Patient Centered Outcomes Research Institute (PCORI) ESCAPED Study: Comparison of Patient Centered Outcomes for People With SCD in the Acute Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 483
- 试验地点
- 3
- 主要终点
- Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered
研究概览
简要总结
The Emergency Department has been the standard location where patients with Sickle Cell Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive Crisis (VOC) is the most common complication of SCD,
The purpose of this study is to compare patient centered outcomes for patients being treated for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four locations around the United States.
详细描述
Emergency Department care is marked by long delays, lack of efficacy, and conflict. A sub-specialty Infusion Center staffed by expert clinicians and delivering individualized care can improve care quality while reducing costs. The study will examine whether care provided in an Infusion Center (IC) is more patient centered and efficient than care provided in an Emergency Department (ED) for adults with Sickle Cell Disease (SCD) and uncomplicated Vaso-Occlusive Crisis (VOC).
Sites will prospectively enroll patients in VOC seen in participating centers from either the EDs or the ICs. Specific data from the acute visits (e.g. Times of arrival, time to first dose of analgesic, etc) will be captured. This study will compare: pain management, disposition of subjects (home or admission) and patient experiences of care delivery in both settings. Subjects will complete surveys/questionnaires to asses subjects' experiences in the setting where care was provided.
The four sites to participate in the study are Baltimore, Maryland (Johns Hopkins Hospital), Cleveland, Ohio (Cleveland Medical Center), Milwaukee, Wisconsin (Medical College of Wisconsin), and Baton Rouge, Louisiana (Our Lady of the Lake Hospital). A maximum of 500 subjects will participate in the study. Participants will be enrolled for 18 months.
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
- •Confirmed Sickle Cell Disease patients who live within 60 miles of the study center or who already receive regular care at the participating centers.
排除标准
- •Stable patients who have been on chronic transfusion therapy and have not had a painful episode within two years of enrollment.
- •Patients who are pregnant.
- •Patients who are unwilling or unable to sign consent.
结局指标
主要结局
Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered
时间窗: Within 6 hours after arrival
Time is recorded from the time the patient arrives for pain treatment at either the ED or IC until the time the patient is dosed with pain medication administered parenterally. Guideline recommendations are that patients receive non-oral pain medication within 60 minutes of arrival.
次要结局
- Disposition From Acute Care Visit(Day 1 of admission)
- Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered(30 minutes after administration)
- Patient Reported Satisfaction With Care Received(within 72 hours of acute visit)
- Patient Reported Perception of Risk From Visit(within 72 hours of acute visit)