Breastfeeding Education in the Time of COVID-19

• Sponsor: University of California, Davis (Other)
• Overall Status: Completed
• CT.gov ID: NCT04519216
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 2
• Actual Duration (Months): 16.3
• Patients Per Site Per Month: 2.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breastfeeding; Breastfeeding, Exclusive; Breastfeeding Jaundice; Educational Problems	Behavioral: Telesimulation	N/A

Detailed Description

1. 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.

2. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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: Single (Outcomes Assessor)
• Masking Description: Outcomes are blinded to the assessor when completing the trial data analysis.
• Primary Purpose: Other
• Official Title: Breastfeeding Education in the Time of COVID-19. Hybrid Telesimulation With Standardized Patients for Pediatric and Family Medicine Trainees, a Randomized Trial
• Actual Study Start Date: Jul 31, 2020
• Actual Primary Completion Date: Oct 30, 2021
• Actual Study Completion Date: Dec 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Traditional education 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 educational intervention
Experimental: Telesimulation 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; Telesimulation educational intervention

Outcome Measures

Primary Outcome Measures

1. Change in practice patterns [at enrollment, 2 weeks and 3 months following intervention]

   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

1. Self efficacy [at enrollment, 2 weeks and 3 months following intervention]

   Physician residents (participants) will fill out a survey about their breastfeeding counseling self efficacy prior to and after the intervention.

2. Satisfaction with simulation [Immediately following the educational intervention]

   Physician residents (participants) will fill out a survey about their satisfaction with the breast feeding medicine curriculum after the educational intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

1. Inclusion Criteria: Pediatric and Family Medicine resident physicians at UC Davis Medical Center

2. Exclusion criteria: Individuals who are unable to communicate in English, Individuals who do not have access to videoconferencing via computer or phone.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California - Davis	Sacramento	California	United States	95817

Sponsors and Collaborators

• University of California, Davis

Investigators

• Principal Investigator: Adrienne Hoyt-Austin, DO, University of California, Davis

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT04519216
• Other Study ID Numbers: 1613611-2
• First Posted: Aug 19, 2020
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Jaundice

Study Results

No Results Posted as of Dec 15, 2021