N/A
Completed N=65
Engaging Families to Improve the Care of Patients With Hypospadias
Source: ClinicalTrials.gov NCT05056311 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Percent of Eligible Parents Screened (Feasibility) — 90.5 percentage of parents recruited
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Eligible Parents Screened (Feasibility) |
90.5 | — |
| PRIMARY Percent of Eligible Parents Enrolled (Feasibility) |
48.5 | — |
| PRIMARY Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability) |
0; 4; 38; 7; 5; 1 | — |
| PRIMARY Percentage of Parents Retained in the Study (Feasibility) |
42.2 | — |
| SECONDARY Mean Decisional Conflict Scale (DCS) Score at T1 and T2 |
35.97; 21.93 | 0.001 sig |
| SECONDARY Mean Decisional Conflict Scale (DCS) Score at T2 and T3 |
21.93; 8.78 | 0.001 sig |
| SECONDARY Mean Decision-Specific Knowledge Scores |
54.32; 75.62 | 0.001 sig |
| SECONDARY Mean Decisional Regret Scale Score |
25.0 | — |
| SECONDARY Hypospadias Treatment Preference by Category at T1 and T2 |
31; 2; 31; 27; 2; 25 | 0.0001 sig |
| SECONDARY Hypospadias Treatment Preference by Category at T2 and T3 |
27; 25; 2; 18; 1; 10 | 0.6374 |
| SECONDARY Awareness of Decision by Category at T1 and T2 |
37; 6; 21; 34; 0; 20 | — |
| SECONDARY Awareness of Decision by Category at T2 and T3 |
34; 20; 0; 20; 1; 8 | — |
| SECONDARY Mean Shared Decision Making Questionnaire Score |
82.5 | — |
| SECONDARY Mean Preparation for Decision Making Score |
82.6 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- As target enrollment groups are filled, parents may be excluded in order to achieve a balanced sample, e.g. exclusion of mothers/female caregivers.
Data sourced from ClinicalTrials.gov (NCT05056311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.