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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: A Stepped Wedge Cluster Randomized Trial (PULSE)

12. maj 2026 opdateret af: Sannya Hede, MD, Driscoll Children's Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

300

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Texas
      • San Antonio, Texas, Forenede Stater, 78251
        • Driscoll Children's Cardiology Clinic- San Antonio
        • Ledende efterforsker:
          • Sannya Hede, MD
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group A: Murmur, Chest Pain
Educational video topic: Murmur, Chest Pain
Andet: Room-based educational video: 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
Andet: Room-based educational video: 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
Andet: Room-based educational video: Sports Clearance, Kawasaki, General
Video topics will be matched to patient referral reason: Sports Clearance, Kawasaki, General

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
Shared decision-making quality
Tidsramme: During the 12 months of study interventions.
CollaboRATE score, 0-100
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Driscoll Children's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. maj 2026

Primær færdiggørelse (Anslået)

1. maj 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • DCHIRB-FY2026-11

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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