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)

May 12, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78251
        • Driscoll Children's Cardiology Clinic- San Antonio
        • Principal Investigator:
          • Sannya Hede, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: Murmur, Chest Pain
Educational video topic: Murmur, Chest Pain
Other: Room-based educational video: Murmur, Chest Pain
Video topics will be matched to patient referral reason: Murmur, Chest Pain
Active Comparator: Group B: Syncope, Palpitations
Educational video topic: Syncope, Palpitations
Other: Room-based educational video: Syncope, Palpitations
Video topics will be matched to patient referral reason: Syncope, Palpitations
Active Comparator: Group C: Sports Clearance, Kawasaki, General
Educational video topic: Sports Clearance, Kawasaki, General
Other: Room-based educational video: Sports Clearance, Kawasaki, General
Video topics will be matched to patient referral reason: Sports Clearance, Kawasaki, General

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the 12 months of study interventions.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the 12 months of study interventions.
Shared decision-making quality
Time Frame: During the 12 months of study interventions.
CollaboRATE score, 0-100
During the 12 months of study interventions.
Family knowledge
Time Frame: During the 12 months of study interventions.
5-item condition-specific quiz
During the 12 months of study interventions.
Patient satisfaction
Time Frame: During the 12 months of study interventions.
single-item 5-point scale
During the 12 months of study interventions.
Physician satisfaction
Time Frame: During the 12 months of study interventions.
brief post-session survey
During the 12 months of study interventions.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Driscoll Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DCHIRB-FY2026-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Education

Clinical Trials on Room-based educational video: Murmur, Chest Pain

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe