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Computer Scan Based Analysing System on Improving Stroke Management Quality Evaluation (CASE)

Primary Purpose

Acute Ischemic Stroke and Transient Ischemic Attacks

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the response of KPI and corresponding suggestion
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke and Transient Ischemic Attacks

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • acute ischemic stroke or transient ischemic attacks patients

Exclusion Criteria:

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

Sites / Locations

  • The second affiliated hosipital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

the response of KPI and corresponding suggestion

a control arm

Arm Description

The hospitals will receive their own monthly KPI and the monthly highest KPI of all hospitals included in the study. Based on the compare of the monthly KPI of all hospitals, Quality control platform will give corresponding suggestions to all hospitals for the improve of next month. The multifaceted quality improvement interventions include: 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.

The control group indicated that the hospitals will not be provided with the multifaceted quality improvement interventions. They just provide patients with routine care.

Outcomes

Primary Outcome Measures

Rate of neurological deficit score
the rate of the case number of cerebral infarction patients who have completed the National Institutes of Health Stroke Scale (NIHSS) at the time of admission in the total number of cerebral infarction patients hospitalized in the same period
Rate of intravenous tPA within therapeutic time windows at symptom onset
the rate of AIS patients who received intravenous recombinant tissue plasminogen activator (rt-pa) thrombolytic therapy within therapeutic time windows at symptom onset in patients with cerebral infarction
Rate of administration of aspirin or other antiplatelet agents within 48 hours of admission
The rate of patients who received aspirin or other antiplatelet agents within 48 hours of admission to the hospital in the total number of cerebral infarction patients hospitalized in the same period
Rate of statin use during hospitalization
The rate of patients hospitalized for cerebral infarction who were treated with statins in the total number of cerebral infarction patients hospitalized in the same period
Rate of statin treatment at discharge
The rate of patients with cerebral infarction who received statin at discharge in the total number of patients with non-cardiac infarction who were hospitalized in the same period
Rate of antithrombotic therapy at discharge
The rate of patients with cerebral infarction who received antithrombotic drugs (such as aspirin, other antiplatelet agents, heparin, warfarin or new oral anticoagulants) at discharge in the total number of hospitalized patients with cerebral infarction in the same period.
Rate of anticoagulant treatment for patients with atrial fibrillation at discharge
The rate of patients with cerebral infarction complicated with atrial fibrillation who received anticoagulants (e.g., heparin, low molecular heparin, warfarin, new oral anticoagulants) at discharge in the total number of patients with cerebral infarction complicated with atrial fibrillation treated in hospital in the same period
a composite measure score of performance measures
a composite measure score, defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients, were also calculated.
a all-or-none measure of evidence-based performance measures
the all-or-none measure was defined as the proportion of patients who received all of the performance measures for which the patient was eligible.

Secondary Outcome Measures

Rate of prevention of deep vein thrombosis
The rate of patients who were unable to get out of bed for cerebral infarction within 48 hours of admission that were given prophylactic measures including heparin and/or DVT (Deep vein thrombosis) in patients who were unable to get out of bed for cerebral infarction treated in hospital in the same period
Rate of blood vessel assessment within one week of hospitalization
The rate of patients with cerebral infarction hospitalized for 1 week who had completed the evaluation of the blood vessels in the neck and cranial (such as the ultrasound of the blood vessels in the neck or cranial, CT or MR angiography, or DSA) in the total number of cerebral infarction patients hospitalized in the same period
Rate of swallowing function evaluation
The rate of patients who had a history of drinking water test in the total number of stroke patients who were hospitalized in the same period.
Rate of lipid level assessment
The rate of the number of patients who were assessed on lipid level during hospitalization in the total number of patients who were hospitalized during the same period.
Rate of rehabilitation evaluation and implementation
The rate of cerebral infarction patients who received rehabilitation evaluation and implementation during the hospital period (48 hours after the patient's condition was stable) in the total number of patients who were hospitalized during the same period.
Rate of offerring quit smoking counseling or health benefits education
The rate of patients who received smoking cessation counseling or health benefits education during hospitalization in total number of patients with cerebral infarction who were hospitalized during the same period
Rate of antihypertensive therapy for cerebral infarction patients with hypertension at discharge
The rate of patients with cerebral infarction complicated with hypertension who were given antihypertensive drugs at discharge in the total number of patients with cerebral infarction complicated with hypertension who were hospitalized in the same period
Rate of Patients with diabetes were given hypoglycemic drug treatment at discharge
The rater of patients with cerebral infarction complicated with diabetes who were given hypoglycemic drugs at discharge in the total number of patients with cerebral infarction complicated with diabetes treated in hospital in the same period
Average day in hospital
The rate of the total number of days in hospital to the total number of patients with cerebral infarction in the same period
Averaged hospital costs
Ratio of total hospital drug costs to total number of patients with cerebral infarction in the same period
Percentage of new clinical vascular events
New clinical vascular events are defined as ischemic stroke, myocardial infarction, or peripheral arterial disease at discharge, 1-year after initial symptom onset.
Distribution of Modified Rankin Score
Distribution of Modified Rankin Score at discharge, 1-year after initial symptom onset.
Distribution of Modified Rankin Score
Distribution of Modified Rankin Score at discharge, 1-year after initial symptom onset.
Severe neurological deficits
mRS score of 5-6 at discharge
Lipid-lowering to LDL >100 mg/dL
The rate of lipid lowering for patients with Low-density lipoprotein (LDL) ≥100 mg/dL at discharge

