- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02781376
Evidence-based Diagnosis and Management of Pediatric Obstructive Sleep Apnea in Primary Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Design: This study will use a cluster randomized control trial (RCT) over a two-year period in four pediatric community clinics affiliated with our institution. To minimize contamination, randomization will occur by clinic, with the individual patient as the unit of analysis. Four clinics are already matched in pairs to facilitate a balance of patient numbers and demographics, and a coin flip will determine which clinic pair will receive CHICA-OSA and which will serve as control clinics. The two control clinics also have the CHICA system in place but the only intervention pertaining to sleep will be a simple module that identifies snoring children. While receiving automated prompts to help identify snoring children, PCPs in control clinics will evaluate and manage OSA using their standard methods (i.e., treatment-as-usual).
Participants: Participants will include all children between the ages of 1 and 11 years presenting to their PCP to one of four pediatric community clinics located in Indianapolis, Indiana.
CHICA System: CHICA is comprised of: (1) a knowledge base of pediatric guideline rules; (2) a repository of patient data; (3) a tablet user interface; and (4) an interface to the existing electronic medical record system. The result is a system that both delivers "just-in-time" patient-relevant guidelines to PCPs during the clinical encounter and captures accurate structured data from all who interact with it. In the waiting room caregivers complete a prescreening form (PSF), available in English and Spanish, consisting of a series of twenty surveillance questions tailored to the child's age and past history. A positive response to a question may trigger additional follow-up questions. During the clinic visit, relevant feedback from caregiver responses and information about clinical guidelines are displayed prominently on a provider worksheet (PWS) in the electronic health record.
Visit 1. While in the waiting room, caregivers for all eligible children will respond to an item on the PSF as follows: "Does your child consistently snore 3 or more nights per week?" For caregivers in CHICA-OSA clinics, a "yes" response will trigger additional questions about signs and symptoms of OSA. Specific items corresponding to the symptoms will be taken from the Pediatric Sleep Questionnaire (PSQ19) and include observed apnea, snorts, gasps, daytime sleepiness, and other signs and symptoms listed in the AAP guideline paper. The PCP will then receive a PWS prompt listing signs and symptoms that apply to the child, based on either existing data in the electronic record (e.g., current ADHD diagnosis; overweight) or on caregiver responses to items assessed in the waiting room (e.g., observed apnea; daytime sleepiness). When evidence-based criteria are met, according to the 2012 American Academy of Pediatrics (AAP) guidelines, the PCP will be encouraged to refer the child (for a PSG, to a sleep specialist, or to an ENT).
In the control clinics, parents will complete a surveillance question about snoring, and PCPs will receive a generic prompt but will not receive any additional information about signs and symptoms or guidance on how to further evaluate or manage. For children in both the CHICA-OSA and control clinics, if a caregiver does not report snoring the item about snoring will be repeated one year later.
Subsequent Visits: At the next visit (sick or WCC), snoring will again be assessed as one of the health surveillance questions for all eligible children. However, children from the CHICA-OSA clinics who were referred for PSG at the previous visit will receive an additional item asking whether or not the child has had an adenotonsillectomy in the past year. If the child has not had this surgery the PCP will receive a prompt to assess the outcome of the original referral (e.g., PSG did not suggest OSA; PSG suggested OSA and surgery scheduled; PSG scheduled; adenotonsillectomy scheduled; family does not have appointment) and re-refer if appropriate. If a caregiver reports that a child has had a T&A and no longer snores, the PCP will not receive any additional prompts and snoring will be reassessed in two years. However, if a caregiver reports residual snoring after surgery, the provider will receive a prompt to refer for possible residual OSA.
Collaborators on this study include: Stephen Downs, MD, Indiana University School of Medicine; Ameet Daftary, MD, Indiana University School of Medicine; and Tamara Dugan, MS, Indiana University School of Medicine
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children between 1-11 years seen at one of four participating primary care clinics in Indianapolis, Indiana.
- Caregiver completes screening items.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CHICA-OSA
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).
|
Computer decision support system module that assesses snoring, assesses additional OSA symptoms, provides guideline-based recommendation to PCPs, and reassesses for residual OSA symptoms.
|
Other: Control
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.
|
Computer decision support system module that assesses snoring and alerts the PCP when caregivers endorse snoring.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Appropriate Referral
Time Frame: Within 6 months of the date at which snoring was first identified
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Confirmed OSA
Time Frame: Day of the PSG (assessed through study completion, up to 18 months)
|
Number of children receiving an confirmed OSA diagnosis (apnea hypopnea index 1.5 or greater) by PSG.
This number will be divided by the number of children referred to PSG through CHICA who completed a PSG.
Rate will be compared between the intervention and control clinics.
|
Day of the PSG (assessed through study completion, up to 18 months)
|
Rate of Completed PSG
Time Frame: Within 6 months of the date child was refered for PSG
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Number of completed PSGs amongst those referred for PSG through the CHICA system.
Rate will be compared between intervention and control clinics.
|
Within 6 months of the date child was refered for PSG
|
Rate of Assessment for Residual OSA
Time Frame: Within 3 months of the first visit to the PCP after initiation of OSA treatment
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Rate of provider documentation of screening for snoring amongst those receiving OSA treatment (e.g., adenotonsillectomy, nasal steroid spray).
|
Within 3 months of the first visit to the PCP after initiation of OSA treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sarah M Honaker, PhD, Indiana University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1603153280
- 2015 (American Sleep Medicine Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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