Clinical trial NCT05353998: Efficacy of Clinical Decision Support and Sleep Navigation (Sleep PASS)
Official title: Evaluating the Efficacy of Clinical Decision Support and Sleep Navigation to Enhance Primary to Specialty Care Management of Sleep Disordered Breathing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep-Disordered Breathing
Obstructive Sleep Apnea
Sleep
Keywords: Sleep Disordered Breathing
Sleep PASS
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 33
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: CDS feasibility (proportion of patients screened for SDB at well child visits of all those eligible for screening at well child visits over the study period)
timeFrame: up to 12 months
measure: Clinician Decision Support Acceptability
timeFrame: up to 12 months
measure: Acceptability of the CDS Tool
timeFrame: up to 12 months
measure: Sleep Navigator feasibility (number of Sleep Navigation activities completed among those randomized to receive Sleep Navigation)
timeFrame: within 8 months of baseline assessment
measure: Sleep Navigator feasibility (Sleep Navigation activities completed among those randomized to receive Sleep Navigation)
timeFrame: within 8 months of baseline assessment
measure: Acceptability of the Sleep Navigation program (Treatment Evaluation Inventory-Short Form)
timeFrame: within 8 months of baseline assessment
measure: Acceptability of the Sleep Navigation program (Multicultural Therapy Competency Inventory)
timeFrame: within 8 months of baseline assessment
Secondary outcomes:
measure: Sleep specialty care referral rates
timeFrame: through study completion, an average of 1 year
measure: Completion of sleep specialty care referral
timeFrame: through study completion, an average of 1 year
measure: Caregiver knowledge of Sleep Disordered Breathing (SDB)
timeFrame: at baseline and within 8 months of baseline assessment
measure: Child SDB symptoms: Pediatric Sleep Questionnaire
timeFrame: at baseline and within 8 months of baseline assessment
measure: Child sleep habits: Brief Child Sleep Questionnaire (BCSQ)
timeFrame: at baseline and within 8 months of baseline assessment
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbances
timeFrame: at baseline and within 8 months of baseline assessment
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment
timeFrame: at baseline and within 8 months of baseline assessment
measure: Child sleep practices
timeFrame: at baseline and within 8 months of baseline assessment
measure: Child obstructive sleep apnea symptoms
timeFrame: at baseline and within 8 months of baseline assessment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Ariel Williamson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27.
citation: Boss EF, Smith DF, Ishman SL. Racial/ethnic and socioeconomic disparities in the diagnosis and treatment of sleep-disordered breathing in children. Int J Pediatr Otorhinolaryngol. 2011 Mar;75(3):299-307. doi: 10.1016/j.ijporl.2010.11.006. Epub 2011 Feb 4.
citation: Meltzer LJ, Plaufcan MR, Thomas JH, Mindell JA. Sleep problems and sleep disorders in pediatric primary care: treatment recommendations, persistence, and health care utilization. J Clin Sleep Med. 2014 Apr 15;10(4):421-6. doi: 10.5664/jcsm.3620.