Communities Helping the Hearing of Infants by Reaching Parents: The CHHIRP Navigator Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,699
- 试验地点
- 4
- 主要终点
- Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)
研究概览
简要总结
Hearing loss is the most common sensory congenital disorder and this condition is diagnosable and treatable. Children that are born with hearing loss have to undergo several hearing tests to diagnose the condition and many families are delayed in receiving this testing or never obtain the needed testing. This research employs a new method for helping children with hearing loss receive timely care by using a patient navigator, who is someone who teaches and provides emotional/social support for the families of these children.
The hypothesis of this study is that a patient navigator will hasten the timing of pediatric audiological testing, improve compliance with scheduled appointments, and expand parental knowledge of pediatric hearing loss.
详细描述
For Specific Arm 1:
The investigators will (1) use a stepped-wedge trial design to deliver patient navigation (PN) sequentially in 10 state-funded Kentucky Commission for Children with Special Healthcare Needs (CCSHCN) (also referred to as the Office for Children with Special Healthcare needs or OCSHCN) clinics randomized to cross from usual care to PN in steps of 6-month intervals over the project period. Prior to initiation of PN at each clinic, the control condition will be the standard of care. The overall effectiveness of PN will be tested by comparing non-adherence rates during the PN condition to those during the standard of care condition. Simultaneously, the investigators will (2) assess preliminary implementation outcomes (i.e., acceptability, adoption, recruitment/retention, and fidelity) as well as multilevel factors influencing implementation of PN in each clinic.
For Specific Arm 2:
Patient navigators will not be used for all subjects at participating clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for parent-infant dyads:
- •Infant failed a hearing screening in one or both ears before postnatal hospital discharge
- •Infant was referred for follow-up diagnostic testing at one of the 10 participating CCSHCN clinics.
- •Parent able to speak either English or another language using Cyracom phone interpreting services.
排除标准
- •Children and parents live outside Kentucky or who will be moving out of Kentucky within the first three months of life.
研究组 & 干预措施
Navigator Arm
Examination of adherence to follow-up with a navigator.
干预措施: Navigator Guidance (Behavioral)
Non-Intervention Arm
Examination of adherence to follow-up without a navigator.
结局指标
主要结局
Number of Participants Who do Not Receive Diagnostic Audiological Testing (Aim 1)
时间窗: 3 months. (This is the amount of time from an abnormal screen at birth to an expected follow-up at a clinic or hospital.)
This outcome is the number of participants who do not follow-up at an OCSHCN Clinic for diagnostic audiologic testing after a failed newborn hearing screening from the date of randomization to 3 months after birth.
次要结局
未报告次要终点
研究者
Matthew Bush, MD
Assistant Professor
University of Kentucky