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

2026年8月26日 更新者:Sannya Hede, MD、Driscoll Children's Hospital

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.

研究概览

详细说明

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

研究类型

介入性

注册 (估计的)

300

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Texas
      • San Antonio、Texas、美国、78251
        • 招聘中
        • Driscoll Children's Cardiology Clinic- San Antonio
        • 首席研究员:
          • Sannya Hede, MD
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:随机化
  • 介入模型:顺序分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Group A: Murmur, Chest Pain
Educational video topic: Murmur, Chest Pain
Video topics will be matched to patient referral reason: Murmur, Chest Pain
有源比较器:Group B: Syncope, Palpitations
Educational video topic: Syncope, Palpitations
Video topics will be matched to patient referral reason: Syncope, Palpitations
有源比较器:Group C: Sports Clearance, Kawasaki, General
Educational video topic: Sports Clearance, Kawasaki, General
Video topics will be matched to patient referral reason: Sports Clearance, Kawasaki, General

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Physician encounter time (minutes)
大体时间:During the 12 months of study interventions.
Measured from physician room entry to exit via electronic health record (EHR) timestamps or direct observation.
During the 12 months of study interventions.

次要结果测量

结果测量
措施说明
大体时间
Clinic throughput
大体时间: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.
Family knowledge
大体时间:During the 12 months of study interventions.
5-item condition-specific quiz
During the 12 months of study interventions.
Patient satisfaction
大体时间:During the 12 months of study interventions.
single-item 5-point scale
During the 12 months of study interventions.
Physician satisfaction
大体时间:During the 12 months of study interventions.
brief post-session survey
During the 12 months of study interventions.
Shared decision-making quality
大体时间:During 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.
During the 12 months of study interventions.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月27日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年12月1日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月18日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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