Clinical trial NCT06828835: The REPOSE Navigation Intervention
Official title: Testing a Strategy to Improve Diagnostic and Treatment Pathways for Children With Sleep-Disordered Breathing: the REPOSE Navigation Intervention
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Pediatrics
Sleep Disorders
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-02-14
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion of specialist evaluation
timeFrame: up to 12months
Secondary outcomes:
measure: Time from referral to specialist consultation
timeFrame: 12months
measure: Completion of PSG
timeFrame: 12months
measure: Time to PSG
timeFrame: 12months
measure: Receipt of treatment
timeFrame: 12months
measure: Time to treatment
timeFrame: 12months
measure: SDB symptom severity
timeFrame: 1-2 weeks following enrollment (T1), 12 months after enrollment (T3)
measure: Quality of life
timeFrame: 1-2 weeks following enrollment (T1), 12 months after enrollment (T3)
measure: Barrier reduction
timeFrame: 1-2 weeks following enrollment (T1), 12months
measure: Unresolved barriers
timeFrame: 12months
measure: Self-efficacy
timeFrame: 1-2 weeks following enrollment (T1), 6 months after enrollment (T2)
Other outcomes:
measure: Sociodemographic factors
timeFrame: Baseline (T0)
measure: Clinical characteristics
timeFrame: Baseline (T0), 12months
measure: Social Support
timeFrame: 1-2 weeks following enrollment (T1), 6 months after enrollment (T2)
measure: REPOSE Accrual Rate
timeFrame: 12months
measure: REPOSE Attrition Rate
timeFrame: 12months
measure: Navigator Caseload
timeFrame: 12months
measure: Navigator Time Allocation (Direct)
timeFrame: 12months
measure: Navigator Time Allocation (Indirect)
timeFrame: 12months
measure: Study Questionnaire Completion Rate (Pre and Post)
timeFrame: 12months
measure: Feasibility of Intervention Measure (FIM)
timeFrame: 12 months after enrollment (T3)
measure: Patient Satisfaction with Navigation
timeFrame: 12 months after enrollment (T3)
measure: Acceptability of Intervention Measure (AIM)
timeFrame: 12 months after enrollment (T3)
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Phayvanh Pecha, MD
role: PRINCIPAL_INVESTIGATOR
References: