Observational Study of Patient-centered Research Into Outcomes Stroke Patients Prefer and Effectiveness Research
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,877
- 试验地点
- 1
- 主要终点
- Depression
研究概览
简要总结
PROSPER (Patient-centered Research into Outcomes Stroke patients Prefer and Effectiveness Research) is a three year research project to create a national, sustainable model to improve decision-making and patient-centered stroke outcomes through comparative effectiveness research.
详细描述
We propose to address existing evidence gaps and develop the requested data on the range of clinical outcomes that may be experienced by stroke survivors. To achieve these goals, we will link the nation's largest stroke registry, the American Heart Association (AHA) Get With The Guidelines-Stroke program and nationwide Medicare claims data, coupled with telephone interviews for longitudinal treatment and downstream patient-reported outcomes.
Design & Procedures:
Retrospective: Using GWTG-Stroke database and its associated 1900 hospitals, we will conduct several comparative research protocols prioritized by stroke survivor focus groups and surveys. GWTG-Stroke registry clinical data linked with Medicare claims will be used for analysis of effectiveness and safety of post-stroke therapies on long-term clinical outcomes (n= 450,000). Outcomes of interest include:
"Home-time" (days alive and at home) Death Stroke/TIA readmission All-cause readmission Cardiovascular readmission Bleeding readmission
Prospective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consistent with GWTG inclusion criteria, patients must be older than 18 and have a primary diagnosis of acute ischemic stroke.
- •Ability to give informed consent or the availability of a surrogate who can consent on the patient's behalf.
排除标准
- •Patients with subarachnoid or intracerebral hemorrhage
- •Patients with transient ischemic attack (TIA)
- •Patients with expected survival less than 6 months/discharged to hospice
结局指标
主要结局
Depression
时间窗: 6 months after enrollment
Patient Health Questionnaire - 2 Item (PHQ-2) Higher score suggests more depression; range of 0-6. A score of two or higher suggests a diagnosis of major depression.
次要结局
- Functional Status(6 months after enrollment)