EVIDENCEBASED CARE SHEET

Core Measure: Perinatal Care – Elective Delivery What We Know › Introduction • The Joint Commission (TJC) is a national nonprofit organization that accredits and certifies nearly 21,000 healthcare organizations (e.g., hospitals, ambulatory care centers) and programs in the United States. TJC seeks to continuously improve health care, patient safety, and patient outcomes through performance standards(11,15,16,17) • In 1987, TJC inaugurated performance measures for improved patient outcomes with the Agenda for Change, which was subsequently titled the ORYX initiative. Through ORYX, hospitals could choose from thousands of performance measures to meet hospital accreditation. This approach led to an inability to compare healthcare organization data across systems. TJC utilized advisory panels in 1999 to reframe the next phase of ORYX for identification and use of evidence-basedand standardized performance measures. Core measures were developed and pilot tested for reliability, validity, and feasibility in 83 hospitals in the nine states of California, Connecticut, Georgia, Michigan, Missouri, Rhode Island, Texas, South Carolina, and Virginia. Core measures are a nationally recognized standardized performance measurement system

Author Hillary Mennella, DNP, MSN, ANCC-BC Cinahl Information Systems, Glendale, CA

Reviewers Hui Xu, RN, MSN, FNP-c, CPHQ Lead Quality Review (SCIP/Core) Organizational Performance Darlene Strayer, RN, MBA Cinahl Information Systems, Glendale, CA Nursing Executive Practice Council Glendale Adventist Medical Center, Glendale, CA

Editor Diane Pravikoff, RN, PhD, FAAN Cinahl Information Systems, Glendale, CA

July 1, 2016

that must meet strict criteria.(11,15,17) (For information about core measures, specific criteria, and changes for 2016 see Evidence-Based Care Sheet: Core Measures: an Overview • The Perinatal Care (PC) core measure set was developed by TJC in 2009. PC replaced the previous core measure set known as Pregnancy and Related Conditions (PR). The purpose of retiring and replacing the PR core measure set was to implement an expanded set of evidence-based core measures. As a result, a technical advisory panel that included experts in the clinical specialty of perinatal care developed the PC core measure set. The resultant PC core measure set was expanded to 5 measures and 1 submeasure, and is endorsed by the National Quality Forum (NQF). The PR core measure set was retired effective March 31, 2010, and the new PC core measure set became effective for all hospital discharges beginning on April 1, 2010. The PC core measure set is unique from other core measure sets because it includes the two distinct Initial Patient Populations of mothers and newborns(13,21) • Core measures are a nationally recognized standardized performance measurement

system that must meet strict criteria(11,14) › Core measure sets consist of process measures, which are defined by TJC as “a measure that focuses on one or more steps that lead to a particular outcome,” and outcome measures, which are defined by TJC as “measures that focus on the result of the

performance or nonperformance of a process.”(11) (For information about core measures, specific criteria, and changes for 2016, see the Evidence-Based Care Sheet: Core Measures: an Overview ) • The composite core measure for Perinatal Care includes(6,14,21) –Elective delivery, which is a process measure –Cesarean section, which is an outcome measure –Antenatal steroids, which is a process measure –Healthcare-associated bloodstream infections in newborns, which is an outcome measure

