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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-12
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE)

    Other intervention

    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.

  • Usual Care

    Other intervention

    Usual care is defined by standard clinical care delivered without a protocolized intervention (e.g., the ordinary course of care).

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Reach for Equity in Pediatric Obstructive Sleep Evaluation (REPOSE)Other 1 intervention
Group B: Usual CareOther 1 intervention

Trial outcomes

Primary outcomes

1

Completion of specialist evaluation

Binary, evaluation of SDB by completion of specialist consultation (e.g., sleep medicine, otolaryngologist) per AAP guidelines.

Time frame
up to 12months

Secondary outcomes

1

Time from referral to specialist consultation

Time in days from referral order to specialist evaluation (sleep medicine or otolaryngology).

Time frame
12months
2

Completion of PSG

Binary, PSG (if ordered) was completed within 90 days of the order.

Time frame
12months
3

Time to PSG

Time in days from PSG order to completion.

Time frame
12months
4

Receipt of treatment

Binary, treatment completion within 60 days.

Time frame
12months

Other outcomes

1

Sociodemographic factors

Sex, age, race, ethnicity, SES, education, employment, income, distance to medical facility, rural/urban residence, and insurance status.

Time frame
Baseline (T0)
2

Clinical characteristics

Comorbidities, body mass index (percentile), and PSG parameters.

Time frame
Baseline (T0), 12months
3

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.

Time frame
1-2 weeks following enrollment (T1), 6 months after enrollment (T2)
4

REPOSE Accrual Rate

REPOSE Accrual Rate is the proportion of eligible patients who enroll in REPOSE.

Time frame
12months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator