Clinical trial NCT04775836: An EHR-based Platform To Facilitate Outcomes and Research Methods in Cerebrovascular Diseases
Official title: A Platform for Linking and Assessing To Facilitate Outcomes and Research Methods in CerebroVascular Diseases Using Electronic Health Records (PLATFORM-CVD)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Cerebrovascular Diseases
Cerebral Infarction
Cerebral Hemorrhage
Transient Ischemic Attack
Subarachnoid Hemorrhage
Keywords: Healthcare Quality
Electronic Health Records
Cerebrovascular Diseases
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: Dalian Jiuzhou Century Hospital
name: Dengzhou Central Hospital
name: Guangxi Ruikang Hospital
name: Guangdong Second Provincial General Hospital
name: Handan Central Hospital
name: Xunxian People's Hospital
name: Kaifeng Central Hospital
name: Laoling People's Hospital
name: New Area People's Hospital of Luoyang
name: Chinese Traditional Medicine Hospital of Meishan
name: Mengjin People's Hospital
name: Nanyang Central Hospital
name: Hexigten Banner Mongolian Traditional Chinese Medicine Hospital
name: Inner Mongolian Hospital of Traditional Chinese Medicine
name: The Affiliated Hospital of Qingdao University
name: Renqiu Kangjixintu Hospital
name: Shenzhen Second People's Hospital
name: Wuhan No.1 Hospital
name: Xingtai City Ninth Hospital
name: Yilong People's Hospital
name: Yongcheng City Central Hospital
name: Chongqing Donghua Hospital
name: The Second Affiliated Hospital of Luohe Medical College
First posted: 2021-03-01
Enrollment: 300000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty-five hospitals were enrolled in the PLATFORM-CVD Study between January 1st, 2017 and May 20th, 2020. Hospitals were included if they: 1) had neurological wards; 2) were secondary or tertiary hospitals; 3) could admit at least 20 cerebrovascular disease patients every month.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: In-hospital mortality
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Length of stay at hospital
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Costs
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
Secondary outcomes:
measure: Rate of antiplatelet medication use
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of dual antiplatelet medication use for non-disabling IS and TIA events
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of DVT prophylaxis ≤ 48 hours
timeFrame: 48 hours within hospitalization
measure: Cerebrovascular assessment ≤ seven days
timeFrame: 7 days within hospitalization
measure: Statin therapy for LDL ≥100 mg/dL during hospitalization
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of anticoagulation medication use for atrial fibrillation during hospitalization
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of antithrombotic medication prescribtion at discharge
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of antihypertensive medication prescribtion for patients with hypertension at discharge
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of statin prescribtion for low-density lipoprotein≥100 mg/dL at discharge
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of hypoglycaemia medication prescribtion for diabetes mellitus at discharge
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of anticoagulation medication prescribtion for atrial fibrillation at discharge
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of thrombolytic therapy
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of thrombectomy therapy
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of DVT prophylaxis ≤ 48 hours for ICH
timeFrame: 48 hours within hospitalization
measure: Rate of antihypertensive medicine use for ICH patients with hypertension at discharge
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of hypoglycemia medication use for ICH patients with diabetes mellitus at discharge
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of neurosurgery for ICH patients
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of DVT prophylaxis ≤ 48 hours for SAH
timeFrame: 48 hours within hospitalization
measure: Rate of antihypertensive medicine use for SAH patients with hypertension at discharge
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of hypoglycemia medication use for SAH patients with diabetes mellitus at discharge
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
measure: Rate of neurosurgery for SAH patients
timeFrame: From date of hospitalization until the date of discharge, assessed up to 90 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Zi-Xiao Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: