Improving counseling about safe sleep for infants using electronic records
Health IT to Reduce Disparities in Risks for Sleep-related Infant Deaths, (SAFE Start 2.0 Project)
This study is testing a new tool to help pediatricians talk to parents about safe sleep for their babies during check-ups to reduce the risk of Sudden Infant Death Syndrome (SIDS).
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 3 Days to 75 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05503771 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of an Infant Sleep Assessment (ISA) tool combined with motivational interviewing (MI) training for pediatricians during well-baby visits. The goal is to enhance communication between clinicians and parents regarding safe sleep practices to reduce the risk of Sudden Infant Death Syndrome (SIDS) and related conditions. The ISA tool assesses parents' reported sleep practices and provides tailored feedback to clinicians through the electronic medical record. The study focuses on a pediatric clinic serving a socioeconomically disadvantaged population, primarily Black/African American families.
Who should consider this trial
Good fit: Ideal candidates are English and Spanish-speaking parents or legal guardians bringing their infants for early well-baby visits at the Harriet Lane Clinic.
Not a fit: Patients with medically complex infants or those whose assigned resident is not participating in the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could lead to safer infant sleep practices and a reduction in the incidence of Sudden Unexplained Infant Death.
How similar studies have performed: Previous studies have shown success in using health information technology and communication training to improve patient outcomes, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * English and Spanish-speaking parents and legal guardians bringing their infants to the Harriet Lane Clinic (pediatric primary care clinic) for any of their early well baby visits (between 3-5 days up to 4 weeks of age) * Maryland recognizes teen parents as emancipated minors, so they will be eligible to provide consent and participate. Exclusion Criteria: * Infant is considered medically complex (e.g., serious congenital anomaly, requires cardiorespiratory monitoring, etc.) * Assigned resident is not enrolled in the study
Where this trial is running
Baltimore, Maryland
- Harriet Lane Clinic — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Barry Solomon, MD, MPH — Division of General Pediatrics
- Study coordinator: Marisa Cordon Villa de Leon, MPH
- Email: mcordon4@jh.edu
- Phone: 443-564-0185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.