Improvement of Medical Quality and Outcomes Through Intelligent Management and Decision System of Cerebrovascular Diseases Based on Hospital Information System - A Multicenter, Open-label, Cluster-Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,540
- 主要终点
- The incidence of unfavorable functional outcome
研究概览
简要总结
This study applied a cerebrovascular disease organizational management and decision system based on hospital information system, aiming to verify the effect of intervention and management after stroke on improving the functional outcomes of acute ischemic cerebrovascular disease through a cluster randomized controlled study.
详细描述
Stroke is a major cerebrovascular disease that causing high morbidity, disability and mortality. Management of the acute phase of stroke is critical to functional outcomes. Our study aims to verify an intervention method based on hospital information management decision system for the prevention and management of post-stroke treatment in acute stroke patients and improve long-term functional prognosis.
This study was a multicenter, open-label, parallel, cohort randomized controlled study, recruiting acute ischemic stroke patients with a post-onset National Institutes of Health Stroke Scale (NIHSS) score of ≥ 2 (limb score ≥1) within 7 days from onset of symptoms. This study will recruit a total of 3540 patients in 30 secondary hospitals. Patients in the intervention group will receive the organizational management based clinical decision support system recommended by the guidelines and conduct intervention management for patients with acute ischemic stroke. All patients in control group were treated with conventional diagnosis and treatment. The primary endpoint event was unfavorable functional outcome 3 months after onset. Secondary outcomes were in-hospital complications (including pneumonia, deep vein thrombosis), unfavorable functional outcomes at 6 and 12 months of onset (Modified Rankin Score (mRS) Score 2-5), recurrent stroke at 3, 6, and 12 months, new vascular events (including ischemic stroke, hemorrhagic stroke, myocardial infarction or vascular death) and all-cause death.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ischemic stroke confirmed by magnetic resonance imaging (MRI) or brain computed tomography (CT).
- •Within 7 days from onset of symptoms.
- •With a NIHSS score of ≥2 at admission (limb score ≥1).
- •With a prestroke mRS score of 0-
- •Admission from the emergency department or outpatient service.
- •Voluntary informed consent.
排除标准
- •Diagnosis of other cerebrovascular diseases (cerebral hemorrhage, subarachnoid hemorrhage, cerebral venous sinus thrombosis, etc.).
- •Diagnosis of non-cerebrovascular disease (central nervous system infection, epilepsy, metabolic encephalopathy, etc.).
- •Ischemic stroke with negative diffusion weighted imaging (DWI).
- •Being tested for interventions such as drugs or instruments.
- •Pregnancy or 6 weeks postpartum.
- •With a life expectancy of less than 3 months or who were unable to complete the study follow-up for other reasons.
研究组 & 干预措施
Intervention Group
Patients in the intervention group will receive the organizational management based clinical decision support system, including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures.
干预措施: Clinical decision support system. (Behavioral)
No intervention
The control group indicated that the physicians will not be provided with the information of multifaceted improvement tools including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators a quality coordinator, and monitoring and feedback system of performance measures. They just provide patients with routine care.
干预措施: no intervention (Behavioral)
结局指标
主要结局
The incidence of unfavorable functional outcome
时间窗: Participants will be followed at 3 months after enrollment.
Unfavorable functional outcome is defined as the modified Rankin Scale (mRS) Score 2-5. mRS is an efficient, reliable and simple scale to assess the recovery of neurological function and disability after stroke. The high score indicates the poor neurological recovery. The minimum score (0) means no symptoms at all. The maximum (6) means death.
次要结局
- The incidence of unfavorable functional outcome(Participants will be followed at 6 and 12 months after enrollment.)
- The incidence of recurrent ischemic stroke(Participants will be followed at 3, 6 and 12 months after enrollment.)
- The incidence of all bleeding events(Participants will be followed at 3, 6 and 12 months after enrollment.)
- The incidence of new vascular events(Participants will be followed at 3, 6 and 12 months after enrollment.)
- The incidence of in-hospital complications(Participants will be followed at 3, 6 and 12 months after enrollment.)
- The incidence of all-cause death(Participants will be followed at 3, 6 and 12 months after enrollment.)
- The incidence of moderate or severe bleeding events(Participants will be followed at 3, 6 and 12 months after enrollment.)
研究者
Zi-Xiao Li
Professor
Beijing Tiantan Hospital