CareLink Express (CLE Research)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Patients evaluated by CareLink Express have a reduction of "time of interrogation" compared to the traditional patient cohort.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who present to the ED with a problem they believe to be cardiac in nature.
排除标准
- •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.
结局指标
主要结局
Patients evaluated by CareLink Express have a reduction of "time of interrogation" compared to the traditional patient cohort.
时间窗: 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.
次要结局
- Significant differences between the two populations from data analysis(2 years)