Cerebrovascular DiseaseNCT06452888
Improvement of Medical Quality and Outcomes Through Intelligent Management and Decision System of Cerebrovascular Diseases Based on Hospital Information System
A study testing Clinical decision support system. in people with Cerebrovascular Disease, run by Beijing Tiantan Hospital.
Trial summary
This study applied a cerebrovascular disease organizational management and decision system based on hospital information system, aiming to verify the effect of intervention and management after stroke on improving the functional outcomes of acute ischemic cerebrovascular disease through a cluster randomized controlled… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrovascular Disease
- What is being tested?
- Clinical decision support system.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,540 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Feb 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18.
- Diagnosed with ischemic stroke confirmed by magnetic resonance imaging (MRI) or brain computed tomography (CT).
- Within 7 days from onset of symptoms.
- With a NIHSS score of ≥2 at admission (limb score ≥1).
- With a prestroke mRS score of 0-1.
- Admission from the emergency department or outpatient service.
- Voluntary informed consent.
Who cannot join
- Diagnosis of other cerebrovascular diseases (cerebral hemorrhage, subarachnoid hemorrhage, cerebral venous sinus thrombosis, etc.).
- Diagnosis of non-cerebrovascular disease (central nervous system infection, epilepsy, metabolic encephalopathy, etc.).
- Ischemic stroke with negative diffusion weighted imaging (DWI).
- Being tested for interventions such as drugs or instruments.
- Pregnancy or 6 weeks postpartum.
- With a life expectancy of less than 3 months or who were unable to complete the study follow-up for other reasons.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Improvement of Medical Quality and Outcomes Through Intelligent Management and Decision System of Cerebrovascular Diseases Based on Hospital Information System - A Multicenter, Open-label, Cluster-Randomized Controlled Study
This study applied a cerebrovascular disease organizational management and decision system based on hospital information system, aiming to verify the effect of intervention and management after stroke on improving the functional outcomes of acute ischemic cerebrovascular disease through a cluster randomized controlled study.
Read the detailed description
Stroke is a major cerebrovascular disease that causing high morbidity, disability and mortality. Management of the acute phase of stroke is critical to functional outcomes. Our study aims to verify an intervention method based on hospital information management decision system for the prevention and management of post-stroke treatment in acute stroke patients and improve long-term functional prognosis.
This study was a multicenter, open-label, parallel, cohort randomized controlled study, recruiting acute ischemic stroke patients with a post-onset National Institutes of Health Stroke Scale (NIHSS) score of ≥ 2 (limb score ≥1) within 7 days from onset of symptoms. This study will recruit a total of 3540 patients in 30 secondary hospitals. Patients in the intervention group will receive the organizational management based clinical decision support system recommended by the guidelines and conduct intervention management for patients with acute ischemic stroke. All patients in control group were treated with conventional diagnosis and treatment. The primary endpoint event was unfavorable functional outcome 3 months after onset. Secondary outcomes were in-hospital complications (including pneumonia, deep vein thrombosis), unfavorable functional outcomes at 6 and 12 months of onset (Modified Rankin Score (mRS) Score 2-5), recurrent stroke at 3, 6, and 12 months, new vascular events (including ischemic stroke, hemorrhagic stroke, myocardial infarction or vascular death) and all-cause death.
- Conditions
- Cerebrovascular Disease
- Being tested
- Clinical decision support system., no intervention
- Keywords
- Ischemic Stroke, Medical Quality, Clinical Complication, Clinical decision Support System, Electronic Health Record, Artificial Intelligence
- Medical subject headings
- Cerebrovascular Disorders, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical decision support system.Behavioural
The clinical decision support system includes evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures. Patients in the intervention group will receive the organizational management based on the guidelines and conduct intervention management for patients with actue ischemic stroke. The clinical decision system will classify the patients into risk factors, automatically generate treatment measures according to the guidelines, in order to standardize the treatment of physicians. Such as the management of complications after stroke, the treatment of antiplatelet, anticoagulation, antihypertensive and hypoglycemic.
