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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke; Adverse Effect of Thrombolytic Drugs, Sequela
• Intervention / Treatment: 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

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.

• Study Type: Observational
• Enrollment (Actual): 2178

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Jinan University
• Investigators: Study Chair: ANDING XU, Prof, Stroke Center, The First Affiliated Hospital,Jinan University Guanzghou

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: October 26, 2014
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Estimate): February 5, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: acute ischemic stroke; intravenous rt-PA thrombolysis; process reengineering; door-to-needle time
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: 2011BAI08B02-02