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

March 1, 2022 updated by: LiquidGoldConcept

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
(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.
Day 1 (Pre-Intervention)
(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.
Day 1 (Post-Intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
1-12 weeks
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)
1-12 weeks
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)

  1. The skills workshop helped me prepare for the positioning and attachment telesimulation.
  2. The multiple-choice questions helped me prepare for the positioning and attachment telesimulation.
  3. What was expected of me as a health professional during the telesimulation was appropriate for my level of training.
  4. The amount of time allotted for the telesimulation was adequate.
  5. The standardized patient in the telesimulation was a realistic breastfeeding mother.
  6. The newborn simulator distracted from the realism of the telesimulation.
1-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
LiquidGoldConcept

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Johns Hopkins University
University of Michigan
Michigan State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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