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Contents: Cesarean Delivery: Original Research

Enhanced Recovery After Surgery to Change Process Measures and Reduce Opioid Use After Cesarean Delivery

A Quality Improvement Initiative

Hedderson, Monique PhD; Lee, Derrick MD; Hunt, Eric MD, PhD; Lee, Kimberly MD; Xu, Fei MS; Mustille, Alex PhD; Galin, Jessica MPH; Campbell, Cynthia PhD; Quesenberry, Charles PhD; Reyes, Vivian MD; Huang, Mengfei PhD; Nicol, Barbara MD; Paulson, Shirley DNP, MPA, RN; Liu, Vincent MD, MS

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doi: 10.1097/AOG.0000000000003406
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Enhanced recovery after surgery (ERAS) programs are evidence-based care pathways designed to decrease the surgical stress response and maximize the potential for recovery.1 These pathways include the use of multimodal analgesia to reduce opioid exposure, avoidance of prolonged fasting, encouragement of early mobility, and education of patients regarding goals and expectations of surgery.2–5 Enhanced recovery after surgery programs have been implemented and evaluated in a variety of surgical populations, including colorectal, thoracic, complex urologic, joint replacement, and gynecologic surgical populations,3–12 but less is known about ERAS programs among patients undergoing elective cesarean delivery.

Kaiser Permanente Northern California, a large integrated health care delivery system, developed and implemented an ERAS pathway protocol for cesarean delivery, with implementation taking place between March and October 2016 across 15 medical centers. We designed this pre–post study to assess changes in process measures (defined as clinical care actions clinicians perform to maintain or improve the health of their patients)13 and outcomes among patients undergoing elective cesarean deliveries during the 12 months before and 12 months after implementation of the ERAS program.

METHODS

This study was approved by the Kaiser Permanente Northern California Institutional Review Board. A multidisciplinary team of obstetricians, anesthesiologists, perinatologists, neonatologists, nursing leaders, and medical research consultants in Kaiser Permanente Northern California developed an ERAS care pathway for patients undergoing cesarean delivery based on prior ERAS efforts targeting other surgical populations; these methods have been previously described.6,14 The Kaiser Permanente Northern California ERAS Program aimed to standardize surgical care with an emphasis on four interventions: 1) multimodal pain management and decreased opioid use, 2) early mobility, 3) optimal nutrition, and 4) patient engagement (Table 1).

Table 1.
Table 1.:
Care Processes Included in the Enhanced Recovery After Surgery Program

For pain management, post-ERAS patients routinely received intrathecal opioids followed by acetaminophen and nonsteroidal antiinflammatory drugs (NSAIDs) every 6 hours, or four times daily. Patients received scheduled 24 hours of intravenous (IV) acetaminophen followed by oral acetaminophen. Oral oxycodone was available for breakthrough pain. Inpatient pain management was directed toward decoupling opioid administration from that of other pain medications (eg, NSAIDs and acetaminophen). A similar practice was implemented for default discharge decoupled pain medication prescriptions (defined as separate prescriptions for opioids, acetaminophen, and NSAIDS as opposed to combination products). Pre-ERAS cohort, the order sets, which consisted of predefined bundles of physician orders with standardized options, included the option for hydrocodone or oxycodone with a default quantity of 30 tablets. Post-ERAS, we decoupled the medications (acetaminophen and oxycodone). There was still the option for hydrocodone, but most providers elected to use decoupled combinations, so patients could maximize their acetaminophen dose before adding an opioid (oxycodone). The number of tablets in the opioid prescription was reduced to 20 tablets. Pre-ERAS patients were encouraged to ambulate as tolerated and the removal of the Foley occurred after ambulation was established. Post-ERAS patients were encouraged to begin ambulation within 12 hours of surgery completion. Pre-ERAS patients were advised to fast after midnight, but this was not standardized; post-ERAS patients were provided 8 oz (237 mL) of carbohydrate drink to be consumed 2 hours before hospital arrival, with diabetic patients instructed to drink water instead, given gum to chew, and offered a regular diet within 12 hours after surgery. Preoperative surgical site infection prophylaxis during the Pre-ERAS period included preoperative antibiotics and a chlorhexidine gluconate abdominal prep. For post-ERAS implementation, chlorhexidine wipes were added to this regimen to use at home.

In the ERAS epoch, patient education was provided during a preoperative visit where patients received an ERAS kit that included a brochure explaining ERAS and what to expect before, during, and after their surgery, the carbohydrate drink with instructions on when to consume it, and instructions on the use of the chlorhexidine wipes. Patients were educated regarding what to expect during their surgery and the benefits of the ERAS pathways by their providers, the cesarean delivery scheduling staff and nurses in the hospitals. At each hospital, a staff member reviewed with patients a brochure explaining ERAS, the principles of ERAS, and answered any questions. Implementation of ERAS care processes were supported by the development of standardized electronic health record (EHR)–based order sets.

