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PARA-HEART Pilot Implementation (PARA-HEART)

3 марта 2022 г. обновлено: Wake Forest University Health Sciences

Can Pre-Hospital Use of the HEART Score and Abbott i-STAT® Point-of-Care Troponin Predict Major Adverse Cardiovascular Events: the PARA-HEART Pilot Implementation

Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. These patients are a challenge to healthcare providers, who are tasked with determining whether these symptoms are due to an acute coronary syndrome (ACS) or a non-ACS cause.In an effort to improve the quality and value of care for patients with acute chest pain, our group recently validated a risk stratification pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on higher-risk patients, who are more likely to benefit from testing.While the HEART score has been well validated in the ED setting, it has yet to be implemented in a prehospital setting. Paramedics are often the first providers to evaluate and begin treating patients with symptoms concerning for ACS. Current pre-hospital risk stratification is largely based on a combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI (ST-segment elevation myocardial infarction) are poor predictors of ACS, paramedics often have difficulty distinguishing high-risk patients from low-risk patients.Thus, multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT® point-of-care (POC) troponin testing in the prehospital setting is needed. To establish the feasibility and accuracy of HEART score and POC testing in the prehospital setting the investigators propose a quality surveillance study of a limited implementation of the HEART score with POC troponin testing.

Обзор исследования

Статус

Завершенный

Подробное описание

Approximately 8-10 million patients complaining of chest pain present to an Emergency Department (ED) annually in the United States. These patients are a challenge to healthcare providers, who are tasked with determining whether these symptoms are due to an acute coronary syndrome (ACS) or a non-ACS cause. Missing the diagnosis of ACS is associated with high rates of morbidity, mortality, and malpractice claims. Therefore, to avoid missing the diagnosis of ACS, patients with chest pain typically undergo extensive evaluations at an estimated cost of $10-13 billion annually. However, less than 10% of these patients are ultimately diagnosed with ACS. As the US healthcare system shifts towards a value-based model, it is clear that the current care patterns for acute chest pain, which fail to focus health system resources, such as hospitalization and cardiac testing, on patients most likely to benefit, are not sustainable.

In an effort to improve the quality and value of care for patients with acute chest pain, our group recently validated a risk stratification pathway, the HEART Pathway, which is designed to focus cardiac testing and admissions on higher-risk patients, who are more likely to benefit from testing. The HEART Pathway, which utilizes an easy to use clinical decision aid (the HEART score) and serial troponin measurement, has been shown to significantly reduce objective cardiac testing (stress testing and coronary angiography), shorten hospital length of stay, and increase the early discharge rate from the Emergency Department among patients with acute chest pain. These important efficiency gains occur without missing ACS and without increasing return visits to the ED or downstream admissions to the hospital over a 30 day period.

While the HEART score has been well validated in the ED setting, it has yet to be implemented in a prehospital setting. Paramedics are often the first providers to evaluate and begin treating patients with symptoms concerning for ACS. Current pre-hospital risk stratification is largely based on a combination of ECG results and paramedic gestalt. Since ECGs without signs of a STEMI are poor predictors of ACS, paramedics often have difficulty distinguishing high-risk patients from low-risk patients. Therefore, integrating objective risk stratification tools, such as the HEART score and point-of-care troponin testing, into Emergency Medical Services (EMS) triage and destination plans represents an opportunity to improve care. Furthermore, expanding use of the HEART score to paramedics in the pre-hospital setting is a natural extension of our prior work, especially given the growing sophistication of mobile integrated healthcare ("community paramedicine") over the last decade. Thus, multidisciplinary leaders within Emergency Medicine, Cardiology, and Prehospital Medicine have agreed that a limited/pilot evaluation of the HEART Score with Abbott's i-STAT® point-of-care (POC) troponin testing in the prehospital setting is needed.

The investigators anticipate that a standardized approach to paramedic risk stratification using the HEART score with Abbott's i-STAT® POC troponin testing will be feasible and achieve high accuracy for the detection of ACS. Ultimately the investigators believe this planned implementation will improve the quality and value of chest pain care. Placing these tools in the hands of our first responders will identify patients with ACS earlier and speed the delivery of potentially life-saving care. For example, EMS triage and destination plans (chest pain treatment and transportation triage and destination plans) could be amended so that patients with positive POC troponins or high HEART scores could be transported directly to a hospital with cardiac catheterization capabilities, avoiding delays and costs associated with inter-facility transfers. However, before EMS triage and destination plans can fully incorporate the HEART score and POC troponin testing, first the feasibility of such an implementation must be established by collecting quality surveillance data.

