The Role of Health Communication Messaging in Evidence-based Pediatric Obstructive Sleep Apnea Detection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Rate of Completed OSA referral
研究概览
简要总结
The goal of this clinical trial is to test whether a health communication message (infographic about obstructive sleep apnea; OSA) seen by parents whose children have OSA symptoms will be helpful in identifying children with OSA. The main questions it aims to answer are:
- Will parents who see this health communication message be more likely to talk to their child's health care provider about OSA?
- Does the use of a health communication message help health care systems identify more children with OSA?
Participants are parents and children who are patients in a specific health care center. As part of clinical care, parents will answer screening questions about OSA symptoms (e.g., snoring, sleepiness) before their child's primary care visit. If their child has OSA symptoms, the health care provider will receive an alert suggesting further evaluation and possible referral for a sleep study or to a specialist.
In this study, children with OSA symptoms whose parents answer screening questions will be randomized to one of two conditions: 1) Health communication message (parent sees message before their child's visit with a primary care provider); or 2) Usual care (no information about OSA or their child's risk).
Researchers will compare groups to see if the health communication message helps identify more children with OSA.
详细描述
Many children with obstructive sleep apnea (OSA) are not identified and thus do not receive treatment. In a previous study, the investigators found that a clinical decision support system helped primary care providers (PCPs) identify children with obstructive sleep apnea (OSA). In this system, parents of children report on possible OSA symptoms (e.g., snoring, sleepiness) in their child before the visit. If the child has OSA symptoms, the PCP receives an alert during the visit recommending further evaluation and a possible referral for a sleep study or to see a specialist. While this system helped increase the number of children with OSA symptoms who received a referral, many children remained unidentified. The goal of this study is to see whether involving parents in the system can identify even more children.
In this study, the investigators propose to test the impact of a health communication message, designed to educate and activate parents about their child's risk for OSA. This message is an infographic that helps parents recognize nighttime symptoms of OSA and how these nighttime symptoms may be impacting their child during the day. If a child has OSA symptoms, parents would view this infographic before their child's PCP visit and could discuss OSA with their child's PCP. For children with OSA symptoms, their parents will be randomized to either: 1) view the health communication message, or; 2) usual care, in which parents are not given any additional information about OSA or their child's risk prior to the appointment. In both cases, PCPs will receive a prompt indicating that the child is at risk for OSA.
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 (Care Provider, Investigator, Outcomes Assessor)
盲法说明
The primary care provider will receive the same alert for a positive OSA screen regardless of randomization condition. The primary outcome (OSA referral completion) will be extracted from the medical record by team members who are not aware of the child's randomization status.
入排标准
- 年龄范围
- 2 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child ages 2.0-13.9 years at the time of OSA screening.
- •Child is a primary care patient at Eskenazi Health
- •Parent completed pre-visit questionnaire with OSA screening items
- •Child screened positive for OSA (snoring >= 3 nights/wk + 1 additional symptom)
排除标准
- •Prior OSA diagnosis
- •Prior OSA referral (ENT, PSG, Sleep medicine) in the past two years
研究组 & 干预措施
Health Communication Message
Parents will review a health communication message (infographic) informing them that their child has OSA symptoms, describing both nighttime and daytime OSA symptoms, and encouraging them to speak to their child's primary care provider at the scheduled visit if they observe symptoms in their child. Primary care providers will receive an alert that the child screened positive for OSA.
干预措施: Health Communication Message (Behavioral)
Usual Care
Like in the intervention group, parents will complete screening items and primary care providers will receive an alert if the child screens positive for OSA. However, parents randomized to this condition will not view the health communication message nor receive any information about OSA or their child's risk for OSA.
结局指标
主要结局
Rate of Completed OSA referral
时间窗: Up to 9 months after study entry (date of positive OSA screen)
Rate of children who received and completed (e.g., attended appointment or sleep study) a referral for sleep-disordered breathing, amongst those who screened positive for OSA. Referrals to include: 1) polysomnogram; 2) ENT referral; or 3) sleep medicine referral.
次要结局
- Rate of Evidence-based Evaluation(Up to 3 months after study entry (date of positive screen))
- Rate of Parent Activation(Immediately after intervention (viewing the Health Communication Message))
- Rate of OSA referral(Up to 3 months after study entry (date of positive screen))
- Rate of OSA Diagnosis(Up to 9 months after study entry (date of positive screen))
- Rate of OSA Treatment(Up to 12 months after study entry (date of positive screen))
研究者
Sarah Honaker
Associate Professor of Pediatrics
Indiana University