The ERAS program was implemented in a staggered nonrandomized fashion across 15 medical centers throughout 2016. Two pilot sites were chosen based on leadership interest, performance improvement expertise, and clinician engagement with implementation occurring in March 2016. Full regional implementation was completed at the remaining 13 centers in October 2016. Nursing and physician leads at each site were supported by local quality and multidisciplinary clinical teams that led ERAS pathway implementation. Thus, existing staff was used to implement the ERAS program. These local teams also oversaw education of physicians, nurses, and other staff, and provided regular feedback on local ERAS process metrics and outcomes. Regional performance dashboards were created to provide a performance report to review the process measures and outcomes at each of the 15 medical centers and for the Kaiser Permanente Northern California region overall were developed to display and track process and outcome measures based on the EHR data and were provided on a weekly basis to local teams. Regional support was also provided through biweekly teleconferencing and frequent communication with nurse consultant mentors,14 who were experts in performance improvement deployed to each medical facility to facilitate ERAS implementation and to identify and provide solutions for any barriers. A regional Kaiser Permanente Northern California leadership team monitored implementation working in conjunction with three clinical regional nursing coordinators.

We used a pre–post study design to compare changes in processes and outcomes among patients undergoing elective cesarean delivery before and after implementation of the ERAS program. Starting with the ERAS implementation month, standardized as “time zero” for each medical center, we collected process and outcomes data from the preceding (pre) 12 months and subsequent (post) 12 months using EHR data, excluding the month of implementation, “time zero.” Kaiser Permanente Northern California's EHR system is designed by Epic Corporation and customized for the needs of Kaiser Permanente and has been renamed KP HealthConnect. All medical centers and hospitals in Kaiser Permanente Northern California use the same KP HealthConnect system.

We identified elective cesarean delivery ERAS patients based on International Classification of Diseases, 10th Revision, Clinical Modification hospital diagnosis and procedure codes, including diagnosis codes 082.1, 082.2, 082.8, 082.9 and procedure code 59510. We restricted our analysis to elective cesarean deliveries to ensure that there was adequate time for the ERAS process measures to be implemented preoperatively. We identified elective procedures based on an EHR operating room scheduling database. A validation of 100 randomly selected cesarean deliveries study found that 95% of cases were correctly identified as elective or urgent when comparing clinical documentation with EHR data.

We selected process of care measures within each ERAS perioperative care element, excluding patient education and engagement, in our analysis. For pain management and sedation, we evaluated: 1) the daily IV morphine-equivalent dosage of opioid medication administered from 4 hours before the operating room through the third postoperative day (“opioid usage”); 2) the use of multimodal analgesia, defined multimodal as the administration of two or more doses of NSAIDs from 4 hours preoperatively through the first postoperative day, and the administration of two or more doses of IV acetaminophen during the same time period; and 3) delta pain scores, defined as the difference between a patient's acceptable level of pain (based on a visual analogue scale from 0 to 10) and the amount of pain they reported feeling at a specific moment in time to assess how well pain was being managed. A score of 0 or less suggests that a patient's pain was being adequately managed. We quantified these metrics using standardized methods based on medication administration records, preoperative checklists, and nursing shift assessments recorded in the EHR6,14

We also identified outpatient opioid dispensations at discharge from the Kaiser Permanente Northern California pharmacy database including generic name, strength, date dispensed, quantity dispensed, and days-supply. More than 90% of Kaiser Permanente Northern California members obtain all or almost all of their prescription medications through Kaiser Permanente Northern California pharmacies.15 We focused on formulations with higher likelihood of abuse, and those used primarily to treat pain based in prior studies,16,17 excluding non–pain related opioid formulations (ie, antitussives, anesthetics, antihistamines, antidiarrheals) and medications to treat opioid use disorder (eg, buprenorphine). We determined the percentage of opioid prescriptions for opioid tablets, for which the opioid was decoupled from a second medication such as acetaminophen. Dispensations were converted into mean morphine milligram equivalents per day using a standard conversion table.18 We also determined the number of tablets per prescription filled at hospital discharge.

For mobility, we evaluated 1) ambulation within 12 hours of surgery (“early ambulation”) and 2) the elapsed hours from surgery to first ambulation (“hours to ambulation”). Time to first ambulation was documented by nurses and recorded in flowsheets in the EHR both pre-ERAS and post-ERAS implementation. For nutrition, we evaluated 1) the provision of last meal or liquids in the preoperative period (no prolonged fast), 2) the provision of postoperative oral nutrition within 12 hours of surgery (“early nutrition”), and 3) the elapsed hours from surgery to first nutrition (“hours to nutrition”).

