Hospital Processes Reengineering of Intravenous Thrombolysis in Acute Ischemic Stroke in China (PROMISE)
4 februari 2016 bijgewerkt door: Anding Xu, First Affiliated Hospital of Jinan University
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.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
- 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.
Studietype
Observationeel
Inschrijving (Werkelijk)
2178
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
AIS patients with an onset-to-door time of less than 3.5 h
Beschrijving
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;
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
|
Advance hospital notification by EMS
stroke team notification
a "key performance indicators real-time feedback form" as continuing quality improvement
standard informed consent procedures with public poster of thrombolysis
performance of thrombolysis at CT-room or emergency room
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The thrombolysis rate of patients treated with rt-PA
Tijdsspanne: within 4.5 hours
|
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
Tijdsspanne: within 4.5 hours
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
intravenous rt-PA thrombolysis with an ODT of less than 2 h
Tijdsspanne: 3 hours
|
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
Tijdsspanne: 90 days
|
"death or dependence at 3-month" was defined as modified Rankin Scale(mRS) score 3-6 points.
|
90 days
|
|
favorable outcome at 3-month
Tijdsspanne: 90 days
|
"favorable outcome at 3-month" was defined as mRS 0-1 points.
|
90 days
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie stoel: ANDING XU, Prof, Stroke Center, The First Affiliated Hospital,Jinan University Guanzghou
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2014
Primaire voltooiing (Werkelijk)
1 december 2015
Studie voltooiing (Werkelijk)
1 december 2015
Studieregistratiedata
Eerst ingediend
26 oktober 2014
Eerst ingediend dat voldeed aan de QC-criteria
11 december 2015
Eerst geplaatst (Schatting)
16 december 2015
Updates van studierecords
Laatste update geplaatst (Schatting)
5 februari 2016
Laatste update ingediend die voldeed aan QC-criteria
4 februari 2016
Laatst geverifieerd
1 februari 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2011BAI08B02-02
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