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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • no intervention

    Behavioral

    No intervention indicated that the physicians among control hospital provide routine

Treatment groups

3,540 Participants
are divided into 2 treatment groups
Group A: No interventionSham comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Participants will be followed at 3 months after enrollment.

Secondary outcomes

1

The incidence of in-hospital complications

In-hospital complications (including pneumonia, deep vein thrombosis, gastrointestinal bleeding, and urinary tract infection).

Time frame
Participants will be followed at 3, 6 and 12 months after enrollment.
2

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.

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

The incidence of new vascular events

Including ischemic stroke, hemorrhagic stroke, myocardial infarction or vascular death.

Time frame
Participants will be followed at 3, 6 and 12 months after enrollment.
4

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.

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

Other outcomes

1

The incidence of average length of stay

The average length of stay of all patients enrolled in the subcenter.

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

The incidence of average total hospital expenses

The average total hospital expenses of all patients enrolled in the subcenter.

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

Locations

This trial has no locations.

Sponsors and contacts

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