RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Health IT to Reduce Disparities in Risks for Sleep-related Infant Deaths, (SAFE Start 2.0 Project)

Quick Facts

Study Start:2022-09-30
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05503771

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Days to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Maryland recognizes teen parents as emancipated minors, so they will be eligible to provide consent and participate.
  1. * Infant is considered medically complex (e.g., serious congenital anomaly, requires cardiorespiratory monitoring, etc.)
  2. * Assigned resident is not enrolled in the study

Contacts and Locations

Study Contact

Marisa Cordon Villa de Leon, MPH
CONTACT
443-564-0185
mcordon4@jh.edu
Eileen M McDonald, MS
CONTACT
410-428-9063
emcdona1@jhu.edu

Principal Investigator

Barry Solomon, MD, MPH
PRINCIPAL_INVESTIGATOR
Division of General Pediatrics
Eileen M McDonald, MS
PRINCIPAL_INVESTIGATOR
Johns Hopkins Bloomberg School of Public Health
Marisabel Cordon Villa de Leon, MPH
STUDY_DIRECTOR
Division of General Pediatrics

Study Locations (Sites)

Harriet Lane Clinic
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Barry Solomon, MD, MPH, PRINCIPAL_INVESTIGATOR, Division of General Pediatrics
  • Eileen M McDonald, MS, PRINCIPAL_INVESTIGATOR, Johns Hopkins Bloomberg School of Public Health
  • Marisabel Cordon Villa de Leon, MPH, STUDY_DIRECTOR, Division of General Pediatrics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-30
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2022-09-30
Study Completion Date2026-02-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Sudden Infant Death
  • Sudden Unexplained Infant Death