Clinical trial NCT05503771: Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record
Official title: Health IT to Reduce Disparities in Risks for Sleep-related Infant Deaths, (SAFE Start 2.0 Project)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sudden Infant Death
Sudden Unexplained Infant Death
Keywords: Counseling
Motivational Interviewing
Medical Informatics
Clinical Decision Support
Electronic Medical Record
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2022-08-17
Enrollment: 470
Sex: ALL
Minimum age (years): 3
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 2-month Well Baby Visit
measure: 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.
timeFrame: 2-month Well Baby Visit
measure: 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.
timeFrame: 4 months
Secondary outcomes:
measure: 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).
timeFrame: Through Study Completion, an average of 2-3 years
measure: 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).
timeFrame: Through Study Completion, an average of 2-3 years
measure: Review parents' experiences using the ISA tool as assessed by the Visit Exit Checklist (VEC) survey after the 4-month Well Baby Visit.
timeFrame: 4 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Harriet Lane Clinic
state: Maryland
Study officials:
affiliation: Division of General Pediatrics
name: Barry Solomon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Eileen M McDonald, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of General Pediatrics
name: Marisabel Cordon Villa de Leon, MPH
role: STUDY_DIRECTOR
References: