Objective
In 1994, the National Institutes of Health recommended a full course of antenatal corticosteroids (ACS) to women who were at risk of delivery at 24-32 weeks of gestation. In 2010, the Joint Commission on Accreditation of Healthcare Organization incorporated ACS administration rates as a perinatal core quality measure. The objective of this study is (1) to assess ACS administration rates among eligible patients at a tertiary care center and (2) to identify modifiable factors to optimize administration rates.
Study Design
A retrospective chart review of preterm deliveries at <37 weeks of gestation from July 2009 to July 2011 was performed. Hospital level data, delivery information, obstetric history, and neonatal outcomes were abstracted. Categoric variables were compared with the use of the χ 2 test. Continuous variables were compared with the use of a 2-sample t -test, Wilcoxon rank-sum, or Kruskal Wallis tests.
Results
Nine hundred four women had preterm delivery; 38% of them delivered from 24-34 weeks of gestation. Of the eligible patients, 81.3% received at least 1 dose of ACS, and 69.6% received both doses before delivery. The median time from evaluation to ACS administration was 2.6 hours (interquartile range, 1.6–4.8 hours). Thirty-three percent of the patients who did not receive ACS had had a previous triage visit within 2 weeks of delivery (66.6% of them were evaluated for symptoms of preterm labor) vs 2.8% for those women who received ACS.
Conclusion
Of the eligible patients, 81.3% received at least 1 dose of ACS. Tangible opportunities that were identified for systems-based improvement in ACS administration rates included decreasing the time interval from patient evaluation to ACS administration and standardizing outpatient follow-up evaluation for patients who were discharged with symptoms of preterm labor.
Since the publication of the landmark article in 1972 by Liggins and Howie, the obstetric intervention of administering antenatal corticosteroids (ACS) has been one of the greatest medical advances in the improvement of neonatal outcomes. Current data demonstrate that ACS administration is most beneficial within 1 week of therapy. In 1994, the National Institutes of Health developed a consensus statement to give a full course of ACS to all pregnant women who are at risk of a preterm delivery at 24-32 weeks of gestation. Although this has been widespread practice for almost 2 decades, the Joint Commission on Accreditation of Healthcare Organization (TJC) recently established ACS administration rates as a Perinatal Core Quality Measure (PC-03) in 2010.
Beginning in January 2014, TJC will require all delivering hospitals to report their ACS administration rate. The rate is defined as the number of patients who receive at least 1 dose of ACS divided by the number of patients who deliver a live preterm infant between 24-32 weeks of gestation. TJC limits the upper gestational age to 32 weeks because of the variation surrounding ACS administration at 32-34 weeks, especially with the diagnosis of preterm premature rupture of membranes. If ACS is not administered, the reason for not administering ACS must be documented. Although ACS is known to be an effective therapy, it is unclear whether the hospital ACS administration rate is an appropriate and strong clinical quality metric.
The Institute of Medicine defines health care quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.” The well-known Donabedian Model, established by Avedis Donabedian, provides 3 broad domains within which to evaluate health care quality: structure (attributes of setting in which care is delivered), process (actual performance that is consistent with good medical practice), and outcome (impact on health care status). An effective quality metric should be easy to classify, easy to measure, be present in all hospitals, and demonstrate variations among hospitals even after control for potential confounders. Administration of ACS is universally accepted as a beneficial therapy, is easily recorded and measured at the hospital level, and has demonstrated variance in administration rates among hospitals. These characteristics suggest that hospital ACS administration rates are an effective process metric of quality. However, limited data exist that analyze ACS administration rates and that evaluate opportunities to improve this quality metric with the goal of the ultimate optimization of patient outcomes.
The aims of this study were to (1) assess the rates of ACS administration at a high-volume single tertiary care urban institution and (2) identify potential opportunities to optimize administration rates, thereby improving outcomes in neonates who are delivered at 24-34 weeks of gestation. We chose to extend our upper limit of ACS administration to 34 weeks of gestation because it is standard of care at our institution to administer ACS routinely to all patients delivering at <34 weeks of gestation.
Materials and Methods
The medical charts of 904 women who experienced a preterm delivery at <37 weeks of gestation between July 1, 2009, and June 31, 2011, at our institution were abstracted systematically by a single investigator (S.C.). The charts were identified with International Classification of Diseases (9th revision) codes for preterm delivery and confirmed by a review of our institutional delivery documentation system. Institutional Review Board approval was obtained from the University of Pennsylvania.
Specific details regarding maternal demographics, delivery methods, obstetric history, antenatal and postnatal complications, neonatal outcomes, and previous visits to the triage unit were collected. If multiple antepartum admissions were noted for a patient, all admissions after 18 weeks of gestation were abstracted. Gestational age was calculated based on last menstrual period or by ultrasound dating. The administration of ACS was confirmed based on medication administration records. Data regarding time of presentation, time of initial triage evaluation, time of admission, time of ACS order placement, time of ACS administration, and time of delivery were also recorded. Time data were abstracted consistently from the completion of the initial registration sheet by the unit clerk and from our electronic triage and labor and delivery system used at our institution. Delivery time was documented from the delivery documentation record. ACS ordering and administration times were abstracted from our medical administration recording system.
