Evidence-based Diagnosis and Management of Pediatric Obstructive Sleep Apnea in Primary Care
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 1 - 11 |
| Updated: | 4/17/2018 |
| Start Date: | January 2017 |
| End Date: | December 2018 |
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.
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.
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
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
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:
We found this trial at
1
site
340 W 10th St #6200
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
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