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› Exclusive breast milk feeding, which is a process measure • Exclusive breast milk feeding during the newborn’s hospitalization considering the mother’s choice was retired and effective for October 1, 2015 discharges(11) › Issue: Elective Delivery • Perinatal care is routine medical and nursing care of a woman and her fetus during pregnancy. Perinatal care provides the mother with healthcare counseling, screening for pregnancy-relatedcomplications, and monitoring of fetal development and the mother’s overall health, exercise, weight, nutrition, and psychosocial issues. Typically, routine perinatal care is scheduled as follows:(1,2) –Monthly visits during the first two trimesters—week 1–28—ofpregnancy –Visits every two weeks from week 28–36 of pregnancy –Weekly visits after 36 weeks of pregnancy until delivery • An elective delivery is a scheduled induction of labor or a cesarean delivery for a nonmedical reason instead of allowing for the development of spontaneous labor. Scheduling a repeat cesarean section is recommended by the treating clinician for many women who have had a previous delivery by cesarean section, and/or these women choose to electively schedule subsequent deliveries by cesarean section (also known as repeated elective cesarean deliveries)(5) • According to the United States National Center for Health Statistics, cesarean rates declined to 32.2% of births in 2014, which was a decrease of 2% from the 2009 peak of 32.9%(19) • The exact incidence of cesarean delivery by maternal request is not known and ranges from 4–18% in the U.S. and internationally. It is estimated that cesarean delivery on maternal request contributes to 2.5% of all births in the U.S.(22) • In the U.S., there are nationwide initiatives to decrease the rate of elective deliveries and to educate mothers and healthcare providers about the benefits of remaining pregnant until 39 weeks of gestation. Benefits include the following:(18,20) –Allowing time for complete organ development in the fetus –Allowing for sufficient fetal weight gain –Improved neonatal sucking and swallowing –Decreased risk for neonatal hearing and vision abnormalities after birth › Evidence Supporting Inclusion of Core Measures • Evidence has demonstrated that elective inductions for delivery increase the cesarean rate and result in longer postpartum stays, increased rate of adverse neonatal outcomes, increased complications in subsequent pregnancies (e.g., placenta previa), and higher economic cost. Elective cesarean deliveries demonstrate lower infection rates than unplanned cesarean deliveries but have higher rates of infection than vaginal deliveries(3,6,8,22,26,27) • Investigators report that nulliparous women who undergo elective induction of delivery are at increased risk for cesarean delivery. In a cohort study of 1,561 term, nulliparous women with vertex singleton gestations, investigators found that women who had spontaneous labor had a cesarean rate of 7.8% compared with 17.5% for women who were induced electively and 17.7% who required medical induction. The most common reason for cesarean section was labor dystocia (i.e., abnormally slow progression of labor or difficult labor)(26) • A consensus statement from the 2006 National Institutes of Health State of the Science conference Cesarean Delivery on Maternal Request that was formulated after finding insufficient evidence to “evaluate fully the benefits and risks of cesarean delivery on maternal request as compared to planned vaginal delivery”(23) recommended in part that –there should be more research on the topic –cesarean delivery should not be performed before 39 weeks of gestation or without verification of lung maturity –unavailability of adequate pain control should not be a motivator to perform cesarean delivery –an appropriate Federal agency should provide risk/benefit information on a Web site(23) • Repeated elective cesarean sections before 39 weeks’ gestation result in increased rates of adverse neonatal outcomes, including respiratory complications (e.g., respiratory distress syndrome) and events (e.g., transient tachypnea), sepsis, hypoglycemia, and/or the need for mechanical ventilation. Of 24,077 repeat cesarean deliveries at term in a U.S. multicenter, investigators found that(27) –13,258 were performed electively –of the elective cesarean deliveries, 35.8% were performed before 39 weeks’ gestation –neonates delivered at 37 weeks’ gestation had a higher rate of adverse health outcomes –postponing elective delivery to 39 weeks’ gestation may prevent 48% of adverse neonatal outcomes among deliveries at 37 weeks of gestation and 27% at 38 weeks of gestation

