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

Sudden Infant Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503771
• Other study ID #: IRB00333492
• Secondary ID: R01MD015818
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: February 28, 2026

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: Marisa Cordon Villa de Leon, MPH
• Phone: 443-564-0185
• Email: mcordon4[@]jh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: February 28, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Days to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Death
• Infant Death
• Sudden Infant Death
• Sudden Unexplained Infant Death

Intervention

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.

Locations

Country	Name	City	State
United States	Harriet Lane Clinic	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in quality of infant safe sleep counseling provided by clinicians using new EMR-based tool as assessed by listening to recorded 2-month Well Baby Visits for control and intervention groups.	To test the impact of implementing a new EMR-based Infant Sleep Assessment (ISA) on pediatric clinicians' delivery of anticipatory guidance (both positive and unintended negative consequences) after watching a self-paced video training on safe sleep information, ISA tutorial, and motivational interviewing	2-month Well Baby Visit
Primary	Changes in quality of infant safe sleep counseling provided by clinicians trained in Motivational Interviewing skills as assessed by listening to recorded 2-month Well Baby Visits for control and intervention groups.	To test the impact of implementing a new EMR-based Infant Sleep Assessment (ISA) and brief Motivational Interviewing training (ISA-MI) on pediatric clinicians' delivery of anticipatory guidance (both positive and unintended negative consequences) after watching a self-paced video training on safe sleep information, ISA tutorial, and motivational interviewing	2-month Well Baby Visit
Primary	Changes in parents' satisfaction with care provided by clinical residents as assessed by the follow-up survey parents in both control and intervention groups will receive at the 4-month Well Baby Visit.	Asses parents' satisfaction with care, infant safe sleep knowledge, beliefs, reported practices, and observed infant sleep environments.	4 months
Secondary	Analyze clinicians' experiences with the ISA intervention as assessed by the clinician close-out survey when clinicians graduate or the study ends (whichever happens first).	Assess clinicians' experiences with the ISA intervention, specifically reactions to using the ISA tool (preparation, satisfaction, ease of use, self-efficacy, burnout, impact on balancing measures).	Through Study Completion, an average of 2-3 years
Secondary	Analyze ISA's advantages and disadvantages over standard anticipatory guidance as assessed by the clinician close-out survey when clinicians graduate or the study ends (whichever happens first).	Assess clinicians' experiences with the ISA intervention, including: a) reactions to using the ISA (preparation, satisfaction, ease of use, self-efficacy, burnout, impact on balancing measures).	Through Study Completion, an average of 2-3 years
Secondary	Review parents' experiences using the ISA tool as assessed by the Visit Exit Checklist (VEC) survey after the 4-month Well Baby Visit.	Perceptions of parents' reactions in the intervention group to using the ISA tool through MyChart.	4 months