Engaging Families to Improve the Care of Patients With Hypospadias

Completed · Not applicable

Conditions studied: Hypospadias

In brief

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.

Key facts

Study ID

NCT05056311

Run by

University of North Carolina, Chapel Hill

People needed

65

Starts

2021-06-09

Expected to finish

2022-10-06

Last updated by the study team

2023-08-30

Who can join

Age: any, up to 5. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• parents 18 years of age and older of sons with hypospadias, or a tentative hypospadias diagnosis, and/or referral to a urologist for hypospadias
• patient newborn up to age 5 years
• parent able to consent and do interview in English
• parent access to a reliable internet and smart phone, tablet, or computer to view the website
• child/patient scheduled to see a urologist, but must not have yet seen the urologist at the time of enrollment
• parent aware that there is an issue with child's pee hole
• parent planning to attend urology appointment

You may not qualify if…

• As target enrollment groups are filled, parents may be excluded in order to achieve a balanced sample, e.g. exclusion of mothers/female caregivers.

Where it is running

• Indiana University — Indianapolis, Indiana, United States
• UNC — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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