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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 augusti 2026 uppdaterad 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.

Studieöversikt

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Beräknad)

300

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

    • Texas
      • San Antonio, Texas, Förenta staterna, 78251
        • Rekrytering
        • Driscoll Children's Cardiology Clinic- San Antonio
        • Huvudutredare:
          • Sannya Hede, MD
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Physician encounter time (minutes)
Tidsram: 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.

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 augusti 2026

Primärt slutförande (Beräknad)

1 maj 2027

Avslutad studie (Beräknad)

1 december 2027

Studieregistreringsdatum

Först inskickad

11 maj 2026

Först inskickad som uppfyllde QC-kriterierna

12 maj 2026

Första postat (Faktisk)

18 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

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Studerar en amerikansk FDA-reglerad produktprodukt

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