Breastfeeding Education in the Time of COVID-19
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|ClinicalTrials.gov Identifier: NCT04519216|
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : August 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breastfeeding Breastfeeding, Exclusive Breastfeeding Jaundice Educational Problems||Behavioral: Telesimulation||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|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.|
|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|
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
Telesimulation educational intervention
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.
Telesimulation educational intervention
- 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.
- 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.
- 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.
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
|Contact: Adrienne Hoyt-Austin, DO||(916) firstname.lastname@example.org|
|United States, California|
|University of California - Davis||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Adrienne Hoyt-Austin 916-734-5387 email@example.com|
|Principal Investigator:||Adrienne Hoyt-Austin, DO||University of California, Davis|