Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07594041
Acronym
PULSE
Enrollment
300
Registered
2026-05-18
Start date
2026-08-27
Completion date
2027-12-01
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiology, Education, Outpatient Clinics, Hospital, Patient Education, Pediatric Cardiac Surgery, Shared Decision-making

Keywords

patient education, videos, outpatient, pediatric, cardiology, pediatric cardiology, shared decision making, outpatient clinic, implementation science

Brief summary

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.

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

Interventions

OTHERRoom-based educational video: Murmur, Chest Pain

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

OTHERRoom-based educational video: Syncope, Palpitations

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

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

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

Sponsors

Driscoll Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Intervention model description

In this stepped wedge design, the unit of randomization is the video topic group, not individual patients or clinic sessions. Since all patients will eventually receive the intervention (videos), what is being randomized is the order in which video topic groups are introduced across the study timeline. The order of video topic group introduction is randomized, not individual patients. Three video groups: * Group A: Murmur, Chest Pain * Group B: Syncope, Palpitations * Group C: Sports Clearance, General

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Physician encounter time (minutes)During the 12 months of study interventions.Measured from physician room entry to exit via electronic health record (EHR) timestamps or direct observation.

Secondary

MeasureTime frameDescription
Clinic throughputDuring 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
Shared decision-making qualityDuring 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.
Family knowledgeDuring the 12 months of study interventions.5-item condition-specific quiz
Patient satisfactionDuring the 12 months of study interventions.single-item 5-point scale
Physician satisfactionDuring the 12 months of study interventions.brief post-session survey

Countries

United States

Contacts

CONTACTSannya Hede, MD
sannya.hede@dchstx.org361-694-5000
CONTACTErin Richmond, MS, RN
erin.richmond@dchstx.org361-694-5978

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026