- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04040257
A Team-based Approach to Improve Knowledge and Judgment Performance in Electronic Fetal Monitoring
Does a Team-based Approach Improve Knowledge and Judgment Performance in Electronic Fetal Monitoring?
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale-New Haven Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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).
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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).
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Team-based participation in the The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam.
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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
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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
Sponsor
Investigators
- Principal Investigator: Krista Mehlhaff, DO, Yale School of Medicine, Department of Obstetrics, Gynecology, & Reproductive Sciences
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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