A Quality Improvement Project - Peripartum Operating Room Leveling System

NCT ID: NCT03552419

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-07-01

Brief Summary

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Investigators propose a four-category triaging system to delineate and facilitate the communication and action plan for all types of obstetric OR cases via a multidisciplinary approach. Investigators omitted ambiguous terms and developed an algorithm to categorize patients according to acuity and risk. Investigators' quality improvement intervention allows for rapidly changing circumstances and accounts for both obstetric and anesthetic considerations.

Several metrics will be collected to evaluate this multidisciplinary quality improvement project, including maternal demographics, labor characteristics, and indication for surgical intervention. Additional data include level assigned, time of patient arrival in OR, type of surgery performed, and anesthetic delivered. Investigators will collect fetal delivery data, including Apgar scores and umbilical cord gases, as well as maternal delivery data, including estimated blood loss, time to uterine incision and delivery, and surgical complications.

Detailed Description

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At investigators' institution, a triage (or leveling) system for emergency surgeries in the general operating rooms (OR) exists with the goal of optimizing patient care and reducing morbidity and mortality. In the obstetric field, while medical terminology exists for these situations to delineate and convey the urgency of a particular peripartum situation, for example "stat, emergent, or urgent," it is generally acknowledged that this terminology is not universal and is somewhat ambiguous, causing confusion and unnecessary delays in patient care.

Investigators propose a quality improvement project which will delineate terminology for obstetrical triaging to the OR and discuss metrics for evaluation of this quality improvement intervention. Investigators developed a multidisciplinary stratification system at investigators' institution to triage obstetric patients into a four-level system with clear guidelines for all OR cases. Investigators' categorization system accounted for maternal and fetal stability, indication for surgical intervention, role for obtaining additional studies, nil per os (NPO) status, and surgical and anesthetic concerns. Within each of the four classifications, investigators defined the expectations for each team member's role, including the obstetrician, anesthesiologist, charge nurse, nursing staff, neonatal intensive care unit (NICU) team, and the surgical and clinical technicians.

Several metrics will be collected to evaluate this multidisciplinary quality improvement project, including maternal demographics, labor characteristics, and indication for surgical intervention. Additional data include level assigned, time of patient arrival in OR, type of surgery performed, and anesthetic delivered. Investigators will collect fetal delivery data, including Apgar scores and umbilical cord gases, as well as maternal delivery data, including estimated blood loss, time to uterine incision and delivery, and surgical complications.

Conditions

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Pregnancy Complications Cesarean Section Complications Morbidity;Perinatal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Level Red

A level red refers to a case with an immediate threat to the life of the fetus or mother and may not be delayed under any circumstance.

No interventions assigned to this group

Level Orange

A level orange case requires the patient to arrive in the OR within 30 minutes from the time of decision with the approximate estimated time of arrival determined by the obstetrician.

No interventions assigned to this group

Level Yellow

A level yellow case requires operative intervention, but there is no maternal and/or fetal compromise at the time of evaluation. Timing to the OR is agreed upon by both the anesthesiology and obstetrical providers. The case may be delayed if a level red or orange case is identified. Possible

No interventions assigned to this group

Level Green

A level green case is most dependent on the acuity of the OR suite and unit. The patient and/or fetus are stable with no threat to the health of either.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Female of child-bearing age, requiring emergent procedure in operating room (including cesarean section, D\&C, cerclage placement or removal)

Exclusion Criteria

* Patients not requiring urgent surgical or invasive procedures
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jamie D Murphy, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Other Identifiers

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IRB00164177

Identifier Type: -

Identifier Source: org_study_id

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