (efficacy) and myocardial infarction or cardiac death after discharge at 30 days (safety). Patients were followed for 1 year to evaluate safety and other secondary outcomes.ResultsWe enrolled 31 492 patients (59±17 years of age [mean±SD]; 45% women) with troponin concentrations <99th percentile at presentation. Length of stay was reduced from 10.1±4.1 to 6.8±3.9 hours (adjusted geometric mean ratio, 0.78 [95% CI, 0.73-0.83]; P<0.001) after implementation and the proportion of patients discharged increased from 50% to 71% (adjusted odds ratio, 1.59 [95% CI, 1.45-1.75]). Noninferiority was not demonstrated for the 30-day safety outcome (upper limit of 1-sided 95% CI for adjusted risk difference, 0.70% [noninferiority margin 0.50%]; P=0.068), but the observed differences favored the early rule-out pathway (0.4% [57/14 700] versus 0.3% [56/16 792]). At 1 year, the safety outcome occurred in 2.7% (396/14 700) and 1.8% (307/16 792) of patients before and after implementation (adjusted odds ratio, 1.02 [95% CI, 0.74-1.40]; P=0.894), and there were no differences in hospital reattendance or all-cause mortality.ConclusionsImplementation of an early rule-out pathway for myocardial infarction reduced length of stay and hospital admission. Although noninferiority for the safety outcome was not demonstrated at 30 days, there was no increase in cardiac events at 1 year. Adoption of this pathway would have major benefits for patients and health care providers. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03005158.

Project description:BackgroundDespite many efforts, long wait times and overcrowding in emergency departments (EDs) have remained a significant health service issue in Canada. For several years, Canada has had one of the longest wait times among the Organisation for Economic Co-operation and Development countries. From a patient's perspective, this challenge has been described as "patients wait in pain or discomfort for hours before being seen at EDs." To overcome the challenge of increased wait times, we developed an innovative ED management platform called SurgeCon that was designed based on continuous quality improvement principles to maintain patient flow and mitigate the impact of patient surge on ED efficiency. The SurgeCon quality improvement intervention includes a protocol-driven software platform, restructures ED organization and workflow, and aims to establish a more patient-centric environment. We piloted SurgeCon at an ED in Carbonear, Newfoundland and Labrador, and found that there was a 32% reduction in ED wait times.ObjectiveThe primary objective of this trial is to determine the effects of SurgeCon on ED performance by assessing its impact on length of stay, the time to a physician's initial assessment, and the number of patients leaving the ED without being seen by a physician. The secondary objectives of this study are to evaluate SurgeCon's effects on patient satisfaction and patient-reported experiences with ED wait times and its ability to create better-value care by reducing the per-patient cost of delivering ED services.MethodsThe implementation of the intervention will be assessed using a comparative effectiveness-implementation hybrid design. This type of hybrid design is known to shorten the amount of time associated with transitioning interventions from being the focus of research to being used for practice and health care services. All EDs with 24/7 on-site physician support (category A hospitals) will be enrolled in a 31-month, pragmatic, stepped wedge cluster randomized trial. All clusters (hospitals) will start with a baseline period of usual care and will be randomized to determine the order and timing of transitioning to intervention care until all hospitals are using the intervention to manage and operationalize their EDs.ResultsData collection for this study is continuing. As of February 2022, a total of 570 randomly selected patients have participated in telephone interviews concerning patient-reported experiences and patient satisfaction with ED wait times. The first of the 4 EDs was randomly selected, and it is currently using SurgeCon's eHealth platform and applying efficiency principles that have been learned through training since September 2021. The second randomly selected site will begin intervention implementation in winter 2022.ConclusionsBy assessing the impact of SurgeCon on ED services, we hope to be able to improve wait times and create better-value ED care in this health care context.Trial registrationClinicalTrials.gov NCT04789902; https://clinicaltrials.gov/ct2/show/NCT04789902.International registered report identifier (irrid)DERR1-10.2196/30454.

Project description:ImportanceOral anticoagulation for adults with atrial fibrillation or atrial flutter (AFF) who are at elevated stroke risk reduces the incidence of ischemic stroke but remains underused. Efforts to increase anticoagulation initiation on emergency department (ED) discharge have yielded conflicting results.ObjectiveTo evaluate the effectiveness of a multipronged intervention supporting anticoagulation initiation for eligible adult ED patients.Design, setting, and participantsThe Clinical Decision Support to Optimize Care of Patients With Atrial Fibrillation or Flutter in the Emergency Department (O'CAFÉ) pragmatic, stepped-wedge cluster randomized clinical trial was conducted from July 1, 2021, through April 30, 2023, at 13 community medical centers (in 9 clusters) of an integrated health system in Northern California. The study included adult ED patients with primary AFF eligible for anticoagulation initiation when discharged home. Clusters were randomly assigned to staggered dates for 1-way crossover from the control phase (usual care) to the intervention phase.InterventionPhysician education, facility-specific audit and feedback, and access to decision support, which identified eligible patients and recommended shared decision-making, anticoagulation initiation (if suitable), and timely follow-up.Main outcomes and measuresThe main outcome was a composite of anticoagulation on discharge or within 30 days. A primary intention-to-treat analysis (decision support access regardless of use) and a secondary per-protocol analysis (decision support use) were performed. Multivariable analyses adjusted for intervention and exposure months with random effects, accounting for clustering by facility and patient.ResultsA total of 3388 eligible patients with atrial fibrillation were discharged home: 2185 (64.5%) were receiving pre-ED arrival anticoagulation and 1203 (35.5%) were eligible for anticoagulation. Among the 1203 patients with an initiation-eligible encounter, the median age was 74.0 (IQR, 68.0-82.0) years and approximately half (618 [51.4%]) were men. Among the 387 patients with an initiation-eligible control encounter, 244 (63.0%) received anticoagulation (190 [49.0%] at discharge and 54 [14.0%] within 30 days). Among the 816 patients with an initiation-eligible intervention encounter, 558 (68.4%) received anticoagulation (428 [52.5%] on discharge and 130 [15.9%] within 30 days). There was no statistically significant change in initiation of anticoagulation associated with the intervention (adjusted odds ratio, 1.33 [95% CI, 0.75-2.35]; P = .13). Decision support was used for 217 eligible case patients (26.6%) (per protocol) and was associated with a statistically significant change in anticoagulation initiation when compared with 599 patients for whom decision support was not used (164 [75.6%] vs 394 [65.8%]; P = .008).Conclusions and relevanceIn this trial, a multipronged intervention to facilitate thromboprophylaxis among eligible ED patients with AFF did not significantly increase anticoagulation initiation. Opportunities exist to further improve stroke prevention among ED patients with primary AFF.Trial registrationClinicalTrials.gov Identifier: NCT05009225.

Dataset Information

Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Efficacy of HEAR and HEART score to rule out major adverse cardiac events in patients presenting to the emergency department with chest pain: study protocol of the eCARE stepped-wedge randomised control trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets