Clinical trial NCT03552419: A Quality Improvement Project - Peripartum Operating Room Leveling System
Official title: A Multidisciplinary Approach to Peripartum Triaging of Patients to the Operating Room: A Quality Improvement Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Complications
Cesarean Section Complications
Morbidity;Perinatal
Keywords: Operating room leveling
Obstetric anesthesia
Time to incision
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 1380
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In obstetrics, triage assessment incorporates both maternal and fetal considerations. Priority is given to situations with obvious threat to life to the mother or to the fetus. 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. Furthermore, simply classifying the need for cesarean into a single "emergency" category is insufficient as varying levels of "emergencies" exist. In the modern-day era, the obstetrical decision for surgical intervention prompts the mobilization of a team of providers, including the obstetrician, anesthesiologist, nursing and surgical technicians, and supporting OR staff. Thus, effective communication among team members is essential.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Materno-fetal stability
timeFrame: 1 year
measure: Indication for surgical intervention
timeFrame: 1 year
measure: Role for obtaining additional studies
timeFrame: 1 year
measure: nil per os (NPO) status
timeFrame: 1 year
measure: Surgical concerns
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Jamie D Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References: