A Team-based Approach to Improve Knowledge and Judgment Performance in Electronic Fetal Monitoring

July 29, 2019 updated by: Yale University

Does a Team-based Approach Improve Knowledge and Judgment Performance in Electronic Fetal Monitoring?

The primary objective of this study is to compare performance of nurses, midwives, and physicians working as individuals versus working as teams in electronic fetal monitoring (as assessed by differences in knowledge and judgment scores).

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Electronic fetal monitoring (EFM) has been used as a tool to evaluate fetal wellbeing in obstetrics for decades, with limited results with regard to improve fetal outcomes. There remains wide variation in the interpretation of fetal heart rate (FHR) tracings between different practitioners, which may explain the limited impact of this ubiquitous tool. The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam was established to improve patient safety in obstetrical care by optimizing and standardizing the credentialing process for EFM.

The Fetal Monitoring Credentialing (FMC) test is a validated tool to assess the knowledge and judgment of test-takers based on script concordance theory, an approach to testing that allows assessment on real-life situations by comparing to the clinical reasoning of a panel of reference experts.

It is known that in clinical practice patients are cared for by teams of individuals (RN's, CNM, resident physicians and attendings). These individuals are all trained to approach a laboring patient from their own unique training. Even amongst experts in the field there is only moderate agreement on the interpretation of tracings with poor agreement on what constitutes a category III tracing. The absence of complete agreement in clinical practice creates differences in opinions of interpretation and agreement regarding next step in management for obstetric patients.

It is hypothesized that a team-based participation in the Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam will improve knowledge and judgment scores.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • 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

    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale-New Haven Hospital

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be a registered nurse, certified midwife, physician (resident, attending, MFM and General OB/Gyn) and have full obstetric privileges to provide patient care at participating hospitals.

Exclusion Criteria:

  • Any individual who does not meet inclusion criteria or is unable to participate in all exams at the designated time points.

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Individual Performance
Each participant will first take the exam as an individual. After a delay of 3-6 months, participants will then be randomized to take the exam again either as an individual again (control group) or as a team (exposure group).
EXPERIMENTAL: Group Performance
Each participant will first take the exam as an individual. After a delay of 3-6 months, participants will then be randomized to take the exam again either as an individual again (control group) or as a team (exposure group).
Team-based participation in the The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) Judgement
Time Frame: Up to 6 months
The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam measures judgement. The is exam is a 72 question computer based exam. There are 35 knowledge questions and 37 judgement questions. The scores for each section are reported as a percentage (maximum score = 100%). Knowledge and judgement questions have scores that are weighted based on exam key.
Up to 6 months
The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) Knowledge
Time Frame: Up to 6 months
The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam measures knowledge. The is exam is a 72 question computer based exam. There are 35 knowledge questions and 37 judgement questions. The scores for each section are reported as a percentage (maximum score = 100%). Knowledge and judgement questions have scores that are weighted based on exam key.
Up to 6 months

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Krista Mehlhaff, DO, Yale School of Medicine, Department of Obstetrics, Gynecology, & Reproductive Sciences

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)

December 12, 2018

Primary Completion (ACTUAL)

April 12, 2019

Study Completion (ACTUAL)

April 22, 2019

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 29, 2019

First Posted (ACTUAL)

July 31, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 31, 2019

Last Update Submitted That Met QC Criteria

July 29, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 2000023716

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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