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Breastfeeding Education in the Time of COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04519216
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Adrienne E Hoyt-Austin, University of California, Davis

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 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.
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 : July 31, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

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




Primary Outcome Measures :
  1. Change in practice patterns [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04519216


Contacts
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Contact: Adrienne Hoyt-Austin, DO (916) 734-5387 aehoyt@ucdavis.edu

Locations
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United States, California
University of California - Davis Recruiting
Sacramento, California, United States, 95817
Contact: Adrienne Hoyt-Austin    916-734-5387    aehoyt@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Adrienne Hoyt-Austin, DO University of California, Davis
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Responsible Party: Adrienne E Hoyt-Austin, Academic General Pediatric Fellow, University of California, Davis
ClinicalTrials.gov Identifier: NCT04519216    
Other Study ID Numbers: 1613611-2
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations