The REPOSE (Reach for Equity in Pediatric Sleep Evaluation) Navigation Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE), Usual Care.
- Who it may be relevant to
- Registry conditions: Sleep Apnea, Obstructive. Basic parameters: 2 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Testing a Strategy to Improve Diagnostic and Treatment Pathways for Children With Sleep-Disordered Breathing: the REPOSE Navigation Intervention
Overview
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.
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.
Interventions
- 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 - Other Usual Care
Usual care is defined by standard clinical care delivered without a protocolized intervention (e.g., the ordinary course of care).
Primary outcome measures
- Completion of specialist evaluation [Time frame: up to 12months]
Secondary outcome measures (10)
- Time from referral to specialist consultation [Time frame: 12months]
- Completion of PSG [Time frame: 12months]
- Time to PSG [Time frame: 12months]
- Receipt of treatment [Time frame: 12months]
- Time to treatment [Time frame: 12months]
- SDB symptom severity [Time frame: 1-2 weeks following enrollment (T1), 12 months after enrollment (T3)]
- Quality of life impact for obstructive sleep apnea in children [Time frame: 1-2 weeks following enrollment (T1), 12 months after enrollment (T3)]
- Barrier reduction [Time frame: 1-2 weeks following enrollment (T1), 12months]
- Unresolved barriers [Time frame: 12months]
- Self-efficacy [Time frame: 1-2 weeks following enrollment (T1), 6 months after enrollment (T2)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT06828835 · Pro00138323 · 1K23HL171952-01A1