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

Obstructive Sleep Apnea Clinical Trial

Official title:

Evaluating the Efficacy of Clinical Decision Support and Sleep Navigation to Enhance Primary to Specialty Care Management of Sleep Disordered Breathing

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05353998
• Other study ID #: 22-019762
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: June 1, 2024

Study information

• Verified date: October 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: June 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Respiratory Aspiration
• Sleep
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep-Disordered Breathing

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	at baseline and within 8 months of baseline assessment
Secondary	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.	at baseline and within 8 months of baseline assessment
Secondary	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.	at baseline and within 8 months of baseline assessment
Secondary	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.	at baseline and within 8 months of baseline assessment
Secondary	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.	at baseline and within 8 months of baseline assessment
Secondary	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.	at baseline and within 8 months of baseline assessment
Secondary	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.	at baseline and within 8 months of baseline assessment