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NCT Number: NCT07594041

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Room-based educational video: Murmur, Chest Pain

Other

Video topics will be matched to patient referral reason: Murmur, Chest Pain

Room-based educational video: Syncope, Palpitations

Other

Video topics will be matched to patient referral reason: Syncope, Palpitations

Room-based educational video: Sports Clearance, Kawasaki, General

Other

Video topics will be matched to patient referral reason: Sports Clearance, Kawasaki, General

Primary outcomes

  1. Physician encounter time (minutes)

    Time frame: During the 12 months of study interventions.

    Measured from physician room entry to exit via EHR timestamps or direct observation.

Secondary outcomes

  1. Clinic throughput

    Time frame: 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

  2. Shared decision-making quality

    Time frame: During the 12 months of study interventions.

    CollaboRATE score, 0-100

  3. Family knowledge

    Time frame: During the 12 months of study interventions.

    5-item condition-specific quiz

  4. Patient satisfaction

    Time frame: During the 12 months of study interventions.

    single-item 5-point scale

  5. Physician satisfaction

    Time frame: During the 12 months of study interventions.

    brief post-session survey

Study contacts

Contact information is provided by the study sponsor or research team.

Erin Richmond, MS, RN

CONTACT

[email protected]

361-694-5978

Sannya Hede, MD

CONTACT

[email protected]

361-694-5000

Sponsors and collaborators

Lead sponsor

Driscoll Children's Hospital

Other

Registry information

Acronym: PULSE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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