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

Ischemic Stroke Clinical Trial

— PROMISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631317
• Other study ID #: 2011BAI08B02-02
• Status: Completed
• Phase: N/A
• First received: October 26, 2014
• Last updated: February 4, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: First Affiliated Hospital of Jinan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2178
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adverse Effect of Thrombolytic Drugs, Sequela
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Behavioral:
• Advance hospital notification by EMS
Advance hospital notification by EMS
• stroke team notification
stroke team notification
• key performance indicators feedback form
a "key performance indicators real-time feedback form" as continuing quality improvement
• standard informed consent procedures
standard informed consent procedures with public poster of thrombolysis
• performance of thrombolysis at CT-room
performance of thrombolysis at CT-room or emergency room

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Jinan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	favorable outcome at 3-month	"favorable outcome at 3-month" was defined as mRS 0-1 points.	90 days	No