A type I hybrid effectiveness-implementation study of a parent-centered tool to promote shared decision-making in hypospadias care
Martin Kaefer, MD
Primary Investigator
Brief description of study
What is the purpose of this study?
Aim 1. Compare the effect of the Hypospadias Hub Intervention vs. control on the quality of SDM. Aim 2. Compare the effect of the Hypospadias Hub Decision Support Intervention vs. control on decisional conflict, decision-relevant knowledge, and decisional regret. Aim 3. Assess barriers and facilitators to future implementation using constructs from the Consolidated Framework for Implementation Research.
Detailed description of study
What will happen during the study?
Parents (n=324) from two pediatric urology practices will be randomized 1:1 to receive the Hypospadias Hub intervention or control (i.e., a basic website about hypospadias) before the urology consultation, stratifying by site.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Hypospadias, Riley
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Age: 100 years or below
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Gender: All
Inclusion criteria:
Parent-Child Dyad Cohort
A parent must meet all of the following criteria:
Age ≥ 18 years old
Fluent and literate in English or Spanish
Parent or legal guardian
Ability to consent
One eligible parent per child
Plan to attend urology consultation
Has access to a smart phone, tablet, or computer with reliable internet access
Has the ability and agrees to receive unencrypted communications by text or email (message may include sensitive information)
A child must meet all of the following criteria:
0-5 years old at the time of urology consultation
Referred for a new potential diagnosis of hypospadias
Exclusion Criteria
Parent-Child Dyad Cohort
Previous participant in hypospadias decision aid study
- Parent has another child with hypospadias or father of the child has a known history of hypospadias
Parent is unaware of any penile abnormality with child
Investigator discretion
If a child meets any of the following criteria:
Prior hypospadias surgery
- Not a surgical candidate (due to other medical comorbidities; assessment performed at T2 chart abstraction, assessment can be performed earlier if evident prior to T2)
Initial hypospadias urology consult scheduled with Dr. Martin Kaefer [AL1] [AL2]
Initial hypospadias urology consult scheduled less than a week away from when the patient was identified
