Evidence-based Diagnosis and Management of Pediatric Obstructive Sleep Apnea in Primary Care

NCT02781376 | Completed

• 2 other identifiers: 16031532802015
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive Sleep Apnea (OSA) is prevalent in children and adolescents and associated with a variety of negative consequences affecting health and cognitive functioning. While clinical guidelines outline effective strategies for the diagnosis and management of pediatric OSA, rates of screening, identification, and management in primary care settings remain low. The aim of the current study is to evaluate the use of a computer decision support system module (CHICA-OSA) designed to improve adherence to OSA guidelines in pediatric primary care clinics. All children ages 1-11 years will be screened for snoring and other symptoms of OSA in the waiting room prior to a visit to their primary care provider (PCP). In clinics randomly assigned to CHICA-OSA, caregivers of snoring children will report on additional OSA symptoms, and PCPs will receive automated prompts in the electronic health record (EHR) to provide evidence-based evaluation and appropriate referral for testing. For children sent for polysomnography (PSG), PCPs will receive automated prompts to reassess symptoms at the next visit. We hypothesize that clinics using CHICA-OSA will have better adherence to guidelines, as evidenced by higher rates of identifying OSAS, referral for PSG, and re-assessment following treatment.

Conditions

Obstructive Sleep Apnea

Keywords

Primary Care; Computer Decision Support System; Guidelines; Snoring

Outcome Measures

Primary Outcomes (1)

• Rate of Appropriate Referral

  Appropriate referral is defined as children with snoring and at least one additional OSA sign or symptom who were referred by the PCP to PSG, ENT, or Sleep Specialist. The number of appropriate referrals will be divided by the number of children identified by the CHICA system as snoring. This outcome will be compared between control and intervention clinics.

  Within 6 months of the date at which snoring was first identified

Secondary Outcomes (3)

• Rate of Confirmed OSA

  Day of the PSG (assessed through study completion, up to 18 months)

• Rate of Completed PSG

  Within 6 months of the date child was refered for PSG

• Rate of Assessment for Residual OSA

  Within 3 months of the first visit to the PCP after initiation of OSA treatment

Study Arms (2)

CHICA-OSA

EXPERIMENTAL

Two clinics will be randomized to receive the advanced CHICA-OSA computer decision support system designed to support PCPs in evidence-based identification and management of pediatric OSA. This module includes a snoring identification component (received by the control group).

Other: CHICA OSA

Control

OTHER

Two clinics will be randomized to receive a control computer decision support system module that automates screening for snoring and alerts the PCP, but does not provide any additional guidance on evidence-based diagnosis or management.

Other: Snoring Identification Only

Interventions

CHICA OSA OTHER

Computer decision support system module that assesses snoring, assesses additional OSA symptoms, provides guideline-based recommendation to PCPs, and reassesses for residual OSA symptoms.

CHICA-OSA

Snoring Identification Only OTHER

Computer decision support system module that assesses snoring and alerts the PCP when caregivers endorse snoring.

Control

Eligibility Criteria

• Age: 1 Year - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 1-11 years seen at one of four participating primary care clinics in Indianapolis, Indiana.
• Caregiver completes screening items.

You may not qualify if:

• None

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator
• American Academy of Sleep Medicine: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• Honaker SM, Street A, Daftary AS, Downs SM. The Use of Computer Decision Support for Pediatric Obstructive Sleep Apnea Detection in Primary Care. J Clin Sleep Med. 2019 Mar 15;15(3):453-462. doi: 10.5664/jcsm.7674.

  PMID: 30853049 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Snoring

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sarah M Honaker, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: May 16, 2016
• First Posted: May 24, 2016
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)