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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04040257
Other study ID # 2000023716
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 12, 2018
Est. completion date April 22, 2019

Study information

Verified date July 2019
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date April 22, 2019
Est. primary completion date April 12, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Team-based approach
Team-based participation in the The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam.

Locations

Country Name City State
United States Yale-New Haven Hospital New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) Judgement 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
Primary The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) Knowledge 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
See also
  Status Clinical Trial Phase
Completed NCT02741284 - Oxygen for Intrauterine Resuscitation of Category II Fetal Heart Tracings N/A
Recruiting NCT05904314 - Evaluation of the Effectiveness of Teaching Method With Simulation in Electronic Fetal Monitoring Management N/A