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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05503771
Status
Recruiting
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Conditions

  • Sudden Infant Death
  • Sudden Unexplained Infant Death

Eligibility Criteria

Sex
ALL
Age
3 Days - 75 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Sep 30, 2022
Status verified
Dec 2025
Primary completion
Jul 1, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group: ISA-MI
    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.
  • Other: Control Group: Standard of Care (SOC)
    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.

Primary Outcome Measure

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. [ Time Frame: 2-month Well Baby Visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Harriet Lane ClinicBaltimoreMaryland21287
Marisa Cordon Villa de Leon, MPH
[email protected]
443-564-0185
Barry Solomon, MD
[email protected]

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By research site
Harriet Lane Clinic· Baltimore, MD

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