Breastfeeding Education in the Time of COVID-19
Primary Purpose
Breastfeeding, Breastfeeding, Exclusive, Breastfeeding Jaundice
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telesimulation
Sponsored by
About this trial
This is an interventional other trial for Breastfeeding
Eligibility Criteria
- Inclusion Criteria: Pediatric and Family Medicine resident physicians at UC Davis Medical Center
- Exclusion criteria: Individuals who are unable to communicate in English, Individuals who do not have access to videoconferencing via computer or phone.
Sites / Locations
- University of California - Davis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Traditional education
Telesimulation
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Self efficacy
Physician residents (participants) will fill out a survey about their breastfeeding counseling self efficacy prior to and after the intervention.
Satisfaction with simulation
Physician residents (participants) will fill out a survey about their satisfaction with the breast feeding medicine curriculum after the educational intervention.
Full Information
NCT ID
NCT04519216
First Posted
August 12, 2020
Last Updated
December 13, 2021
Sponsor
University of California, Davis
1. Study Identification
Unique Protocol Identification Number
NCT04519216
Brief Title
Breastfeeding Education in the Time of COVID-19
Official Title
Breastfeeding Education in the Time of COVID-19. Hybrid Telesimulation With Standardized Patients for Pediatric and Family Medicine Trainees, a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Establish that pediatric and family medicine residents who complete a novel breastfeeding medicine curriculum that includes an online unfolding case scenario along with telemedicine simulation with a standardized patient (SP) will provide timely, skilled lactation support more frequently than residents randomized to an online unfolding case scenario followed by traditional didactic breastfeeding case-presentation via videoconference.
Establish that online learning via unfolding case scenario and telemedicine simulation with a SP will be feasible for family medicine and pediatric residents to complete during their newborn nursery rotation.
Intern and third year residents completing their newborn nursery rotation at UC Davis Medical Center will be cluster-randomized by rotation month to receipt of breastfeeding education via telesimulation with standardized patient or traditional case-based learning via videoconferencing with pediatric faculty. The primary outcome of this study will be the translation of clinical lactation skills to the care of breastfeeding mothers and newborns. I hypothesize that pediatric and family medicine residents randomized to complete the telesimulation with SP will translate their acquired clinical lactation skills to the care of breastfeeding mothers and newborns at a greater rate than residents who complete a videoconference case-based traditional curriculum discussion with a newborn nursery pediatrician.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Breastfeeding, Exclusive, Breastfeeding Jaundice, Educational Problems
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Outcomes are blinded to the assessor when completing the trial data analysis.
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional education
Arm Type
Active Comparator
Arm Description
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
Arm Title
Telesimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telesimulation
Intervention Description
Telesimulation educational intervention
Primary Outcome Measure Information:
Title
Change in practice patterns
Description
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.
Time Frame
at enrollment, 2 weeks and 3 months following intervention
Secondary Outcome Measure Information:
Title
Self efficacy
Description
Physician residents (participants) will fill out a survey about their breastfeeding counseling self efficacy prior to and after the intervention.
Time Frame
at enrollment, 2 weeks and 3 months following intervention
Title
Satisfaction with simulation
Description
Physician residents (participants) will fill out a survey about their satisfaction with the breast feeding medicine curriculum after the educational intervention.
Time Frame
Immediately following the educational intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pediatric and Family Medicine resident physicians at UC Davis Medical Center
Exclusion criteria: Individuals who are unable to communicate in English, Individuals who do not have access to videoconferencing via computer or phone.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrienne Hoyt-Austin, DO
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California - Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Breastfeeding Education in the Time of COVID-19
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