A Quality Improvement Project - Peripartum Operating Room Leveling System

• ClinicalTrials.gov Identifier: NCT03552419
• Recruitment Status: Completed
• First Posted: June 11, 2018
• Last Update Posted: August 17, 2020
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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.

Condition or disease
Pregnancy Complications; Cesarean Section Complications; Morbidity;Perinatal

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1380 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Multidisciplinary Approach to Peripartum Triaging of Patients to the Operating Room: A Quality Improvement Project
• Actual Study Start Date: January 2017
• Actual Primary Completion Date: July 2019
• Actual Study Completion Date: July 1, 2020

Groups and Cohorts

Group/Cohort
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.
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.
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
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.

Outcome Measures

Primary Outcome Measures :

1. Materno-fetal stability [ Time Frame: 1 year ]
   This will be assessed by ICU admissions (days) and total length of hospital stay (days)
2. Indication for surgical intervention [ Time Frame: 1 year ]
   surgery is required if patient has one or more of the following reasons: non-reassuring fetal tracing, umbilical cord prolapse, peripartum hemorrhage, or emergency dilation and curettage.
3. Role for obtaining additional studies [ Time Frame: 1 year ]
   determine by the number of additional testing including Labs, imaging or EKG a patient required on top of standard studies.
4. nil per os (NPO) status [ Time Frame: 1 year ]
   Time of last intake (fluid or solids) measured in hours and minutes
5. Surgical concerns [ Time Frame: 1 year ]
   Concerns that may change our care, i.e. patient is full stomach but needs to have urgent surgery. This will be assessed via observation of patient condition and need of hospital care

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female of child-bearing age
• Accepts Healthy Volunteers: No
• 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.

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

Contacts and Locations

Sponsors and Collaborators

Johns Hopkins University

Investigators

• Principal Investigator: Jamie D Murphy, MD; Johns Hopkins University

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03552419
• Other Study ID Numbers: IRB00164177
• First Posted: June 11, 2018
• Last Update Posted: August 17, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:

Operating room leveling; Obstetric anesthesia; Time to incision

Additional relevant MeSH terms:

Pregnancy Complications