no interventionBehavioural
No intervention indicated that the physicians among control hospital provide routine
| Study group | Role | What they receive |
|---|---|---|
| No intervention | Sham comparator | The control group indicated that the physicians will not be provided with the information of multifaceted improvement tools including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators a quality coordinator, and monitoring and feedback system of performance measures. They just provide patients with routine care. Receives: Behavioral: no intervention |
| Intervention Group | Experimental | Patients in the intervention group will receive the organizational management based clinical decision support system, including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures. Receives: Behavioral: Clinical decision support system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of unfavorable functional outcome
Unfavorable functional outcome is defined as the modified Rankin Scale (mRS) Score 2-5. mRS is an efficient, reliable and simple scale to assess the recovery of neurological function and disability after stroke. The high score indicates the poor neurological recovery. The minimum score (0) means no symptoms at all. The maximum (6) means death.
Measured: Participants will be followed at 3 months after enrollment.
Secondary outcomes (7)
The incidence of in-hospital complications
In-hospital complications (including pneumonia, deep vein thrombosis, gastrointestinal bleeding, and urinary tract infection).
Measured: Participants will be followed at 3, 6 and 12 months after enrollment.
The incidence of unfavorable functional outcome
Unfavorable functional outcome is defined as the modified Rankin Scale (mRS) Score 2-5. mRS is an efficient, reliable and simple scale to assess the recovery of neurological function and disability after stroke. The high score indicates the poor neurological recovery. The minimum score (0) means no symptoms at all. The maximum (6) means death.
Measured: Participants will be followed at 6 and 12 months after enrollment.
The incidence of new vascular events
Including ischemic stroke, hemorrhagic stroke, myocardial infarction or vascular death.
Measured: Participants will be followed at 3, 6 and 12 months after enrollment.
The incidence of recurrent ischemic stroke
Stroke recurrence is defined as a new focal neurological impairment that was confirmed by neuroimaging, including both ischemic stroke and hemorrhagic stroke.
Measured: Participants will be followed at 3, 6 and 12 months after enrollment.
The incidence of all-cause death
An all-cause death is defined as a death from any cause.
Measured: Participants will be followed at 3, 6 and 12 months after enrollment.
The incidence of moderate or severe bleeding events
Defined by the Global Utilisation of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO).
Measured: Participants will be followed at 3, 6 and 12 months after enrollment.
The incidence of all bleeding events
Including moderate or severe bleeding events, gastrointestinal bleeding, mucocutaneous hemorrhage, respiratory system bleeding and other.
Measured: Participants will be followed at 3, 6 and 12 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zi-Xiao Li, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452888
- Sponsor's protocol ID
- 2022YFC2504902
- Status last verified
- Jun 2024
- First submitted
- 21 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Medical Quality and Outcomes Through Intelligent Management and Decision System of Cerebrovascular Diseases Based on Hospital Information System - A Multicenter, Open-label, Cluster-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06452888
- Acronym / sponsor ID
- 2022YFC2504902
- Conditions
- Cerebrovascular Disease
- Keywords
- Ischemic Stroke, Medical Quality, Clinical Complication, Clinical decision Support System, Electronic Health Record, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,540 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 11 Jun 2024 (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.
This study applied a cerebrovascular disease organizational management and decision system based on hospital information system, aiming to verify the effect of intervention and management after stroke on improving the functional outcomes of acute ischemic cerebrovascular disease through a cluster randomized controlled study.
Detailed description
Stroke is a major cerebrovascular disease that causing high morbidity, disability and mortality. Management of the acute phase of stroke is critical to functional outcomes. Our study aims to verify an intervention method based on hospital information management decision system for the prevention and management of post-stroke treatment in acute stroke patients and improve long-term functional prognosis.