Full Information

First Posted
September 24, 2018
Last Updated
November 21, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Jinhua Hospital of Zhejiang University, Taizhou Hospital, Wenzhou Medical University, Zhuji People's Hospital of Zhejiang Province, Huizhou Municipal Central Hospital, The Second Affiliated Hospital of Jiaxing University, Taizhou First People's Hospital, Shaoxing People's Hospital, Yongkang First People's Hospital, The First People's Hospital of Xiaoshan District, Haining People's Hospital, Shanghai Zhongshan Hospital, Lihuili Hospital of Ningbo Medical Center, Tiantai People's Hospital, Yuyao People's Hospital, Haiyan People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Yiwu Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03684629
Brief Title
Computer Scan Based Analysing System on Improving Stroke Management Quality Evaluation
Acronym
CASE
Official Title
Computer Scan Based Analysing System on Improving Stroke Management Quality Evaluation (CASE)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
Jinhua Hospital of Zhejiang University, Taizhou Hospital, Wenzhou Medical University, Zhuji People's Hospital of Zhejiang Province, Huizhou Municipal Central Hospital, The Second Affiliated Hospital of Jiaxing University, Taizhou First People's Hospital, Shaoxing People's Hospital, Yongkang First People's Hospital, The First People's Hospital of Xiaoshan District, Haining People's Hospital, Shanghai Zhongshan Hospital, Lihuili Hospital of Ningbo Medical Center, Tiantai People's Hospital, Yuyao People's Hospital, Haiyan People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Yiwu Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: Implementation of standardized templates of medical record, evidence-based clinical pathway, and written care protocols. Feedback system of performance measures. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke and Transient Ischemic Attacks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16570 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the response of KPI and corresponding suggestion
Arm Type
Experimental
Arm Description
The hospitals will receive their own monthly KPI and the monthly highest KPI of all hospitals included in the study. Based on the compare of the monthly KPI of all hospitals, Quality control platform will give corresponding suggestions to all hospitals for the improve of next month. The multifaceted quality improvement interventions include: 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.
Arm Title
a control arm
Arm Type
No Intervention
Arm Description
The control group indicated that the hospitals will not be provided with the multifaceted quality improvement interventions. They just provide patients with routine care.
Intervention Type
Behavioral
Intervention Name(s)
the response of KPI and corresponding suggestion
Intervention Description
Standardized templates of medical record, evidence-based clinical pathway, and written care protocols are applied in all hospitals.The KPI of the AIS patients who were admitted to a single hospital continuously at the time of hospitalization were studied. Feedback system of performance measures: the hospital included in the study upload the medical records of all AIS patients by medical records scanning system since that month into the group. Quality control platform of Cerebral apoplexy in Zhejiang province extracts and analyze the data through the computer and calculates the corresponding monthly KPI. The hospitals will receive their own monthly KPI and the monthly highest KPI of all hospitals included in the study. Expert online consultation: based on the compare of the monthly KPI of all hospitals, Quality control platform will give corresponding suggestions to all hospitals for the improve of next month.
Primary Outcome Measure Information:
Title
Rate of neurological deficit score
Description
the rate of the case number of cerebral infarction patients who have completed the National Institutes of Health Stroke Scale (NIHSS) at the time of admission in the total number of cerebral infarction patients hospitalized in the same period
Time Frame
six month
Title
Rate of intravenous tPA within therapeutic time windows at symptom onset
Description
the rate of AIS patients who received intravenous recombinant tissue plasminogen activator (rt-pa) thrombolytic therapy within therapeutic time windows at symptom onset in patients with cerebral infarction
Time Frame
six month
Title
Rate of administration of aspirin or other antiplatelet agents within 48 hours of admission
Description
The rate of patients who received aspirin or other antiplatelet agents within 48 hours of admission to the hospital in the total number of cerebral infarction patients hospitalized in the same period
Time Frame
six month
Title
Rate of statin use during hospitalization
Description
The rate of patients hospitalized for cerebral infarction who were treated with statins in the total number of cerebral infarction patients hospitalized in the same period
Time Frame
six month
Title
Rate of statin treatment at discharge
Description
The rate of patients with cerebral infarction who received statin at discharge in the total number of patients with non-cardiac infarction who were hospitalized in the same period
Time Frame
six month
Title
Rate of antithrombotic therapy at discharge
Description
The rate of patients with cerebral infarction who received antithrombotic drugs (such as aspirin, other antiplatelet agents, heparin, warfarin or new oral anticoagulants) at discharge in the total number of hospitalized patients with cerebral infarction in the same period.
Time Frame
six month
Title
Rate of anticoagulant treatment for patients with atrial fibrillation at discharge
Description
The rate of patients with cerebral infarction complicated with atrial fibrillation who received anticoagulants (e.g., heparin, low molecular heparin, warfarin, new oral anticoagulants) at discharge in the total number of patients with cerebral infarction complicated with atrial fibrillation treated in hospital in the same period
Time Frame
six month
Title
a composite measure score of performance measures
Description
a composite measure score, defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients, were also calculated.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Title
a all-or-none measure of evidence-based performance measures
Description
the all-or-none measure was defined as the proportion of patients who received all of the performance measures for which the patient was eligible.
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary Outcome Measure Information:
Title
Rate of prevention of deep vein thrombosis
Description
The rate of patients who were unable to get out of bed for cerebral infarction within 48 hours of admission that were given prophylactic measures including heparin and/or DVT (Deep vein thrombosis) in patients who were unable to get out of bed for cerebral infarction treated in hospital in the same period
Time Frame
six month
Title
Rate of blood vessel assessment within one week of hospitalization
Description
The rate of patients with cerebral infarction hospitalized for 1 week who had completed the evaluation of the blood vessels in the neck and cranial (such as the ultrasound of the blood vessels in the neck or cranial, CT or MR angiography, or DSA) in the total number of cerebral infarction patients hospitalized in the same period
Time Frame
six month
Title
Rate of swallowing function evaluation
Description
The rate of patients who had a history of drinking water test in the total number of stroke patients who were hospitalized in the same period.
Time Frame
six month
Title
Rate of lipid level assessment
Description
The rate of the number of patients who were assessed on lipid level during hospitalization in the total number of patients who were hospitalized during the same period.
Time Frame
six month
Title
Rate of rehabilitation evaluation and implementation
Description
The rate of cerebral infarction patients who received rehabilitation evaluation and implementation during the hospital period (48 hours after the patient's condition was stable) in the total number of patients who were hospitalized during the same period.
Time Frame
six month
Title
Rate of offerring quit smoking counseling or health benefits education
Description
The rate of patients who received smoking cessation counseling or health benefits education during hospitalization in total number of patients with cerebral infarction who were hospitalized during the same period
Time Frame
six month
Title
Rate of antihypertensive therapy for cerebral infarction patients with hypertension at discharge
Description
The rate of patients with cerebral infarction complicated with hypertension who were given antihypertensive drugs at discharge in the total number of patients with cerebral infarction complicated with hypertension who were hospitalized in the same period
Time Frame
six month
Title
Rate of Patients with diabetes were given hypoglycemic drug treatment at discharge
Description
The rater of patients with cerebral infarction complicated with diabetes who were given hypoglycemic drugs at discharge in the total number of patients with cerebral infarction complicated with diabetes treated in hospital in the same period
Time Frame
six month
Title
Average day in hospital
Description
The rate of the total number of days in hospital to the total number of patients with cerebral infarction in the same period
Time Frame
six month
Title
Averaged hospital costs
Description
Ratio of total hospital drug costs to total number of patients with cerebral infarction in the same period
Time Frame
six month
Title
Percentage of new clinical vascular events
Description
New clinical vascular events are defined as ischemic stroke, myocardial infarction, or peripheral arterial disease at discharge, 1-year after initial symptom onset.
Time Frame
1-year
Title
Distribution of Modified Rankin Score
Description
Distribution of Modified Rankin Score at discharge, 1-year after initial symptom onset.
Time Frame
At discharge
Title
Distribution of Modified Rankin Score
Description
Distribution of Modified Rankin Score at discharge, 1-year after initial symptom onset.
Time Frame
1-year
Title
Severe neurological deficits
Description
mRS score of 5-6 at discharge
Time Frame
At discharge
Title
Lipid-lowering to LDL >100 mg/dL
Description
The rate of lipid lowering for patients with Low-density lipoprotein (LDL) ≥100 mg/dL at discharge
Time Frame
at discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lou Min, Ph.D
Phone
8613738085675
Email
loumingxc@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lou Min, Ph.D
Organizational Affiliation
The second affiliated hosipital of Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
The second affiliated hosipital of Zhejiang University
City
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Lou, Ph.D
Phone
13958007213
Email
loumingxc@vip.sina.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
32709249
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.
Results Reference
derived

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Computer Scan Based Analysing System on Improving Stroke Management Quality Evaluation

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