- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04035772
The WikiTrauma Interrupted Time Series Protocol (WikiTrauma)
Implementation and Evaluation of a Wiki Involving Multiple Stakeholders Including Patients in the Promotion of Best Practices in Trauma Care: the WikiTrauma Interrupted Time Series Protocol
The purpose of this study is to study the combined effect of WikiTrauma, a free collaborative database of clinical decision support tools, and Wiki101, a training course teaching participants how to use WikiTrauma, on the quality of care in four trauma centers in Quebec.
The hypothesis that the theory-based intervention (Wiki101), in combination with use of WikiTrauma, will result in better adoption of best practices in trauma care, safer care (less complications), improved patient outcomes and less costly care in Canada.
Descripción general del estudio
Descripción detallada
Trauma is the most common cause of mortality among people between the ages of 1 and 45 years, costing Canadians 19.8 billion dollars a year (2004 data), yet half of all patients with major traumatic injuries do not receive evidence-based care, and significant regional variation in the quality of care across Canada exists. Accordingly, the goal of this study is to lead a research project in which stakeholders themselves will adapt evidence-based trauma care knowledge tools to the varied institutional contexts and cultures. This will be done by developing and assessing the combined impact of WikiTrauma, a free collaborative database of clinical decision support tools, and Wiki101, a training course teaching participants how to use WikiTrauma. WikiTrauma has the potential to ensure that all stakeholders (eg, patients, clinicians, and decision makers) can all contribute to, and benefit from, evidence-based clinical knowledge about trauma care that is tailored to the needs and clinical setting.
The main goal will be to study the combined effect of WikiTrauma and Wiki101 on the quality of care in four trauma centers in Quebec.
First, the wiki will be pilot-tested with potential users to create a version ready to test in practice. A rapid, iterative prototyping process with 15 health professionals from nonparticipating centers will allow to identify and resolve usability issues prior to finalizing the definitive version for the interrupted time series. Second, an interrupted time series will be performed to measure the impact of the combined intervention on the quality of care in four trauma centers that will be selected;one level I, one level II, and two level III centers. Participants will be health care professionals working in the selected trauma centers. Also, five patient representatives will be recruited to participate in the creation of knowledge tools destined for the use (eg, handouts). All participants will be invited to complete the Wiki101 training and then use, and contribute to, WikiTrauma for 12 months. The primary outcome will be the change over time of a validated, composite, performance indicator score based on 15 process performance indicators found in the Quebec Trauma Registry.
The project was funded in November 2014 by the Canadian Medical Protective Association. The trial will start in early 2015 and preliminary results should be available in June 2016. Two trauma centers have already agreed to participate and two more will be recruited in the next months.
This study is expected to add important and unique evidence about the effectiveness, safety, and cost savings of using collaborative platforms to adapt knowledge implementation tools across jurisdictions.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Quebec
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Lévis, Quebec, Canadá, G6V 3Z1
- Pascal Y Smith
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- decision makers (eg, trauma program coordinators) or,
- health care professionals (eg, emergency physicians, critical care physicians, trauma surgeons, nurses, respiratory therapists, physiotherapists, or pharmacists).
- Patient representatives will be selected without any restrictions or limitations with regard to the qualifications.
- Health care professional students and trainees (eg, residents, medical students, and nursing students) will have the same access to WikiTrauma and Wiki101 as fully certified professionals.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Wiki101 and WikiTrauma
Wiki101, a theory-based continuing professional development (CPD) program, will train participants at the selected trauma centers to use WikiTrauma effectively and safely to create and share different types of Knowledge Transfer (KT) tools (e.g., care protocols, order sets, patient decision aids). Participants will receive Wiki101 training and then gain access to WikiTrauma with editing rights to the knowledge implementation tools (e.g. care protocols, order sets, care pathways) found in the wiki. WikiTrauma is the wiki we created to promote best practices in trauma care and will be implemented in four trauma centers in Quebec during 12 months. During this period, we will continue to measure the impact on the quality of care. |
Wiki101 is a theory-based continuing professional development course to teach healthcare professionals how to use WikiTrauma.
WikiTrauma is a wiki containing implementation tools built upon the Google Sites platform.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Composite performance indicator score (change is assessed)
Periodo de tiempo: 30 months prior to implementation and up to 12 months later
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Composite performance indicator score based on 15 process performance indicators found in the Quebec Trauma Registry
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30 months prior to implementation and up to 12 months later
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rate of complications (change is assessed)
Periodo de tiempo: 30 months prior to implementation and up to 12 months later
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Rate of complication in the trauma center
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30 months prior to implementation and up to 12 months later
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Mortality rate (change is assessed)
Periodo de tiempo: 30 months prior to implementation and up to 12 months later
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Mortality rate in the trauma center
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30 months prior to implementation and up to 12 months later
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Length of stay (change is assessed)
Periodo de tiempo: 30 months prior to implementation and up to 12 months later
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Length of stay in the trauma center
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30 months prior to implementation and up to 12 months later
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Functional Independence Measure (FIM) (change is assessed)
Periodo de tiempo: 30 months prior to implementation and up to 12 months later
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an 18-item of physical, psychological and social function
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30 months prior to implementation and up to 12 months later
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Patrick M Archambault, MD MSc FRCPC, CISSS Chaudières-Appalaches (Hôtel-Dieu de Lévis)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Wiki Implementation 1415-041
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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