Clinical trial NCT06832280: Improving Parental Support in Hypospadias Care
Official title: Improving Parental Support in Hypospadias Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypospadias
Keywords: Hypospadias
Pediatric Urologists
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Indiana University
First posted: 2025-02-18
Enrollment: 324
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study team will use block randomization (i.e., four treatment assignments per block) to assign participants to the intervention or control group, stratifying by study site. The full description of the invention vs control arms will be registered after data collection is completed to preserve the scientific integrity of the study.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The proposed study will enroll parent-child pairs and is designed to obtain new knowledge and improve hypospadias care. Parent-child pairs will be randomized into different groups over 36 months and participate for at least 6 months.

Detailed description: The proposed study will approach and enroll parent-child dyads to receive one of two educational websites about hypospadias, a condition that their child may have. The parents will be approached and consented before their initial consultation with a pediatric urologist regarding hypospadias. The child may have one or two consultation visits with the pediatric urologist. Before the first consultation, the parents will be asked about their current hypospadias knowledge, questions about how they typically interact with doctors, comfort with information presented in a healthcare setting and demographics and then receive access to one of the educational websites. After reviewing the website, the parent will complete a pre-consultation survey asking about hypospadias knowledge and other items. The 1 or 2 urology clinic consultation visits then occur and are optionally audio recorded. After the consultation visit, if the child was found to have no evidence of hypospadias, the child may no longer meet eligibility criteria for the study and may be asked to complete one final telephone call. If the child was otherwise diagnosed with hypospadias, after the final urology consultation visit, a study team member will perform the post consultation phone call, which consists of questions regarding hypospadias knowledge, care management options, and the treatment chosen. Parents may also be asked to complete an additional phone call regarding any challenges experienced with the website and suggestions for improvement. The final follow up phone call will be about 6 months after the treatment decision has been made and will again discuss the treatment option chosen, now that some time has passed.

Pediatric urologists from the two study sites will be asked permission to record their clinic consultations, if the participant family agrees as well.\*

\*To preserve scientific integrity certain details of the record are not included in the registration, and will be added to the record after the relevant data are gathered.

Eligibility criteria: Inclusion Criteria

A parent must meet all of the following criteria to be included:

* Age ≥ 18 years old
* Fluent and literate in English or Spanish
* Parent or legal guardian
* Ability to consent
* One eligible parent per child
* Plan to attend urology consultation
* Has access to a smart phone, tablet, or computer with reliable internet access
* Has the ability and agrees to receive unencrypted communications by text or email

A child must meet all of the following criteria to be included:

* 0-5 years old at the time of urology consultation
* Referred to a urologist participating in the study for a new potential diagnosis of hypospadias

Exclusion Criteria

If a parent meets any of the following criteria they will be excluded:

* Previous participant in hypospadias study
* Parent has another child with hypospadias or father of the child has a known history of hypospadias
* Parent is unaware of any penile abnormality with child
* Investigator discretion

If a child meets any of the following criteria they will be excluded:

* Prior hypospadias surgery
* Initial hypospadias urology consult scheduled less than a week away from when the patient was identified

Primary outcomes:
measure: Mean primary outcome measure 1 score (to be disclosed after final subject completes T3 data collection)*
timeFrame: Post-clinic visit, 1-30 days after the final clinic visit (T3)
measure: Mean primary outcome measure 2 score among 50% of participants (to be disclosed after final subject completes T3 data collection)**
timeFrame: Clinic visit(s), 3-60 days after enrollment (T2a) and up to 12 months after the first clinic visit (T2b). Note some patients will only have T2a.
Secondary outcomes:
measure: Mean visit duration among 50% of participants
timeFrame: Clinic visit(s), 3-60 days after enrollment (T2a) and up to 12 months after the first clinic visit (T2b). Note some patients will only have T2a.
measure: Mean change in Low Literacy Decisional Conflict Scale (DCS-LL) scores (T1-T0, T3-T0, and T3-T1)
timeFrame: Baseline, 3-60 days before the first clinic visit (T0) Pre-clinic visit, 1-7 days before the first clinic visit (T1) Post-clinic visit, 1-30 days after the final clinic visit (T3)
measure: Mean change in Hypospadias Knowledge Assessment scores (T1-T0, T3-T0, and T3-T1)
timeFrame: Baseline, 3-60 days before the first clinic visit (T0) Pre-clinic visit, 1-7 days before the first clinic visit (T1) Post-clinic visit, 1-30 days after the final clinic visit (T3)
measure: Mean score on Decisional Regret Scale
timeFrame: Follow-up (T4): 150-210 days post-final clinic visit in non-surgery patients;150-210 days postoperatively in surgery patients. Because surgery may occur up to 18 months after the last clinic visit, not all participants will complete T4 before study end
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Chapel Hill
name: Samantha Schilling, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: