Infant Night Wakings in Pediatric Primary Care

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

Inclusion Criteria:

- 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.

Exclusion Criteria: