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

NCT05353998 | Completed

• 1 other identifier: 22-019762
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep-Disordered Breathing; Obstructive Sleep Apnea; Sleep

Keywords

Sleep Disordered Breathing; Sleep PASS

Outcome Measures

Primary Outcomes (7)

• 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)

  Proportion of patients screened for SDB at well child visits will be calculated with data from the electronic health records.

  up to 12 months

• Clinician Decision Support Acceptability

  Clinician Decision Support acceptability will be measured through clinician-completed system usability survey. This measure is rated on a 5-point Likert scale (1=strongly disagree; 2=somewhat disagree; 3=neither agree or disagree; 4=somewhat agree; and 5=strongly agree) with a range in score from 12 to 60. Higher total scores indicate better acceptability.

  up to 12 months

• Acceptability of the CDS Tool

  CDS acceptability will be measured by semi-structured qualitative interviews completed by the clinicians. Up to 15 primary care clinicians will be invited to participate in an interview focused on acceptability of the CDS tool. The interview includes multiple, open-ended questions completed by the clinician.

  up to 12 months

• Sleep Navigator feasibility (number of Sleep Navigation activities completed among those randomized to receive Sleep Navigation)

  Feasibility will be measured using data from the Sleep Navigator-completed intervention-specific fidelity checklist.

  within 8 months of baseline assessment

• Sleep Navigator feasibility (Sleep Navigation activities completed among those randomized to receive Sleep Navigation)

  Feasibility will be measured using data from the caregiver-completed qualitative interview.

  within 8 months of baseline assessment

• Acceptability of the Sleep Navigation program (Treatment Evaluation Inventory-Short Form)

  Acceptability of the Sleep Navigation program will be measured through the Treatment Evaluation Inventory-Short Form that has been adapted for the Sleep PASS program. This measure is rated on a 5-point Likert scale (1=strongly disagree; 2=disagree; 3=neutral; 4=agree; and 5=strongly agree) with a range in raw score from 11 to 55. Higher total scores indicate better acceptability.

  within 8 months of baseline assessment

• Acceptability of the Sleep Navigation program (Multicultural Therapy Competency Inventory)

  Sleep Navigation acceptability will be measured through the Multicultural Therapy Competency Inventory- Client Version questionnaire that has been adapted for the Sleep PASS program. This measure is rated on a 5-point Likert scale (1=strongly disagree; 2=disagree; 3=neutral; 4=agree; and 5=strongly agree) with a range in raw score from 5 to 25. Higher total scores indicate better outcomes.

  within 8 months of baseline assessment

Secondary Outcomes (9)

• Sleep specialty care referral rates

  through study completion, an average of 1 year

• Completion of sleep specialty care referral

  through study completion, an average of 1 year

• Caregiver knowledge of Sleep Disordered Breathing (SDB)

  at baseline and within 8 months of baseline assessment

• Child SDB symptoms: Pediatric Sleep Questionnaire

  at baseline and within 8 months of baseline assessment

• Child sleep habits: Brief Child Sleep Questionnaire (BCSQ)

  at baseline and within 8 months of baseline assessment

Study Arms (2)

Sleep Navigation group

EXPERIMENTAL

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

Other: CDS with Sleep Navigation

CDS-only group

OTHER

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.

Other: CDS-only

Interventions

CDS with Sleep Navigation 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.

Sleep Navigation group

CDS-only OTHER

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

CDS-only group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Caregiver-child dyads:
• Child is between 2 years and 17 years of age
• 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
• Child receives well child care at Cobbs Creek or Karabots CHOP primary care network sites
• Parental/guardian permission (informed consent) and if applicable, child assent
• Caregiver participant is the parent or legal guardian of the child subject
• Caregiver is 18 years of age or older
• English-speaking
• Clinicians:
• Primary care clinician practicing at Cobbs Creek or Karabots CHOP primary care network sites
• English-speaking

You may not qualify if:

• Caregiver-child dyads:
• Caregiver is not the parent or legal guardian of child participant or is \<18 years of age
• Non-English speaking, as intervention sessions and qualitative interviews will be conducted in English
• Child receives well child care at a non-participating primary care site at enrollment
• Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
• Clinicians:
• Does not see patients at Cobs Creek or Karabots CHOP primary care network sites
• Non-English speaking, as qualitative interviews will be conducted in English

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (7)

• Archbold KH, Pituch KJ, Panahi P, Chervin RD. Symptoms of sleep disturbances among children at two general pediatric clinics. J Pediatr. 2002 Jan;140(1):97-102. doi: 10.1067/mpd.2002.119990.

  PMID: 11815771 BACKGROUND

• Rosen CL, Larkin EK, Kirchner HL, Emancipator JL, Bivins SF, Surovec SA, Martin RJ, Redline S. Prevalence and risk factors for sleep-disordered breathing in 8- to 11-year-old children: association with race and prematurity. J Pediatr. 2003 Apr;142(4):383-9. doi: 10.1067/mpd.2003.28.

  PMID: 12712055 BACKGROUND

• Bonuck KA, Chervin RD, Cole TJ, Emond A, Henderson J, Xu L, Freeman K. Prevalence and persistence of sleep disordered breathing symptoms in young children: a 6-year population-based cohort study. Sleep. 2011 Jul 1;34(7):875-84. doi: 10.5665/SLEEP.1118.

  PMID: 21731137 BACKGROUND

• 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.

  PMID: 22926173 BACKGROUND

• 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.

  PMID: 21295865 BACKGROUND

• 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.

  PMID: 24733988 BACKGROUND

• Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.

  PMID: 39382077 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Interventions

Compact Disks

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Videodisc Recording; Optical Storage Devices; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Ariel Williamson, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 29, 2022
• Study Start: August 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)