Hospital Processes Reengineering of Intravenous Thrombolysis in Acute Ischemic Stroke in China

Study Overview
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Brief Summary
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PROMISE is a prospective, nationwide, multicenter, longitudinal cohort study, focusing on hospital intravenous thrombolysis process reengineering for acute ischemic stroke (AIS). With a proposed Reengineered Process Framework for intravenous thrombolysis process by the PROMISE study steering committee, about 30 medical centers enters would be recruited nationwide, and each center would include consecutive AIS patients with an onset-to-door time (ODT) of less than 3.5 h. The investigators hypothesize that the proposed Reengineered Process Framework is suitable and feasible for hospitals in mainland of China; the rate of intravenous rt-PA thrombolysis in ischemic stroke patients with an ODT of less than 3.5 h would be more than 20% or be increased by 40% as compared with baseline; the proportion of patients with a door-to-needle (DNT) time of less than 60 min would be more than 20%, or be with an increase by ≥ 40% as compared with baseline.

Detailed Description
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After reviewing domestic and international clinical research literature, the PROMISE study steering committee constructed the Reengineered Process Framework for intravenous thrombolysis process with business process reengineering theory. The suggested Reengineered Process Framework is regarded as feasible and suitable for hospitals in mainland of China. The study period is 12 months, of which the first 3 months is the baseline period. After 3 months, all centers should develop new thrombolytic processes according to the Reengineered Process Framework. The new processes are gradually implemented since the 4th month with continues care quality improvements. The Reengineered Process Framework adopts a form of comprehensive package, proposes unified key points of process reengineering, provides a series of supporting, standardized tools for process management, and establishes a real-time key performance indicator (KPI) monitoring feedback system, etc. Supporting, standardized tools includes: rapid identification tools of suspected stroke for medical personnel in the emergency system; stroke team building programs; real-time feedback form of KPI; standardized thrombolysis informed consent form and informed conversation public service advertising posters; suggested indications and contraindications for intravenous thrombolysis; standard operation procedure of intravenous rt-PA thrombolysis, etc. With these methods, it is expected to raise the thrombolytic rate for patients arrived at medical center within 3.5 hours after the onset, and to shorten the door to needle time in China.

Official Title
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Hospital Processes Reengineering of Intravenous Thrombolysis in Acute Ischemic Stroke in China

Conditions
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Ischemic Stroke, Adverse Effect of Thrombolytic Drugs, Sequela

Intervention / Treatment
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* Behavioral: Advance hospital notification by EMS
* Behavioral: stroke team notification
* Behavioral: key performance indicators feedback form
* Behavioral: standard informed consent procedures
* Behavioral: performance of thrombolysis at CT-room


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All AIS patients with an onset-to-door time of less than 3.5 h of onset; informed consent Exclusion Criteria: Complete remission of symptoms and signs, in consideration for patients with transient ischemic attack; Silent cerebral infarction without symptoms or signs;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rt-PA<br>patients treated with rt-PA, followed strategies were used: advance hospital notification by EMS, stroke team notification, key performance indicators feedback form, standard informed consent procedures, performance of thrombolysis at CT-room. | Behavioral: Advance hospital notification by EMS<br>* Advance hospital notification by EMS<br>Behavioral: stroke team notification<br>* stroke team notification<br>Behavioral: key performance indicators feedback form<br>* a key performance indicators real-time feedback form as continuing quality improvement<br>Behavioral: standard informed consent procedures<br>* standard informed consent procedures with public poster of thrombolysis<br>Behavioral: performance of thrombolysis at CT-room<br>* performance of thrombolysis at CT-room or emergency room<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The thrombolysis rate of patients treated with rt-PA | The rate of intravenous rt-PA thrombolysis in ischemic stroke patients with an ODT of less than 3.5 h: ≥ 20%, with an increase over the baseline ≥ 40% | within 4.5 hours | 
| The rate of DNT less than 60 min within the patients treated with rt-PA | The rate of patients with a door-to-needle (DNT) time of less than 60 min for intravenous rt-PA thrombolysis: ≥20%, with an increase over the baseline ≥ 40% | within 4.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intravenous rt-PA thrombolysis with an ODT of less than 2 h | intravenous rt-PA thrombolysis in ischemic stroke patients with an onset-to-door time(ODT) of less than 2 h | 3 hours | 
| death or dependence at 3-month | death or dependence at 3-month was defined as modified Rankin Scale(mRS) score 3-6 points. | 90 days | 
| favorable outcome at 3-month | favorable outcome at 3-month was defined as mRS 0-1 points. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, intravenous rt-PA thrombolysis, process reengineering, door-to-needle time