Infant Night Wakings in Pediatric Primary Care
Condition: Insomnia; Night Wakings
Study type: Interventional

Summary: 
      This study aims to:

        1. identify which single item or combination of two items perform best in identifying
           problematic infant night wakings and

        2. 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.
    

Detailed description: 
      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:

        1. pediatric guidelines encoded in Arden Syntax;

        2. a dynamic, scannable paper user interface; and

        3. 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.

      If a child is identified as possibly having a sleep disturbance (e.g., caregiver answered yes
      to one or two items), CHICA will prominently display this information on the physician
      worksheet, viewed during the office visit. The PCP will receive feedback (e.g, "CHILD NAME
      may have problematic night wakings") via the electronic health record. At this time,
      providers will not be given additional guidance about how to proceed. At the end of the
      visit, the provider will be asked to indicate whether or not a sleep problem was confirmed
      based on their clinical judgment.

      A sub-sample of caregivers whose primary care provider (PCP) confirmed a sleep problem will
      be contacted by phone within two weeks of the clinic visit and asked to complete an exit
      interview. Caregivers will be asked questions about their child's sleep, the content of the
      visit with their pediatrician that day (e.g., what the pediatrician recommended), their
      perceptions of those recommendations, and the outcome of those recommendations if they
      attempted them. Exit interviews will be conducted on an on-going basis until a sample of 100
      has been completed. Up to 600 families may be contacted in order to complete 100 interviews.

      Collaborators on this study include the following individuals:

      Stephen Downs, MD, Indiana University School of Medicine; Tamara Dugan MS, Indiana University
      School of Medicine; Amy Schwichtenberg, PhD, Purdue University; and Jodi Mindell, PhD; St.
      Joseph's University
    

Intervention name(s): Item1; Item2; Item3; Item4; Item5
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Does CHILD NAME often wake one or more times during the night?; Does CHILD NAME often wake one or more times per night, and does and adult go to him/her?; Do you think CHILD'S SLEEP is a problem?; Do you think CHILD NAME has a sleep problem?; Do you have any concerns about CHILD NAME'S sleep?
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Infant; Toddler; Primary Care