An interventional study of Clinical decision support system. and no intervention in Cerebrovascular Disease, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Health services research
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.
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.
374 studies on the registry are indexed under Cerebrovascular Disorders; 129 are open to participants now.
This study's planned enrollment of 3,540 is above the median of 110 across 214 interventional studies indexed under Cerebrovascular Disorders.
Browse Cerebrovascular Disorders studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
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Exclusion Criteria:
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
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.
No intervention indicated that the physicians among control hospital provide routine
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.
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.
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.
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.
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.
The incidence of all-cause death
An all-cause death is defined as a death from any cause.
Time frame: 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).
Time frame: 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.
Time frame: Participants will be followed at 3, 6 and 12 months after enrollment.
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.
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.
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Beijing Tiantan Hospital