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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zixiao Li, MD | Contact | 00861067013383 | lizixiao2008@hotmail.com | |
| Meng Wang, PhD | Contact | 008613261053863 | wangmengpumc@163.com |
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| no intervention | Behavioral | No intervention indicated that the physicians among control hospital provide routine |
|
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. |
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. |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020521 | Stroke |
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