• An investigator studied 10,608 spontaneously laboring women compared with 1,241 women in whom labor was electively induced. All women were low risk pregnancies with singleton, vertex, 37–40.9 weeks' gestation, no prior cesarean section, and no presenting medical or obstetric diagnoses that were considered indications for cesarean or induction. Factors and outcomes associated with elective medical induction of labor were evaluated and neonatal outcomes were reported to be unaffected. However, elective induction of labor was associated with increased rate of cesarean deliveries, longer postpartum stays, and the need for intrapartum interventions (e.g., instrumental delivery, internal fetal heart rate monitoring)(8) • Elective delivery before 39 weeks’ gestation is associated with higher rates of neonatal morbidity. Authors of a prospective observational study of 17,794 deliveries from 14 states and 27 U.S. hospitals during a 3-month period reported the following:(6) –84%of deliveries occurred at > 37 weeks’ gestation –44% of term deliveries were planned, of which 71% were elective instead of medically indicated (e.g., due to preeclampsia or maternal seizures in eclampsia) –8 hospitals had elective term induction rates that were > 20% –17.8% of neonates were delivered electively without medical indication at 37–38 weeks’ gestation, and 8% of neonates that were delivered electively without medical indication at 38–39 weeks’ gestation required admission to a neonatal special care unit • The average length of stay for neonates requiring admission to a neonatal special care unit was 4.5 days › Current Evidence Supporting/Not Supporting Core Measure • According to guidelines by the American College of Obstetricians and Gynecologists (ACOG) and the U. S. National Institutes of Health (NIH), patients should have at least 39 completed weeks’ gestation prior to elective vaginal or cesarean delivery(5) › In response to ACOG recommendations, hospital policies have changed nationwide to support elective cesarean delivery only if patients are at 39 completed weeks’ gestation(19) • A lower score in the PC outcome measure indicates better performance on the cesarean section rates. TJC data from 2013 show that the elective cesarean rate was 4.3% compared with 8.2% in 2012 and 13.6% in 2011(11) • The 2013 Committee on Obstetric Practice submitted the following recommendations:(5) –In the absence of maternal or fetal indications for cesarean delivery, a plan for vaginal delivery is safe and appropriate and should be recommended to pregnant women by their treating clinician –In cases planned cesarean delivery based on maternal request, the committee recommends the following: - Cesarean delivery on maternal request should not be performed before 39 weeks’ gestation - Cesarean delivery on maternal request should not be motivated by the unavailability of effective pain management - Cesarean delivery on maternal request is not recommended for women who are planning to have several children due to the increasing risks of placenta previa, placenta accreta, and gravid hysterectomy with each cesarean delivery › Specific Measures • The goal of this measure is to decrease the number of patients with elective vaginal deliveries or elective cesarean sections at ≥ 37 and < 39 weeks of gestation completed • The numerator statement includes patients with elective deliveries –Included populations are those patients with an ICD-10-CMPrincipal Procedure Code or ICD-10-CM Other Procedure Codes for elective delivery by medical induction of labor or cesarean section while not in labor prior to the procedure –Cesarean birth and both of the following:not in labor and no history of a prior uterine surgery –There are no excluded populations in the numerator • The denominator statement includes patients delivering newborns with ≥ 37 and < 39 weeks of gestation completed –The included patient populations are those with an ICD-10-CMPrincipal Diagnosis Code or ICD-10-CM Other Diagnosis Codes for pregnancy and planned cesarean section in labor • Patient populations to be excluded in the denominator include the following: –ICD-10-CM Principal Diagnosis Code or ICD-10-CM Other Diagnosis Codes for conditions that possibly justify elective delivery prior to 39 weeks’ gestation –Gestational age < 37 weeks or ≥ 39 weeks or unable to be determined (UTD) –Pregnant patients who are < 8 years of age –Pregnant patients who are > 65 years of age –Length of stay > 120 days

–Patients who are enrolled in clinical trials –Patients with a history of prior uterine surgery, including patients with the following: - Prior classical cesarean section that resulted in a vertical incision in the upper uterine segment - Prior myomectomy - Prior uterine surgery that resulted in perforation of the uterus - History of a uterine window noted during prior uterine surgery - History of uterine rupture that required surgical repair - History of a corneal ectopic pregnancy › Data Elements Included • Data elements for this core measure include those for the Inpatient Population Patient of the mother as follows: –Documentation of the mother’s admission date to the hospital –Documentation of the mother’s birthdate –Documentation of the mother’s ICD-10-CM Principal or Other Diagnosis Code - A Principal Diagnosis Code is the condition or reason that the patient is admitted to the hospital for care –Documentation of the discharge date • Additional specific data elements include the following: –Documentation of the gestational age of the fetus (i.e., completed weeks of gestation) –Documentation that the patient was in active, early, or spontaneous labor –Documentation of the patient’s history of prior uterine surgery –Documentation that during admission to the hospital the patient was enrolled in a clinical trial, including - a signed consent form for clinical trial - documentation with the signed consent form indicating that during admission the patient was enrolled in a clinical trial in which patients with the same condition (e.g., elective delivery) as the core measure set were being studied • General data elements include the following: –Hispanic ethnicity –Race –Sex –Payment source –Discharge status (e.g., to home) –Healthcare organization identifier (HCOI) - The HCOI is a unique number that is assigned to accredited facilities by TJC › Desired Outcome • Decreased rate of the number of patients with elective vaginal deliveries or elective cesarean sections at ≥ 37 weeks and < 39 weeks of gestation • Decreased complications in mothers and newborns as a result of elective delivery › Remaining Issues • Data collection for the PC core measure set was not required by TJC except from women’s specialty hospitals that serve an obstetric patient population. Beginning January of 2014, hospitals with at least 1,100 births per year were required to collect data for the PC core measure set in order to meet the ORYX initiative requirements for hospital accreditation. Hospitals with less than 1,100 births per year were not required to report PC core measure data to TJC(7,21) › Hospitals must select and report on 6 of 9 sets of chart-abstracted measures for calendar year 2016 that are applicable to the services that are provided and the patient populations that are served by the hospital. Beginning January 1, 2016, all hospitals that are accredited by TJC with 300 live births annually will be required to collect data and report on all 5 measures in the PC core measure set(10,12) › According to data from America’s hospitals: Improving quality and safety. The Joint Commission’s annual report 2015, hospitals that were accredited by TJC had(11) › an overall PC composite of 96.3% compliance › 3.3% for elective delivery, which is a –10.3% improvement since 2011. For this measure, a decrease in the rate is desired and a negative percentage point difference is considered favorable • Evidence has suggested that the ACOG guidelines to not perform elective cesarean before 39 weeks’ gestation have been disregarded in at least 10% of all deliveries(6) • Ultrasound of the fetus can be inaccurate by as much as 2 weeks(20)

• Experts estimate that delaying elective deliveries > 40 weeks’ gestation is associated with a higher rate of stillbirths(27) • Pregnant women need full disclosure of the potential adverse health outcomes of elective labor induction(8) • Elective cesarean delivery at < 39 weeks’ gestation should be avoided. In a retrospective study of 675,302 singleton infants born alive at 37-44 weeks of gestation, investigators reported that infants born to mothers in the early elective cesarean delivery group had increased chance of developing respiratory morbidities (66%), NICU admission (51%), and feeding difficulties (36%) compared with infants who were born in the expectantly managed (i.e., full-term) group with > 39 weeks’ gestation(25) • Different cultures can have different perceptions and personal goals regarding labor and delivery. Healthcare providers should educate the mother about the benefits and risks of cesarean delivery on maternal request versus planned vaginal delivery, and the cultural and personal importance of labor and delivery should be evaluated(22) • ACOG recommends that hospitals establish procedures to review the appropriateness of the scheduling the induction of labor(4) • The measure specifications (i.e., numerator and denominator) between various organizations (e.g., ACOG, California Maternity Quality Care Collaborative, TJC, NQF) differ for reporting of elective delivery rates. Currently, TJC requires validation of reported data for elective delivery rates.(28) This measure is adopted for the CMS Hospital Inpatient Quality Reporting Program fiscal year (FY) 2015 and for the Stage 2 Medicare and Medicaid Health Electronic Record (HER) Incentive Program(15,24) › The submission deadline was April 1 to May 15, 2015 for the CMS FY 2016 for elective delivery for discharges occurring on January 1, 2014 through December 31, 2014(9) • The U.S. NIH recommends implementing surveys of women before and after delivery and of healthcare providers, insurers, and healthcare facilities regarding cesarean delivery on maternal request in order to provide a basis for assessing the current extent of elected cesarean delivery and maternal attitudes(22)

What We Can Do › Learn the evidence-based, best practice reasons for following the Core Measure: Perinatal Care: Elective Delivery and share this information with colleagues, new nurses, and patients and their family members › Collaborate with your colleagues to promote accurate data collection › Discuss core measure with the treating clinician › Educate women about the risks and benefits of elective delivery › Participate in the interrater reliability process to maintain accurate data collection › Collaborate to develop guidelines to support the use of core measures › Develop and use clinical pathways or patient care plans to structure care in a consistent, formalized manner › Be aware of patients who are not included (e.g., patients with a history of prior uterine surgery) › Refer to TJC manual, appendix A for acceptable ICD-10-CM Principal Procedure Code or ICD-10-CM Other Procedure Codes for elective delivery; for information, see https://manual.jointcommission.org/releases/TJC2015B2/ AppendixATJC.html › For more information, refer to TJC PC-01: Perinatal Care, Elective Delivery algorithm at https:// manual.jointcommission.org/releases/TJC2015B2/MIF0166.html

Related Guidelines › The California Maternal Quality Care Collaborative, California Department of Public Health, and March of Dimes provides a quality improvement toolkit to decrease the rate of deliveries at < 39 weeks’ gestational age; for details, see the toolkit at https://www.cmqcc.org/resources-tool-kits/toolkits/early-elective-deliveries-toolkit › Refer to the 2016 Joint Commission 2016 flexible ORYX performance measure reporting options at http://www.jointcommission.org/assets/1/18/2016_Flexible_Reporting_Options_10-28-2015.pdf › ACOG provides a series of safety checklists for maternal health, including scheduling induction of labor; for more information, see http://www.acog.org/~/media/Patient%20Safety%20Checklists/psc005.pdf? dmc=1&ts=20140110T1713536975

Coding Matrix References are rated using the following codes, listed in order of strength: M Published meta-analysis SR Published systematic or integrative literature review RCT Published research (randomized controlled trial) R Published research (not randomized controlled trial)

RV Published review of the literature

PP Policies, procedures, protocols

RU Published research utilization report QI Published quality improvement report

X Practice exemplars, stories, opinions GI General or background information/texts/reports

L Legislation

C Case histories, case studies

PGR Published government report

G Published guidelines

PFR Published funded report

U Unpublished research, reviews, poster presentations or other such materials CP Conference proceedings, abstracts, presentation

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