Clinical trial NCT03684629: Computer Scan Based Analysing System on Improving Stroke Management Quality Evaluation
Official title: Computer Scan Based Analysing System on Improving Stroke Management Quality Evaluation (CASE)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Ischemic Stroke and Transient Ischemic Attacks
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Jinhua Hospital of Zhejiang University
name: Taizhou Hospital, Wenzhou Medical University
name: Zhuji People's Hospital of Zhejiang Province
name: Huizhou Municipal Central Hospital
name: The Second Affiliated Hospital of Jiaxing University
name: Taizhou First People's Hospital
name: Shaoxing People's Hospital
name: Hangzhou Medical College
name: The First People's Hospital of Xiaoshan District
name: Haining People's Hospital
name: Shanghai Zhongshan Hospital
name: Lihuili Hospital of Ningbo Medical Center
name: Tiantai People's Hospital
name: Yuyao People's Hospital
name: Haiyan People's Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Yiwu Central Hospital
First posted: 2018-09-26
Enrollment: 16570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study is designed for two parts, a perspective, multi-center, historial control study and a randomized controlled study of acute ischemic stroke patients. For achieving the target of diagnosis and treatment KPI (Key performance indicator) of AIS patients and improving the defects of the traditional working mode, our center developed the medical records data acquisition and KPI statistics system based on computer scan. This method guarantees the authenticity of the data, It computes the KPI of the corresponding medical institutions in the corresponding period and gives feedback on a regular basis. Based on the KPI feedback system, a multifaceted quality improvement intervention is conducted in the intervention group hospitals. This study aims to explore whether this new working mode can continuously improve the overall KPI in Zhejiang province, and thus reflect the improvement of quality and standardization of medical service in AIS patients.

Detailed description: Study population:patients with acute ischemic stroke who were admitted to the hospital within 7 days after the initial symptom onset.

Program:

There are multifaceted quality improvement interventions including:

1. Implementation of standardized templates of medical record, evidence-based clinical pathway, and written care protocols.
2. Feedback system of performance measures.
3. Expert online consultation.

Endpoints:

Primary outcome:increase of diagnosis and treatment key performance indicator for acute ischemic stroke patients; Secondary outcome: the occurrence of ischemic stroke, total mortality, disability, and new clinical vascular events.

Eligibility criteria: Inclusion Criteria:

* acute ischemic stroke or transient ischemic attacks patients

Exclusion Criteria:

* patients who losing his medical record of having the incomplete medical record

Primary outcomes:
measure: Rate of neurological deficit score
timeFrame: six month
measure: Rate of intravenous tPA within therapeutic time windows at symptom onset
timeFrame: six month
measure: Rate of administration of aspirin or other antiplatelet agents within 48 hours of admission
timeFrame: six month
measure: Rate of statin use during hospitalization
timeFrame: six month
measure: Rate of statin treatment at discharge
timeFrame: six month
measure: Rate of antithrombotic therapy at discharge
timeFrame: six month
measure: Rate of anticoagulant treatment for patients with atrial fibrillation at discharge
timeFrame: six month
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: a 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
Secondary outcomes:
measure: Rate of prevention of deep vein thrombosis
timeFrame: six month
measure: Rate of blood vessel assessment within one week of hospitalization
timeFrame: six month
measure: Rate of swallowing function evaluation
timeFrame: six month
measure: Rate of lipid level assessment
timeFrame: six month
measure: Rate of rehabilitation evaluation and implementation
timeFrame: six month
measure: Rate of offerring quit smoking counseling or health benefits education
timeFrame: six month
measure: Rate of antihypertensive therapy for cerebral infarction patients with hypertension at discharge
timeFrame: six month
measure: Rate of Patients with diabetes were given hypoglycemic drug treatment at discharge
timeFrame: six month
measure: Average day in hospital
timeFrame: six month
measure: Averaged hospital costs
timeFrame: six month
measure: Percentage of new clinical vascular events
timeFrame: 1-year
measure: Distribution of Modified Rankin Score
timeFrame: At discharge
measure: Distribution of Modified Rankin Score
timeFrame: 1-year
measure: Severe neurological deficits
timeFrame: At discharge
measure: Lipid-lowering to LDL >100 mg/dL
timeFrame: at discharge
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: The second affiliated hosipital of Zhejiang University
Study officials:
affiliation: The second affiliated hosipital of Zhejiang University
name: Lou Min, Ph.D
role: STUDY_DIRECTOR
References:
citation: Chen Y, Zhong W, Gong X, Hu H, Yan S, Zhang X, Chen Z, Zhou Y, Lou M. Rationale and design of individualized quality improvement based on the Computer Analysing system to improve Stroke management quality Evaluation (CASE): a multicenter historically controlled study. Trials. 2020 Jul 24;21(1):677. doi: 10.1186/s13063-020-04598-3.