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

NCT04717128 | Completed

• 1 other identifier: 21-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breastfeeding; Patient Simulation

Outcome Measures

Primary Outcomes (2)

• (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 Outcomes (3)

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

  1-12 weeks

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

  1-12 weeks

• Satisfaction with the Breastfeeding Skills Workshop

  1-12 weeks

Study Arms (2)

Baby doll with user remote controlled jaw

EXPERIMENTAL

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

Baby doll with hand controlled jaw

ACTIVE COMPARATOR

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

Interventions

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.

Baby doll with hand controlled jaw; Baby doll with user remote controlled jaw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• LiquidGoldConcept: lead
• University of Michigan: collaborator
• Michigan State University: collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

LiquidGoldConcept

Ypsilanti, Michigan, 48197, United States

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Standardized patients leading the workshop will know which baby doll they are using in the workshop. Participants will not know whether or not they are receiving "treatment" and investigators and data analysts will be blinded to the treatment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be cluster randomized to complete the standardized-patient led breastfeeding skills workshop with one of the baby dolls.

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 20, 2021
• Study Start: January 28, 2021
• Primary Completion: February 4, 2021
• Study Completion: June 1, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)