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- Ensaio Clínico NCT03223207
CareLink Express (CLE Research) (CLE)
The primary objective of this research is to determine if evaluating CIEDs using CareLink Express® can lead to shorter time to interrogation in the Emergency Department compared to evaluation of devices using traditional evaluation procedures. The goal of the research is to determine if patients evaluated by CareLink Express® have a reduction of "time to interrogation" compared to the traditional patient cohort.
Secondary objectives of the study are to determine any significant differences in the two populations regarding:
- Health care resource utilization including total charges for ED care.
- Number of patients leaving the ED without being seen (LWBS) or left without the device interrogation completed.
- Device related issues detected.
Visão geral do estudo
Status
Condições
Descrição detalhada
Background:
Over the past 15 years the number of Cardiac Implantable Electronic Devices (CIEDs) implanted has increased dramatically. This is due in part to the aging of the population in general, but primarily due to expanded indications for implantable cardioverter-defibrillators (ICDs), cardiac resynchronization pacemaker therapy (CRT-P) devices, and CRT devices with defibrillator capabilities ("biventricular ICDs" or CRT-D devices). As more patients with structural heart disease survive longer, and as more CIEDs are placed, the number of patients requiring treatment in the emergency departments for arrhythmias and potential device-related matters has increased.
When a patient with a CIED experiences a problem they presume to be cardiac in nature, they often go to the emergency room to seek care. Most emergency departments (ED) are neither equipped to interrogate the CIED, nor staffed with personnel trained to interrogate the CIED. These CIEDs often record data that can assist the physician in the formulation of a diagnostic and treatment strategy tailored to the specific needs of the patient. However, interrogation of the device is dependent on proprietary programming equipment that is not routinely kept in the emergency department. The programming equipment has traditionally been a "stand-alone" unit, which can store the data from the device interrogation (onto a USB drive or floppy disk), but does not have the capability to transmit the data to the patient's physician for rapid interpretation. In addition, ED personnel are not routinely trained to assess CIEDs. In most health care institutions, it is standard practice for a representative of the manufacturer to be contacted so the device can be evaluated. The representative must then travel to the ED with the programming equipment to interrogate the CIED on site. After interrogation, either the representative discusses the findings with the ED physician, or calls the physician that manages the patient's device. The process of in-person device evaluation can be cumbersome and inefficient, especially in an emergency setting. The time involved in the device interrogation process can cause delays in patient care and add unnecessary costs for the patient and health care institution.
Methods:
Patients with CIEDs will be evaluated in the ED setting. Patients will be divided into two cohorts. Each cohort will have a minimum of 50 patients.
The control group will include CIED patients who have been evaluated in the ED at The Heart Hospital Baylor Plano and Baylor Regional Medical Center at Plano. A minimum of 50 devices not compatible with the CareLink Express® system will be prospectively interrogated in the traditional evaluation method using the device manufacturer representative.
The study group will include CIED patients who present to the ED and receive a device evaluation using the CareLink Express® system. A minimum of 50 devices will be prospectively evaluated using CareLink Express®.
The patient's presenting symptoms in the ED include any medical conditions (not just cardiac).
Consent will be obtained from the subject after treatment has occurred in the ED and prior to release. Consent can be obtained from the subject or the subject's Legally Authorized Representative. This will ensure that treatment is not delayed or altered for research purposes.
Initial data will be collected using a Data Collection Form. The research staff or a research trained Emergency Department staff member will complete the Data Form.
Data will be collected by the research coordinators who will collect the Data Collection Forms from the ED at The Heart Hospital Baylor Plano and Baylor Regional Medical Center at Plano. The Data Collection Form will be used by the research coordinators to determine the patient's study cohort.
Other data will be collected by the research coordinators using the hospital EMR and Financial systems.
Data Collection:
Criteria for the hospital and ED encounters will be extracted from the hospital EMR, the Data Collection Form, or the hospital financial system. Device data will be extracted from the device report completed at the time of the device interrogation.
Tipo de estudo
Inscrição (Real)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
1) Patients who present to the ED with a problem they believe to be cardiac in nature.
Exclusion Criteria:
- Patients who present to the ED after transmitting a remote device evaluation within the last 24 hours.
- Patients referred to the ED from a physician's office or other health care facility where the CIED has already been interrogated or evaluated.
- Patients in cardiac arrest or other life threatening situations.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
---|
Control Group
The control group will include CIED patients who have been evaluated in the ED at The Heart Hospital Baylor Plano and Baylor Regional Medical Center at Plano.
A minimum of 50 devices not compatible with the CareLink Express® system will be prospectively interrogated in the traditional evaluation method using the device manufacturer representative.
|
CareLink Express
The study group will include CIED patients who present to the ED and receive a device evaluation using the CareLink Express® system.
A minimum of 50 devices will be prospectively evaluated using CareLink Express®.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Patients evaluated by CareLink Express have a reduction of "time of interrogation" compared to the traditional patient cohort.
Prazo: 1 year
|
The primary objective of this research is to determine if evaluating CIEDs using CareLink Express® can lead to shorter time to interrogation in the Emergency Department compared to evaluation of devices using traditional evaluation procedures.
|
1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Significant differences between the two populations from data analysis
Prazo: 2 years
|
Health care resource utilization including total charges for ED care, number of patients leaving the ED without being seen (LWBS) or left without the device interrogation completed, or device related issues detected.
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 015-234
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