- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01315626
Bronchiectasis: Evaluation of an Educational Intervention
Identification of Patients With a Diagnosis of Bronchiectasis: Evaluation of an Educational Intervention
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A pilot study will be conducted for the purpose of evaluating an educational intervention (Description in Appendix A). As part of the educational intervention, primary care physician(s) will be trained in the use of an algorithm to guide assessment of patients seen with a respiratory chief complaint, and who have not previously been identified as having a diagnosis of BE. We propose an evaluation of three primary care practice(s) to compare the number of patients identified in three three-month periods as having a diagnosis of BE.
The evaluation periods will be as follows: Period 1) the three-month period immediately following the intervention, Period 2) the three-month period immediately preceding the intervention, Period 3) the three month period starting one year prior to the intervention.
Tipo de estudio
Contactos y Ubicaciones
Ubicaciones de estudio
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Tennessee
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Shelbyville, Tennessee, Estados Unidos, 37160
- Howard Rupard, MD Primary Care Practice
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Respiratory is the chief complaint
- Patient > 35 years of age
- Seen in practice for > 12 months
Exclusion Criteria:
1) Prior diagnosis with bronchiectasis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Perspectivas temporales: Retrospectivo
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Immediately preceding intervention
3 months immediately before the education event.
Charts of patients with a primary respiratory complaint will be reviewed so evaluate if they 1) have experienced 3 or more suppurative respiratory infections and 2) have required 3 or more courses of antibiotic therapy for respiratory infection over the period of one year.
4) Whether or not they underwent a HRCT, and if so, and 5) Were the patients diagnosed with BE.
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3 months after educational event
3 months immediately after the education event.
An active assessment will be preformed as per the proposed diagnostic algorithm (attachment B) Patients that meet all criteria in the algorithm are considered at risk for bronchiectasis and based on these criteria, physicians will be encouraged to order HRCT, and the number/ proportion of patients identified with BE will be noted and compared to the other time periods.
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The purpose of this study is to assess the accuracy of primary care physicians in diagnosing BE and evaluate the impact of an educational intervention targeting those primary care physicians and providing instruction in the recognition and treatment of BE.
The hope is that a better understanding of the disease will result in more accurate diagnoses and ultimately in more appropriate care for these patients.
In addition to better care for patients, earlier recognition of bronchiectasis may result in a decrease in health care costs.
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Seasonal prior year
As respiratory illnesses are commonly seasonal, an assessment of rate of Bronchiectasis diagnosis during the months of Period 2 in the year prior to the educational intervention will also be assessed as described in Period 1
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The purpose of this study is to assess the accuracy of primary care physicians in diagnosing BE and evaluate the impact of an educational intervention targeting those primary care physicians and providing instruction in the recognition and treatment of BE.
The hope is that a better understanding of the disease will result in more accurate diagnoses and ultimately in more appropriate care for these patients.
In addition to better care for patients, earlier recognition of bronchiectasis may result in a decrease in health care costs.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number / Percent of BE patients
Periodo de tiempo: 18 months
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The primary outcome for this study will be the number/proportion of patients that meet entrance criteria that are subsequently diagnosed with bronchiectasis.
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18 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
HRCT patients
Periodo de tiempo: 18 months
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Secondary outcomes are the number/proportion of those subjects that undergo HRCT, and the number/proportion of subjects that are then identified as having Bronchiectasis.
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18 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
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
- CR-2010-04
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