Electronic Fetal MonitoringNCT04040257
A Team-based Approach to Improve Knowledge and Judgment Performance in Electronic Fetal Monitoring
A study testing Team-based approach in people with Electronic Fetal Monitoring, run by Yale University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electronic Fetal Monitoring
- What is being tested?
- Team-based approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2018to 22 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any individual who does not meet inclusion criteria or is unable to participate in all exams at the designated time points.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-New Haven Hospital
New Haven, Connecticut, 06510
About this study
Official title: 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).
Read the 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.
- Conditions
- Electronic Fetal Monitoring
- Being tested
- Team-based approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Team-based approachBehavioural
Team-based participation in the The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam.
| Study group | Role | What they receive |
|---|---|---|
| Individual Performance | No intervention | 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). |
| Group Performance | Experimental | 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). Receives: Behavioral: Team-based approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start12 Dec 2018
- Primary completion12 Apr 2019
- Study completion22 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electronic Fetal MonitoringStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krista Mehlhaff, DO, Principal investigator, Yale School of Medicine, Department of Obstetrics, Gynecology, & Reproductive Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040257
- Sponsor's protocol ID
- 2000023716
- Status last verified
- Jul 2019
- First submitted
- 29 Jul 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does a Team-based Approach Improve Knowledge and Judgment Performance in Electronic Fetal Monitoring?
- ClinicalTrials.gov ID
- NCT04040257
- Acronym / sponsor ID
- 2000023716
- Conditions
- Electronic Fetal Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 22 Apr 2019 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual Performance | No intervention | –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). |
| Group Performance | Experimental | Behavioral: Team-based approachEach 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Any individual who does not meet inclusion criteria or is unable to participate in all exams at the designated time points.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team-based approachTeam-based participation in the The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam. | Behavioural | Group Performance |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Electronic Fetal Monitoring
Not yet recruiting
Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Induced Labor, Cervical Ripening
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Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
Recruiting
Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)
Pregnancy
Not yet recruitingObservational study
Evaluation of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology and Eucapnic pH Assessment
Neonatal Acidemia and Hypoxia
RecruitingObservational study
Association of Maternal Thyroid Function and Anxiety With Fetal Cardiotocography Parameters in High-Risk Pregnancies
High-risk Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krista Mehlhaff, DO principal investigator
Yale School of Medicine, Department of Obstetrics, Gynecology, & Reproductive Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Team-based approach in people with Electronic Fetal Monitoring, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) Judgement (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.