# A type I hybrid effectiveness-implementation study of a parent-centered tool to promote shared decision-making in hypospadias care

> **NIH NIH R01** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2024 · $685,747

## Abstract

SUMMARY/ABSTRACT
Hypospadias, a urethral opening on the underside of the penis, is one of the most common birth defects in
boys (1 in 250 newborns). Left untreated, hypospadias may affect quality of life, cosmetic appearance,
urination, sexual function, and fertility. Currently, parents must make this important, preference-sensitive
treatment decision with neither evidence-based guidance nor a clearly superior option. Consequently, 55-71%
of parents experience decisional regret regardless of whether they choose surgery which is strongly associated
with decisional conflict. We aim to reduce parental decisional conflict and regret by improving information
delivery through use of a shared decision-making (SDM) tool called the Hypospadias Hub. It was developed
and pilot-tested at two U.S. sites by our team. The objective of this proposal is to conduct a type 1 hybrid
effectiveness-implementation study of the Hypospadias Hub Intervention. Our two-arm randomized controlled
trial will assess its effectiveness to: 1) improve quality of SDM during hypospadias consultations as measured
by parent report (primary outcome), and observer report (secondary outcome), 2) decrease decisional conflict
and regret, and increase decision-relevant hypospadias knowledge (secondary outcomes). We will also assess
barriers and facilitators to its future implementation. Our aims are 1. Compare the effect of the Hypospadias
Hub Intervention vs. control on the quality of SDM (primary outcome). We will assess how providers
influence parents’ choices using qualitative content analysis of transcripts of the consultations. Parents will be
randomized to the respective arms of the study. Hypothesis: The quality of SDM during the consultation will be
higher in the intervention than the control group. 2. Compare the effect of the Hypospadias Hub
Intervention vs. control on decisional conflict, decision-relevant knowledge, and decisional regret
(secondary outcomes). Hypothesis: Decisional conflict and regret will be lower, and knowledge higher in the
intervention vs. control group. 3. Assess barriers and facilitators to future implementation using
constructs from the Consolidated Framework for Implementation Research. We will use qualitative
interviews with a diverse sample of parents, providers, nurses, and clinic staff to explore recommendations for
implementation, and potential future implementation strategies. Evidence of the effectiveness of the
Hypospadias Hub Intervention to improve quality of SDM and decision quality for parents making decisions
about hypospadias, combined with insights gained from our implementation assessment, will support wider
adoption, and inform development of tools for other preference-sensitive decisions, which will improve child
health and quality of life.

## Key facts

- **NIH application ID:** 10938970
- **Project number:** 1R01DK140178-01
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Samantha S Schilling
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $685,747
- **Award type:** 1
- **Project period:** 2024-08-22 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10938970

## Citation

> US National Institutes of Health, RePORTER application 10938970, A type I hybrid effectiveness-implementation study of a parent-centered tool to promote shared decision-making in hypospadias care (1R01DK140178-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10938970. Licensed CC0.

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