Study outcome metrics included hospital length of stay, discharge to home, 30-day readmission, and 30-day intensive care unit (ICU) admission extracted from EHR data. We identified surgical site infections based on manually abstracted data compiled in the National Healthcare Safety Network. We also extracted EHR data on breastfeeding from inpatient flowsheets and based on data from the first well-child visit typically at 7 days postdelivery.

To assess for potential secular changes in our elective cesarean cohort, we extracted data on maternal age at delivery, race–ethnicity, parity, and gestational age at delivery. We identified neonatal birth weights using EHR data including categories such as large for gestational age (birth weight greater than 90th percentile) and small for gestational age (birth weight less than 10th percentile) according to the Kaiser Permanente Northern California race–ethnicity and gestational age-specific birth weight distribution.19

Descriptive statistics are reported separately for the pre-ERAS and post-ERAS implementation periods. Medians and interquartile range are used to describe continuous variables. Frequencies and percentages are used to describe categorical variables. Unadjusted comparisons between groups are based on t-tests, Wilcoxon rank-sum, or chi-squared tests, respectively. Our pre–post analyses adjusted for calendar month and demographic variables to account for seasonal changes in cesarean delivery rates, which may affect outcomes and the characteristics of the underlying population including demographics and reproductive risk factors (ie, age at delivery, race–ethnicity, prepregnancy body mass index [BMI, calculated as weight in kilograms divided by height in meters squared], parity, and preterm birth). We used generalized linear regression to estimate the effect of exposure to the ERAS program (post compared with pre) on continuous outcomes of interest. The regression model form (ie, link) and distributional assumptions varied, as appropriate to each outcome of interest. Poisson regression with robust standard errors were used to provide crude and adjusted estimates of relative risks (RR) to estimate the effect of exposure to the ERAS program (post compared with pre) on dichotomous outcomes of interest.20

RESULTS

A total of 4,689 patients underwent an elective cesarean delivery in the 12 months before, and 4,624 patients in the 12 months after ERAS program implementation. Patient demographic and reproductive characteristics were similar in the preimplementation and postimplementation periods, except that patients delivering during the post-ERAS implementation period were slightly more likely to be black or Hispanic and to be overweight or obese compared with patients delivering during the pre-ERAS implementation period (Table 2).

Table 2.
Table 2.:
Characteristics of Patients in the 1-Year Periods Before (Pre) and After (Post) Enhanced Recovery After Surgery Implementation

The daily inpatient morphine equivalents decreased significantly from 10.7 to 5.4 equivalents in the multivariable adjusted model (Table 3). The use of multimodal analgesia increased significantly from 9.7% to 88.8%, with a 9-fold increased adjusted RR for meeting multimodal analgesic goals, driven by an 8-fold increase in IV acetaminophen use. The percent of time patients reported acceptable pain scores increased significantly from 82.1% before ERAS to 86.4% after ERAS implementation. The patient reported acceptable pain scores were significantly higher in the post-ERAS implementation period for all postoperative days (0–3) (data not shown). The percent of patients that did not use any postoperative inpatient opioids increased significantly (Table 2). The average number of tablets per prescription of outpatient opioid prescription at hospital discharge also decreased significantly from 37 to 26; with the average morphine milligram equivalents per day of the outpatient prescription at hospital discharge decreasing from 53.3 to 50.4.

Table 3.
Table 3.:
Multivariate Adjusted* Associations of Post-ERAS Implementation Changes With Process Measures

Most process measures of surgical care among patients undergoing elective cesarean delivery changed significantly between the pre-ERAS and post-ERAS implementation phases in multivariable models adjusting for patient age, race–ethnicity, BMI, parity, preterm birth, medical center, and calendar month (Table 3). After ERAS implementation, the adjusted mean hours to first ambulation decreased by 2.7 hours (95% CI −3.1 to −2.4) with a concomitant increase in the percentage of patients who walked within 12 hours of surgery from 43.6% to 60.9% (RR 1.4; 95% CI 1.3–1.5). The percent of patients that had last liquids, instead of a prolonged fast, before surgery increased four-fold after ERAS implementation (RR 3.99; 95% CI 3.68–4.33). There was a four-fold increase in patients that received early nutrition (RR 4.50; 95% CI 4.19–4.84) and the mean time to first nutrition decreased by 11.1 hours (95% CI −11.5 to −10.7).

The changes in process measures after ERAS implementation appeared to be sustained through the 1-year period after implementation (Fig. 1).