To establish the feasibility and accuracy of HEART score and POC testing in the prehospital setting the investigators propose a quality surveillance study of a limited implementation of the HEART score with POC troponin testing. This pilot will include paramedics from three demographically distinct counties (Forsyth, Surry, and Stokes counties) in North Carolina, who will begin using the HEART score and i-STAT POC Troponin as part of their risk assessment for patients with acute chest pain. However, EMS triage and transportation plans will not be altered based on the HEART score assessment until feasibility and accuracy have been established. To ensure the feasibility and accuracy of paramedic chest pain risk assessment the investigators will be performing surveillance of electronic health records (EHR) and contacting patients by phone (which is a common practice in EMS quality assurance). Quality surveillance participants (n=500) will be identified retrospectively and quality assurance data will be collected electronically using EHR (EMS records, and Wake Forest Baptist Health health records) and via telephone follow-up calls (which are customary in EMS quality assurance projects).

Тип исследования

Наблюдательный

Регистрация (Действительный)

511

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

21 год и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Вероятностная выборка

Исследуемая популяция

Adult patients with symptoms concerning for acute coronary syndrome who are being transported to the Wake Forest Baptist Medical Center Emergency Department by paramedics trained to complete a HEART Score and POC troponin assessment will be eligible for inclusion in this quality surveillance study.

Описание

Inclusion Criteria:

  • age greater than or equal to 21 years
  • Non-traumatic chest discomfort or other symptoms consistent with possible
  • Patient being transported to Wake Forest Baptist Health ED for further care

Exclusion Criteria:

  • ST-segment elevation in contiguous leads on any electrocardiogram
  • Inter-facility transfers
  • Short Pre-hospital times: anticipated scene + transportation time less than 5 mins
  • Unstable vitals signs
  • Known terminal diagnosis with life expectancy less than 1 year
  • Concomitant non-cardiac medical, surgical, or psychiatric emergency

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Pre-hospital HEART Score
All subjects included in this quality surveillance study will have had a HEART score, including POC troponin calculated by paramedics prior to arrival at the emergency department.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Major Adverse Cardiac Events (MACE) at 30 days
Временное ограничение: 30 Days
The primary outcome is MACE at 30 days. MACE is a composite outcome of cardiac death, acute myocardial infarction, and coronary revascularization.
30 Days

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Rate of objective cardiac testing
Временное ограничение: 30 Days
Objective cardiac testing will be defined by any stress testing modality, coronary computed tomography (CT) angiography, or invasive coronary angiography.
30 Days
Length of Stay
Временное ограничение: 30 Days
Length of stay (LOS) will be the time from ED arrival to hospital discharge for all patients, whether admitted or not.
30 Days
Rate of hospitalization at index
Временное ограничение: 30 Days
Index visit hospitalization will be defined as an inpatient or observation admission (including Observation Unit evaluations with stress testing or cardiac imaging).
30 Days
Rate of cardiac related hospital admissions and ED visits during follow-up
Временное ограничение: 30 Days
Hospital admissions and ED visits occurring during the 30 day follow up period will be categorized as cardiac-related if a cardiac procedure is performed, the primary reason for admission/visit is chest pain, possible ACS, or a discharge diagnosis relates to chest pain, myocardial infarction (MI), acute coronary syndrome, heart failure, dysrhythmias, pericardial disease, or other cardiac disease. Cardiac procedures include cardiac imaging / stress testing (excluding resting echo), coronary revascularization, and pacemaker or defibrillator insertion.
30 Days

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Следователи

  • Главный следователь: Simon Mahler, MD, MS, Associate professor

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 декабря 2016 г.

Первичное завершение (Действительный)

30 августа 2018 г.

Завершение исследования (Действительный)

30 августа 2018 г.

Даты регистрации исследования

Первый отправленный

3 марта 2016 г.

Впервые представлено, что соответствует критериям контроля качества

9 марта 2016 г.

Первый опубликованный (Оценивать)

15 марта 2016 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

4 марта 2022 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

3 марта 2022 г.

Последняя проверка

1 сентября 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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