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Evidence-based Pediatric Obstructive Sleep Apnea Detection

Primary Purpose

Obstructive Sleep Apnea of Child

Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Health Communication Message
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obstructive Sleep Apnea of Child

Eligibility Criteria

2 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Health Communication Message

Usual Care

Arm Description

Parents will review a health communication message (infographic) informing them that their child has OSA symptoms, describing both nighttime and daytime OSA symptoms, and encouraging them to speak to their child's primary care provider at the scheduled visit if they observe symptoms in their child. Primary care providers will receive an alert that the child screened positive for OSA.

Like in the intervention group, parents will complete screening items and primary care providers will receive an alert if the child screens positive for OSA. However, parents randomized to this condition will not view the health communication message nor receive any information about OSA or their child's risk for OSA.

Outcomes

Primary Outcome Measures

Rate of Completed OSA referral
Rate of children who received and completed (e.g., attended appointment or sleep study) a referral for sleep-disordered breathing, amongst those who screened positive for OSA. Referrals to include: 1) polysomnogram; 2) ENT referral; or 3) sleep medicine referral.

Secondary Outcome Measures

Rate of OSA referral
Rate of children who received referral for sleep-disordered breathing, amongst whose who screened positive for OSA. Referrals to include: 1) polysomnogram; 2) ENT referral; or 3) sleep medicine referral.
Rate of Evidence-based Evaluation
Rate of child who received evidence-based evaluation for pediatric OSA, amongst those who screened positive for OSA. Evidence-based evaluation includes 1) OSA referral; 2) documented watchful waiting with follow-up plan; and/or 3) documentation of evaluation not consistent with sleep-disordered breathing.
Rate of OSA Diagnosis
Rate of children who received an OSA diagnosis (verified via polysomnogram; apnea hypopnea index >1.5), amongst those who screened positive for OSA.
Rate of OSA Treatment
Rate of children receiving OSA treatment, amongst those who screened positive for OSA. Treatment to include 1) surgical intervention; 2) CPAP; 3) dental device; and/or 4) medication.
Rate of Parent Activation
Rate of parents who report planning to speak with child's provider about OSA, amongst those who viewed the health communication message. This will be measured by parental response to an item asking if they plan to speak with their child's provider about OSA, presented at the time that the parent reviews the health communication message.

Full Information

First Posted
May 22, 2023
Last Updated
July 24, 2023
Sponsor
Indiana University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Eskenazi Health
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1. Study Identification

Unique Protocol Identification Number
NCT05908110
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Eskenazi Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Child

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned to: 1) intervention (seeing a health communication message about OSA) or 2) Usual care.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The primary care provider will receive the same alert for a positive OSA screen regardless of randomization condition. The primary outcome (OSA referral completion) will be extracted from the medical record by team members who are not aware of the child's randomization status.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health Communication Message
Arm Type
Experimental
Arm Description
Parents will review a health communication message (infographic) informing them that their child has OSA symptoms, describing both nighttime and daytime OSA symptoms, and encouraging them to speak to their child's primary care provider at the scheduled visit if they observe symptoms in their child. Primary care providers will receive an alert that the child screened positive for OSA.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Like in the intervention group, parents will complete screening items and primary care providers will receive an alert if the child screens positive for OSA. However, parents randomized to this condition will not view the health communication message nor receive any information about OSA or their child's risk for OSA.
Intervention Type
Behavioral
Intervention Name(s)
Health Communication Message
Intervention Description
The health communication message is a single infographic developed iteratively with input from stakeholders (parents and providers). This image informs the parent that their child may have OSA, lists common nighttime symptoms parents may observe (e.g., snoring, apnea) and common daytime symptoms (e.g., hyperactivity, sleepiness) that can result from OSA. Parents are then encouraged to speak to their child's primary care provider if they observe these symptoms in their child.
Primary Outcome Measure Information:
Title
Rate of Completed OSA referral
Description
Rate of children who received and completed (e.g., attended appointment or sleep study) a referral for sleep-disordered breathing, amongst those who screened positive for OSA. Referrals to include: 1) polysomnogram; 2) ENT referral; or 3) sleep medicine referral.
Time Frame
Up to 9 months after study entry (date of positive OSA screen)
Secondary Outcome Measure Information:
Title
Rate of OSA referral
Description
Rate of children who received referral for sleep-disordered breathing, amongst whose who screened positive for OSA. Referrals to include: 1) polysomnogram; 2) ENT referral; or 3) sleep medicine referral.
Time Frame
Up to 3 months after study entry (date of positive screen)
Title
Rate of Evidence-based Evaluation
Description
Rate of child who received evidence-based evaluation for pediatric OSA, amongst those who screened positive for OSA. Evidence-based evaluation includes 1) OSA referral; 2) documented watchful waiting with follow-up plan; and/or 3) documentation of evaluation not consistent with sleep-disordered breathing.
Time Frame
Up to 3 months after study entry (date of positive screen)
Title
Rate of OSA Diagnosis
Description
Rate of children who received an OSA diagnosis (verified via polysomnogram; apnea hypopnea index >1.5), amongst those who screened positive for OSA.
Time Frame
Up to 9 months after study entry (date of positive screen)
Title
Rate of OSA Treatment
Description
Rate of children receiving OSA treatment, amongst those who screened positive for OSA. Treatment to include 1) surgical intervention; 2) CPAP; 3) dental device; and/or 4) medication.
Time Frame
Up to 12 months after study entry (date of positive screen)
Title
Rate of Parent Activation
Description
Rate of parents who report planning to speak with child's provider about OSA, amongst those who viewed the health communication message. This will be measured by parental response to an item asking if they plan to speak with their child's provider about OSA, presented at the time that the parent reviews the health communication message.
Time Frame
Immediately after intervention (viewing the Health Communication Message)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will share data consistent with the requirements of the funder (NHLBI) and my institution.
IPD Sharing Time Frame
Deidentified data will be available 1 year after study completion for a period of 5 years.
IPD Sharing Access Criteria
By investigator request to the PI. Requesting investigator to submit description of research aims and analytic plan.

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Evidence-based Pediatric Obstructive Sleep Apnea Detection

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