Neonatal data were abstracted from the neonatal chart. Patients with multiple gestations were included, and neonatal outcomes in this situation were evaluated individually for each neonate. Diagnosis of respiratory distress syndrome, intraventricular hemorrhage, or necrotizing enterocolitis was documented as a single composite outcome if the neonatal chart listed any of these. Neonatal intensive care unit admission, number of days in the neonatal intensive care unit, length of stay in the hospital, and disposition from the hospital were also recorded.
The primary outcome for this study is the rate of ACS administration in patients who deliver between 24 and 34 weeks of gestation. All outcome variables were compared among those who received no ACS, 1 dose of ACS, and 2 doses of ACS. Categoric variables were compared with the use of the Pearson χ 2 test. Tests for skewness/kurtosis and the Shapiro-Wilk tests were performed to examine normality of continuous variables. Normally distributed continuous variables were compared with the use of the Student t test or 1-way analysis of variance, as appropriate, and nonparametric data were compared with the use of the Mann-Whitney U or Kruskal-Wallis tests, as appropriate. This cohort included a fixed sample size that was dependent on the time period of the study. STATA software (version 12.1; StataCorp, College Station, TX) was used for data analysis; a probability value of < .05 was considered statistically significant.
Results
Nine hundred four women (11%) had a preterm delivery at <37 weeks of gestation over a 2-year period at our institution. Three hundred forty-four women (38%) delivered between 24 and 34 weeks of gestation and would have been considered eligible for ACS administration. Of the 344 women who were eligible, 81% received at least 1 dose of ACS. Specifically, 195 women (56.6%) received 2 doses of ACS; 85 women (24.7%) received 1 dose of ACS, and 64 women (18.6%) did not receive any therapy ( Figure ). The median gestational ages at delivery for those who received 2 doses of ACS, 1 dose of ACS, and no ACS was 31.4, 31.8, and 30.6 weeks of gestation, respectively ( P = .03; Table 1 ). These administration rates were similar when limited to patients who delivered between 24 and 32 weeks of gestation (TJC PC-03 metric; 78.45% administration rate of at least 1 dose of ACS). Because nearly 20% of eligible patients did not receive any ACS, we sought to evaluate modifiable systems-based factors that may improve administration rates and capture the reason that patients were untreated before delivery.
Variable | Antenatal corticosteroid administration | P value a | ||
---|---|---|---|---|
None (n = 64) | 1 dose (n = 85) | 2 doses (n = 195) | ||
Maternal age, y b | 27.9 (22.5–33.0) | 27.7 (22.6–33.5) | 28.2 (21.0–33.4) | .69 |
Race, n (%) | .39 | |||
White | 7 (12.9) | 6 (7.5) | 27 (14.21) | |
Black | 46 (85.2) | 69 (86.2) | 158 (83.2) | |
Insurance, n (%) | 0.33 | |||
Medicaid | 43 (79.63) | 59 (77.63) | 147 (79.46) | |
Private | 9 (16.67) | 8 (10.53) | 29 (15.68) | |
None | 2 (3.70) | 8 (10.53) | 8 (4.32) | |
Prenatal care, n (%) | .07 | |||
Limited c or none | 14 (22.58) | 13 (15.48) | 21 (10.9) | |
Received care | 48 (77.42) | 71 (84.52) | 170 (89.01) | |
Indication for preterm delivery, n (%) | < .05 | |||
Preterm labor | 35 (54.69) | 39 (45.88) | 46 (23.59) | |
Preterm premature rupture of membranes | 8 (12.50) | 21 (24.71) | 68 (34.87) | |
Other | 21 (32.8) | 25 (29.4) | 81 (41.5) | |
Birth history, n (%) | .61 | |||
Nulliparous | 11 (17.19) | 18 (21.18) | 42 (21.54) | |
Parous without previous preterm delivery | 28 (17.39) | 37 (43.53) | 96 (49.23) | |
Parous with previous preterm delivery | 25 (39.06) | 30 (35.29) | 57 (29.23) | |
Gestational age at delivery, wk b | 30.6 (25.5–32.5) | 31.8 (29.4–33.2) | 31.4 (29.1–33.0) | .03 |
Median time from registration to delivery, h b | 1.27 (0.53–2.42) | 7.96 (4.1–17.3) | 93.65 (60.5–198.8) | < .05 |
Mean cervical dilation on presentation, cm d | 6.05 ± 3.60 | 3.45 ± 2.3 | 1.31 ± 1.34 | < .05 |
a Determined by χ 2 for categoric variables and nonparametric tests of medians for continuous variables, as appropriate, for overall case to control comparison
b Data are given as median (interquartile range)
c Defined as <2 clinic visits or solely emergency room/triage unit visits
Median times from presentation to delivery
The median time from presentation to delivery was calculated for the 3 groups. Presentation time was documented from the time that the initial registration sheet was signed by the unit clerk. The median time from presentation to delivery in those who received both doses of ACS and delivered within the same admission (n = 155 women) was 93.65 hours (interquartile range [IQR], 60.5–198.8 hours). Median time from presentation to delivery in those who received 1 dose (n = 85) was 7.96 hours (IQR, 4.1–17.3). In those who did not receive ACS (n = 64), the median time from presentation to delivery was 1.27 hours (IQR, 0.53–2.42; P < .0001).
