Contemporary rates of cesarean delivery in the United States are a cause of concern. Compared with vaginal deliveries, cesarean deliveries are associated with increased risks for maternal morbidity and mortality.1–3 Women with a prior cesarean delivery are at risk for severe complications such as uterine rupture, abnormal placentation, and unplanned hysterectomy in a subsequent pregnancy.2–4 Thus, the increase in cesarean delivery rates, from 20.7% in 1996 to a relative plateau around 32% from 2009 to 2017,4 likely has contributed to overall increases in maternal mortality and morbidity documented during the past two decades.5–7
Reducing cesarean delivery rates, particularly for first-time mothers with low-risk pregnancies, is a stated goal for key professional organizations and federal agencies.9–11 In a 2014 consensus statement, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine recommended adoption of evidence-based practices for improving clinical care and changing practice culture to reduce cesarean delivery rates among nulliparous, term, singleton, vertex pregnancies.8 Selected practice guidelines have been packaged by the Council on Patient Safety in Women's Health Care into the Safe Reduction of Primary Cesarean Births patient safety bundle (hereafter cesarean bundle), which is now being implemented in several states with technical assistance from the Alliance for Innovation in Maternal Health and support from the Health Resources and Services Administration.9 Several other patient safety bundles developed to address key contributors to maternal mortality and morbidity in the United States are increasingly implemented through the Alliance for Innovation in Maternal Health program across the country.10 Of note, the Alliance for Innovation in Maternal Health promotes widespread adoption of obstetric patient safety bundles through state-based perinatal quality collaborative networks, currently functional in more than 40 states.11,12
All patient safety bundles implemented through the Alliance for Innovation in Maternal Health program include a list of evidence-based or evidence-informed clinical practice and institutional policy recommendations organized under four domains—Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning (the 4 “Rs”). They are designed to be adaptable, allowing each hospital to choose which bundle components to implement and in what order, given local context.9,13 Each hospital's overall implementation design and specific implementation strategies may influence its success with the Alliance for Innovation in Maternal Health bundles. Implementation strategies are commonly defined as “methods or techniques used to enhance the adoption, implementation, and sustainability of a clinical program or practice.”14 A wide variety of strategies are employed for quality improvement (QI) in clinical practice—some are more common (eg, consensus building, monitoring progress), whereas others are infrequent (eg, creating financial incentives).15 With a limited number of studies having tested strategies for implementing evidence-based practice in obstetric care, further exploratory research is needed to identify the most promising implementation strategies that may lead to desired changes in clinical practice and inform clinicians of these strategies.16
This study presents results from an assessment of the implementation of the Alliance for Innovation in Maternal Health cesarean bundle through the Maryland Perinatal Quality Improvement Collaborative. The primary objective of this study is to describe the status of implementation of practices recommended in the cesarean bundle at 1 year. The secondary objective is to assess whether hospital characteristics and implementation strategies employed are associated with bundle implementation.
The work of the Maryland Perinatal Quality Improvement Collaborative is coordinated by the Maryland Patient Safety Center and has the voluntary participation of 31 of the 32 birthing hospitals in Maryland. The collaborative began implementing the cesarean bundle with support from the Alliance for Innovation in Maternal Health program in June 2016 (Appendix 1, available online at http://links.lww.com/AOG/B403, for a description of activities and resources for Maryland's primary cesarean birth collaborative). One year after the start of the collaborative, we sent a computer-based survey in Qualtrics to hospital collaborative leaders to assess progress with bundle implementation at each hospital. The survey instrument's first section included questions about characteristics of survey respondents (position, gender, years of experience working in labor and delivery, and years of experience working in the index hospital) and hospitals (level of maternity care I–IV, health system membership, continuous availability of in-hospital anesthesia care, numbers of obstetricians and nurse midwives delivering in the hospital, annual number of deliveries).
For the second section of the survey, we unpacked the cesarean bundle recommendations into specific, discrete clinical practices and policies. In doing so, we aimed to align our efforts with work conducted by the California Maternal Quality Care Collaborative in their Implementation Guide for the Toolkit to Support Vaginal Births and Reduce Primary Cesarean.17 We arrived at 26 bundle-recommended clinical practices included as “priority steps” for hospitals aiming to reduce their primary cesarean delivery rates in the Implementation Guide (Appendix 2, available online at http://links.lww.com/AOG/B403). For one of the bundle's components in the Recognition and Prevention domain (ie, “Adopt protocols for timely identification of specific problems […]”), the number of possible protocols to be adopted was judged as too large to assess adoption of any one such protocol statewide. However, the adoption of training or procedures for identifying breech position and performing external cephalic version technique is assessed in relation to one of the bundle components in the Response domain. For each specific practice recommended in the cesarean bundle, the survey asked respondents to characterize their hospital's implementation progress as follows: not started, in the planning phase, partially implemented, fully implemented during the collaborative, or fully implemented before the collaborative.
The survey's third section asked whether hospitals employed each of 15 strategies to support implementation of practices in the bundle. The list of 15 strategies was derived from a comprehensive expert compilation published in Implementation Science.18 Of note, these strategies used for our assessment were not specifically recommended by the Alliance for Innovation in Maternal Health or during collaborative trainings. The survey provided corresponding definitions for each implementation strategy (Appendix 3, available online at http://links.lww.com/AOG/B403). Our research team included both obstetricians practicing in Maryland hospitals and implementation science experts, all of whom reviewed and provided feedback on the survey instrument.
Collaborative leaders at the 31 birthing hospitals were identified from the email list maintained by the Maryland Perinatal Quality Improvement Collaborative. They were informed about the survey at the collaborative's in-person meeting in June 2017 and subsequently received email invitations to complete the survey online; up to four email reminders to complete the survey were sent between July 1 and August 31, 2017. Participation in the survey was voluntary. All participants provided informed consent to complete the survey. Surveys were completed by collaborative leaders at 27 of the 31 hospitals (87.1%) participating in the collaborative. One respondent completed the respondent and hospital characteristics sections but reported only on practices under the Readiness domain of the bundle; another respondent did not complete the section regarding employment of the 15 implementation strategies. Survey responses were exported from Qualtrics into Stata 15 for analysis.
Several secondary sources provided additional data on hospital characteristics. We obtained information on hospital type (for-profit or not-for-profit), teaching status, and annual number of births from publicly-available American Hospital Association hospital profiles.19 We used the Office of Rural Health Policy's 2016 list of rural counties to identify hospitals serving rural areas,20 and obtained the percentage of patients covered by Medicaid from the Maryland Hospital Community Benefit Report.21
We calculated descriptive statistics for respondent and hospital characteristics, the implementation status of each of the 26 bundle practices of interest, and the use of the 15 implementation strategies. We tested for statistically significant differences in the number of bundle practices implemented before and during the collaborative by hospital characteristics and implementation strategies using the Wilcoxon rank-sum and Kruskal-Wallis tests. Level III and IV hospitals are combined for analysis to prevent identification of participating hospitals. Hospitals with missing responses for a variable were excluded from respective analyses of that variable.
This study was reviewed and approved by the Institutional Review Board of the University of Maryland, Baltimore County (protocol # Y17K21240).
Collaborative leaders from 27 hospitals responded to the survey. Seventeen respondents (63.0%) were Nursing Directors or Managers, three (11.1%) were Safety Quality Managers, one (3.7%) was a Medical Director, and the other six (22.2%) were nurses or midwives (Table 1). All respondents were female with an average of 24.5 years (SD 10.9) of experience working in labor and delivery and 13.8 years (SD 12.2) of experience at the index hospital. All 27 hospitals were not-for-profit, seven (25.9%) offered level I maternity care, eight (29.6%) level II maternity care, and 12 (44.4%) level III or IV maternity care. Only two hospitals (7.4%) were in rural areas, 18 (66.7%) were teaching hospitals, and 20 (74.1%) were part of a health system. The majority of hospitals (81.5%) had continuous anesthesia coverage. On average, 2,030 annual deliveries occurred at the 27 hospitals, of which about one-fifth were covered by Medicaid.
Hospitals reported substantial variability in implementation of most bundle practices both before and during the collaborative (Fig. 1 and Appendix 4 [Appendix 4 is available online at http://links.lww.com/AOG/B404]). Before the collaborative, 23 of the 26 hospitals with complete reporting had implemented at least one of the bundle-recommended practices assessed, whereas three had not implemented any. On average, hospitals had fully implemented a third (mean 8.6; SD 5.5; range 0–17) of bundle practices before the start of the collaborative. During the first year of the collaborative, 23 of the 26 hospitals fully implemented at least one new bundle practice. In three of the 23 hospitals that fully implemented a new practice during the collaborative (one level I and two levels III to IV), no bundle practice had been implemented before the collaborative. On average, hospitals fully implemented three (SD 2.4; range 0–8) new practices during the first year of the collaborative.
Interestingly, practices in the Readiness domain had the lowest level of implementation compared with the other three bundle domains. The only practice under Readiness that was implemented at the majority of hospitals (59.3%) was formation of a multidisciplinary implementation team. Each of the remaining four practices in this domain had only been implemented at one-third or fewer of 27 reporting hospitals (Table 2). Staff training on labor and support techniques was fully implemented at nine hospitals (33.3%), with five of these hospitals (18.5%) having implemented such training during the collaborative. The Readiness practice with the lowest level of implementation was the establishment of a policy to integrate doulas into the birth care team, with the majority of hospitals (59.3%) not having started to implement such a policy. The average number of fully implemented Readiness practices either before or during the collaborative was 1.5 out of 5 (range 0–5).
More than half of the 26 hospitals reporting on implementation of practices in the Recognition and Prevention as well as Response domains had implemented 7 of the 15 corresponding practices. Standardized assessment, interpretation, and documentation of fetal heart rate status using recognized terminology was the most commonly implemented practice, in place in 19 hospitals (73.1%) before the collaborative and adopted by 5 hospitals (19.2%) during the collaborative. Twenty-two (84.6%) and 19 (73.1%) hospitals had fully implemented standardized induction scheduling and ensured in-house maternity care provider or alternative coverage for labor problems, respectively; most of these hospitals did so before the collaborative. Although all practices in the Response domain were implemented by at least 30% of reporting hospitals, two practices (training on forceps and vacuum extraction, and training or procedures for identification of breech position and external cephalic version technique) stand out for having had a slow implementation start. Moreover, more than 42% of reporting hospitals had not started planning for implementing these two practices. On average, reporting hospitals had fully implemented four of eight Recognition and Prevention domain practices (range 0–8) and 3.8 of 7 Response domain practices (range 0–7) at 1 year into the collaborative.
Some Reporting and Systems Learning practices had a high degree of implementation during the collaborative. Monthly case reviews—a bundle practice that hospitals in the collaborative are expected to report as a process measure—were implemented by 12 of the 26 reporting hospitals (46.2%) during the collaborative; three other hospitals (11.5%) were already performing such reviews before the collaborative. Also of note, eight reporting hospitals (30.8%) began tracking provider-level cesarean delivery rates during the collaborative, whereas 10 hospitals (43.5%) were already doing so before the collaborative. The most commonly tracked provider-level rates are overall cesarean delivery rate (20/26 hospitals), primary and nulliparous, term, singleton, and vertex cesarean delivery rates (18/26 hospitals), and vaginal birth after cesarean delivery rate (8/26 hospitals; data not shown). Yet, only 8 of 26 reporting hospitals were sharing provider-specific cesarean delivery rates with the department 1 year after the start of the collaborative. On average, reporting hospitals had adopted 2.2 of 6 bundle practices (range 0–6) in the Reporting domain within the first year of the collaborative.
Although the mean number of bundle practices fully implemented before and during the collaborative does appear to vary by maternity level of care and other hospital characteristics (Table 3), we had limited power to detect statistically significant differences with the small population of hospitals in Maryland. The only hospital characteristic found to have a significant association with bundle implementation in this small sample was having 20 or more full-time obstetricians on staff—this led to 2.01 more bundle practices having been implemented during the collaborative (P<.05).
Twenty-four of the 25 hospitals with complete reporting of implementation strategies had employed at least one of the 15 strategies we assessed (Table 4). The most commonly used strategies were conducting readiness assessments and consensus discussions (15/25 reporting hospitals); the least commonly used were those designed to engage patients in the implementation effort (2/25 hospitals). Despite our limited statistical power, six of the 15 implementation strategies were found to be associated with statistically significant differences in practice adoption during the collaborative at P<.05. Hospitals that conducted a local needs assessment, developed a formal implementation blueprint, and staged implementation scale up, fully implemented an average of 2.0, 3.7, and 2.5 more bundle practices, respectively, during the collaborative's first year compared with hospitals not using these strategies (all P<.05). Also, hospitals that conducted consensus discussions and identified and prepared champions implemented around two more practices than other hospitals (all P<.05). Finally, hospitals that tailored recommended strategies and interventions had implemented 2.3 more practices (P<.05) than those not doing so during the collaborative's first year.
Reported levels of full adoption of cesarean bundle practices 1 year into Maryland's collaborative are variable and low—only 10 of 26 practices were fully implemented by more than 50% of hospitals. However, it is promising that a majority of hospitals implemented new bundle practices during this first year and, if not already fully implemented, bundle components are in the planning stage or partially implemented in most reporting hospitals. The cesarean bundle is large, and this interim assessment indicates that implementing bundle practices takes time and progress is incremental. All but three hospitals in this study had adopted some of the practices included in the bundle before the collaborative, so progress made during the collaborative builds on previous efforts.
