NCT05503771

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 3 Days – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

This research addresses the problem of unsafe infant sleep practices that increase the risk of Sudden Unexplained Infant Death (SUID), which includes Sudden Infant Death Syndrome and Accidental Suffocation and Strangulation in Bed. The study team will examine how a unique health information technology (HIT) tool impacts patient and provider outcomes when implemented in a pediatric primary care clinic serving a socioeconomically disadvantaged population that is primarily Black/African American. The study team's HIT tool - the Infant Sleep Assessment (ISA) - was developed through prior NIH-funded work and builds on the team's track record of innovative injury prevention research with parents and pediatric health care clinicians. During well-baby visits, the ISA assesses parents' reported sleep practices for their newborns. Using a programmed algorithm, the ISA identifies risky infant sleep practices and generates associated suggested feedback messages for the clinician that are derived from behavior change theory. This information is delivered via the electronic medical record (EMR) for the clinician's use during routine anticipatory guidance. To maximize the ISA's effectiveness, clinicians (pediatric residents) will receive a brief training in communication skills that are derived from Motivational Interviewing (MI). The study team will evaluate the impact of the ISA with 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.

Conditions

• Sudden Infant Death
• Sudden Unexplained Infant Death

Interventions

Type	Name	Description
BEHAVIORAL	ISA-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.
OTHER	Standard 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.

Timeline

• Start date: 2022-09-30
• Primary completion: 2026-07-01
• Completion: 2027-02-28
• First posted: 2022-08-17
• Last updated: 2025-12-09

Locations

1 site across 1 country: United States