Evidence-based Diagnosis and Management of Pediatric Obstructive Sleep Apnea in Primary Care
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

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.
    

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
    

Intervention name(s): CHICA OSA; Snoring Identification Only
Intervention type(s): Other; Other
Intervention description(s): Computer decision support system module that assesses snoring, assesses additional OSA symptoms, provides guideline-based recommendation to PCPs, and reassesses for residual OSA symptoms.; Computer decision support system module that assesses snoring and alerts the PCP when caregivers endorse snoring.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Primary Care; Computer Decision Support System; Guidelines; Snoring