Clinical trial NCT04524624: An AI-Based CDSS for Integrated Management of Patients With Acute Ischemic Stroke(GOLDEN BRIDGE II)
Official title: A Multi-centre, Cluster Randomized Controlled Trial of an Artificial Intelligence-Based Clinical Decision Support System for Integrated Management of Patients With Acute Ischemic Stroke: The GOLDEN BRIDGE II Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: acute ischemic stroke
artificial intelligence
clinical decision support system
cluster randomized controlled trial
evidence-based performance
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 21689
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will conduct a cluster randomized controlled trial to evaluate the impact of an artificial intelligence-based clinical decision support system for the integrated management of patients with acute ischemic stroke on the adherence to guideline-based therapies and the incidence of new clinical vascular events.

Detailed description: Artificial intelligence (AI) and clinical decision support system (CDSS) have demonstrated great progress in the diagnosis and treatment of cerebrovascular diseases.CDSS can use computer technology to simulate and extend expert knowledge and empirical evidence in a timely and efficient manner. The combination of AI and CDSS is a potential solution to the shortage of medical resources and can improve the quality of and promote the standardization of medical services. At intervention sites, neurologists will receive support on use of the AI-based CDSS.

Aim: To evaluate the effectiveness of an AI-based CDSS for stroke management in patients with acute ischemic stroke within 7 days of symptom onset.

Intervention: An AI-based CDSS for an integrated management of patients with acute ischemic stroke. The strategy includes automatically identifying acute stroke lesions and lesion patterns, automated classification of stroke subtypes and mechanisms, evidence-based alerts, and guideline-recommended secondary stroke prevention strategies.

Eighty eligible hospitals in china, stratified by hospital capacity (secondary grade or tertiary) and economic-geographical regions (eastern, central, and western), will be randomized into either the CDSS group or the usual care group.

Eligibility criteria: Inclusion Criteria:

* Cluster Inclusion Criteria:

  * Secondary or tertiary hospitals with an emergency department and neurologic wards that receive patients with AIS.
  * Hospitals with available brain MRI scans (1.5T or 3.0T).
* Patient Inclusion Criteria:

  * Patients of 18 years or older.
  * Patients admitted with neurological deficit consistent with ischemic stroke within 7 days of of symptoms onset. (\*Symptom onset is defined by the "last seen normal" principle)
  * Confirmation of new ischemic stroke by objective modality of CT scan and MRI (had relevant lesions on DWI).
  * Informed consent from patient or legally authorised representative (primarily spouse, parents, adult children, otherwise indicated).

Exclusion Criteria:

* Cluster Exclusion Criteria:

  * Grade-one hospitals and rural hospitals.
  * The specialized hospitals, such as women and children specialist hospital and tumor hospital.
  * Hospitals with less than 20 patients with suspected AIS per month.
* Patient Exclusion Criteria:

  * Diagnosed DWI negative stroke.
  * Diagnosed other types of cerebrovascular diseases, such as transient ischaemic attack, hemorrhagic stroke, cerebral venous sinus thrombosis, and so on.
  * Diagnosed non cerebral vascular disease, such as stroke mimic, seizures, central nervous system infections, metabolic encephalopathy, and so on.
  * Received carotid endarterectomy (CEA) and carotid angioplasty and stenting (CAS).
  * Involving in other investigational drug or device clinical trials.
  * Patients with malignant disease and life expectancy of less than 3 months or patients who are unable to complete the study for other reasons.
  * Women who are pregnant or postpartum (≤6 weeks).
  * Patients refuse to participate in this study.

Primary outcomes:
measure: Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)
timeFrame: 3 months
Secondary outcomes:
measure: Incidence rate of new clinical vascular events (ischemic stroke, hemorrhagic stroke, myocardial infarction, or vascular death)
timeFrame: 6, 12 months
measure: Disability
timeFrame: 3, 6, 12 months
measure: All-or-none measure of evidence-based performance measures
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: A composite measure score of performance measures
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: All-cause mortality
timeFrame: 3, 6, 12 months
Other outcomes:
measure: Moderate and severe bleeding events according to the GUSTO criteria
timeFrame: 3, 6, 12 months
measure: All bleeding events
timeFrame: 3, 6, 12 months
measure: Intracranial hemorrhagic events
timeFrame: 3, 6, 12 months
measure: Total costs of care
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Average length of stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Home time
timeFrame: 3, 6, 12 months
measure: All-cause readmission
timeFrame: 3, 6, 12 months
measure: Ischemic stroke readmission
timeFrame: 3, 6, 12 months
measure: Hemorrhagic stroke readmission
timeFrame: 3, 6, 12 months
measure: Cardiovascular readmission
timeFrame: 3, 6, 12 months
measure: Adverse events
timeFrame: 3, 6, 12 months
measure: Stratified analysis
timeFrame: 3, 6, 12 months
Locations:
city: Beijing
country: China
facility: Beijing Tian tan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tian Tan Hospital, Capital Medical University, Beijing, China
name: Yongjun Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Y, Li Z, Zhao X, Wang C, Wang X, Wang D, Liang L, Liu L, Wang C, Li H, Shen H, Bettger J, Pan Y, Jiang Y, Yang X, Zhang C, Han X, Meng X, Yang X, Kang H, Yuan W, Fonarow GC, Peterson ED, Schwamm LH, Xian Y, Wang Y; GOLDEN BRIDGE-AIS Investigators. Effect of a Multifaceted Quality Improvement Intervention on Hospital Personnel Adherence to Performance Measures in Patients With Acute Ischemic Stroke in China: A Randomized Clinical Trial. JAMA. 2018 Jul 17;320(3):245-254. doi: 10.1001/jama.2018.8802.