A Study to Determine the Efficacy of Continuous Ambulatory Wearable Technology and a Cascading Alert System in Reducing 30d Readmission in High Risk Heart Failure Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Attrition Rate
研究概览
简要总结
Invasive telemonitoring has shown promising results in reducing readmissions and health service utilization, and improving patient outcomes; however, such evidence is lacking for non-invasive telemonitoring. Our proposal is to deploy a wearable solution that predicts physiological perturbation comparable to invasive devices and to perform continuous remote patient monitoring; this will be connected to a structured, cascading, escalation pathway involving home health nurses, advanced practitioner providers, specialists, and surgeons, and has the potential to transform care management in the post-discharge period, where patients are the most vulnerable for readmission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
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
- •Patient is an inpatient at NorthShore University HealthSystem
- •Patient is on the heart failure consult list
- •Patient has a history of heart failure
- •Patient received at least one dose of IV diuretics at index hospitalization
- •Patient is discharging with NorthShore Home Health services
- •Symptoms corresponding to New York Heart Association function class II-IV
- •Patient has heart failure with reduced left ventricular ejection fraction (LVEF)<40%, or HF with mid-ranged ejection fraction (LVEF 40-50%), or HF with preserved ejection fraction (LVEF≥50%)
- •Patient is in the top 50% risk of readmission across NorthShore University HealthSystem's CAPE 30-day readmission model
- •Patient is at least 18 years of age
- •Patient is fluent in English
- •Patient agrees to protocol-required procedures
排除标准
- •Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to maintain patch, phone
- •Patient has allergy to hydrocolloid adhesives
- •Patient has present skin damage preventing them from wearing a study device
- •Patient has renal dysfunction requiring dialysis
- •Pregnancy
结局指标
主要结局
Attrition Rate
时间窗: 30 days from patient discharge date
Drop out from study
Enrollment Rate
时间窗: Through study completion, an average of 30 days for each patient
Enrollment rate for entire patient cohort
次要结局
- 30-day Readmission(30 days from patient discharge date)
- Number of Participants With Diuretic Escalation(30 days from patient discharge date)
研究者
Nirav Shah
Medical Director of Quality Innovation and Clinical Practice Analytics, Program Director of Outcomes Research for Quality and Transformation
NorthShore University HealthSystem