Infant Night Wakings in Pediatric Primary Care

Insomnia Clinical Trial

Official title:

Management of Infant Night Wakings in Pediatric Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02780596
• Other study ID #: 1506090982
• Secondary ID: N109471
• Status: Completed
• Phase: N/A
• First received: May 16, 2016
• Last updated: February 16, 2018
• Start date: February 2016
• Est. completion date: November 2017

Study information

• Verified date: February 2018
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3501
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Months to 20 Months

Eligibility

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:

Related Conditions & MeSH terms

• Insomnia
• Night Wakings

Intervention

Other:
• Item1
Does CHILD NAME often wake one or more times during the night?
• Item2
Does CHILD NAME often wake one or more times per night, and does and adult go to him/her?
• Item3
Do you think CHILD'S SLEEP is a problem?
• Item4
Do you think CHILD NAME has a sleep problem?
• Item5
Do you have any concerns about CHILD NAME'S sleep?

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana University Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Problematic infant night wakings (per validated questionnaire)	Identifying the individual item or combination of two items that most strongly predict a positive score on the Infant Sleep Questionnaire	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).
Secondary	Problematic infant night wakings (per provider clinical judgment)	Identifying the individual item or combination of two items that most strongly predict a provider endorsement of a sleep problem	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).
Secondary	Night wakings management (per caregiver report)	Descriptive and qualitative responses from the caregiver phone interview. Variables of interest include 1) caregiver description of provider recommendations to address night wakings; 2) caregiver perception of these recommendations; 3) outcome of the recommended action.	Within two weeks after the visit to the primary care provider