Breastfeeding Education in the Time of COVID-19

NCT04519216 | Completed

• 1 other identifier: 1613611
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This project will establish that pediatric and family medicine residents who complete a hybrid breastfeeding medicine curriculum that includes an asynchronous unfolding case scenario along with telesimulation with a standardized patient (SP) will provide timely, skilled lactation support more frequently than residents randomized to an asynchronous unfolding case scenario followed by videoconference group discussion regarding care for the breastfeeding dyad.

Conditions

Breastfeeding; Breastfeeding, Exclusive; Breastfeeding Jaundice; Educational Problems

Outcome Measures

Primary Outcomes (1)

• Change in practice patterns

  Breastfeeding medicine practice patterns of physician residents will be assessed at enrollment and following the intervention/control. Physician resident participants will complete a survey querying the number of times they have counseled patients about breastfeeding, the number of breast examinations performed, the number of witnessed breastfeeding sessions, and any experience with counseling about manual expression of breast milk.

  at enrollment, 2 weeks and 3 months following intervention

Secondary Outcomes (2)

• Self efficacy

  at enrollment, 2 weeks and 3 months following intervention

• Satisfaction with simulation

  Immediately following the educational intervention

Study Arms (2)

Traditional education

ACTIVE COMPARATOR

Participants in the control group will complete an online unfolding case scenario. Then these same participants will participate in a videoconferencing case based lecture with the academic pediatric fellow

Behavioral: Telesimulation

Telesimulation

EXPERIMENTAL

Participants in the intervention group will complete an online unfolding case scenario. Then these participants will complete a telesimulation case with a standardized patient via video conferencing.

Behavioral: Telesimulation

Interventions

Telesimulation BEHAVIORAL

Telesimulation educational intervention

Telesimulation; Traditional education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California - Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast Feeding; Breastfeeding Jaundice

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Adrienne Hoyt-Austin, DO

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes are blinded to the assessor when completing the trial data analysis.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective cluster randomized controlled trial of a novel educational intervention in pediatric and family medicine residents during the nursery rotation. In this study, we will enroll 1st year pediatric and family medicine residents and 3rd year supervising pediatric residents on their newborn nursery 4-week rotation and randomization will occur clustered by rotation month. The educational intervention will be conducted during the first week of the rotation. Both groups will complete pre-intervention survey that collects demographic information, personal infant feeding experiences, and any breastfeeding medicine experience. All participants will be invited to complete a free online course (Lactation Support in a Telehealth Setting Course) prior to the telemedicine intervention or control group discussion with the clinical pediatrician.

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 19, 2020
• Study Start: July 31, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 10, 2021
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)