- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02977858
ISE to Support Constipation Management
Interactive Spaced Education Game to Support Constipation Management in Pediatric Primary Care
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Primary care practices in the Greater Cincinnati region, that are part of the Ohio Valley Pediatric Care Association (OVPCA) will be recruited to take part in the study. It is estimated that approximately 170 providers in 40 practices will take part overall. The study participants will be the PCPs and nurses in their practices.
Prior to the educational intervention (described below), participating PCPs and nurses will be asked to complete Constipation Action Plan (CAP) forms detailing the treatments they prescribed to each patient with constipation symptoms at each new visit and the subsequent follow up visits for constipation. The CAP form will contain a section to describe the patient's symptoms as well as fields to be checked for each treatment the PCP instructed the patient to follow.
Practices will be clustered by size (number of providers) and randomly assigned to 1 of 2 educational interventions (Dissemination or Dissemination +Interactive Spaced Education).
Dissemination will include webinars and e-mail distribution of the Constipation Management Guideline and a slide set containing the evidence-based rationale as well as clinical tips for advanced management of functional constipation. All PCPs will receive the guideline and slide set and be offered an opportunity to ask questions of a gastroenterologist.
Participating PCPs and nurses randomized to the Interactive Spaced Education (ISE) arm will complete an online ISE course assessing their understanding of the constipation guidelines.
Constipation knowledge will be tested via quiz in multiple choice format. Online surveys to assess satisfaction with the educational intervention, likelihood to change practice, ease of participation in the SE course (if applicable) and feedback for ways to improve future educational efforts will be administered at three time-points.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- PCPs and nurses who are willing and able to complete the education intervention throughout the study time-frame, as outlined in the protocol (education intervention does not need to be completed prior to taking part in the study)
- PCPs and nurses who are willing to complete Constipation Action Plans and submit them in a timely fashion to the CCHMC Quality Improvement program staff
Exclusion Criteria:
- PCPs or nurses who are unwilling and/or unable to follow protocol requirements.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Dissemination
Educational practice for HCPs,Dissemination only - Practices who will participate in education for constipation management guidelines via dissemination of webinar alone.
|
Study participants are health care professionals (HCPs) who will be provided educational material and complete knowledge assessments
|
|
Dissemination + ISE
Educational practice for HCPs,Spaced Education - Practices who will participate in education for constipation management guidelines via dissemination of webinar along with a web-based format referred to as Interactive Spaced Education.
|
Study participants are health care professionals (HCPs) who will be provided educational material and complete knowledge assessments
Study participants are health care professionals (HCPs) who will be provided educational material via a Spaced Education program; participants will subsequently complete knowledge assessments
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient Referral
Periodo de tiempo: 2 years
|
Determine if online ISE reduces referrals of patients with constipation to pediatric gastroenterologists
|
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Improved knowledge gains
Periodo de tiempo: 2 years
|
Determine if online ISE in addition to dissemination improves knowledge gains by pediatricians and medical staff
|
2 years
|
|
Improved adherence to Constipation Management Guideline
Periodo de tiempo: 2 years
|
Determine if online ISE in addition to dissemination improves adherence by pediatricians to the Constipation Management Guideline
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Daniel Mallon, MD, Children's Hospital Medical Center, Cincinnati
Publicaciones y enlaces útiles
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 (Estimar)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015-9317
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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. .