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Infant Night Wakings in Pediatric Primary Care

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02780596
First Posted: May 23, 2016
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Indiana University Health
Information provided by (Responsible Party):
Sarah Honaker, Indiana University
  Purpose

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.


Condition Intervention
Insomnia Night Wakings Other: Item1 Other: Item2 Other: Item3 Other: Item4 Other: Item5

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Management of Infant Night Wakings in Pediatric Primary Care

Further study details as provided by Sarah Honaker, Indiana University:

Primary Outcome Measures:
  • Problematic infant night wakings (per validated questionnaire) [ Time Frame: 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


Secondary Outcome Measures:
  • Problematic infant night wakings (per provider clinical judgment) [ Time Frame: 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 provider endorsement of a sleep problem

  • Night wakings management (per caregiver report) [ Time Frame: Within two weeks after the visit to the primary care provider ]
    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.


Estimated Enrollment: 1000
Actual Study Start Date: February 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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?
Other: Item1
Does CHILD NAME often wake one or more times during the night?
Other: Item3
Do you think CHILD'S SLEEP is a problem?
Experimental: 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?
Other: Item1
Does CHILD NAME often wake one or more times during the night?
Other: Item4
Do you think CHILD NAME has a sleep problem?
Experimental: 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?
Other: Item1
Does CHILD NAME often wake one or more times during the night?
Other: Item5
Do you have any concerns about CHILD NAME'S sleep?
Experimental: 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?
Other: Item2
Does CHILD NAME often wake one or more times per night, and does and adult go to him/her?
Other: Item3
Do you think CHILD'S SLEEP is a problem?
Experimental: 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?
Other: Item2
Does CHILD NAME often wake one or more times per night, and does and adult go to him/her?
Other: Item4
Do you think CHILD NAME has a sleep problem?
Experimental: 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?
Other: Item2
Does CHILD NAME often wake one or more times per night, and does and adult go to him/her?
Other: Item5
Do you have any concerns about CHILD NAME'S sleep?
Experimental: 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?
Other: Item3
Do you think CHILD'S SLEEP is a problem?
Other: Item5
Do you have any concerns about CHILD NAME'S sleep?
Experimental: 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?
Other: Item4
Do you think CHILD NAME has a sleep problem?
Other: Item5
Do you have any concerns about CHILD NAME'S sleep?

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   5 Months to 20 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02780596


Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Indiana University Health
Investigators
Principal Investigator: Sarah M Honaker, PhD Indiana University School of Medicine
  More Information

Responsible Party: Sarah Honaker, Assistant Professor of Pediatrics, Indiana University
ClinicalTrials.gov Identifier: NCT02780596     History of Changes
Other Study ID Numbers: 1506090982
N109471 ( Other Grant/Funding Number: Indiana University Health Values Grant )
First Submitted: May 16, 2016
First Posted: May 23, 2016
Last Update Posted: March 7, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sarah Honaker, Indiana University:
Infant
Toddler
Primary Care