An interventional study of CDS with Sleep Navigation and CDS-only in Sleep-Disordered Breathing, Obstructive Sleep Apnea and Sleep, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-07-12.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Other
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).
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.
2,183 studies on the registry are indexed under Sleep Apnea Syndromes; 284 are open to participants now.
This study's enrollment of 33 is below the median of 53 across 1,400 interventional studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →Children's Hospital of Philadelphia is the lead sponsor of 488 studies on the registry; 91 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Caregiver-child dyads:
English-speaking
Clinicians:
Exclusion Criteria:
Caregiver-child dyads:
Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Clinicians:
Caregiver-child dyads in this study arm (intervention condition) will participate in the Sleep Navigation program.
Other: CDS with Sleep Navigation
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
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.
Participants will complete baseline and post-intervention assessments. Participants will be able to follow-up with their primary care clinician as needed.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: within 8 months of baseline assessment
Sleep specialty care referral rates
The change in referral rates will be measured through the proportion of patients referred for SDB specialty care of those identified with sleep disordered breathing symptoms based on well visit sleep screener over the study period.
Time frame: through study completion, an average of 1 year
Completion of sleep specialty care referral
The change in referral completion for child sleep disordered breathing care will be measured through the proportion of patients randomized to Sleep Navigation who complete their specialty care referral of those referred to specialty care.
Time frame: through study completion, an average of 1 year
Caregiver knowledge of Sleep Disordered Breathing (SDB)
The magnitude and direction of change in caregiver knowledge of SDB will be measured through the obstructive Sleep Disordered Breathing and Adenotonsillectomy knowledge scale for caregivers. This measure is rated on a dichotomous scale (True/False) with a total raw score range of 0 to 39. Correct answers are summed to attain an overall percentage score representing the degree of knowledge level, with a minimum value of zero and a maximum of 100%. A higher percentage indicates better outcomes.
Time frame: at baseline and within 8 months of baseline assessment
Child SDB symptoms: Pediatric Sleep Questionnaire
The magnitude and direction of change in child sleep will be measured through the Pediatric Sleep Questionnaire scores, the most validated questionnaire assessing children's SDB symptoms. This measure is rated on a dichotomous scale ("yes" = 1, "no" = 0, and "don't know"=missing). The result is a proportion that ranges from 0.0 to 1.0. Scores greater than 0.33 are considered positive and suggestive of high risk for a pediatric sleep-related breathing disorder.
Time frame: at baseline and within 8 months of baseline assessment
Child sleep habits: Brief Child Sleep Questionnaire (BCSQ)
The magnitude and direction of change in child sleep will be measured through the BCSQ which assesses child sleep habits including sleep time, total sleep duration, night waking, aspects of the sleep environment, etc. The BCSQ uses a nominal scale system. Scores on each subscale and the total score are scaled from 0 to 100. Higher scores denote better sleep quality, more positive perception of child sleep, and parent behaviors that promote healthy and independent sleep.
Time frame: at baseline and within 8 months of baseline assessment
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbances
The PROMIS Sleep Disturbances survey would measure the magnitude and direction of change in child sleep. This measure is rated on a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40. The raw scores are converted to a standardized T-score, with higher scores indicating greater severity of sleep disturbance.
Time frame: at baseline and within 8 months of baseline assessment
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment
The PROMIS Sleep-Related Impairment survey would measure the magnitude and direction of change in child sleep. This measure is rated on a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40. The raw scores are converted to a standardized T-score, with higher scores indicating greater severity of sleep-related impairment.
Time frame: at baseline and within 8 months of baseline assessment
Child sleep practices
Sleep practices would be assessed using the Patient-Reported Outcomes Measurement Information System Sleep Practices survey. This measure assesses 5 sleep practices: sleep timing, sleep routines and consistency, technology use before bedtime, sleep environment, and the need for parental presence to fall asleep. This measure is rated on a nominal scale and 5-point Likert scale. Scores on each subscale and the total score are scaled from 0 to 100. Higher scores indicate better sleep practices.
Time frame: at baseline and within 8 months of baseline assessment
Child obstructive sleep apnea symptoms
The change in child obstructive sleep apnea (OSA) symptoms will be measured through the OSA-18, a validated caregiver-completed questionnaire. This measure is rated on a 7-point Likert scale. Total raw score ranges from 18 to 126. Higher scores indicates worse outcomes.
Time frame: at baseline and within 8 months of baseline assessment
Plan to share: No
Ran from Aug 2022 to primary completion in Sep 2023, 13 months.
Of 433 non-industry interventional studies with no phase under Sleep Apnea Syndromes, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 55. This study's 13 months is below that.
Counting every sponsor, half of 538 studies reached it within 24 months; a quarter within 11 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital of Philadelphia →