Evaluation of Health Professional Learners' Competence in Newborn Positioning and Attachment Following a Standardized Patient-led Lactation Skills Workshop

Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating patients. Thus, positioning and attachment training is traditionally conducted through passive modalities, primarily videos.

Investigators aim to evaluate the impact of an interactive breastfeeding skills workshop using a baby doll on health professional learners' ability to identify effective and ineffective positioning and attachment at the breast.

Study Overview

• Status: Completed
• Conditions: Breastfeeding; Patient Simulation
• Intervention / Treatment: Other: Breastfeeding Skills Workshop

Detailed Description

Faculty at the University of Michigan School of Public Health (UM-SPH), Johns Hopkins School of Nursing (JHUSON), and Michigan State University (MSU) are collaborating with LiquidGoldConcept (LGC), a company focusing on simulation-based training in maternal-child care, to evaluate the impact of high-fidelity simulation on health professional learner outcomes. For the Phase I SBIR, LGC is developing a high-fidelity newborn simulator for healthcare professional education in clinical lactation.

Evaluating newborn positioning and attachment is a key skill for maternal-child healthcare providers. Trainees have limited opportunities to practice this skill in their clinical rotations due to a lack of access to lactating patients. Thus, positioning and attachment training is traditionally conducted through passive modalities, primarily videos.

Investigators aim to evaluate the impact of an interactive breastfeeding skills workshop using a baby doll on health professional learners' ability to identify effective and ineffective positioning and attachment at the breast.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • LiquidGoldConcept

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Enrollment in a health professional training program (e.g. medical student, nursing student, physician resident)

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baby doll with user remote controlled jaw; In this arm, standardized patients will use the Newborn Oral Assessment and Latch Simulator (NORALSim) to demonstrate and teach newborn positioning and attachment in the breastfeeding skills workshop.	Other: Breastfeeding Skills Workshop; Participants will complete the standardized patient-led breastfeeding skills workshop where they will learn breast massage techniques to alleviate plugged ducts and engorgement, hand expression of breast milk, effective breast pump use, and newborn positioning and attachment.
Active Comparator: Baby doll with hand controlled jaw; In this arm, standardized patients will use a cloth baby doll with a puppet-style mouth to demonstrate and teach newborn positioning and attachment in the breastfeeding skills workshop.	Other: Breastfeeding Skills Workshop; Participants will complete the standardized patient-led breastfeeding skills workshop where they will learn breast massage techniques to alleviate plugged ducts and engorgement, hand expression of breast milk, effective breast pump use, and newborn positioning and attachment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Pre-Intervention) Competence in Evaluating Newborn Positioning and Attachment	Participants will complete a pre-intervention knowledge check on newborn positioning and attachment prior to and immediately following the Breastfeeding Skills Workshop. The knowledge check will consist of 5 true-false questions. For each question, the participant will watch a 3-second clip of positioning and attachment and respond to the question "True or False, I would recommend adjustments to this dyad's positioning and attachment." For each true/false question, participants will respond to a multiple-choice question with 4 options on why they would or would not make adjustments to the dyad.	Day 1 (Pre-Intervention)
(Post-Intervention) Competence in Evaluating Newborn Positioning and Attachment	Participants will complete a post-intervention knowledge check on newborn positioning and attachment prior to and immediately following the Breastfeeding Skills Workshop. The knowledge check will consist of 5 true-false questions. For each question, the participant will watch a 3-second clip of positioning and attachment and respond to the question "True or False, I would recommend adjustments to this dyad's positioning and attachment." For each true/false question, participants will respond to a multiple-choice question with 4 options on why they would or would not make adjustments to the dyad.	Day 1 (Post-Intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of Clinical Lactation Skills related to positioning and attachment in a Video-based Simulation (Telesimulation)	The Standardized Patient in that telesimulation will rate their performance of clinical and communication skills using a 10-item Formative Assessment Rubric (FAR). The FAR includes four "I know" statements rating clinical skills specific to the case scenario (e.g. I know why my nipples have been hurting when I breastfeed my baby).	1-12 weeks
Performance of Clinical Lactation Skills related to positioning and attachment in a Video-based Simulation (Telesimulation)	An independent rater will watch audio-video recordings of the telesimulation and grade learner's completion of technical skills relevant to positioning and attachment according to a 14-point checklist (Point values: 0=did not complete, 1=did complete)	1-12 weeks
Satisfaction with the Breastfeeding Skills Workshop	Participants will complete a 6-item satisfaction survey immediately following completion of the second telesimulation with the following items. Participants will rate their agreement on a 6-point Likert scale (1=strongly disagree, 6=strongly agree); The skills workshop helped me prepare for the positioning and attachment telesimulation.; The multiple-choice questions helped me prepare for the positioning and attachment telesimulation.; What was expected of me as a health professional during the telesimulation was appropriate for my level of training.; The amount of time allotted for the telesimulation was adequate.; The standardized patient in the telesimulation was a realistic breastfeeding mother.; The newborn simulator distracted from the realism of the telesimulation.	1-12 weeks

Collaborators and Investigators

• Sponsor: LiquidGoldConcept
• Collaborators: Johns Hopkins University; University of Michigan; Michigan State University

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Actual): February 4, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: January 5, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 21-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No