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An EHR-based Platform To Facilitate Outcomes and Research Methods in Cerebrovascular Diseases

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04775836
Acronym
PLATFORM-CVD
Enrollment
300000
Registered
2021-03-01
Start date
2018-01-01
Completion date
2021-12-31
Last updated
2021-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Hemorrhage, Cerebral Infarction, Cerebrovascular Diseases, Stroke, Subarachnoid Hemorrhage, Transient Ischemic Attack

Keywords

Healthcare Quality, Electronic Health Records, Cerebrovascular Diseases

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.

Interventions

None listed

Sponsors

Dalian Jiuzhou Century Hospital
CollaboratorUNKNOWN
Dengzhou Central Hospital
CollaboratorUNKNOWN
Guangxi Ruikang Hospital
CollaboratorOTHER
Guangdong Second Provincial General Hospital
CollaboratorOTHER
Handan Central Hospital
CollaboratorOTHER
Xunxian People's Hospital
CollaboratorUNKNOWN
Kaifeng Central Hospital
CollaboratorOTHER
Laoling People's Hospital
CollaboratorUNKNOWN
New Area People's Hospital of Luoyang
CollaboratorUNKNOWN
Chinese Traditional Medicine Hospital of Meishan
CollaboratorUNKNOWN
Mengjin People's Hospital
CollaboratorUNKNOWN
Nanyang Central Hospital
CollaboratorOTHER
Hexigten Banner Mongolian Traditional Chinese Medicine Hospital
CollaboratorUNKNOWN
Inner Mongolian Hospital of Traditional Chinese Medicine
CollaboratorUNKNOWN
The Affiliated Hospital of Qingdao University
CollaboratorOTHER
Renqiu Kangjixintu Hospital
CollaboratorUNKNOWN
Shenzhen Second People's Hospital
CollaboratorOTHER
Wuhan No.1 Hospital
CollaboratorOTHER
Xingtai City Ninth Hospital
CollaboratorUNKNOWN
Yilong People's Hospital
CollaboratorUNKNOWN
Yongcheng City Central Hospital
CollaboratorUNKNOWN
Chongqing Donghua Hospital
CollaboratorUNKNOWN
The Second Affiliated Hospital of Luohe Medical College
CollaboratorUNKNOWN
Ministry of Science and Technology of the People´s Republic of China
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortalityFrom date of hospitalization until the date of discharge, assessed up to 90 daysPatients who died during hospitalization due to cerebrovascular diseases
Length of stay at hospitalFrom date of hospitalization until the date of discharge, assessed up to 90 daysThe total days for a patients with cerebrovascular diseases at hospitalization
CostsFrom date of hospitalization until the date of discharge, assessed up to 90 daysThe total costs for a patients with cerebrovascular diseases at hospitalization

