Engaging Families to Improve the Care of Patients With Hypospadias

NCT05056311 | Completed Results

• 2 other identifiers: 21-0146K23DK111987
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypospadias

Keywords

hypospadias; shared decision making; decisional regret; decision aid

Outcome Measures

Primary Outcomes (4)

• Percent of Eligible Parents Screened (Feasibility)

  Recruitment is defined as the number of potential participants who are eligible divided by the total number screened multiplied by 100.

  Baseline (T1)

• Percent of Eligible Parents Enrolled (Feasibility)

  The number of parents enrolled divided by the total number of parents who were eligible multiplied by 100.

  Baseline (T1)

• Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability)

  Acceptability of a decision aid refers to ratings regarding the comprehensibility of components of a decision aid, its length, clarity, amount of information, and balance in presentation of information about options. The tool has 4 questions with answers on a Likert scale ranging from 1-5 (length, amount of information, and balance) and 1-4 (clarity). A response of 3 is ideal for information, length, and balance and a response of 1 is ideal for clarity.

  Pre-consultation, 1 week after baseline (T2)

• Percentage of Parents Retained in the Study (Feasibility)

  Number of parents who completed the study divided by the number of eligible parents enrolled who completed the study multiplied by 100.

  T1 to T4, a total of approximately 6 months

Secondary Outcomes (10)

• Mean Decisional Conflict Scale (DCS) Score at T1 and T2

  Baseline (T1), Pre-consultation, 1 week after baseline (T2)

• Mean Decisional Conflict Scale (DCS) Score at T2 and T3

  Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3)

• Mean Decision-Specific Knowledge Scores

  Baseline (T1), Pre-consultation, 1 week after baseline (T2)

• Mean Decisional Regret Scale Score

  3-month post-consultation (T4)

• Hypospadias Treatment Preference by Category at T1 and T2

  Baseline (T1), Pre-consultation, 1 week after baseline (T2)

Study Arms (1)

Parent Utilization of Decision Aid Website

EXPERIMENTAL

All enrolled parents will view the decision aid website for as long and as frequently as they wish before the initial visit to the urologist.

Other: Decision Aid Website

Interventions

Decision Aid Website OTHER

The (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery.

Parent Utilization of Decision Aid Website

Eligibility Criteria

• Age: 0 Years - 5 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Indiana University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

UNC

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Hypospadias

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Elaine Cuevas
• Organization: Indiana University

elinder@iu.edu

317-278-7495

Study Officials

• Katherine Hubert Chan, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 24, 2021
• Study Start: June 9, 2021
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: August 30, 2023
• Results First Posted: August 30, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)