Acute Ischemic Stroke and Transient Ischemic AttacksCASENCT03684629
Computer Scan Based Analysing System on Improving Stroke Management Quality Evaluation
A study testing the response of KPI and corresponding suggestion in people with Acute Ischemic Stroke and Transient Ischemic Attacks, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke and Transient Ischemic Attacks
- What is being tested?
- the response of KPI and corresponding suggestion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,570 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute ischemic stroke or transient ischemic attacks patients
Who cannot join
- patients who losing his medical record of having the incomplete medical record
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hosipital of Zhejiang University
Zhejiang
Min Lou, Ph.D, 13958007213, loumingxc@vip.sina.com
About this study
Official title: Computer Scan Based Analysing System on Improving Stroke Management Quality Evaluation (CASE)
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.
Read the 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.
- Being tested
- the response of KPI and corresponding suggestion
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the response of KPI and corresponding suggestionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the response of KPI and corresponding suggestion | Experimental | 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. Receives: Behavioral: the response of KPI and corresponding suggestion |
| a control arm | No intervention | The control group indicated that the hospitals will not be provided with the multifaceted quality improvement interventions. They just provide patients with routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: six month
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
Measured: six month
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
Measured: six month
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
Measured: six month
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
Measured: six month
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.
Measured: six month
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
Measured: six month
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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (15)
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
Measured: six month
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
Measured: six month
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.
Measured: six month
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.
Measured: six month
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.
Measured: six month
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
Measured: six month
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
Measured: six month
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
Measured: six month
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
Measured: six month
Averaged hospital costs
Ratio of total hospital drug costs to total number of patients with cerebral infarction in the same period
Measured: six month
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.
Measured: 1-year
Distribution of Modified Rankin Score
Distribution of Modified Rankin Score at discharge, 1-year after initial symptom onset.
Measured: At discharge
Distribution of Modified Rankin Score
Distribution of Modified Rankin Score at discharge, 1-year after initial symptom onset.
Measured: 1-year
Severe neurological deficits
mRS score of 5-6 at discharge
Measured: 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
Measured: at discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Aug 2018
- Primary completion31 Jan 2020
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic Stroke and Transient Ischemic AttacksStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16,570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- 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, Hangzhou Medical College, The First People's Hospital of Xiaoshan District, Haining People's Hospital, Shanghai Zhongshan Hospital, Ningbo Medical Center Lihuili Hospital, Tiantai County People's Hospital, Yuyao People's Hospital, Haiyan People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Yiwu Central Hospital
- Responsible party
- Sponsor
- Investigators
- Lou Min, Ph.D, Study director, The second affiliated hosipital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684629
- Sponsor's protocol ID
- CASE
- Acronym
- CASE
- Status last verified
- Nov 2022
- First submitted
- 24 Sep 2018
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32709249
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Scan Based Analysing System on Improving Stroke Management Quality Evaluation (CASE)
- ClinicalTrials.gov ID
- NCT03684629
- Acronym / sponsor ID
- CASE / CASE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16,570 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- 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, Hangzhou Medical College, The First People's Hospital of Xiaoshan District, Haining People's Hospital, Shanghai Zhongshan Hospital, Ningbo Medical Center Lihuili Hospital, Tiantai County People's Hospital, Yuyao People's Hospital, Haiyan People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Yiwu Central Hospital
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the response of KPI and corresponding suggestion | Experimental | Behavioral: the response of KPI and corresponding suggestionThe 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. |
| a control arm | No intervention | –The control group indicated that the hospitals will not be provided with the multifaceted quality improvement interventions. They just provide patients with routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- acute ischemic stroke or transient ischemic attacks patients
Key exclusion criteria (1 listed)
- patients who losing his medical record of having the incomplete medical record
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the response of KPI and corresponding suggestionStandardized 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. | Behavioural | the response of KPI and corresponding suggestion |
Primary outcome
Rate of neurological deficit score
Time frame: six month
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
Time frame: six month
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
Time frame: six month
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
Time frame: six month
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
Time frame: six month
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
Time frame: six month
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
Time frame: six month
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
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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.
15 secondary outcomes
Rate of prevention of deep vein thrombosis
Time frame: six month
Rate of blood vessel assessment within one week of hospitalization
Time frame: six month
Rate of swallowing function evaluation
Time frame: six month
Rate of lipid level assessment
Time frame: six month
Rate of rehabilitation evaluation and implementation
Time frame: six month
Rate of offerring quit smoking counseling or health benefits education
Time frame: six month
Rate of antihypertensive therapy for cerebral infarction patients with hypertension at discharge
Time frame: six month
Rate of Patients with diabetes were given hypoglycemic drug treatment at discharge
Time frame: six month
Average day in hospital
Time frame: six month
Averaged hospital costs
Time frame: six month
Percentage of new clinical vascular events
Time frame: 1-year
Distribution of Modified Rankin Score
Time frame: At discharge
Distribution of Modified Rankin Score
Time frame: 1-year
Severe neurological deficits
Time frame: At discharge
Lipid-lowering to LDL >100 mg/dL
Time frame: at discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Derived from this study: PubMed 32709249Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lou Min, Ph.D study director
The second affiliated hosipital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the response of KPI and corresponding suggestion in people with Acute Ischemic Stroke and Transient Ischemic Attacks, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lou Min, Ph.D (8613738085675, loumingxc@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of neurological deficit score (time frame: six month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03684629, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.