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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02631317
Acronym
PROMISE
Enrollment
2178
Registered
2015-12-16
Start date
2014-07-31
Completion date
2015-12-31
Last updated
2016-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Effect of Thrombolytic Drugs, Sequela, Ischemic Stroke

Keywords

acute ischemic stroke, intravenous rt-PA thrombolysis, process reengineering, door-to-needle time

Brief summary

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.

Interventions

BEHAVIORALAdvance hospital notification by EMS

Advance hospital notification by EMS

BEHAVIORALstroke team notification

stroke team notification

BEHAVIORALkey performance indicators feedback form

a key performance indicators real-time feedback form as continuing quality improvement

BEHAVIORALstandard informed consent procedures

standard informed consent procedures with public poster of thrombolysis

BEHAVIORALperformance of thrombolysis at CT-room

performance of thrombolysis at CT-room or emergency room

Sponsors

First Affiliated Hospital of Jinan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All AIS patients with an onset-to-door time of less than 3.5 h of onset; informed consent

Exclusion criteria

1. Complete remission of symptoms and signs, in consideration for patients with transient ischemic attack; 2. Silent cerebral infarction without symptoms or signs;

Design outcomes

Primary

MeasureTime frameDescription
The thrombolysis rate of patients treated with rt-PAwithin 4.5 hoursThe 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%
The rate of DNT less than 60 min within the patients treated with rt-PAwithin 4.5 hoursThe 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%

Secondary

MeasureTime frameDescription
intravenous rt-PA thrombolysis with an ODT of less than 2 h3 hoursintravenous rt-PA thrombolysis in ischemic stroke patients with an onset-to-door time(ODT) of less than 2 h
death or dependence at 3-month90 daysdeath or dependence at 3-month was defined as modified Rankin Scale(mRS) score 3-6 points.
favorable outcome at 3-month90 daysfavorable outcome at 3-month was defined as mRS 0-1 points.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026