Improvement of Medical Quality and Outcomes Through Intelligent Management and Decision System of Cerebrovascular Diseases Based on Hospital Information System
NCT ID: NCT06452888
Last Updated: 2024-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
3540 participants
INTERVENTIONAL
2024-07-01
2026-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
no intervention
No intervention indicated that the physicians among control hospital provide routine
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.
Clinical decision support system.
The clinical decision support system includes evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures. Patients in the intervention group will receive the organizational management based on the guidelines and conduct intervention management for patients with actue ischemic stroke. The clinical decision system will classify the patients into risk factors, automatically generate treatment measures according to the guidelines, in order to standardize the treatment of physicians. Such as the management of complications after stroke, the treatment of antiplatelet, anticoagulation, antihypertensive and hypoglycemic.
Interventions
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Clinical decision support system.
The clinical decision support system includes evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures. Patients in the intervention group will receive the organizational management based on the guidelines and conduct intervention management for patients with actue ischemic stroke. The clinical decision system will classify the patients into risk factors, automatically generate treatment measures according to the guidelines, in order to standardize the treatment of physicians. Such as the management of complications after stroke, the treatment of antiplatelet, anticoagulation, antihypertensive and hypoglycemic.
no intervention
No intervention indicated that the physicians among control hospital provide routine
Eligibility Criteria
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Inclusion Criteria
* 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 0-1.
* Admission from the emergency department or outpatient service.
* Voluntary informed consent.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Zi-Xiao Li
Professor
Central Contacts
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Other Identifiers
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2022YFC2504902
Identifier Type: -
Identifier Source: org_study_id
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