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Background: As an evidence-based intervention to prevent maternal and neonatal morbidity and mortality, cesarean birth at rates of under 2%, which is the case in rural Southwest Ethiopia, is an unacceptable public health problem and represents an important disparity in the use of this life-saving treatment compared to more developed regions. The objective of this study is to explore an innovative clinical solution (a mobile cesarean birth center) to low cesarean birth rates resulting from the Three Delays to emergency obstetric care in isolated and underserved regions of Ethiopia, and the world. Methods: We will use mixed but primarily qualitative methods to explore and prepare the mobile cesarean birth center for subsequent implementation in communities in Bench Sheko and West Omo Zones. This will involve interviews and focus groups with key stakeholders and retreat settings for user-centered design activities. We will present stakeholders with a prototype surgical truck that will help them conceive of the cesarean birth center concept and discuss implementation issues related to staffing, supplies, referral patterns, pre- and post-operative care, and relationship to locations for vaginal birth. Discussion: Completion of our study aims will allow us to describe participants’ perceptions about barriers and facilitators to cesarean birth and their attitudes regarding the appropriateness, acceptability, and feasibility of a mobile cesarean birth center as a solution. It will also result in a specific, measurable, attainable, relevant, and timely (SMART) implementation blueprint(s), with implementation strategies defined, as well as recruitment plans identified. This will include the development of a logic model and process map, a timeline for implementation with strategies selected that will guide implementation, and additional adaptation/adjustment of the mobile center to ensure fit for the communities of interest. Trial registration: There is no healthcare intervention on human participants occurring as part of this research, so the study has not been registered.
Despite extensive research to improve access to care in low- and middle-income countries (LMIC), access to cesarean section to all women in need is not universal, even though the Three Delays model was published 25 years ago [7]. As such, there is a critical implementation gap in determining how best to provide cesarean birth in vast, rural regions of the continent. Our overarching hypotheses are (1) the cesarean birth surgical disparity in rural Ethiopia can be addressed by the implementation of a novel, mobile cesarean birth center staffed by advanced practice providers and (2) the methods we will use to explore, prepare, and design the center for eventual adaptation, implementation, and dissemination will be generalizable to other underserved settings and/or surgical disparities. Preliminary data from 21 individuals from target communities and 10 physicians at the regional referral center found that the mobile cesarean birth center concept was highly (90–100%) acceptable, appropriate, feasible, and usable in their setting. Therefore, our overall objective is to adapt a mobile cesarean birth concept for use in geographically isolated and underserved areas of Ethiopia in order to prepare for subsequent implementation and potential dissemination, considering all three delays. We want to learn about the acceptability, appropriateness, and feasibility of the mobile unit as a semi-permanent solution for access to care, which will eventually be replaced by improved healthcare infrastructure in the rural areas. We will collect preliminary data on cost considerations as well as the mobile versus stationary nature of the potential unit. Our multidisciplinary team of cesarean birth and obstetrics, implementation science, and public health experts as well as representative stakeholders from Ethiopia are poised to successfully achieve our objectives, guided by the Exploration-Preparation-Implementation-Sustainment (EPIS) framework (implementation process framework), as follows: [32, 33] Objective 1: EXPLORE (first phase of the EPIS framework) the outer and inner contexts of the communities in rural Ethiopia where we will study the pre-implementation of the mobile cesarean birth center [33] Implementation strategies: Identify barriers and facilitators to the delivery of cesarean and test the appropriateness, acceptability, and feasibility of a mobile cesarean birth center as one potential solution [34] Objective 2: PREPARE (second phase of the EPIS framework) to address the outer and inner contextual components of the communities where we will study the pre-implementation of the mobile cesarean birth center [33] Implementation strategies: Develop a formal implementation blueprint (with implementation strategies) for the center that addresses the barriers and facilitators (including all Three Delays) to the delivery of cesarean birth [34] In order to adapt and prepare the mobile cesarean birth center to address the public health problem of low cesarean birth rates in the region, our research is guided by the EPIS implementation research process and determinant framework; the author of the framework is part of our research team and has applied the framework in sub-Saharan Africa, previously [14, 32, 33, 35–37]. EPIS provides guidance on understanding barriers and facilitators and adapting our intervention (exploration phase, aim 1); taking what is learned in exploration and preparing to implement it (preparation phase, aim 1); putting structures, processes, and action into place (implementation phase, aim 2); and beginning with the end goal in mind (sustainment phase) so that implementation gains are realized and have the greatest public health impact [14]. The framework examines both the “Outer Context,” which refers to system-level factors in the country and community, and “Inner Context,” which refers to organizational level factors, and “Bridging Factors” that link outer and inner contexts (e.g., policies, collaborations), inter-organizational relationships, and innovation factors (e.g., cesarean procedures in Hospitainers) [32, 33, 38]. Using a stakeholder framework, we will include patients and the public, providers, purchasers, payers, policy-makers, product makers, and principal investigators [39]. In our target region, this translates to women, husbands, and community leaders (patients and the public); IESOs/physicians (providers); Ministry of Health and Local, Zonal, Regional, and Federal Government representatives (purchasers, payers, policy-makers); and our research collaborators (principal investigators). These will be the stakeholders involved in our research activities, guided by the EPIS framework, to ensure rigorous execution of our objectives. The only referral facility capable of providing cesarean birth for the Bench Sheko and West Omo Zones of Ethiopia is Mizan-Tepi University Teaching Hospital (MTUTH), which is located in the Mizan-Aman, Ethiopia, in the Southern Nations Nationalities and People’s Region (SNNPR). The catchment area of the hospital includes 2.5 million people in the Bench Sheko and West Omo Zones. Women account for 51% of the population, and 48% are of reproductive age; this suggests that about 612,000 women of reproductive age live in these two zones [10]. Based on the overall population size, the WHO would recommend five emergency obstetric facilities in the region [40]. If it is assumed that half are pregnant with a 10% cesarean birth rate, about 30,000 women per year would require cesarean birth. This would require MTUTH and four other “Hospitainers” to perform about 6000 cesareans per year, which is 16–23 cesareans per day, or one surgery every 1–1.5 h in the unit. A cesarean takes about 30–60 min to perform, which leaves 30–60 min to clean before the next birth. Per personal communication with Hospitainer, they estimate their containers are capable of 8–10 surgeries in 10 h. We estimate a need for four Hospitainers in the region to meet emergency obstetrical care WHO guidelines [40]. We intend for these four containers to initially serve the needs of at least four tribes in five communities: the Bench, Me’en, Dizy, and Suri tribes. Because each tribal group is unique, this population includes significant heterogeneity. We visited all of these communities with our partners in April 2019 to discuss the project and begin the necessary preparations for recruitment; the concept for the mobile cesarean birth center was enthusiastically received at that time. We will recruit volunteers in the communities with the help of community leadership until we have at least 10 participants in each morning and afternoon session, although we expect numbers closer to 20 participants per session. At MTUTH, we will invite all physicians and administrators to participate, as well as Zonal health leadership [41]. Women 18 years and older seeking antenatal or postnatal care at the community health clinics will be offered enrollment, in person, by study staff. We will offer enrollment until 10 women agree to participate. Community (religious or tribal) leaders will offer men enrollment in person at community gatherings that they host, until we have at least 10 participants. Dr. Muldrow, President of 501c3 Village Health Partnership (our research partner), has a 40-year relationship with leaders in our target communities. By leveraging both her established relationships and discussing the specific project during our recent travel to the sites in 2019, we have started prep-to-research activities. Community leaders are generally tribal leaders, religious leaders, or other prestigious members of the community; in order to enter communities during our visit, we had to engage these individuals through Dr. Muldrow’s established partnerships. These are the most crucial stakeholders to engage, in our experience and according to the physicians at MTUTH as presented in the preliminary data section. We have already conducted preliminary assessments of the health centers in our target communities and as such have met with the aforementioned stakeholders, including some of the zonal and woreda (regional) health officials. For objective 1, we will conduct semi-structured interviews and focus groups with representative stakeholders (community