PULSE - Patient Understanding and Learning Through Structured Education - Effectiveness and Implementation of Patient Education Videos in a New Pediatric Cardiology Clinic (PULSE)
PULSE - Patient Understanding and Learning Through Structured Education - Effectiveness and Implementation of Patient Education Videos in a New Pediatric Cardiology Clinic: A Stepped Wedge Cluster Randomized Trial
This study is looking at whether short educational videos shown during pediatric cardiology visits can help families better understand their child's condition while also making clinic visits run more efficiently. Families coming to a pediatric cardiology clinic may watch short videos related to why they are there (for example: chest pain, heart murmurs, fainting, sports clearance, or Kawasaki disease). The videos are meant to explain common heart-related conditions and answer questions before the doctor comes into the room.
Researchers want to see if this:
- helps parents and patients learn more,
- improves satisfaction with the visit,
- helps families feel more involved in decisions,
- and reduces the amount of time doctors spend repeating the same explanations.
How the study works:
One clinic site in San Antonio, TX will start using the videos at different times. Researchers will compare clinic visits before and after the videos are introduced.
Who is included:
Children being seen in pediatric cardiology clinics and their caregivers. Pregnant women referred for fetal heart evaluations may also be included.
What information is collected:
Clinic timing information (such as wait times and doctor visit length), Satisfaction surveys, Optional knowledge questionnaires, Basic medical record information needed for the study.
Risk level: The study is considered "minimal risk." Patients are still getting normal medical care. No drugs, devices, or experimental treatments are being tested.
Privacy protections:
Data will be stored on secure hospital systems. Researchers plan to remove identifying information when analyzing results. Medical record numbers are only temporarily used to connect survey data with clinic data.
Why the study matters:
The clinic hopes the videos can make visits less stressful, improve understanding for families, and help doctors spend more time on personalized care instead of repeating the same explanations over and over. It may also help clinics work more efficiently and reduce delays.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Patient education is a cornerstone of high-quality pediatric care, yet time constraints limit physicians' ability to provide comprehensive condition-specific education during clinic visits. Educational videos offer a scalable solution to enhance patient/family understanding while potentially improving clinic efficiency.
This study evaluates the effectiveness and implementation of educational videos in a newly established pediatric cardiology clinic using a stepped wedge design. The stepped wedge design is appropriate because:
- Operational feasibility: Videos will be implemented sequentially during clinic ramp-up, making simultaneous implementation impractical
- Ethical considerations: All patients eventually receive the intervention
- Statistical efficiency: The design accounts for temporal trends during clinic maturation
- Implementation science: Allows evaluation of both effectiveness and implementation outcomes
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sannya Hede, MD
- Número de teléfono: 361-694-5000
- Correo electrónico: sannya.hede@dchstx.org
Copia de seguridad de contactos de estudio
- Nombre: Erin Richmond, MS, RN
- Número de teléfono: 361-694-5978
- Correo electrónico: erin.richmond@dchstx.org
Ubicaciones de estudio
-
-
Texas
-
San Antonio, Texas, Estados Unidos, 78251
- Reclutamiento
- Driscoll Children's Cardiology Clinic- San Antonio
-
Investigador principal:
- Sannya Hede, MD
-
Contacto:
- Erin Richmond, MS, RN
- Número de teléfono: 361-694-5978
- Correo electrónico: erin.richmond@dchstx.org
-
Contacto:
- Sannya V Hede, MD
- Número de teléfono: 361-694-5000
- Correo electrónico: sannya.hede@dchstx.org
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Pediatric patients (ages 0-18 years) presenting for outpatient pediatric cardiology evaluation
- Caregiver present and able to complete surveys
- Referral reason matches available video topic (during intervention periods)
Exclusion Criteria:
- Emergency or urgent consultations
- Caregiver unable to read/understand English or Spanish
- Patient/family opts out of study participation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Group A: Murmur, Chest Pain
Educational video topic: Murmur, Chest Pain
|
Video topics will be matched to patient referral reason: Murmur, Chest Pain
|
|
Comparador activo: Group B: Syncope, Palpitations
Educational video topic: Syncope, Palpitations
|
Video topics will be matched to patient referral reason: Syncope, Palpitations
|
|
Comparador activo: Group C: Sports Clearance, Kawasaki, General
Educational video topic: Sports Clearance, Kawasaki, General
|
Video topics will be matched to patient referral reason: Sports Clearance, Kawasaki, General
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physician encounter time (minutes)
Periodo de tiempo: During the 12 months of study interventions.
|
Measured from physician room entry to exit via electronic health record (EHR) timestamps or direct observation.
|
During the 12 months of study interventions.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinic throughput
Periodo de tiempo: During the 12 months of study interventions.
|
Patients/session: Measured through timestamps (check-in, rooming, physician entry, discharge), visit type, referral reason and Provider schedules, patient volume
|
During the 12 months of study interventions.
|
|
Family knowledge
Periodo de tiempo: During the 12 months of study interventions.
|
5-item condition-specific quiz
|
During the 12 months of study interventions.
|
|
Patient satisfaction
Periodo de tiempo: During the 12 months of study interventions.
|
single-item 5-point scale
|
During the 12 months of study interventions.
|
|
Physician satisfaction
Periodo de tiempo: During the 12 months of study interventions.
|
brief post-session survey
|
During the 12 months of study interventions.
|
|
Shared decision-making quality
Periodo de tiempo: During the 12 months of study interventions.
|
CollaboRATE Shared Decision Making Score, 0-100.
The CollaboRATE measure provides a performance score representing the percentage of adults 18 and older who experience a high level of shared decision making.
|
During the 12 months of study interventions.
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- DCHIRB-FY2026-11
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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. .