Management of Infant Night Wakings in Pediatric Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,501
- 试验地点
- 2
- 主要终点
- Problematic infant night wakings (per validated questionnaire)
研究概览
简要总结
This study aims to:
- identify which single item or combination of two items perform best in identifying problematic infant night wakings and
- describe current practices by pediatricians in addressing problematic infant night wakings.
Using a novel computer decision support system in several primary care clinics, caregivers accompanying their child to a health visit will be randomly assigned to receive two of five items assessing night wakings and/or sleep problems, followed by a validated questionnaire for infant night wakings. If caregiver responses to the items suggest a possible sleep problem, pediatricians will receive a prompt in the electronic health record identifying a possible infant sleep problem. A sub-sample of caregivers will then be interviewed regarding the content of the visit that day.
详细描述
Study investigators have developed a novel decision support system for implementing clinical guidelines in pediatric practices. CHICA (Child Health Improvement through Computer Automation) combines three elements:
- pediatric guidelines encoded in Arden Syntax;
- a dynamic, scannable paper user interface; and
- an HL7-compliant interface to existing electronic medical record systems.
The result is a system that both delivers "just-in-time" patient-relevant guidelines to physicians during the clinical encounter and accurately captures structured data from all who interact with it. Preliminary work with CHICA has demonstrated the feasibility of using the system to implement and evaluate clinical guidelines.
Investigators propose to expand CHICA to include surveillance and screening algorithms for problematic infant night wakings. While an eventual aim is to create and test specific management tools for addressing sleep problems, aims of the current study focus on 1) testing items for the identification of sleep disruption, and 2) identifying current management practices in pediatric primary care.
All caregivers of children between the ages of 5 and 20 months presenting to one of five primary care health clinics will be randomly assigned to receive two of five items pertaining to sleep on the prescreening form (PSF) that is currently administered as part of standard clinical care. Parents will have the option to respond "yes" or "no." Regardless of their responses on the pre-screener form, each parent will then receive a form containing ten items from the Infant Sleep Questionnaire (ISQ). Two combinations of items that are similar (Items 1/2 and Items 3/4) will not be presented together, resulting in 8 possible arms or combinations of items.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 5 Months 至 20 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant between the ages of 5 and 20 months (at the time of the visit)
- •Caregiver responds to questions on the prescreening form in the waiting room
- •Infant is a patient at one of five participating primary care health clinics in Indianapolis Indiana.
- •For participation in the phone interviews, caregiver speaks English.
排除标准
- 未提供
研究组 & 干预措施
Items1;3
Caregiver is randomly assigned to receive screening items 1 and 3. Item 1: Does CHILD NAME often wake one or more times during the night? Item 3: Do you think CHILD NAME's sleep is a problem?
干预措施: Item1 (Other)
Items1;3
Caregiver is randomly assigned to receive screening items 1 and 3. Item 1: Does CHILD NAME often wake one or more times during the night? Item 3: Do you think CHILD NAME's sleep is a problem?
干预措施: Item3 (Other)
Items1;4
Caregiver is randomly assigned to receive screening items 1 and 4. Item 1: Does CHILD NAME often wake one or more times during the night? Item 4: Does you think CHILD NAME has a sleep problem?
干预措施: Item1 (Other)
Items1;4
Caregiver is randomly assigned to receive screening items 1 and 4. Item 1: Does CHILD NAME often wake one or more times during the night? Item 4: Does you think CHILD NAME has a sleep problem?
干预措施: Item4 (Other)
Items1;5
Caregiver is randomly assigned to receive screening items 1 and 5. Item 1: Does CHILD NAME often wake one or more times during the night? Item 5: Do you have any concerns about CHILD NAME's sleep?
干预措施: Item1 (Other)
Items1;5
Caregiver is randomly assigned to receive screening items 1 and 5. Item 1: Does CHILD NAME often wake one or more times during the night? Item 5: Do you have any concerns about CHILD NAME's sleep?
干预措施: Item5 (Other)
Items2;3
Caregiver is randomly assigned to receive screening items 2 and 3. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 3: Do you think CHILD NAME's sleep is a problem?
干预措施: Item2 (Other)
Items2;3
Caregiver is randomly assigned to receive screening items 2 and 3. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 3: Do you think CHILD NAME's sleep is a problem?
干预措施: Item3 (Other)
Items2;4
Caregiver is randomly assigned to receive screening items 2 and 4. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 4: Does you think CHILD NAME has a sleep problem?
干预措施: Item2 (Other)
Items2;4
Caregiver is randomly assigned to receive screening items 2 and 4. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 4: Does you think CHILD NAME has a sleep problem?
干预措施: Item4 (Other)
Items2;5
Caregiver is randomly assigned to receive screening items 2 and 5. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 5: Do you have any concerns about CHILD NAME's sleep?
干预措施: Item2 (Other)
Items2;5
Caregiver is randomly assigned to receive screening items 2 and 5. Item 2: Does CHILD NAME often wake one or more times per night and does an adult go to him/her? Item 5: Do you have any concerns about CHILD NAME's sleep?
干预措施: Item5 (Other)
Items3;5
Caregiver is randomly assigned to receive screening items 3 and 5. Item 3: Do you think CHILD NAME's sleep is a problem? Item 5: Do you have any concerns about CHILD NAME's sleep?
干预措施: Item3 (Other)
Items3;5
Caregiver is randomly assigned to receive screening items 3 and 5. Item 3: Do you think CHILD NAME's sleep is a problem? Item 5: Do you have any concerns about CHILD NAME's sleep?
干预措施: Item5 (Other)
Items4;5
Caregiver is randomly assigned to receive screening items 4 and 5. Item 4: Does you think CHILD NAME has a sleep problem? Item 5: Do you have any concerns about CHILD NAME's sleep?
干预措施: Item4 (Other)
Items4;5
Caregiver is randomly assigned to receive screening items 4 and 5. Item 4: Does you think CHILD NAME has a sleep problem? Item 5: Do you have any concerns about CHILD NAME's sleep?
干预措施: Item5 (Other)
结局指标
主要结局
Problematic infant night wakings (per validated questionnaire)
时间窗: On the day of each visit to the PCP for the duration of the study (18 months) or until patient no longer meets eligibility (e.g. ages out).
Identifying the individual item or combination of two items that most strongly predict a positive score on the Infant Sleep Questionnaire
次要结局
- Problematic infant night wakings (per provider clinical judgment)(On the day of each visit to the PCP for the duration of the study (18 months) or until patient no longer meets eligibility (e.g. ages out).)
- Night wakings management (per caregiver report)(Within two weeks after the visit to the primary care provider)
研究者
Sarah Honaker
Assistant Professor of Pediatrics
Indiana University