Hospital Processes Reengineering of Intravenous Thrombolysis in Acute Ischemic Stroke in China (PROMISE)
4. februar 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
- 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2178
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
AIS patients with an onset-to-door time of less than 3.5 h
Beskrivelse
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;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The thrombolysis rate of patients treated with rt-PA
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
intravenous rt-PA thrombolysis with an ODT of less than 2 h
Tidsramme: 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
Tidsramme: 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
Tidsramme: 90 days
|
"favorable outcome at 3-month" was defined as mRS 0-1 points.
|
90 days
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: ANDING XU, Prof, Stroke Center, The First Affiliated Hospital,Jinan University Guanzghou
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2014
Primær færdiggørelse (Faktiske)
1. december 2015
Studieafslutning (Faktiske)
1. december 2015
Datoer for studieregistrering
Først indsendt
26. oktober 2014
Først indsendt, der opfyldte QC-kriterier
11. december 2015
Først opslået (Skøn)
16. december 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. februar 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. februar 2016
Sidst verificeret
1. februar 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011BAI08B02-02
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