Sixty-two percent of those who received only 1 dose of ACS delivered in <12 hours after the initial presentation. Of the 64 patients who did not receive ACS, 18.7% (n = 12 women), 21.8% (n = 14 women), 21.8% (n = 14 women), and 37.5% (n = 24 women) delivered at <30 minutes, 30-59 minutes, 60-120 minutes, and >120 minutes after presentation, respectively. Noting that approximately 40% of patients who did not receive any ACS delivered >2 hours after presentation, we investigated the median time at our institution from presentation to evaluation and from evaluation to administration of ACS.
Median times from presentation to evaluation and evaluation to administration of ACS
There was not a significant difference in the median time from presentation to evaluation among the 3 groups ( P = .38). Overall, the median time from initial patient evaluation to the administration of the first dose of ACS was 2.6 hours (IQR, 1.6–4.8 hours). Among those who received both doses of ACS, the median time from patient evaluation to the administration of the first dose of ACS was 2.65 hours (IQR, 1.75–4.8 hours). Among those who received only 1 dose of ACS, the median time from patient evaluation to the administration of ACS was 1.6 hours (IQR, 1–2.8 hours; P < .05). There was no difference in median time from evaluation to administration based on time of day (7 am to 7 pm ) compared with (7 pm to 7 am ; P = .30).
Nineteen of the 64 patients (29.64%) who did not receive ACS had the medication ordered by the physician, which demonstrated clinical intent by the ordering physician to give the medication. The median time from presentation to delivery in the 19 patients who had it ordered was 1.9 hours (IQR, 1.72–2.57 hours), compared with 0.88 hours (IQR, 0.43–3.87 hours; P = .04) for the 45 patients who did not have it ordered.
We next proceeded to analyze rates of administration based on the indication for the preterm birth to understand how this modified the ability to administer this medication.
Indications for preterm birth
Sixty-seven percent of the patients who did not receive any ACS, 71% of the patients who received 1 dose of ACS, and 58% of the patients who received both doses experienced a spontaneous preterm birth ( Table 1 ). Spontaneous preterm birth included those patients who presented in preterm labor or experienced preterm premature rupture of membranes. Thirty-three percent of the patients who did not receive any ACS, 29% of the patients who received 1 dose, and 42% of the patients who received both doses experienced a medically indicated preterm birth, which included those with placental abruption that necessitated induction or augmentation, maternal hypertensive or cardiovascular diseases, or other maternal or fetal medical indications that required preterm delivery. We finally looked at clinical characteristics that could assist in the improvement of administration rates.
Clinical characteristics
In evaluating the clinical characteristics of parity, a history of preterm birth, or initiation of prenatal care, there is not a statistically significant difference among those who received and did not receive ACS. Mean cervical dilation at presentation was significantly different between those who received no ACS, 1 dose of ACS, and both doses of ACS (6 cm, 3.6 cm, and 1 cm, respectively; P < .001; Table 1 ). Of those who arrived with a cervical dilation of <4 cm, 92.24% of the women received ACS.
Finally, to evaluate whether there was under usage of ACS therapy, previous visits to the triage unit within 2 weeks of delivery for symptoms of preterm labor were compared among those who received at least 1 dose of ACS vs those who did not receive ACS ( Table 2 ). Thirty-three percent of the women who did not receive ACS had a previous triage visit within 2 weeks of delivery, and 66.6% of those visits were for symptoms of preterm labor. Of the women who had received ACS, only 2.8% had a previous triage visit within 2 weeks of delivery. The mean cervical dilation on discharge from previous triage visit was not statistically different between the 2 groups.
Outcome variable | Antenatal corticosteroids | P value a | |
---|---|---|---|
Administered (n = 280) | Not administered (n = 64) | ||
Previous triage visit within 2 weeks of delivery, n (%) | 8 (2.8) | 21 (32.8) | .04 |
Reason for triage, n (%) | |||
Preterm labor | 5 (62.5) | 14 (66.6) | .833 |
Other | 3 (37.5) | 7 (33.3) | .833 |
Cervical dilation on discharge, cm b | 1 ± 0.81 | 1.6 ± 1.13 | .577 |