Engaging Families to Improve the Care of Patients With Hypospadias
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Percent of Eligible Parents Screened (Feasibility)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 5 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •As target enrollment groups are filled, parents may be excluded in order to achieve a balanced sample, e.g. exclusion of mothers/female caregivers.
结局指标
主要结局
Percent of Eligible Parents Screened (Feasibility)
时间窗: Baseline (T1)
Recruitment is defined as the number of potential participants who are eligible divided by the total number screened multiplied by 100.
Percent of Eligible Parents Enrolled (Feasibility)
时间窗: Baseline (T1)
The number of parents enrolled divided by the total number of parents who were eligible multiplied by 100.
Decision Aid Acceptability by Categories of Information, Length, Clarity, and Balance (Acceptability)
时间窗: Pre-consultation, 1 week after baseline (T2)
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.
Percentage of Parents Retained in the Study (Feasibility)
时间窗: T1 to T4, a total of approximately 6 months
Number of parents who completed the study divided by the number of eligible parents enrolled who completed the study multiplied by 100.
次要结局
- Hypospadias Treatment Preference by Category at T1 and T2(Baseline (T1), Pre-consultation, 1 week after baseline (T2))
- Awareness of Decision by Category 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 Shared Decision Making Questionnaire Score(Initial post-consultation, within 48 hours of urology visit (T3))
- Mean Decisional Conflict Scale (DCS) Score at T1 and T2(Baseline (T1), Pre-consultation, 1 week after baseline (T2))
- 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 T2 and T3(Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3))
- Awareness of Decision by Category at T2 and T3(Pre-consultation, 1 week after baseline (T2), Initial post-consultation, within 48 hours of urology visit (T3))
- Mean Preparation for Decision Making Score(Pre-consultation, 1 week after baseline (T2))