RecruitingNot ApplicableNCT05503771

Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record

Health IT to Reduce Disparities in Risks for Sleep-related Infant Deaths, (SAFE Start 2.0 Project)

Sponsor

Johns Hopkins University

Enrollment

350 participants

Start Date

Sep 30, 2022

Study Type

INTERVENTIONAL

Conditions

Sudden Infant Death Sudden Unexplained Infant Death

Summary

The study team will evaluate the impact of an Infant Sleep Assessment (ISA) tool with motivational interviewing (MI) communication training on clinician-parent communication during 2-month Well Baby Visits (WBV) and parent reported and observed infant sleep practices. The study team's hypotheses are that 1) clinicians who utilize the ISA with MI training will more effectively communicate safe sleep information to their patients' parents, and 2) these parents will have safer infant sleep practices than parents whose clinicians are in a standard of care control group.

Eligibility

Min Age: 3 DaysMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether adding an electronic medical record (EMR) reminder tool can help pediatricians better counsel new parents about safe infant sleep practices (to reduce the risk of SIDS), during early well-baby visits. You may be eligible if: - You are a parent or legal guardian bringing your newborn (3 days to 4 weeks old) to the Harriet Lane Clinic for early well-baby care - You speak English or Spanish - Teen parents are welcome as Maryland law considers them emancipated You may NOT be eligible if: - Your infant has a complex medical condition (such as a serious birth defect or needs a heart/breathing monitor) - The pediatric resident assigned to your visit is not enrolled in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALISA-MI

Parents seen by clinicians randomized to the intervention group will complete the Infant Sleep Assessment (ISA), either prior to their visit using MyChart (Epic patient portal) or on a tablet computer in the exam room while they wait for their clinician; 2) a Clinical Decision Support (CDS) smart form is created in the EMR based on the assessment results, with risks and MI-informed strategies highlighted; this information will be derived from a pre-programmed algorithm and theory-based, tailored communication strategies and messages; 3) the clinician uses the CDS smart form to guide counseling with the parent during the visit, applying their training in MI-informed counseling skills; and 4) Clinician gives the parent an After Visit Summary (AVS) from the EMR (or informs them that they can access the AVS in MyChart if the parent or other caregivers use the patient portal, MyChart), which summarizes and reinforces the safe sleep counseling.

OTHERStandard of Care (SOC)

Parents seen by clinicians randomized to the control group will receive the usual practice that pediatric residents are taught which follows the American Academy of Pediatrics (AAP) Bright Futures Health Supervision Guidelines and includes age and developmentally based anticipatory guidance. As part of their training, residents receive formal teaching on core aspects of providing primary care to infants, including the AAP recommendations on safe sleep. This includes the recommended ABCS: babies should sleep Alone (no objects or people), on their Back (supine), in a Crib (or safe alternative including portable crib or bassinet), and in a Smoke-free environment.