Secondary

MeasureTime frameDescription
Cerebrovascular assessment ≤ seven days7 days within hospitalizationCerebrovascular assessment (TCD, IVUS, brain CT or MR scan) within seven days of hospitalization
Statin therapy for LDL ≥100 mg/dL during hospitalizationFrom date of hospitalization until the date of discharge, assessed up to 90 daysLipid lowering agent prescribed during hospitalization if LDL ≥ 100 mg/dL, if patient treated with lipid lowering agent prior to admission, or LDL not documented
Rate of anticoagulation medication use for atrial fibrillation during hospitalizationFrom date of hospitalization until the date of discharge, assessed up to 90 daysAnticoagulation prescribed during hospitalization in patients with documented atrial fibrillation
Rate of antithrombotic medication prescribtion at dischargeFrom date of hospitalization until the date of discharge, assessed up to 90 daysAntithrombotic therapy prescribed at discharge, including antiplatelet or anticoagulant therapy
Rate of antihypertensive medication prescribtion for patients with hypertension at dischargeFrom date of hospitalization until the date of discharge, assessed up to 90 daysAntihypertension medication prescribed at discharge for patients with history of hypertension disease or hypertension disease documented during the hospitalization
Rate of statin prescribtion for low-density lipoprotein≥100 mg/dL at dischargeFrom date of hospitalization until the date of discharge, assessed up to 90 daysLipid lowering agent prescribed at discharge if LDL ≥ 100 mg/dL, if patient treated with lipid lowering agent prior to admission, or LDL not documented
Rate of hypoglycaemia medication prescribtion for diabetes mellitus at dischargeFrom date of hospitalization until the date of discharge, assessed up to 90 daysHypoglycemic medication prescribed at discharge for patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization
Rate of anticoagulation medication prescribtion for atrial fibrillation at dischargeFrom date of hospitalization until the date of discharge, assessed up to 90 daysAnticoagulation prescribed at discharge in patients with documented atrial fibrillation
Rate of thrombolytic therapyFrom date of hospitalization until the date of discharge, assessed up to 90 daysIntravenous r-tPA in IS patients
Rate of antiplatelet medication useFrom date of hospitalization until the date of discharge, assessed up to 90 daysRate of antiplatelet therapy during hospitalization
Rate of DVT prophylaxis ≤ 48 hours for ICH48 hours within hospitalizationPatients with ICH at risk for DVT (non-ambulatory) who received DVT prophylaxis by end of hospital 48 hours, including pneumatic compression.
Rate of antihypertensive medicine use for ICH patients with hypertension at dischargeFrom date of hospitalization until the date of discharge, assessed up to 90 daysAntihypertension medication prescribed at discharge for ICH patients with history of hypertension disease or hypertension disease documented during the hospitalization
Rate of hypoglycemia medication use for ICH patients with diabetes mellitus at dischargeFrom date of hospitalization until the date of discharge, assessed up to 90 daysHypoglycemic medication prescribed at discharge for ICH patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization
Rate of neurosurgery for ICH patientsFrom date of hospitalization until the date of discharge, assessed up to 90 daysNeurosurgery of ICH include removal of hematoma by craniotomy, aspiration of hematoma by drilling, decompressive craniectomy, ventriculocentesis and drainage, other removal of intracranial hematoma
Rate of DVT prophylaxis ≤ 48 hours for SAH48 hours within hospitalizationPatients with SAH at risk for DVT (non-ambulatory) who received DVT prophylaxis by end of hospital 48 hours, including pneumatic compression
Rate of antihypertensive medicine use for SAH patients with hypertension at dischargeFrom date of hospitalization until the date of discharge, assessed up to 90 daysAntihypertension medication prescribed at discharge for SAN patients with history of hypertension disease or hypertension disease documented during the hospitalization
Rate of hypoglycemia medication use for SAH patients with diabetes mellitus at dischargeFrom date of hospitalization until the date of discharge, assessed up to 90 daysHypoglycemic medication prescribed at discharge for SAH patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization
Rate of neurosurgery for SAH patientsFrom date of hospitalization until the date of discharge, assessed up to 90 daysNeurosurgery of SAH include aneurysm clipping, endovascular embolization of aneurysm, extraventricular shunt
Rate of thrombectomy therapyFrom date of hospitalization until the date of discharge, assessed up to 90 daysThrombectomy therapy for IS patients
Rate of dual antiplatelet medication use for non-disabling IS and TIA eventsFrom date of hospitalization until the date of discharge, assessed up to 90 daysRate of aspirin and clopidogrel therapy for ischemic cerebrovascular diseases (IS or TIA) during hospitalization
Rate of DVT prophylaxis ≤ 48 hours48 hours within hospitalizationPatients at risk for DVT (non-ambulatory) who received DVT prophylaxis by end of hospital 48 hours, including pneumatic compression, warfarin sodium, and novel oral anticoagulant

Countries

China

Contacts

Primary ContactMeng Wang, PhD
wangmengpumc@163.com13261053863
Backup ContactXin Yang, PhD
yangxin_tt@163.com13552336551

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026