Clinical trial NCT05056311: Engaging Families to Improve the Care of Patients With Hypospadias
Official title: Engaging Families to Improve the Care of Patients With Hypospadias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypospadias
Keywords: hypospadias
shared decision making
decisional regret
decision aid
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Indiana University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-09-24
Enrollment: 65
Sex: MALE
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.


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.

Primary outcomes:
measure: Percent of Eligible Parents Screened (Feasibility)
timeFrame: Baseline (T1)
measure: Percent of Eligible Parents Enrolled (Feasibility)
timeFrame: Baseline (T1)
measure: Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability)
timeFrame: Pre-consultation, 1 week after baseline (T2)
measure: Percentage of Parents Retained in the Study (Feasibility)
timeFrame: T1 to T4, a total of approximately 6 months
Secondary outcomes:
measure: Mean Decisional Conflict Scale (DCS) Score at T1 and T2
timeFrame: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
measure: Mean Decisional Conflict Scale (DCS) Score at T2 and T3
timeFrame: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
measure: Mean Decision-Specific Knowledge Scores
timeFrame: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
measure: Mean Decisional Regret Scale Score
timeFrame: 3-month post-consultation (T4)
measure: Hypospadias Treatment Preference by Category at T1 and T2
timeFrame: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
measure: Hypospadias Treatment Preference by Category at T2 and T3
timeFrame: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
measure: Awareness of Decision by Category at T1 and T2
timeFrame: Baseline (T1), Pre-consultation, 1 week after baseline (T2)
measure: Awareness of Decision by Category at T2 and T3
timeFrame: Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)
measure: Mean Shared Decision Making Questionnaire Score
timeFrame: Initial post-consultation, within 48 hours of urology visit (T3)
measure: Mean Preparation for Decision Making Score
timeFrame: Pre-consultation, 1 week after baseline (T2)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Chapel Hill
country: United States
facility: UNC
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Katherine Hubert Chan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: