Clinical trial NCT05908110: Evidence-based Pediatric Obstructive Sleep Apnea Detection
Official title: The Role of Health Communication Messaging in Evidence-based Pediatric Obstructive Sleep Apnea Detection
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obstructive Sleep Apnea of Child
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Eskenazi Health
First posted: 2023-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to: 1) intervention (seeing a health communication message about OSA) or 2) Usual care.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to test whether a health communication message (infographic about obstructive sleep apnea; OSA) seen by parents whose children have OSA symptoms will be helpful in identifying children with OSA. The main questions it aims to answer are:

* Will parents who see this health communication message be more likely to talk to their child's health care provider about OSA?
* Does the use of a health communication message help health care systems identify more children with OSA?

Participants are parents and children who are patients in a specific health care center. As part of clinical care, parents will answer screening questions about OSA symptoms (e.g., snoring, sleepiness) before their child's primary care visit. If their child has OSA symptoms, the health care provider will receive an alert suggesting further evaluation and possible referral for a sleep study or to a specialist.

In this study, children with OSA symptoms whose parents answer screening questions will be randomized to one of two conditions: 1) Health communication message (parent sees message before their child's visit with a primary care provider); or 2) Usual care (no information about OSA or their child's risk).

Researchers will compare groups to see if the health communication message helps identify more children with OSA.

Detailed description: Many children with obstructive sleep apnea (OSA) are not identified and thus do not receive treatment. In a previous study, the investigators found that a clinical decision support system helped primary care providers (PCPs) identify children with obstructive sleep apnea (OSA). In this system, parents of children report on possible OSA symptoms (e.g., snoring, sleepiness) in their child before the visit. If the child has OSA symptoms, the PCP receives an alert during the visit recommending further evaluation and a possible referral for a sleep study or to see a specialist. While this system helped increase the number of children with OSA symptoms who received a referral, many children remained unidentified. The goal of this study is to see whether involving parents in the system can identify even more children.

In this study, the investigators propose to test the impact of a health communication message, designed to educate and activate parents about their child's risk for OSA. This message is an infographic that helps parents recognize nighttime symptoms of OSA and how these nighttime symptoms may be impacting their child during the day. If a child has OSA symptoms, parents would view this infographic before their child's PCP visit and could discuss OSA with their child's PCP. For children with OSA symptoms, their parents will be randomized to either: 1) view the health communication message, or; 2) usual care, in which parents are not given any additional information about OSA or their child's risk prior to the appointment. In both cases, PCPs will receive a prompt indicating that the child is at risk for OSA.

Eligibility criteria: Inclusion Criteria:

* Child ages 2.0-13.9 years at the time of OSA screening.
* Child is a primary care patient at Eskenazi Health
* Parent completed pre-visit questionnaire with OSA screening items
* Child screened positive for OSA (snoring \>= 3 nights/wk + 1 additional symptom)

Exclusion Criteria:

* Prior OSA diagnosis
* Prior OSA referral (ENT, PSG, Sleep medicine) in the past two years

Primary outcomes:
measure: Rate of Completed OSA referral
timeFrame: Up to 9 months after study entry (date of positive OSA screen)
Secondary outcomes:
measure: Rate of OSA referral
timeFrame: Up to 3 months after study entry (date of positive screen)
measure: Rate of Evidence-based Evaluation
timeFrame: Up to 3 months after study entry (date of positive screen)
measure: Rate of OSA Diagnosis
timeFrame: Up to 9 months after study entry (date of positive screen)
measure: Rate of OSA Treatment
timeFrame: Up to 12 months after study entry (date of positive screen)
measure: Rate of Parent Activation
timeFrame: Immediately after intervention (viewing the Health Communication Message)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
References: