CardiologyPULSENCT07594041
PULSE - Patient Understanding and Learning Through Structured Education - Effectiveness and Implementation of Patient Education Videos in a New Pediatric Cardiology Clinic
A study testing Room-based educational video: Murmur, Chest Pain, Room-based educational video: Syncope, Palpitations and Room-based educational video: Sports Clearance, Kawasaki, General in people with Cardiology and Pediatric Cardiac Surgery, run by Driscoll Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Cardiology, Pediatric Cardiac Surgery, Education
- What is being tested?
- Room-based educational video: Murmur, Chest Pain, Room-based educational video: Syncope, Palpitations and Room-based educational video: Sports Clearance, Kawasaki, General
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Emergency or urgent consultations
- Caregiver unable to read/understand English or Spanish
- Patient/family opts out of study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Driscoll Children's Cardiology Clinic- San Antonio
San Antonio, Texas, 78251
Sannya V Hede, MD, 361-694-5000, sannya.hede@dchstx.org
Erin Richmond, MS, RN, 361-694-5978, erin.richmond@dchstx.org
About this study
Official title: 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:
Read more
- 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.
Read the 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
- Conditions
- Cardiology, Pediatric Cardiac Surgery, Education, Patient Education, Shared Decision-making, Outpatient Clinics, Hospital
- Being tested
- Room-based educational video: Murmur, Chest Pain, Room-based educational video: Syncope, Palpitations, Room-based educational video: Sports Clearance, Kawasaki, General
- Keywords
- patient education, videos, outpatient, pediatric, cardiology, pediatric cardiology, shared decision making, outpatient clinic, implementation science
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Room-based educational video: Murmur, Chest PainOther
Video topics will be matched to patient referral reason: Murmur, Chest Pain
Room-based educational video: Syncope, PalpitationsOther
Video topics will be matched to patient referral reason: Syncope, Palpitations
Room-based educational video: Sports Clearance, Kawasaki, GeneralOther
Video topics will be matched to patient referral reason: Sports Clearance, Kawasaki, General
| Study group | Role | What they receive |
|---|---|---|
| Group A: Murmur, Chest Pain | Active comparator | Educational video topic: Murmur, Chest Pain Receives: Other: Room-based educational video: Murmur, Chest Pain |
| Group B: Syncope, Palpitations | Active comparator | Educational video topic: Syncope, Palpitations Receives: Other: Room-based educational video: Syncope, Palpitations |
| Group C: Sports Clearance, Kawasaki, General | Active comparator | Educational video topic: Sports Clearance, Kawasaki, General Receives: Other: Room-based educational video: Sports Clearance, Kawasaki, General |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician encounter time (minutes)
Measured from physician room entry to exit via electronic health record (EHR) timestamps or direct observation.
Measured: During the 12 months of study interventions.
Secondary outcomes (5)
Clinic throughput
Patients/session: Measured through timestamps (check-in, rooming, physician entry, discharge), visit type, referral reason and Provider schedules, patient volume
Measured: During the 12 months of study interventions.
Shared decision-making quality
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.
Measured: During the 12 months of study interventions.
Family knowledge
5-item condition-specific quiz
Measured: During the 12 months of study interventions.
Patient satisfaction
single-item 5-point scale
Measured: During the 12 months of study interventions.
Physician satisfaction
brief post-session survey
Measured: During the 12 months of study interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start27 Aug 2026
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Driscoll Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sannya Hede, MD, Driscoll Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594041
- Sponsor's protocol ID
- DCHIRB-FY2026-11
- Acronym
- PULSE
- Status last verified
- Aug 2026
- First submitted
- 11 May 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, results of the study are unknown and whether patients will feel comfortable sharing their experiences must first be determined.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07594041
- Acronym / sponsor ID
- PULSE / DCHIRB-FY2026-11
- Conditions
- Cardiology, Pediatric Cardiac Surgery, Education, Patient Education, Shared Decision-making, Outpatient Clinics, Hospital
- Keywords
- patient education, videos, outpatient, pediatric, cardiology, pediatric cardiology, shared decision making, outpatient clinic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Driscoll Children's HospitalUniversity, hospital or other
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Group A: Murmur, Chest Pain | Active comparator | Other: Room-based educational video: Murmur, Chest PainEducational video topic: Murmur, Chest Pain |
| Group B: Syncope, Palpitations | Active comparator | Other: Room-based educational video: Syncope, PalpitationsEducational video topic: Syncope, Palpitations |
| Group C: Sports Clearance, Kawasaki, General | Active comparator | Other: Room-based educational video: Sports Clearance, Kawasaki, GeneralEducational video topic: Sports Clearance, Kawasaki, General |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Emergency or urgent consultations
- Caregiver unable to read/understand English or Spanish
- Patient/family opts out of study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Room-based educational video: Murmur, Chest PainVideo topics will be matched to patient referral reason: Murmur, Chest Pain | Other | Group A: Murmur, Chest Pain |
| Room-based educational video: Syncope, PalpitationsVideo topics will be matched to patient referral reason: Syncope, Palpitations | Other | Group B: Syncope, Palpitations |
| Room-based educational video: Sports Clearance, Kawasaki, GeneralVideo topics will be matched to patient referral reason: Sports Clearance, Kawasaki, General | Other | Group C: Sports Clearance, Kawasaki, General |
Primary outcome
Physician encounter time (minutes)
Time frame: During the 12 months of study interventions.
Measured from physician room entry to exit via electronic health record (EHR) timestamps or direct observation.
5 secondary outcomes
Clinic throughput
Time frame: During the 12 months of study interventions.
Shared decision-making quality
Time frame: During the 12 months of study interventions.
Family knowledge
Time frame: During the 12 months of study interventions.
Patient satisfaction
Time frame: During the 12 months of study interventions.
Physician satisfaction
Time frame: During the 12 months of study interventions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No. At this time, results of the study are unknown and whether patients will feel comfortable sharing their experiences must first be determined.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Room-based educational video: Murmur, Chest Pain, Room-based educational video: Syncope, Palpitations and Room-based educational video: Sports Clearance, Kawasaki, General in people with Cardiology and Pediatric Cardiac Surgery, run by Driscoll Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sannya Hede, MD (361-694-5000, sannya.hede@dchstx.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician encounter time (minutes) (time frame: During the 12 months of study interventions.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.