Hospital Processes Reengineering of Intravenous Thrombolysis in Acute Ischemic Stroke in China (PROMISE)
4 de febrero de 2016 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Descripción detallada
- 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.
Tipo de estudio
De observación
Inscripción (Actual)
2178
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
AIS patients with an onset-to-door time of less than 3.5 h
Descripción
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;
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The thrombolysis rate of patients treated with rt-PA
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
intravenous rt-PA thrombolysis with an ODT of less than 2 h
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 90 days
|
"favorable outcome at 3-month" was defined as mRS 0-1 points.
|
90 days
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: ANDING XU, Prof, Stroke Center, The First Affiliated Hospital,Jinan University Guanzghou
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2014
Finalización primaria (Actual)
1 de diciembre de 2015
Finalización del estudio (Actual)
1 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
26 de octubre de 2014
Primero enviado que cumplió con los criterios de control de calidad
11 de diciembre de 2015
Publicado por primera vez (Estimar)
16 de diciembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
5 de febrero de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
4 de febrero de 2016
Última verificación
1 de febrero de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Necrosis
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Isquemia cerebral
- Infarto
- Infarto cerebral
- Carrera
- Accidente cerebrovascular isquémico
- Isquemia
- Infarto cerebral
Otros números de identificación del estudio
- 2011BAI08B02-02
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