Trials / Completed
CompletedNCT05056311
Engaging Families to Improve the Care of Patients With Hypospadias
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 65 (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- Male
- Age
- 0 Years – 5 Years
- Healthy volunteers
- Not accepted
Summary
Reconstructive surgery is advocated for most children with hypospadias, a condition in which the pee hold is not in the correct place on the penis, to prevent potentially serious cosmetic and functional problems. Parents faced with a decision about hypospadias repair encounter an irreversible choice with potentially lifelong consequences. Recent studies have identified decisional conflict (DC) and decisional regret (DR) as a significant problem for parents. Several recent guidelines on complex urologic topics suggest that shared decision-making (SDM) is the optimal approach. A pilot test of a decision aid website by parents potentially facing this decision will be conducted to measure pre- and post-outcomes, in order to develop a fuller understanding of how urologists can effectively provide parents with optimal decision support. Parents will answer questions via phone up to four time points, twice before (T1 and T2) and twice after seeing a urologist for a hypospadias referral (T3 and T4). If the urologist diagnoses hypospadias but recommends no surgery, the final data collection point will be three months after the urology visit. If the urologist recommends repair surgery, the final data collection point will be six months after surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Decision Aid Website | The (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery. |
Timeline
- Start date
- 2021-06-09
- Primary completion
- 2022-10-06
- Completion
- 2022-10-06
- First posted
- 2021-09-24
- Last updated
- 2023-08-30
- Results posted
- 2023-08-30
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05056311. Inclusion in this directory is not an endorsement.