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Completed

NCT Number: NCT04717128

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.

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior Patient Simulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LiquidGoldConcept

Ypsilanti, Michigan, 48197, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Breastfeeding Skills Workshop

Other

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.

Primary outcomes

  1. (Pre-Intervention) Competence in Evaluating Newborn Positioning and Attachment

    Time frame: Day 1 (Pre-Intervention)

    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.

  2. (Post-Intervention) Competence in Evaluating Newborn Positioning and Attachment

    Time frame: Day 1 (Post-Intervention)

    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.

Secondary outcomes

  1. Performance of Clinical Lactation Skills related to positioning and attachment in a Video-based Simulation (Telesimulation)

    Time frame: 1-12 weeks

    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).

  2. Performance of Clinical Lactation Skills related to positioning and attachment in a Video-based Simulation (Telesimulation)

    Time frame: 1-12 weeks

    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)

  3. Satisfaction with the Breastfeeding Skills Workshop

    Time frame: 1-12 weeks

    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.

Sponsors and collaborators

Lead sponsor

LiquidGoldConcept

Industry

Collaborators

  • Johns Hopkins University
  • Michigan State University
  • University of Michigan

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 20, 2021
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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