Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-75
SponsorJohns Hopkins University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Infant is considered medically complex (e.g., serious congenital anomaly, requires cardiorespiratory monitoring, etc.)
Assigned resident is not enrolled in the study
Trial design
Design model
Parallel
Treatments tested in this trial
ISA-MI
BehavioralParents 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 interventionParents 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.
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Intervention Group: ISA-MIExperimental treatment 1 intervention
Group B: Control Group: Standard of Care (SOC)Other 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
2-month Well Baby Visit2
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
Time frame
2-month Well Baby Visit3
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.
Time frame
4 monthsSecondary outcomes
1
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).
Time frame
Through Study Completion, an average of 2-3 years2
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).
Time frame
Through Study Completion, an average of 2-3 years3
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.
Time frame
4 monthsSponsors and contacts
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Johns Hopkins University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov