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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Physician encounter time (minutes)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Emergency or urgent consultations
- •Caregiver unable to read/understand English or Spanish
- •Patient/family opts out of study participation
研究组 & 干预措施
Group A: Murmur, Chest Pain
Educational video topic: Murmur, Chest Pain
干预措施: Room-based educational video: Murmur, Chest Pain (Other)
Group B: Syncope, Palpitations
Educational video topic: Syncope, Palpitations
干预措施: Room-based educational video: Syncope, Palpitations (Other)
Group C: Sports Clearance, Kawasaki, General
Educational video topic: Sports Clearance, Kawasaki, General
干预措施: Room-based educational video: Sports Clearance, Kawasaki, General (Other)
结局指标
主要结局
Physician encounter time (minutes)
时间窗: During the 12 months of study interventions.
Measured from physician room entry to exit via electronic health record (EHR) timestamps or direct observation.
次要结局
- Shared decision-making quality(During the 12 months of study interventions.)
研究者
Sannya Hede, MD
Physician- CPSST Cardiology Services
Driscoll Children's Hospital
