- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01562509
PEARL Study: Improvement of Non-Hodgkin's Lymphoma Care
Improvement of Hospital Care for Patients With Non-Hodgkin's Lymphoma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In a previous study among 22 Dutch hospitals many gaps in the care for patients with non-Hodgkin's lymphomas (NHL) were found, compared to best evidence as described in guidelines. In a problem analysis study, barriers and facilitators for good quality of NHL-care were assessed and a tailored implementation strategy was developed, based on these findings. The proposed study aims at the effectiveness, feasibility and costs of this tailored strategy to improve quality of care for patients with an NHL in a clustered randomized controlled trial in 19 Dutch hospitals.
Multilevel regression analyses will be performed to evaluate the effectiveness of both strategies. Exposure to and experiences with the strategy elements will be analysed descriptively.
Regarding the costs, the two strategies are compared with a health care perspective. The input of resources will be assessed by collecting volumes of consumed resources and multiplying these by the price of each resource unit; the implementation process and consequently costs will be estimated by an Activity Based Costing (ABC) approach. The output will be determined by the level of adherence to the NHL quality indicators.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Gelderland
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Nijmegen, Gelderland, Países Bajos, 6500 HB
- Radboud University Nijmegen Medical Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Clinical diagnosis of non-Hodgkin lymphoma
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Standard implementation strategy
Standard intervention
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Standard intervention consists of audit&feedback
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Experimental: Innovative implementation strategy
Implementation tools
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in adherence to quality indicators for NHL care
Periodo de tiempo: baseline and 1 year
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The effect of our interventions will be measured by means of adherence to quality indicators for optimal NHL care.
The effects of the audit and feedback strategy (9 hospitals) versus the tailored strategy (9 hospitals) will be evaluated using previously developed quality indicators.
These indicators for optimal NHL care were developed on the basis of evidence based guidelines, literature and opinions of clinicians about NHL care in a previous study and were validated.
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baseline and 1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Exposure to and experiences with the interventions
Periodo de tiempo: after 1 year
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To study the feasibility of both strategies, a process evaluation has to give insight into the mechanisms and processes responsible for the result (= extent of adherence to the indicator set for optimal NHL care).
The actual 'exposure' of the patients and professionals to the implementation elements, together with their experience with these elements may have influenced the final result (success or failure of adherence).
Data about 'exposure' to the different interventions will be collected using questionnaires.
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after 1 year
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Costs of the strategy and the changed care
Periodo de tiempo: after 1 year
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Non-adherence to the multidisciplinary NHL guideline may lead to unnecessary medical interventions and more complications, and subsequently to efficiency losses.
This economic evaluation compares the two implementation strategies.
The perspective of this economic evaluation will be a health care perspective.
Both the costs of the implementation strategy and changes in health care consumption will be assessed.
The outcome should facilitate local health care decision making on implementation.
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after 1 year
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Change from baseline in morbidity
Periodo de tiempo: baseline and 1 year
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Morbidity is an important outcome measure for the effect of the intervention strategy.
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baseline and 1 year
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Differences between both groups in Patient Related Outcome Measures (PROMs)
Periodo de tiempo: after 1 year
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Patient Related Outcome Measures as quality of life are important measures to evaluate the outcome of care from a patient perspective.
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after 1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rosella Hermens, PhD, Radboud University Nijmegen Medical Center
- Investigador principal: Nelleke Ottevanger, MD, PhD, Radboud University Nijmegen Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Stienen JJ, Hermens RP, Wennekes L, van de Schans SA, Dekker HM, Blijlevens NM, van der Maazen RW, Adang EM, van Krieken JH, Ottevanger PB. Improvement of hospital care for patients with non-Hodgkin's lymphoma: protocol for a cluster randomized controlled trial (PEARL study). Implement Sci. 2013 Jul 9;8:77. doi: 10.1186/1748-5908-8-77.
- Stienen JJ, Ottevanger PB, Wennekes L, van de Schans SA, Dekker HM, Blijlevens NM, van der Maazen RW, van Krieken JH, Hermens RP. Delivering high-quality care to patients with a non-Hodgkin's lymphoma: barriers perceived by patients and physicians. Neth J Med. 2014 Jan;72(1):41-8.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- ZonMW 171103002
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. .
Ensayos clínicos sobre No linfoma de Hodgkin
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-
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-
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Ensayos clínicos sobre Standard intervention
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Istituto Auxologico ItalianoReclutamientoComportamiento de saludItalia
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Shiraz University of Medical SciencesTerminado
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University of OxfordTerminado
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