Efficacy of Clinical Decision Support and Sleep Navigation (Sleep PASS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-06-01

Brief Summary

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The purpose of the study is to examine the feasibility, acceptability, and initial outcomes of clinical decision support (CDS) and a Sleep Navigation program to enhance primary to specialty care management of pediatric sleep-disordered breathing (SDB).

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Detailed Description

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Sleep disordered breathing (SDB), which ranges from mild snoring to severe obstructive sleep apnea, impacts up to 17% of all children and is a significant public health concern. Untreated SDB is associated with significant risks to child health and well-being, including child neurobehavioral problems, hypertension, and obesity. Despite the robust evidence base for treating SDB, there are notable racial, ethnic, and socioeconomic disparities in its prevalence and treatment; even when SDB is identified in primary care visits, referral rates to specialty care are extremely low.

This is a randomized controlled trial of the Sleep PASS program, with the primary objectives to (1) determine the feasibility and acceptability of CDS for SDB in primary care, and (2) determine the feasibility and acceptability of Sleep Navigation for patients with SDB who meet criteria for further clinical evaluation. The secondary objective is to examine the initial efficacy of CDS and Sleep Navigation on referral rates and rates of referral completion for SDB-related specialty care, caregiver SDB knowledge, and child sleep for patients with SDB who meet criteria for further clinical evaluation. Up to 200 caregiver-child dyads with a child (ages 2 years 0 months to \< 18 years) who has been screened for SDB symptoms in Children's Hospital of Philadelphia primary care and meets criteria for further clinical evaluation will be recruited. Up to 70 primary care clinicians will also be recruited.

Eligible and interested caregiver-child dyads will be randomly assigned to the intervention condition (CDS with Sleep Navigation) or to the CDS only condition. The Sleep Navigation program will involve 1-3 meetings, conducted virtually, in-person, or via telephone, between the Sleep Navigator (SN) and the participating family. The SN will provide: SDB and sleep health psychoeducation using Patient-Family Education handouts and videos that are currently part of usual care practices; Care coordination for scheduling of specialty care referral(s) for clinical SDB evaluation; Problem-solving for family-identified barriers to accessing specialty care; and Motivational interviewing to enhance family engagement, communication, and collaboration with the family's medical team.

Study procedures involves medical record review, caregiver- and child-completed questionnaires, clinician-completed questionnaires, interviews, and Navigator sessions (for the Intervention condition). Following sleep screening as part of well child visit care, electronic health records and the sleep screener will be reviewed for eligibility. Eligible and interested participants will be scheduled for a baseline assessment visit that occurs in-person or electronically and includes informed consent (or e-consent), random assignment to the intervention condition (CDS with Sleep Navigation) or to the CDS only condition, and completion of baseline measures. The intervention group will start receiving the Sleep Navigation program 1-2 weeks following baseline assessment. The CDS only condition will be directed to follow up with their primary care clinician as needed. Post-intervention and follow-up assessment will occur within 8 months of baseline questionnaire completion. Clinicians will complete questionnaires at the post-intervention phase. Randomly selected caregiver-child dyads in the intervention condition and clinicians will be invited to participate in qualitative interviews.

Conditions

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Sleep-Disordered Breathing Obstructive Sleep Apnea Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Caregiver-child dyads with a child who meets criteria for further SDB evaluation will be randomly assigned (1:1) to either the intervention condition, which is the CDS and the Sleep Navigation program, or to a CDS only condition.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Sleep Navigation group

Caregiver-child dyads in this study arm (intervention condition) will participate in the Sleep Navigation program.

Group Type EXPERIMENTAL

CDS with Sleep Navigation

Intervention Type OTHER

The Sleep Navigation program will involve 1-3 meetings between the Sleep Navigator (SN) and the participating family. Participants will also complete baseline and post-intervention assessments, and about 10 to 15 caregivers will be randomly invited to participate in an interview on the acceptability and feasibility of the program. The SN will provide: SDB and sleep health psychoeducation using Patient-Family Education handouts and videos that are currently part of usual care practices; Care coordination for scheduling of specialty care referral(s) for clinical SDB evaluation; Problem-solving for family-identified barriers to accessing specialty care; and Motivational interviewing to enhance family engagement, communication, and collaboration with the family's medical team.

CDS-only group

Caregiver-child dyads in this study arm (control group) will not participate in the Sleep Navigation program, but will be directed to follow up with their primary care clinician as needed.

Group Type OTHER

CDS-only

Intervention Type OTHER

Participants will complete baseline and post-intervention assessments. Participants will be able to follow-up with their primary care clinician as needed.

Interventions

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CDS with Sleep Navigation

The Sleep Navigation program will involve 1-3 meetings between the Sleep Navigator (SN) and the participating family. Participants will also complete baseline and post-intervention assessments, and about 10 to 15 caregivers will be randomly invited to participate in an interview on the acceptability and feasibility of the program. The SN will provide: SDB and sleep health psychoeducation using Patient-Family Education handouts and videos that are currently part of usual care practices; Care coordination for scheduling of specialty care referral(s) for clinical SDB evaluation; Problem-solving for family-identified barriers to accessing specialty care; and Motivational interviewing to enhance family engagement, communication, and collaboration with the family's medical team.

Intervention Type OTHER

CDS-only

Participants will complete baseline and post-intervention assessments. Participants will be able to follow-up with their primary care clinician as needed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Caregiver-child dyads:

1. Child is between 2 years and 17 years of age
2. Child has an abnormal SDB screen (i.e., a positive response to whether the child snores 3 or more nights/week) on the sleep screener used as part of well child visit care in the Children's Hospital of Philadelphia (CHOP) primary care network
3. Child receives well child care at Cobbs Creek or Karabots CHOP primary care network sites
4. Parental/guardian permission (informed consent) and if applicable, child assent
5. Caregiver participant is the parent or legal guardian of the child subject
6. Caregiver is 18 years of age or older
7. English-speaking

Clinicians:
8. Primary care clinician practicing at Cobbs Creek or Karabots CHOP primary care network sites
9. English-speaking

Exclusion Criteria

Caregiver-child dyads:

1. Caregiver is not the parent or legal guardian of child participant or is \<18 years of age
2. Non-English speaking, as intervention sessions and qualitative interviews will be conducted in English
3. Child receives well child care at a non-participating primary care site at enrollment
4. Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Clinicians:
5. Does not see patients at Cobs Creek or Karabots CHOP primary care network sites
6. Non-English speaking, as qualitative interviews will be conducted in English

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No