This study was a multicenter, open-label, parallel, cohort randomized controlled study, recruiting acute ischemic stroke patients with a post-onset National Institutes of Health Stroke Scale (NIHSS) score of ≥ 2 (limb score ≥1) within 7 days from onset of symptoms. This study will recruit a total of 3540 patients in 30 secondary hospitals. Patients in the intervention group will receive the organizational management based clinical decision support system recommended by the guidelines and conduct intervention management for patients with acute ischemic stroke. All patients in control group were treated with conventional diagnosis and treatment. The primary endpoint event was unfavorable functional outcome 3 months after onset. Secondary outcomes were in-hospital complications (including pneumonia, deep vein thrombosis), unfavorable functional outcomes at 6 and 12 months of onset (Modified Rankin Score (mRS) Score 2-5), recurrent stroke at 3, 6, and 12 months, new vascular events (including ischemic stroke, hemorrhagic stroke, myocardial infarction or vascular death) and all-cause death.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | Sham comparator | Behavioral: no interventionThe control group indicated that the physicians will not be provided with the information of multifaceted improvement tools including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators a quality coordinator, and monitoring and feedback system of performance measures. They just provide patients with routine care. |
| Intervention Group | Experimental | Behavioral: Clinical decision support system.Patients in the intervention group will receive the organizational management based clinical decision support system, including evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18.
- Diagnosed with ischemic stroke confirmed by magnetic resonance imaging (MRI) or brain computed tomography (CT).
- Within 7 days from onset of symptoms.
- With a NIHSS score of ≥2 at admission (limb score ≥1).
- With a prestroke mRS score of 0-1.
Key exclusion criteria (6 listed)
- Diagnosis of other cerebrovascular diseases (cerebral hemorrhage, subarachnoid hemorrhage, cerebral venous sinus thrombosis, etc.).
- Diagnosis of non-cerebrovascular disease (central nervous system infection, epilepsy, metabolic encephalopathy, etc.).
- Ischemic stroke with negative diffusion weighted imaging (DWI).
- Being tested for interventions such as drugs or instruments.
- Pregnancy or 6 weeks postpartum.
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 |
|---|---|---|
| Clinical decision support system.The clinical decision support system includes evidence-based clinical pathway, standard operating procedures (SOP) of performance indicators, a quality coordinator, and monitoring and feedback system of performance measures. Patients in the intervention group will receive the organizational management based on the guidelines and conduct intervention management for patients with actue ischemic stroke. The clinical decision system will classify the patients into risk factors, automatically generate treatment measures according to the guidelines, in order to standardize the treatment of physicians. Such as the management of complications after stroke, the treatment of antiplatelet, anticoagulation, antihypertensive and hypoglycemic. | Behavioural | Intervention Group |
| no interventionNo intervention indicated that the physicians among control hospital provide routine | Behavioural | No intervention |
Primary outcome
The incidence of unfavorable functional outcome
Time frame: Participants will be followed at 3 months after enrollment.
Unfavorable functional outcome is defined as the modified Rankin Scale (mRS) Score 2-5. mRS is an efficient, reliable and simple scale to assess the recovery of neurological function and disability after stroke. The high score indicates the poor neurological recovery. The minimum score (0) means no symptoms at all. The maximum (6) means death.
7 secondary outcomes
The incidence of in-hospital complications
Time frame: Participants will be followed at 3, 6 and 12 months after enrollment.
The incidence of unfavorable functional outcome
Time frame: Participants will be followed at 6 and 12 months after enrollment.
The incidence of new vascular events
Time frame: Participants will be followed at 3, 6 and 12 months after enrollment.
The incidence of recurrent ischemic stroke
Time frame: Participants will be followed at 3, 6 and 12 months after enrollment.
The incidence of all-cause death
Time frame: Participants will be followed at 3, 6 and 12 months after enrollment.
The incidence of moderate or severe bleeding events
Time frame: Participants will be followed at 3, 6 and 12 months after enrollment.
The incidence of all bleeding events
Time frame: Participants will be followed at 3, 6 and 12 months after enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical decision support system. in people with Cerebrovascular Disease, run by Beijing Tiantan Hospital.
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 7 inclusion and 6 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Zixiao Li, MD (00861067013383, lizixiao2008@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of unfavorable functional outcome (time frame: Participants will be followed at 3 months after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2024.