Improvement of Medical Quality and Outcomes Through Intelligent Management and Decision System of Cerebrovascular Diseases Based on Hospital Information System

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebrovascular Disease
• Intervention / Treatment: Behavioral: no intervention; Behavioral: Clinical decision support system.

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 Type: Interventional
• Enrollment (Estimated): 3540
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zixiao Li, MD; Phone Number: 00861067013383; Email: lizixiao2008@hotmail.com
• Study Contact Backup: Name: Meng Wang, PhD; Phone Number: 008613261053863; Email: wangmengpumc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: No intervention; 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.	Behavioral: no intervention; No intervention indicated that the physicians among control hospital provide routine
Experimental: Intervention Group; 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Participants will be followed at 3 months after enrollment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of in-hospital complications	In-hospital complications (including pneumonia, deep vein thrombosis, gastrointestinal bleeding, and urinary tract infection).	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.	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.	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.	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.	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).	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.	Participants will be followed at 3, 6 and 12 months after enrollment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of average length of stay	The average length of stay of all patients enrolled in the subcenter.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
The incidence of average total hospital expenses	The average total hospital expenses of all patients enrolled in the subcenter.	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Ischemic Stroke; Electronic Health Record; Medical Quality; Clinical Complication; Clinical decision Support System
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: 2022YFC2504902

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No