An EHR-based Platform To Facilitate Outcomes and Research Methods in Cerebrovascular Diseases (PLATFORM-CVD)

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Transient Ischemic Attack; Cerebral Infarction; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Cerebrovascular Diseases

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 Type: Observational
• Enrollment (Anticipated): 300000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Meng Wang, PhD; Phone Number: 13261053863; Email: wangmengpumc@163.com
      • Principal Investigator: Zi-Xiao Li, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In-hospital mortality	Patients who died during hospitalization due to cerebrovascular diseases	From date of hospitalization until the date of discharge, assessed up to 90 days
Length of stay at hospital	The total days for a patients with cerebrovascular diseases at hospitalization	From date of hospitalization until the date of discharge, assessed up to 90 days
Costs	The total costs for a patients with cerebrovascular diseases at hospitalization	From date of hospitalization until the date of discharge, assessed up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of antiplatelet medication use	Rate of antiplatelet therapy during hospitalization	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	Rate of aspirin and clopidogrel therapy for ischemic cerebrovascular diseases (IS or TIA) during hospitalization	From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours	Patients 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	48 hours within hospitalization
Cerebrovascular assessment ≤ seven days	Cerebrovascular assessment (TCD, IVUS, brain CT or MR scan) within seven days of hospitalization	7 days within hospitalization
Statin therapy for LDL ≥100 mg/dL during hospitalization	Lipid lowering agent prescribed during hospitalization if LDL ≥ 100 mg/dL, if patient treated with lipid lowering agent prior to admission, or LDL not documented	From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of anticoagulation medication use for atrial fibrillation during hospitalization	Anticoagulation prescribed during hospitalization in patients with documented atrial fibrillation	From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of antithrombotic medication prescribtion at discharge	Antithrombotic therapy prescribed at discharge, including antiplatelet or anticoagulant therapy	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	Antihypertension medication prescribed at discharge for patients with history of hypertension disease or hypertension disease documented during the hospitalization	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	Lipid lowering agent prescribed at discharge if LDL ≥ 100 mg/dL, if patient treated with lipid lowering agent prior to admission, or LDL not documented	From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of hypoglycaemia medication prescribtion for diabetes mellitus at discharge	Hypoglycemic medication prescribed at discharge for patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization	From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of anticoagulation medication prescribtion for atrial fibrillation at discharge	Anticoagulation prescribed at discharge in patients with documented atrial fibrillation	From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of thrombolytic therapy	Intravenous r-tPA in IS patients	From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of thrombectomy therapy	Thrombectomy therapy for IS patients	From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours for ICH	Patients with ICH at risk for DVT (non-ambulatory) who received DVT prophylaxis by end of hospital 48 hours, including pneumatic compression.	48 hours within hospitalization
Rate of antihypertensive medicine use for ICH patients with hypertension at discharge	Antihypertension medication prescribed at discharge for ICH patients with history of hypertension disease or hypertension disease documented during the hospitalization	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	Hypoglycemic medication prescribed at discharge for ICH patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization	From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of neurosurgery for ICH patients	Neurosurgery of ICH include removal of hematoma by craniotomy, aspiration of hematoma by drilling, decompressive craniectomy, ventriculocentesis and drainage, other removal of intracranial hematoma	From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of DVT prophylaxis ≤ 48 hours for SAH	Patients with SAH at risk for DVT (non-ambulatory) who received DVT prophylaxis by end of hospital 48 hours, including pneumatic compression	48 hours within hospitalization
Rate of antihypertensive medicine use for SAH patients with hypertension at discharge	Antihypertension medication prescribed at discharge for SAN patients with history of hypertension disease or hypertension disease documented during the hospitalization	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	Hypoglycemic medication prescribed at discharge for SAH patients with history of diabetes mellitus or diabetes mellitus documented during the hospitalization	From date of hospitalization until the date of discharge, assessed up to 90 days
Rate of neurosurgery for SAH patients	Neurosurgery of SAH include aneurysm clipping, endovascular embolization of aneurysm, extraventricular shunt	From date of hospitalization until the date of discharge, assessed up to 90 days

Collaborators and Investigators

• Sponsor: Ministry of Science and Technology of the People´s Republic of China
• Collaborators: The Affiliated Hospital of Qingdao University; Shenzhen Second People's Hospital; Guangdong Second Provincial General Hospital; Wuhan No.1 Hospital; Nanyang Central Hospital; Guangxi Ruikang Hospital; Kaifeng Central Hospital; Handan Central Hospital; Dalian Jiuzhou Century Hospital; Dengzhou Central Hospital; Xunxian People's Hospital; Laoling People's Hospital; New Area People's Hospital of Luoyang; Chinese Traditional Medicine Hospital of Meishan; Mengjin People's Hospital; Hexigten Banner Mongolian Traditional Chinese Medicine Hospital; Inner Mongolian Hospital of Traditional Chinese Medicine; Renqiu Kangjixintu Hospital; Xingtai City Ninth Hospital; Yilong People's Hospital; Yongcheng City Central Hospital; Chongqing Donghua Hospital; The Second Affiliated Hospital of Luohe Medical College
• Investigators: Principal Investigator: Zi-Xiao Li, PhD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (Actual): March 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Healthcare Quality; Electronic Health Records; Cerebrovascular Diseases
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Intracranial Hemorrhages; Infarction; Ischemic Attack, Transient; Hemorrhage; Cerebral Infarction; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Cerebrovascular Disorders
• Other Study ID Numbers: 2017YFC1310901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will share the data dictionary of the study. The data could be applied by the PI's email. Applicant should make an SAP first. The PI will check the SAP and appoint a statistician for the analysis.
• IPD Sharing Time Frame: The data will be available when the data collection finished.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No