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 (PULSE)
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Sannya Hede, MD
- Numero di telefono: 361-694-5000
- Email: sannya.hede@dchstx.org
Backup dei contatti dello studio
- Nome: Erin Richmond, MS, RN
- Numero di telefono: 361-694-5978
- Email: erin.richmond@dchstx.org
Luoghi di studio
-
-
Texas
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San Antonio, Texas, Stati Uniti, 78251
- Driscoll Children's Cardiology Clinic- San Antonio
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Investigatore principale:
- Sannya Hede, MD
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Contatto:
- Erin Richmond, MS, RN
- Numero di telefono: 361-694-5978
- Email: erin.richmond@dchstx.org
-
Contatto:
- Sannya V Hede, MD
- Numero di telefono: 361-694-5000
- Email: sannya.hede@dchstx.org
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Group A: Murmur, Chest Pain
Educational video topic: Murmur, Chest Pain
|
Video topics will be matched to patient referral reason: Murmur, Chest Pain
|
|
Comparatore attivo: Group B: Syncope, Palpitations
Educational video topic: Syncope, Palpitations
|
Video topics will be matched to patient referral reason: Syncope, Palpitations
|
|
Comparatore attivo: 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
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Physician encounter time (minutes)
Lasso di tempo: During the 12 months of study interventions.
|
Measured from physician room entry to exit via EHR timestamps or direct observation.
|
During the 12 months of study interventions.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Clinic throughput
Lasso di tempo: 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.
|
|
Shared decision-making quality
Lasso di tempo: During the 12 months of study interventions.
|
CollaboRATE score, 0-100
|
During the 12 months of study interventions.
|
|
Family knowledge
Lasso di tempo: During the 12 months of study interventions.
|
5-item condition-specific quiz
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During the 12 months of study interventions.
|
|
Patient satisfaction
Lasso di tempo: During the 12 months of study interventions.
|
single-item 5-point scale
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During the 12 months of study interventions.
|
|
Physician satisfaction
Lasso di tempo: During the 12 months of study interventions.
|
brief post-session survey
|
During the 12 months of study interventions.
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- DCHIRB-FY2026-11
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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