The REPOSE Navigation Intervention

Not Applicable

Not yet recruiting

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT06828835
• Lead Sponsor: Medical University of South Carolina

Brief Summary

This research study aims to find out the effect of REPOSE, a patient navigation intervention, on the receipt of equitable care among racially and ethnically diverse children with Sleep Disordered Breathing (SDB).

In the REPOSE intervention, a centralized patient navigator a) identifies and addresses dynamic individual barriers, b) provides resources and social support for parent-child dyads, and c) facilitates bidirectional SDB care coordination between clinical teams and parents to achieve evidence-based care.

This study will evaluate the effects of the REPOSE intervention on SDB care delivery and clinical process outcomes for racially diverse children by reducing barriers and increasing self-efficacy among parents.

Detailed Description

Sleep disordered breathing (SDB), defined as nocturnal respiratory disturbances ranging from snoring to severe obstructive sleep apnea, affects 12% children in the United States. The American Academy of Pediatrics recommends that all children be screened for snoring, and that those with symptoms or signs of SDB are further evaluated for medical treatment. Despite this recommendation, the rates for recognizing and screening SDB remain low. Black children are also 4-6 times more likely to have SDB but are less likely to undergo evaluation and to receive timely standard of care treatments to address their SDB. Untreated SDB is associated with significant health consequences including behavioral impairments, poor academic performance, and neurocognitive deficits. While evidence-based treatment is available, it is not accessible to all. Black children are 83% less likely than their White peers to attend consultations for SDB. A critical need exists for a theory-based intervention to reduce barriers to care for children with SDB.

Patient navigation is an evidence-based intervention that has been shown to improve screening, referral, and treatment in many health conditions and has high potential to be a culturally acceptable intervention to promote equity in the setting of racial disparities in SDB. Preliminary data informed the development of a novel, multilevel theory-based patient navigation intervention, Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE). In the REPOSE intervention, a centralized patient navigator a) identifies and addresses dynamic individual barriers, b) provides resources and social support for parent-child dyads, and c) facilitates bidirectional SDB care coordination between clinical teams and parents to achieve evidence-based care. In this hybrid type I effectiveness implementation study, the candidate will conduct a pilot randomized controlled trial (RCT) in which N=80 parent-child dyads will be randomized to REPOSE or usual care for SDB. The study team will examine the extent to which the REPOSE intervention improves rates of adherence to evidence-based guidelines among racially diverse children with SDB and changes in barrier resolution and self-efficacy among parents. In addition, barriers and facilitators to implementation will be evaluated as guided by the Consolidated Framework for Implementation Research (CFIR) with a focus on social determinants of health.

The findings of this randomized pilot trial will inform the design of a future fully powered RCT.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-11
• Last Update Submitted: 2025-02-11
• Study First Posted: 2025-02-14
• Last Update Posted: 2025-02-14
• Study Start: 2025-07-01
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Parents or caregivers (18 and older) of children who were referred by any primary care for SDB evaluation with sleep medicine or pediatric otolaryngology
• Patients 2.00 to 11.99 years old
• Parents with a working phone who are willing to participate in the study for a 12-month period after enrollment

Exclusion Criteria

• Patients already established with sleep medicine or otolaryngology which would bias ease of completing specialty evaluation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Completion of specialist evaluation	up to 12months	Binary, evaluation of SDB by completion of specialist consultation (e.g., sleep medicine, otolaryngologist) per AAP guidelines.

Secondary Outcome Measures

Name	Time	Method
Time from referral to specialist consultation	12months	Time in days from referral order to specialist evaluation (sleep medicine or otolaryngology).
Completion of PSG	12months	Binary, PSG (if ordered) was completed within 90 days of the order.
Time to PSG	12months	Time in days from PSG order to completion.
Receipt of treatment	12months	Binary, treatment completion within 60 days.
Time to treatment	12months	Time in days from initial consultation or from PSG results to recommended treatment.
SDB symptom severity	1-2 weeks following enrollment (T1), 12 months after enrollment (T3)	Pediatric Sleep Questionnaire-Sleep-Related Breathing Disorder (PSQ-SRBD) Scale is a 22-item scale which measures symptoms of obstructive sleep apnea including snoring, observed apneas, difficulty breathing during sleep, daytime sleepiness, inattentive or hyperactive behavior, and other pediatric obstructive sleep apnea features. The responses are 0 "No" and 1 "Yes". The instrument is scored by averaging the response on non-missing items. A score greater than 0.33 corresponds to a high risk for a pediatric sleep-related breathing disorder.
Quality of life	1-2 weeks following enrollment (T1), 12 months after enrollment (T3)	Sleep-specific quality of life; Obstructive Sleep Apnea (OSA-18) is an 18-item health-related quality of life survey to measure the quality- of-life impact for obstructive sleep apnea syndrome in children.
Barrier reduction	1-2 weeks following enrollment (T1), 12months	Proportion and types of barriers resolved.
Unresolved barriers	12months	Proportion of barriers unresolved by the navigator.
Self-efficacy	1-2 weeks following enrollment (T1), 6 months after enrollment (T2)	The NIH Toolbox Self-Efficacy Item Bank is a 10-item survey designed to assess the participant's belief in his or her capacity to manage problems and have control over meaningful events.