PULSE - Patient Understanding and Learning Through Structured Education - Effectiveness and Implementation of Patient Education Videos in a New Pediatric Cardiology Clinic (PULSE)
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.
調査の概要
状態
詳細な説明
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
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Sannya Hede, MD
- 電話番号：361-694-5000
- メール：sannya.hede@dchstx.org
研究連絡先のバックアップ
- 名前：Erin Richmond, MS, RN
- 電話番号：361-694-5978
- メール：erin.richmond@dchstx.org
研究場所
-
-
Texas
-
San Antonio、Texas、アメリカ、78251
- 募集
- Driscoll Children's Cardiology Clinic- San Antonio
-
主任研究者：
- Sannya Hede, MD
-
コンタクト：
- Erin Richmond, MS, RN
- 電話番号：361-694-5978
- メール：erin.richmond@dchstx.org
-
コンタクト：
- Sannya V Hede, MD
- 電話番号：361-694-5000
- メール：sannya.hede@dchstx.org
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Group A: Murmur, Chest Pain
Educational video topic: Murmur, Chest Pain
|
Video topics will be matched to patient referral reason: Murmur, Chest Pain
|
|
アクティブコンパレータ：Group B: Syncope, Palpitations
Educational video topic: Syncope, Palpitations
|
Video topics will be matched to patient referral reason: Syncope, Palpitations
|
|
アクティブコンパレータ：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Physician encounter time (minutes)
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinic throughput
時間枠：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
時間枠：During the 12 months of study interventions.
|
5-item condition-specific quiz
|
During the 12 months of study interventions.
|
|
Patient satisfaction
時間枠：During the 12 months of study interventions.
|
single-item 5-point scale
|
During the 12 months of study interventions.
|
|
Physician satisfaction
時間枠：During the 12 months of study interventions.
|
brief post-session survey
|
During the 12 months of study interventions.
|
|
Shared decision-making quality
時間枠：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.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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