Hospital Processes Reengineering of Intravenous Thrombolysis in Acute Ischemic Stroke in China (PROMISE)
4 februari 2016 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
- 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.
Studietyp
Observationell
Inskrivning (Faktisk)
2178
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
AIS patients with an onset-to-door time of less than 3.5 h
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The thrombolysis rate of patients treated with rt-PA
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
intravenous rt-PA thrombolysis with an ODT of less than 2 h
Tidsram: 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
Tidsram: 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
Tidsram: 90 days
|
"favorable outcome at 3-month" was defined as mRS 0-1 points.
|
90 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: ANDING XU, Prof, Stroke Center, The First Affiliated Hospital,Jinan University Guanzghou
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2014
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 december 2015
Studieregistreringsdatum
Först inskickad
26 oktober 2014
Först inskickad som uppfyllde QC-kriterierna
11 december 2015
Första postat (Uppskatta)
16 december 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
5 februari 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 februari 2016
Senast verifierad
1 februari 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2011BAI08B02-02
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