- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05503771
Improving Pediatrician Counseling About Infant Safe Sleep Using the Electronic Medical Record
Health IT to Reduce Disparities in Risks for Sleep-related Infant Deaths, (SAFE Start 2.0 Project)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marisa Cordon Villa de Leon, MPH
- Phone Number: 443-564-0185
- Email: mcordon4@jh.edu
Study Contact Backup
- Name: Eileen M McDonald, MS
- Phone Number: 410-428-9063
- Email: emcdona1@jhu.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Harriet Lane Clinic
-
Contact:
- Marisa Cordon Villa de Leon, MPH
- Phone Number: 443-564-0185
- Email: mcordon4@jh.edu
-
Contact:
- Barry Solomon, MD
- Email: bsolomon@jhmi.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
Time Frame: 2-month Well Baby Visit
|
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.
Time Frame: 4 months
|
Asses parents' satisfaction with care, infant safe sleep knowledge, beliefs, reported practices, and observed infant sleep environments.
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
Time Frame: Through Study Completion, an average of 2-3 years
|
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
|
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).
Time Frame: Through Study Completion, an average of 2-3 years
|
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
|
Review parents' experiences using the ISA tool as assessed by the Visit Exit Checklist (VEC) survey after the 4-month Well Baby Visit.
Time Frame: 4 months
|
Perceptions of parents' reactions in the intervention group to using the ISA tool through MyChart.
|
4 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Barry Solomon, MD, MPH, Division of General Pediatrics
- Principal Investigator: Eileen M McDonald, MS, Johns Hopkins Bloomberg School of Public Health
- Study Director: Marisabel Cordon Villa de Leon, MPH, Division of General Pediatrics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00333492
- R01MD015818 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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