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PULSE - Patient Understanding and Learning Through Structured Education - Effectiveness and Implementation of Patient Education Videos in a New Pediatric Cardiology Clinic (PULSE)

26. august 2026 oppdatert av: Sannya Hede, MD, Driscoll Children's Hospital

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.

Studieoversikt

Detaljert beskrivelse

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

Studietype

Intervensjonell

Registrering (Antatt)

300

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Texas
      • San Antonio, Texas, Forente stater, 78251
        • Rekruttering
        • Driscoll Children's Cardiology Clinic- San Antonio
        • Hovedetterforsker:
          • Sannya Hede, MD
        • Ta kontakt med:
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Group A: Murmur, Chest Pain
Educational video topic: Murmur, Chest Pain
Video topics will be matched to patient referral reason: Murmur, Chest Pain
Aktiv komparator: Group B: Syncope, Palpitations
Educational video topic: Syncope, Palpitations
Video topics will be matched to patient referral reason: Syncope, Palpitations
Aktiv komparator: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Physician encounter time (minutes)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Clinic throughput
Tidsramme: 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
Tidsramme: During the 12 months of study interventions.
5-item condition-specific quiz
During the 12 months of study interventions.
Patient satisfaction
Tidsramme: During the 12 months of study interventions.
single-item 5-point scale
During the 12 months of study interventions.
Physician satisfaction
Tidsramme: During the 12 months of study interventions.
brief post-session survey
During the 12 months of study interventions.
Shared decision-making quality
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. august 2026

Primær fullføring (Antatt)

1. mai 2027

Studiet fullført (Antatt)

1. desember 2027

Datoer for studieregistrering

Først innsendt

11. mai 2026

Først innsendt som oppfylte QC-kriteriene

12. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

At this time, results of the study are unknown and whether patients will feel comfortable sharing their experiences must first be determined.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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