NCT04040257

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 29, 2019

Last Update Submit

July 29, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

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).

Behavioral: Team-based approach

Interventions

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

Group Performance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Study Officials

  • Krista Mehlhaff, DO

    Yale School of Medicine, Department of Obstetrics, Gynecology, & Reproductive Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2019

First Posted

July 31, 2019

Study Start

December 12, 2018

Primary Completion

April 12, 2019

Study Completion

April 22, 2019

Last Updated

July 31, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations