- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00366028
Increasing Evidence-based Clinical Practices in VA
Strengthening Organization to Implement Evidence-based Clinical Practice
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background:
The Veterans Health Administration (VHA) needs to develop efficient ways to broadly implement evidence based practices and foster a learning organization culture that systematically and continuously applies research to improve VA healthcare. Recognizing this need, VHA Health Services Research and Development (HSR&D) invited applications in the fall of 2003 for collaboration HSR&D investigators and Integrated Service Networks (VISNs) on a) implementing and evaluating an evidenced-based interventions or b) undergoing and evaluating an organizational or structural change to transform the VISN in to a learning organization that can efficiently implement evidence-based practices. Collaborations are intended to help improve clinical services locally within participating VISNs and provide templates for expanding successful changes nationwide.
Objectives:
Despite recognition that successful implementation of evidence-based clinical practices (EBCPs) usually depends on the on the structure and processes of the larger healthcare organization in which new clinical practices are introduced, the processes and dynamics of implementation are not well understood. The aim of this project was to deepen that understanding by testing an organizational model that we hypothesized would strengthen the ability of healthcare organizations to implement evidence-based clinical practices. The research objectives were to: - Test the hypothesis that medical centers with high fidelity to the organizational model would be more successful in improving system use of a selected EBCP; - Identify and analyze organizational factors that affect model implementation; - Test the feasibility of intervention activities to introduce and support the model.
Methods:
The three-year study used a mixed-methods pre-post comparison-group design to implement and evaluate the organizational model in medical centers in 3 VISNs in the Department of Veterans Affairs. The model posits that the implementation of evidence-based practices will be enhanced through the presence of three interacting components in the organization: 1) active leadership commitment to quality, 2) robust clinical process redesign to incorporate evidence-based practices into routine operations, and 3) use of management structures and processes to support and align redesign. The target clinical practice was hand-hygiene compliance. One VISN was randomly assigned to the intervention arm that implemented the organizational model; two VISNs were assigned to a comparison arm that participated in a more limited data feedback strategy. Measures included: 1) ratings of implementation fidelity, as measured on a 0-4 scale at the site level supported by narrative evidence by research team; 2) percent compliance with national hand-hygiene guidelines for each site, as measured through structured observations by medical center staff; 3) staff ratings of team effectiveness and facility emphasis on quality, as measured through a written survey; and 4) factors affecting model implementation, as identified qualitatively through interviews and quantitatively through staff surveys
Status:
Data collection and analysis is complete. Manuscript preparation is ongoing.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Massachusetts
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Boston, Massachusetts, Estados Unidos, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
-
-
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:
VA employees of VISNs 1, 10 and 23 working in participating clinical units or holding a leadership position in medical centers identified by facility leadership for participation in the study.
Exclusion Criteria:
Must have operational proficiency in English. All to be interviewed and surveyed will hold professional positions in VA, so this is not expected to be a major barrier to inclusion.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: Organizational Model
Organizational Model: Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.
Participants in this arm of the study will be interviewed and participate in the data feedback portion of the study as well.
|
The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.
The research team will periodically interview the facilities and provide them with reported hand hygiene data.
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Otro: Data Feedback
Data Feedback Only: Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study.
|
The research team will periodically interview the facilities and provide them with reported hand hygiene data.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Fidelity to the Organizational Model
Periodo de tiempo: Fidelity was assessed at the end of the 3 year study.
|
Final fidelity to the Organizational Model was assessed by averaging scores for each component of the model. Scores ranged from 0 (no evidence of that factor present) to 4 (factor fully present and used as intended). The 3 main components of the model included 1) active leadership commitment to quality, 2) robust clinical process redesign to incorporate evidence-based practices into routine operations, and 3) use of management structures and processes to support and align redesign. Scores for each component of the model were measured by the study team using structured rating instruments based on data collected during interviews. Sites with an overall fidelity score above 3.0 were considered to have high fidelity to the organizational model. |
Fidelity was assessed at the end of the 3 year study.
|
Effect Size of Improvement in Hand Hygiene Compliance
Periodo de tiempo: 3 months pre and post study intervention
|
The effect size of improvement in hand-hygiene compliance was calculated by comparing the baseline three-month periods to the last three-month periods of the study.
To evaluate the statistical significance of changes in proportion adherence over time, we ran a weighted least squares regression model with time (i.e.
month) as the independent variable and adherence proportion as the dependent variable.
The sample size in each data collection period was used as the weight.
Our interest is in the statistical significance of the coefficient associated with time.
To evaluate the practical significance of the change pre and post intervention, we examined the effect size associated with the change in proportion adherence in the first 3-month period of data collection and the last 3-month period.
Effect size was calculated as 2*arcsin(sqr(p2)) - 2*arcsin(sqr(p1)).
Using Cohen's criteria, an effect size of .2 is interpreted as small, .5 as medium and .8 as large.
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3 months pre and post study intervention
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Carol VanDeusen-Lukas, EdD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (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
Otros números de identificación del estudio
- IMV 04-055
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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