The REPOSE (Reach for Equity in Pediatric Sleep Evaluation) Navigation Intervention

Testing a Strategy to Improve Diagnostic and Treatment Pathways for Children With Sleep-Disordered Breathing: the REPOSE Navigation Intervention

This research study aims to find out the effect of REPOSE, a patient navigation intervention, on the receipt of equitable care among children with a broad range of socioeconomic and rural/urban status 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 children with a broad range of socioeconomic and rural/urban status by reducing barriers and increasing self-efficacy among parents.

Study Overview

• Status: Recruiting
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Other: Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE); Other: Usual Care

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 children with a broad range of socioeconomic and rural/urban status 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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Phayvanh P Pecha, MD; Phone Number: 612-267-8739; Email: pechap@musc.edu
• Study Contact Backup: Name: Caroline B King, BS; Phone Number: 843-300-5600; Email: kingba@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Recruiting
      • Medical University of South Carolina
      • Contact: Caroline B King, BS; Phone Number: 8433005600; Email: kingba@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE); REPOSE is a theory-based patient navigation intervention to address multilevel barriers to timely diagnosis and treatment of obstructive sleep-disordered breathing.	Other: Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE); The REPOSE intervention consists of a centralized patient navigator who (1) identifies and addresses dynamic individual barriers, (2) provides support for parent-child dyads, and (3) facilitates bidirectional SDB care coordination between clinical teams and parents to achieve evidence-based care. The goals of the REPOSE intervention are to systematically address barriers to care, develop parental self-efficacy to enhance healthcare utilization (e.g., receipt of recommended care and adherence to evidence-based care), and to improve symptom severity and quality of life.
Other: Usual Care; The ordinary course of care.	Other: Usual Care; Usual care is defined by standard clinical care delivered without a protocolized intervention (e.g., the ordinary course of care).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from referral to specialist consultation	Time in days from referral order to specialist evaluation (sleep medicine or otolaryngology).	12months
Completion of PSG	Binary, PSG (if ordered) was completed within 90 days of the order.	12months
Time to PSG	Time in days from PSG order to completion.	12months
Receipt of treatment	Binary, treatment completion within 60 days.	12months
Time to treatment	Time in days from initial consultation or from PSG results to recommended treatment.	12months
SDB symptom severity	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.	1-2 weeks following enrollment (T1), 12 months after enrollment (T3)
Barrier reduction	Proportion and types of barriers resolved.	1-2 weeks following enrollment (T1), 12months
Unresolved barriers	Proportion of barriers unresolved by the navigator.	12months
Self-efficacy	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.	1-2 weeks following enrollment (T1), 6 months after enrollment (T2)
Quality of life impact for obstructive sleep apnea in children	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.	1-2 weeks following enrollment (T1), 12 months after enrollment (T3)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic factors	Sex, age, race, ethnicity, SES, education, employment, income, distance to medical facility, rural/urban residence, and insurance status.	Baseline (T0)
Clinical characteristics	Comorbidities, body mass index (percentile), and PSG parameters.	Baseline (T0), 12months
Social Support	The Interpersonal Support Evaluation List (ISEL-12) is a 12-item measure of perceptions of social support with three subscale scores representing appraisal, belonging, and tangible social support.	1-2 weeks following enrollment (T1), 6 months after enrollment (T2)
REPOSE Accrual Rate	REPOSE Accrual Rate is the proportion of eligible patients who enroll in REPOSE.	12months
REPOSE Attrition Rate	REPOSE Attrition Rate is the proportion of enrolled participants lost to follow-up over the study period.	12months
Navigator Caseload	Navigator Caseload is the number of simultaneous cases being navigated.	12months
Navigator Time Allocation (Direct)	Navigator Time Allocation (Direct) is the time (in minutes) that the navigator spends directly interacting with the patient to identify and address barriers to SDB care.	12months
Navigator Time Allocation (Indirect)	Navigator Time Allocation (Indirect) is the time (in minutes), that the navigator spends generating and enacting each Barrier Reduction Plan that is not directly interacting with the patient.	12months
Study Questionnaire Completion Rate (Pre and Post)	Study Questionnaire Completion Rate (Pre and Post) is the proportion of study questionnaires completed by enrolled study participants.	12months
Feasibility of Intervention Measure (FIM)	Feasibility of Intervention Measure (FIM) is a four-item tool that evaluates feasibility by measuring demonstrated content validity, reliability, structural validity, structural invariance, known-groups validity, and responsiveness to change.	12 months after enrollment (T3)
Patient Satisfaction with Navigation	Patient Satisfaction with Navigation (PSN-I questionnaire) is a validated, nine-item measure of the satisfaction with the interpersonal relationship with the patient navigator.	12 months after enrollment (T3)
Acceptability of Intervention Measure (AIM)	Acceptability of Intervention Measure (AIM) is a four-item tool that evaluates acceptability by measuring demonstrated content validity, reliability, structural validity, structural invariance, known-groups validity, and responsiveness to change.	12 months after enrollment (T3)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Phayvanh Pecha, MD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: February 5, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pediatrics; Sleep Disorders
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Respiratory Tract Diseases; Respiration Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Sleep Apnea, Obstructive; Sleep Wake Disorders
• Other Study ID Numbers: Pro00138323; 1K23HL171952-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No