Fig. 1.
Fig. 1.:
Monthly process measure attainment before and after enhanced recovery after surgery implementation. Implementation is standardized to the go-live month within each facility. Each point represents averaged values over a 1-month period; data from the implementation month (month zero) are not included. Early ambulation (%) (A); early nutrition (%) (B); average morphine equivalents rate per day (mg), median (C); met multimodal analgesic (%) (D).Hedderson. Enhanced Recovery After Surgery and Elective Cesarean Deliveries. Obstet Gynecol 2019.

There were no statistically significant changes in any of the outcome metrics during the post-ERAS period. For example, surgical site infection rates after ERAS were not significantly different compared with before ERAS implementation (RR; 1.26; 95% CI 0.94–1.70) (Table 4).

Table 4.
Table 4.:
Multivariable Adjusted* Associations of Post-ERAS Implementation Changes With Outcome Metrics

DISCUSSION

Multi-center implementation of an ERAS program in a large integrated health care delivery system was associated with significant practice changes among patients undergoing elective cesarean delivery. The most significant finding after ERAS program implementation was an almost 50% decrease in the average inpatient opioid exposure per day which was accompanied by stable, or increased, rates of patient-reported acceptable pain thresholds. There was also more than 85% adoption of multimodal analgesia for managing perioperative pain among patients undergoing elective cesarean deliveries post-ERAS implementation. Enhanced recovery after surgery implementation was also associated with improved early mobilization and nutrition targets. There were no significant increases in adverse outcomes after program implementation.

Implementation of the ERAS program was associated with changes in process measures without negatively affecting outcomes, including surgical site infections, length of stay, hospital readmissions, or breastfeeding rates. Although we did not observe a significant decrease in hospital length of stay or surgical site infections, as has been observed in other ERAS patient populations in Kaiser Permanente Northern California,6 this may be a result of the fact that the length of stay is already short (less than 3 days) and surgical site infections were rare among the elective cesarean delivery patient population, making it more difficult to affect those outcomes. We also did not anticipate a significant decrease in length of stay, given clear regulatory guidelines on maternal length of stay of 96 hours after cesarean delivery. Therefore, a length of stay reduction was specifically excluded as a goal of the ERAS program.

Consistent with past studies of acute pain management following both obstetrics and gynecology procedures and non–obstetrics and gynecology procedures that have demonstrated multimodal analgesia is associated with superior pain relief and decreased opioid use,6,21 we found a significant, almost 50%, reduction in inpatient morphine milligram equivalents of opioid exposure associated with the adoption of multimodal analgesia use post-ERAS. These changes in pain management were associated with improved patient-reported acceptable pain scores. A recent quality improvement intervention designed to eliminate routine use of oral opioids for analgesia postcesarean delivery was also associated with a reduced use of oral opioids in-hospital from 68% to 40%, with no associated change in patient satisfaction or pain relief and also decreased opioid prescriptions at hospital discharge.22 Our findings contribute to a growing body of evidence that is possible to implement quality improvement programs to reduce inpatient and outpatient opioid exposure without negatively affecting pain relief.

Enhanced recovery after surgery implementation was associated with a shift to prescribing outpatient decoupled opioids.23 This is consistent with The American Pain Society published guidelines for the management of acute pain,24 recommending that nonopioid analgesics, such as NSAIDs and acetaminophen, should be used as first-line therapy, with the use of supplemental opioid medications only if needed.

The study has important limitations. First, a pre–post study design is unable to distinguish association from causation. Thus, the results may be affected by residual confounding and baseline differences in the pre and post patient populations as well as other institutional or practice changes occurring during the study period other than the ERAS implementation. The finding of a decrease in outpatient postdischarge opioid dispensations may have been affected by Center for Disease Control and Prevention guidelines25 and a recent opioid safety initiative implemented by the health system. The initiative implemented local guidelines and provider training around screening for opioid misuse, implementing signed opioid agreements, increasing urine drug screening, and reducing high-dose prescribing as appropriate.26 Kaiser Permanente Northern California is an integrated health care delivery system, thus it may not be representative of other health care systems in the United States. Enhanced recovery after surgery implementation and results may vary in other settings depending on the model of surgical practice and performance improvement methodology. We did not collect information on patient-reported outcomes so we were unable to assess whether the ERAS program affected patient satisfaction.

Implementation of the program was associated with positive process-of-care metrics for patients undergoing elective cesarean delivery in 15 hospitals. In this study, ERAS implementation was associated with significantly reduced inpatient opioid exposure with improvement in the proportion of time patients reported their pain as acceptable and had no association with postoperative complication rates.

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