Clinical trial NCT06452888: Improvement of Medical Quality and Outcomes Through Intelligent Management and Decision System of Cerebrovascular Diseases Based on Hospital Information System
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebrovascular Disease
Keywords: Ischemic Stroke
Medical Quality
Clinical Complication
Clinical decision Support System
Electronic Health Record
Artificial Intelligence
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 3540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18.
* 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 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.

Primary outcomes:
measure: The incidence of unfavorable functional outcome
timeFrame: Participants will be followed at 3 months after enrollment.
Secondary outcomes:
measure: The incidence of in-hospital complications
timeFrame: Participants will be followed at 3, 6 and 12 months after enrollment.
measure: The incidence of unfavorable functional outcome
timeFrame: Participants will be followed at 6 and 12 months after enrollment.
measure: The incidence of new vascular events
timeFrame: Participants will be followed at 3, 6 and 12 months after enrollment.
measure: The incidence of recurrent ischemic stroke
timeFrame: Participants will be followed at 3, 6 and 12 months after enrollment.
measure: The incidence of all-cause death
timeFrame: Participants will be followed at 3, 6 and 12 months after enrollment.
measure: The incidence of moderate or severe bleeding events
timeFrame: Participants will be followed at 3, 6 and 12 months after enrollment.
measure: The incidence of all bleeding events
timeFrame: Participants will be followed at 3, 6 and 12 months after enrollment.
Other outcomes:
measure: The incidence of average length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
measure: The incidence of average total hospital expenses
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
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