Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452888
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-21
Brief Title:
Improvement of Medical Quality and Outcomes Through Intelligent Management and Decision System of Cerebrovascular Diseases Based on Hospital Information System
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None