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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04519216
Other study ID # 1613611-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 31, 2020
Est. completion date December 10, 2021

Study information

Verified date December 2021
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date December 10, 2021
Est. primary completion date October 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
Telesimulation
Telesimulation educational intervention

Locations

Country Name City State
United States University of California - Davis Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Self efficacy Physician residents (participants) will fill out a survey about their breastfeeding counseling self efficacy prior to and after the intervention. at enrollment, 2 weeks and 3 months following intervention
Secondary Satisfaction with simulation Physician residents (participants) will fill out a survey about their satisfaction with the breast feeding medicine curriculum after the educational intervention. Immediately following the educational intervention
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