Improving Parental Support in Hypospadias Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Mean primary outcome measure 1 score (to be disclosed after final subject completes T3 data collection)*
研究概览
简要总结
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.
详细描述
The proposed study will approach and enroll parent-child dyads to receive one of two educational websites about hypospadias, a condition that their child has or may have. The parents will be approached and consented before their upcoming consultation with a pediatric urologist regarding hypospadias. The child may have one or more 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 urology consultation visit, the parent will complete a post consultation survey, 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 survey 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Certain members of the research team will also be masked.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Have an upcoming urology consult with an enrolled pediatric urologist regarding hypospadias
排除标准
- •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
- •A final hypospadias treatment decision has been made in discussion with a pediatric urologist
- •Investigator discretion
- •If a child meets any of the following criteria they will be excluded:
- •Prior hypospadias surgery
- •Upcoming hypospadias urology consult is less than five days away from when the patient was identified
研究组 & 干预措施
Enhanced Hypospadias Education
The parents randomized to this cohort will receive access to an educational website about hypospadias developed by the study team.
干预措施: Educational Website Developed by Study Team (Other)
Basic Hypospadias Education
Parents randomized into the control arm will receive access to a basic educational website about hypospadias.
干预措施: Basic Educational Website (Other)
结局指标
主要结局
Mean primary outcome measure 1 score (to be disclosed after final subject completes T3 data collection)*
时间窗: Post-clinic visit, 1-30 days after the final clinic visit (T3)
Measures primary outcome 1 construct. The total possible range of scores is from 1 to 6, where higher scores indicate more of the primary outcome 1 construct. \*To preserve scientific integrity certain details of the record are not included in the registration and will be added to the record after all primary outcome data have been gathered.
Mean primary outcome measure 2 score among 50% of participants (to be disclosed after final subject completes T3 data collection)**
时间窗: 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.
Clinic visits will be audio recorded and coded using primary outcome measure 2 to measure primary outcome 2 construct. The total possible range of scores is from 0 to 4, where higher scores indicate more of the primary outcome 2 construct. \*\*To preserve scientific integrity certain details of the record are not included in the registration and will be added to the record after all primary outcome data have been gathered.
次要结局
- Mean visit duration among 50% of participants(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.)
- Mean change in Hypospadias Knowledge Assessment scores (T1-T0, T3-T0, and T3-T1)(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))
- Mean score on Decisional Regret Scale(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)
- Mean change in Low Literacy Decisional Conflict Scale (DCS-LL) scores (T1-T0, T3-T0, and T3-T1)(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))