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

NCT05503771 | Recruiting

• 2 other identifiers: IRB00333492R01MD015818
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sudden Infant Death; Sudden Unexplained Infant Death

Keywords

Counseling; Motivational Interviewing; Medical Informatics; Clinical Decision Support; Electronic Medical Record

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (3)

• 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).

  Through Study Completion, an average of 2-3 years

• 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).

  Through Study Completion, an average of 2-3 years

• Review parents' experiences using the ISA tool as assessed by the Visit Exit Checklist (VEC) survey after the 4-month Well Baby Visit.

  4 months

Study Arms (2)

Intervention Group: ISA-MI

EXPERIMENTAL

The ISA-MI study condition involves, in addition to the standard of care described for the SOC group, a clinician training activity related to using the ISA (Infant Sleep Assessment) tool. Clinicians assigned to the ISA-MI Group will view a 20-30-minute recorded video training session on infant safe sleep (including its epidemiology, risk factors and recommendations), use of the ISA tool, and use of motivational interviewing-inspired (MI) communication skills to respond to ISA parent responses. The ISA tool builds on the 2022 AAP infant sleep recommendations and will be implemented at the 2-month WBV. Parents/patients of physicians in the ISA-MI study condition will also be given several infant safe sleep related products that facilitate compliance with safe sleep recommendations, namely, a portable crib, a sleep sack and a pacifier.

Behavioral: ISA-MI

Control Group: Standard of Care (SOC)

OTHER

The SOC study condition consists of WBVs that follow the usual practice of American Academy of Pediatrics (AAP) Bright Futures Health Supervision Guidelines and includes age- and developmentally based anticipatory guidance. As part of their training, pediatric 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.

Other: Standard of Care (SOC)

Interventions

ISA-MI BEHAVIORAL

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.

Intervention Group: ISA-MI

Standard of Care (SOC) OTHER

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.

Control Group: Standard of Care (SOC)

Eligibility Criteria

• Age: 3 Days - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Infant is considered medically complex (e.g., serious congenital anomaly, requires cardiorespiratory monitoring, etc.)
• Assigned resident is not enrolled in the study

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Harriet Lane Clinic

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Sudden Infant Death

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Barry Solomon, MD, MPH

  Division of General Pediatrics

  PRINCIPAL INVESTIGATOR

• Eileen M McDonald, MS

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Marisabel Cordon Villa de Leon, MPH

  Division of General Pediatrics

  STUDY DIRECTOR

Central Study Contacts

Marisa Cordon Villa de Leon, MPH

CONTACT

443-564-0185; mcordon4@jh.edu

Eileen M McDonald, MS

CONTACT

410-428-9063; emcdona1@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 17, 2022
• Study Start: September 30, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)