members and leaders, clinicians, administrators); participants will discuss the center and alternative solutions and ways to ensure the solution(s) respond to the Three Delays and meet community needs [42]. To achieve objective 2, representative stakeholders in modeling and simulating the proposed cesarean birth center [or other potential solution(s)], we will conduct cyclic consensus discussions to optimize the cesarean birth center into a clinically implementable innovation that will be adaptable for future dissemination [43] To achieve our objectives, we will host five, 2-day retreats, one with each of the Bench, Me’en, Dizzy, and Suri communities at a location chosen by community leadership, and a sixth retreat at MTUTH with the purchasers/payers/policy-makers/providers contingent of outer and inner context stakeholders. The exploration phase of the EPIS framework begins when stakeholders are aware of a public health need and are considering ways to address it [8]. Providers at MTUTH were surveyed and reported that the three delays are relevant to care for their patients, and preliminary data we collected from patients at the facility who hailed from all areas of the zone (we did not collect their self-identified tribal group so this data may not reflect our study population) suggested that women and their husbands are also aware of the need for improved access to emergency obstetric care and consider the mobile cesarean birth center as an acceptable, appropriate, and feasible solution [17]. To achieve the first objective, the exploration phase, we will focus on exploring the Hospitainer for pilot testing in the region. To do this, on the first day of the visit, we will have a morning session with women and an afternoon session with men and community leaders as most community leaders are male (female leaders will participate with the female focus groups); each iteration noted in the table (Table (Table1)1) will take about 45 min to complete. The goal of these retreats is to ensure that the Hospitainer is explored to address specific barriers and facilitators to emergency obstetric care in each community, using Human-Centered Design methods and considering EPIS constructs [43–45]. Human-Centered Design “offers problem solvers…a chance to design with communities, to deeply understand the people they’re looking to serve…and to create innovative new solutions rooted in people’s actual needs” [43–45]. These methods have been used successfully in rural Ethiopia with teff (grain) farmers to co-create interventions that have been designed through academic-community collaboration, but it is innovative to apply them to optimizing a surgical intervention for cesarean birth, as outlined in Table Table11 [43, 44]. Exploration phase: co-creation retreat Role playing: act out a woman and her husband/family using the cesarean birth center • One group; act out the scenario • Discuss ideas What was realistic? What worked? What issues arose? Storyboard: visually plot out the elements of the cesarean birth center • Two groups; draw the story • Present ideas Who will use it? Where will they use it? How will they use it? Individual optimization: ask each participant to write down/draw what they would change about the storyboard they worked on • Individual work time • Present ideas Make it efficient Make it effective Make it appropriate Make it acceptable Business Model Canvas: complete a worksheet about key aspects of the cesarean birth center and what key criteria are required for the cesarean birth center to provide high-quality specialized care for obstructed labor • Two groups; complete worksheet; present ideas Make it feasible Identify outcomes Integrate feedback and iterate: share the feedback, synthesize, refine idea • Focus group format, guided • Conduct Four-Item quantitative assessment tool [46] Ensure it is appropriate Ensure it is acceptable Ensure it is feasible To achieve our second objective, in the preparation phase, we will produce a detailed implementation plan to capitalize on implementation facilitators and address potential barriers and further assess needs for adaptation [27, 47]. Critical to this phase is planning implementation strategies and developing a positive implementation climate in which the adapted Hospitainer is valued and supported; in order to achieve this goal, during the exploration phase (Table (Table1)1) and preparation activities (Table (Table2),2), the service and policy environment and the characteristics of the individuals (women who are patients and consumers) who will use the Hospitainer must be clarified [47]. In order to consider the inter-organizational relationships between entities such as governments, funders, professional societies, and consumers, the second day of the retreat will focus on taking the explored and preliminarily adapted Hospitainer approach that stakeholders have determined is appropriate, acceptable, and feasible, and develop a specific, measurable, attainable, relevant, and timely implementation blueprint(s), with implementation strategies defined, through activities listed in Table Table22 [32, 33, 47]. Preparation phase: develop the implementation blueprint(s) and