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

Completed

Phase N/A Results N/A

Trial Description

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

1. 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.
2. 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.
3. 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.
4. 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.

Conditions

Interventions

  • Advance hospital notification by EMS Behavioral
    Intervention Desc: Advance hospital notification by EMS
    ARM 1: Kind: Experimental
    Label: rt-PA
    Description: 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.
  • Stroke team notification Behavioral
    Intervention Desc: stroke team notification
    ARM 1: Kind: Experimental
    Label: rt-PA
    Description: 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.
  • Key performance indicators feedback form Behavioral
    Intervention Desc: a "key performance indicators real-time feedback form" as continuing quality improvement
    ARM 1: Kind: Experimental
    Label: rt-PA
    Description: 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.
  • Standard informed consent procedures Behavioral
    Intervention Desc: standard informed consent procedures with public poster of thrombolysis
    ARM 1: Kind: Experimental
    Label: rt-PA
    Description: 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.
  • Performance of thrombolysis at CT-room Behavioral
    Intervention Desc: performance of thrombolysis at CT-room or emergency room
    ARM 1: Kind: Experimental
    Label: rt-PA
    Description: 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.

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

AIS patients with an onset-to-door time of less than 3.5 h

Outcomes

Type Measure Time Frame Safety Issue
Primary The thrombolysis rate of patients treated with rt-PA within 4.5 hours No
Primary The rate of DNT less than 60 min within the patients treated with rt-PA within 4.5 hours No
Secondary intravenous rt-PA thrombolysis with an ODT of less than 2 h 3 hours No
Secondary death or dependence at 3-month 90 days No
Secondary favorable outcome at 3-month 90 days No

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