- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07594041
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sannya Hede, MD
- Numéro de téléphone: 361-694-5000
- E-mail: sannya.hede@dchstx.org
Sauvegarde des contacts de l'étude
- Nom: Erin Richmond, MS, RN
- Numéro de téléphone: 361-694-5978
- E-mail: erin.richmond@dchstx.org
Lieux d'étude
-
-
Texas
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San Antonio, Texas, États-Unis, 78251
- Recrutement
- Driscoll Children's Cardiology Clinic- San Antonio
-
Chercheur principal:
- Sannya Hede, MD
-
Contact:
- Erin Richmond, MS, RN
- Numéro de téléphone: 361-694-5978
- E-mail: erin.richmond@dchstx.org
-
Contact:
- Sannya V Hede, MD
- Numéro de téléphone: 361-694-5000
- E-mail: sannya.hede@dchstx.org
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Group A: Murmur, Chest Pain
Educational video topic: Murmur, Chest Pain
|
Video topics will be matched to patient referral reason: Murmur, Chest Pain
|
|
Comparateur actif: Group B: Syncope, Palpitations
Educational video topic: Syncope, Palpitations
|
Video topics will be matched to patient referral reason: Syncope, Palpitations
|
|
Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Physician encounter time (minutes)
Délai: 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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinic throughput
Délai: 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
Délai: During the 12 months of study interventions.
|
5-item condition-specific quiz
|
During the 12 months of study interventions.
|
|
Patient satisfaction
Délai: During the 12 months of study interventions.
|
single-item 5-point scale
|
During the 12 months of study interventions.
|
|
Physician satisfaction
Délai: During the 12 months of study interventions.
|
brief post-session survey
|
During the 12 months of study interventions.
|
|
Shared decision-making quality
Délai: 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.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- DCHIRB-FY2026-11
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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