The variation in implementation of bundle practices is likely linked to the marked variability between birthing hospitals throughout Maryland in the types of services offered,22,23 clinical practice structures,23 and other contextual factors that influence cesarean delivery rates (eg, presence of a residency program,24 for-profit status,25 proportion of private providers,26 number of midwives,26 availability of and payment for doulas assisting deliveries).16,27 Although implementation of the cesarean bundle was not expected to be standard across hospitals, some of the bundle components received relatively greater attention from hospitals. About 50% of the rise in primary cesarean deliveries in the United States over the past two decades has been attributed to subjective indications such as labor arrest disorders (18%) and nonreassuring fetal status (32%).28,29 Both diagnoses are provider-dependent, showing not only that practice style, providers' decision-making, and the unit culture help drive cesarean delivery rates, but emphasizing the need to provide labor support to prevent dysfunctional labor and reduce cesarean delivery rates. The cesarean bundle heavily promotes such practices, yet they were not among the most commonly adopted in Maryland hospitals during the Maryland Perinatal Quality Improvement Collaborative's first year implementing the cesarean bundle. Notably, some of the most commonly-implemented practices (eg, consistent in-house coverage by an obstetrician), are not the least costly or labor intensive. There appears to have been widespread buy-in from physicians and hospitals for these specific practices, which may be a result of perceptions about their ability to change outcomes or decrease risk of litigation.
Studies before ours have demonstrated that some implementation strategies are more effective than others at changing and improving provider practices.30–32 In our study, six implementation strategies were significantly associated with adoption of more bundle practices by hospitals. Although these associations may be the result of unmeasured differences in hospitals' culture or implementation capacity, all six strategies identified are highly dependent on strong clinician involvement. Further research is needed to validate our findings and better understand which strategies are most effective for the implementation of the cesarean bundle—this will help ensure the much needed implementation support from a majority of clinicians. The recent study by Main et al33 provides the needed reassurance of the safety of practices in the Alliance for Innovation in Maternal Health cesarean bundle.
Our assessment has limitations. The study's small sample size does not provide statistical power to detect small differences in the adoption of bundle practices by hospital characteristics or employed implementation strategies, thus results should be interpreted with caution. We only surveyed collaborative leaders at participating hospitals and could not validate their responses; however, the involvement of Maryland Perinatal Quality Improvement Collaborative's leadership in the study has likely benefitted our obtaining accurate responses. Our survey was designed to provide an overview of the status of bundle practice adoption and, thus, we did not examine the characteristics of the practices adopted (eg, complexity, adaptability, relative advantage) and their effects. Vamos et al34 did so after implementation of the hemorrhage bundle in Florida and learned that when practices are perceived to be complex, staff experience with implementation is adversely affected and more implementation support is needed. Overall, hospitals that are slow adopters of bundle interventions can be targeted with additional support from the collaborative.
The hemorrhage bundle is recognized as having served as the “template” for QI in obstetrics in the United States.12 Main et al35 documented that participation in the hemorrhage collaborative in California was associated with significant reductions in severe maternal morbidity among hemorrhage patients; hospitals in their second rather than first collaborative had greater reductions in morbidity. Maryland birthing hospitals had previously implemented QI action through a statewide collaborative model and reduced early elective deliveries and inductions to less than 2% of deliveries in the state by December 2013.36 Although related, adoption of the cesarean bundle is considerably more complex and resource-intensive. Clinicians hold variable attitudes regarding cesarean delivery37 and may be more motivated to adopt practices directly addressing the most prevalent causes of morbidity (ie, hemorrhage, severe hypertension) than to reduce cesarean delivery. With QI considered to be a cumulative process,35 we expect positive changes in primary cesarean delivery rates across most hospitals when outcomes data become available after the end of the collaborative (ie, December 2018).
States' experiences with the patient safety bundles and the Alliance for Innovation in Maternal Health program is starting to emerge.12 Learnings to date suggest that “cookie cutter” approaches for their implementation are not useful. Thus, in line with our findings, the goal should be for hospitals to create their own blueprint for implementing the Alliance for Innovation in Maternal Health bundles and gain clinicians' support and commitment to practice changes. It is the latter that will help ensure the long-term sustainability of the Alliance for Innovation in Maternal Health program.
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