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

NCT06452888 | Not Yet Recruiting DMC

• 1 other identifier: 2022YFC2504902
• Study Type: interventional
• Target: 3,540
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebrovascular Disease

Keywords

Ischemic Stroke; Medical Quality; Clinical Complication; Clinical decision Support System; Electronic Health Record; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The incidence of in-hospital complications

  Participants will be followed at 3, 6 and 12 months after enrollment.

• The incidence of unfavorable functional outcome

  Participants will be followed at 6 and 12 months after enrollment.

• The incidence of new vascular events

  Participants will be followed at 3, 6 and 12 months after enrollment.

• The incidence of recurrent ischemic stroke

  Participants will be followed at 3, 6 and 12 months after enrollment.

• The incidence of all-cause death

  Participants will be followed at 3, 6 and 12 months after enrollment.

Other Outcomes (2)

• The incidence of average length of stay

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

• The incidence of average total hospital expenses

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Study Arms (2)

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.

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.

Behavioral: Clinical decision support system.

Interventions

Clinical decision support system. BEHAVIORAL

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.

Intervention Group

no intervention BEHAVIORAL

No intervention indicated that the physicians among control hospital provide routine

No intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Cerebrovascular Disorders; Ischemic Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Central Study Contacts

Zixiao Li, MD

CONTACT

00861067013383; lizixiao2008@hotmail.com

Meng Wang, PhD

CONTACT

008613261053863; wangmengpumc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: June 11, 2024
• Study Start: July 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: February 1, 2026
• Last Updated: June 11, 2024

Record last verified: 2024-06