strategies Stand in the community space where the cesarean birth center will be piloted: stress test (role play) the solution in “real world conditions” • Walk through use case scenarios including people trying to use the Hospitainer for non-obstetric purposes; troubleshoot obstacles that arise Sort logistics of use Understand feasibility Understand viability Resource assessment: complete a worksheet about what exactly is needed to execute the solution including issues like water, electricity, and laundry • Two groups; complete worksheet; present ideas Distribution, activities Capabilities, responsibilities Relying on partners: who do you need to make implementation happen and what implementation strategies will be necessary • Focus group format, guided Make it feasible Select implementation Strategies Create an implementation plan: timeline, responsibilities, set benchmarks on a large calendar, process map, produce a logic model • Focus group format, guided Purchasing, delivery Supply chain At the beginning of the retreats, verbal consent will be obtained from participants and sociodemographic information will be collected. The sessions will be recorded and transcribed in Amharic. Translation into English will be performed by the facilitators (analysts). No identifiable information will be collected in the proposed research project. There will be no biospecimens or other records obtained. De-identified transcribed data will then be transmitted securely in English and stored on password-protected computers at the University of Colorado under a data transfer agreement defined in a memorandum of understanding. These data will not be linked to any other previously collected data. Completion of objective 1, or the exploration phase, will allow us to describe participants’ perceptions about barriers and facilitators to cesarean birth and their attitudes regarding the appropriateness, acceptability, and feasibility of the Hospitainer as a solution. Each community may have variants in the prototype; given the eventual plan for four Hospitainers, tribes will be able to adapt the unit per their preferences (external color, decorations). This approach is consistent with work in the adaptation of evidence-based practices while preserving core elements (e.g., surgical setting and procedures) while making adaptations to fit local culture and preferences [48]. Observing, addressing, and documenting these adaptations may assist with subsequent dissemination to other local or global regions. Completion of objective 2, or the preparation phase, should result in a specific, measurable, attainable, relevant, and timely (SMART) implementation blueprint(s), with implementation strategies defined, as well as recruitment plans identified [32, 33, 47]. This will include the development of a logic model and process map, a timeline for implementation with strategies selected that will guide implementation, and additional adaptation/adjustment of the Hospitainer to ensure fit for the communities of interest [34]. The implementation will be more successful if there is a high degree of fit between the values and needs of the stakeholders and the characteristics of the innovation to be implemented [27]. A summary of the outcomes is presented in Table Table33. Outcome summary table Focus groups Quantitative assessment EPIS and Human-Center Design-framed interview guide Weiner et al. Tool [46] Barriers and facilitators Acceptability Appropriateness Feasibility Logic model Process map SMART timeline Implementation strategies Plan recruitment We will utilize qualitative content analysis to analyze the data [49]. Using an inductive approach, the team will develop a set of codes from multiple readings of the transcripts using Atlas.ti qualitative data management software [50]. The senior professional research assistant will code the transcripts with the PI and qualitative expert heavily involved in codebook development (e.g., coding the first few iterations), with feedback and participation of the facilitators. All discrepancies in the code definitions and applications will be reconciled through consensus. Codes will be clustered into related categories, which will then guide theme development [42]. We will utilize a quantitative assessment tool to have participants rate the appropriateness, acceptability, and feasibility of the intervention during iteration 5 (Table (Table1)1) [46]. The tool uses four questions to ask about each concept with a grading system to quantify the results [46]. It will be translated, back-translated, and piloted to ensure applicability to the study populations. Qualitative research with community members has been successful in Ethiopia, previously, including in this region and regarding barriers to surgical care, specifically [8, 51–57]. The two types of data will be triangulated to produce a joint display of our qualitative and quantitative findings. The same analytic methods that were used during the exploration phase will be used during the preparation phase. All our study activities are planned for October 2021 and will not require any ongoing follow-up of study participants.
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