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Clinical Trials/NCT04775836
NCT04775836UnknownNot Applicable

A Platform for Linking and Assessing To Facilitate Outcomes and Research Methods in CerebroVascular Diseases Using Electronic Health Records (PLATFORM-CVD)

Ministry of Science and Technology of the People´s Republic of China1 site in 1 country300,000 target enrollmentStarted: January 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
300,000
Locations
1
Primary Endpoint
In-hospital mortality

Study Overview

Brief Summary

In this protocol, the investigators present methods and preliminary results from the PLATFORM-CVD Study, an EHR-based multicenter cohort. This study will focus on assessing the distribution of major cerebrovascular diseases, determining the risk factors associated with disease incidence and worse in-hospital outcomes, as well as describing the quality of care. Data from this cohort will be used to develop suitable prediction models for cerebrovascular diseases using real-world data and to understand how outcomes for cerebrovascular diseases would change with quality improvement interventions.

Detailed Description

Adherence to healthcare quality measures is needed to reduce the burden of cerebrovascular disease and improve clinical outcomes. Electronic health records (EHRs) can facilitate the standardization of care provision and the improvement of disease prediction and prevention. Although the EHRs in clinical settings are increasingly prevalent in China, they are rarely used for healthcare research. the investigators aimed to conduct an EHR-based registry study to improve the healthcare and outcomes for cerebrovascular diseases.

Twenty-four hospitals were enrolled in the PLATFORM-CVD Study in January 2018. Data collection began on February 1st, 2019. Historical data from January 2017 are abstracted first and prospective data are continuously reported until May 20th, 2020. Data were abstracted from the medical records, including hospital information system, laboratory information management system, and picture archiving and communication systems by an extract-transform-load tool. The EHR system included diagnostic information for cerebral infarctions (I63), nontraumatic intracerebral hemorrhages (I61), nontraumatic subarachnoid hemorrhages (I60), transient cerebral ischemic attacks and related syndromes (G45), intracranial and intraspinal phlebitis and thrombophlebitis (G08), vascular dementia (F01), and other aneurysms (I72). The quality of stroke care was assessed by 21 evidence-based performance measures. In-hospital outcomes were calculated including mortality, length of stay, and costs.

The PLATFORM-CVD Study leverages EHRs to better understand incident cerebrovascular diseases in China. Data from this cohort will serve as a unique platform for quality assessment and improvement for acute treatment and secondary prevention of cerebrovascular diseases, as well as in-hospital outcome risk predictions and health economic evaluations.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients were included in the registry if they were hospitalized with a primary diagnose of:
  • cerebral infarction (I63)
  • nontraumatic intracerebral hemorrhage (I61)
  • nontraumatic subarachnoid hemorrhage (I60)
  • transient cerebral ischemic attack and related syndromes (G45)
  • intracranial and intraspinal phlebitis and thrombophlebitis (G08)
  • vascular dementia (F01)
  • other aneurysms (I72)

Exclusion Criteria

  • Patients diagnosed with other diseases.

Outcomes

Primary Outcomes

In-hospital mortality

Time Frame: From date of hospitalization until the date of discharge, assessed up to 90 days

Patients who died during hospitalization due to cerebrovascular diseases

Length of stay at hospital

Time Frame: From date of hospitalization until the date of discharge, assessed up to 90 days

The total days for a patients with cerebrovascular diseases at hospitalization

Costs

Time Frame: From date of hospitalization until the date of discharge, assessed up to 90 days

The total costs for a patients with cerebrovascular diseases at hospitalization

Secondary Outcomes

  • Rate of antiplatelet medication use(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of dual antiplatelet medication use for non-disabling IS and TIA events(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of DVT prophylaxis ≤ 48 hours(48 hours within hospitalization)
  • Cerebrovascular assessment ≤ seven days(7 days within hospitalization)
  • Statin therapy for LDL ≥100 mg/dL during hospitalization(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of anticoagulation medication use for atrial fibrillation during hospitalization(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of antithrombotic medication prescribtion at discharge(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of antihypertensive medication prescribtion for patients with hypertension at discharge(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of statin prescribtion for low-density lipoprotein≥100 mg/dL at discharge(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of hypoglycaemia medication prescribtion for diabetes mellitus at discharge(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of anticoagulation medication prescribtion for atrial fibrillation at discharge(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of thrombolytic therapy(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of thrombectomy therapy(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of DVT prophylaxis ≤ 48 hours for ICH(48 hours within hospitalization)
  • Rate of antihypertensive medicine use for ICH patients with hypertension at discharge(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of hypoglycemia medication use for ICH patients with diabetes mellitus at discharge(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of neurosurgery for ICH patients(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of DVT prophylaxis ≤ 48 hours for SAH(48 hours within hospitalization)
  • Rate of antihypertensive medicine use for SAH patients with hypertension at discharge(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of hypoglycemia medication use for SAH patients with diabetes mellitus at discharge(From date of hospitalization until the date of discharge, assessed up to 90 days)
  • Rate of neurosurgery for SAH patients(From date of hospitalization until the date of discharge, assessed up to 90 days)

Investigators

Sponsor
Ministry of Science and Technology of the People´s Republic of China
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Yongjun Wang, MD

Professor

Ministry of Science and Technology of the People´s Republic of China

Study Sites (1)

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