Implementation and evaluation of nonclinical interventions for appropriate use of cesarean section in low- And middle-income countries: Protocol for a multisite hybrid effectiveness-implementation type III trial

Background: While cesarean sections (CSs) are a life-saving intervention, an increasing number are performed without medical reasons in low- and middle-income countries (LMICs). Unnecessary CS diverts scarce resources and thereby reduces access to healthcare for women in need. Argentina, Burkina Faso, Thailand, and Vietnam are committed to reducing unnecessary CS, but many individual and organizational factors in healthcare facilities obstruct this aim. Nonclinical interventions can overcome these barriers by helping providers improve their practices and supporting women’s decision-making regarding childbirth. Existing evidence has shown only a modest effect of single interventions on reducing CS rates, arguably because of the failure to design multifaceted interventions effectively tailored to the context. The aim of this study is to design, adapt, and test a multifaceted intervention for the appropriate use of CS in Argentina, Burkina Faso, Thailand, and Vietnam. Methods: We designed an intervention (QUALIty DECision-making – QUALI-DEC) with four components: (1) opinion leaders at heathcare facilities to improve adherence to best practices among clinicians, (2) CS audits and feedback to help providers identify potentially avoidable CS, (3) a decision analysis tool to help women make an informed decision on the mode of birth, and (4) companionship to support women during labor. QUALI-DEC will be implemented and evaluated in 32 hospitals (8 sites per country) using a pragmatic hybrid effectiveness-implementation design to test our implementation strategy, and information regarding its impact on relevant maternal and perinatal outcomes will be gathered. The implementation strategy will involve the participation of women, healthcare professionals, and organizations and account for the local environment, needs, resources, and social factors in each country. Discussion: There is urgent need for interventions and implementation strategies to optimize the use of CS while improving health outcomes and satisfaction in LMICs. This can only be achieved by engaging all stakeholders involved in the decision-making process surrounding birth and addressing their needs and concerns. The study will generate robust evidence about the effectiveness and the impact of this multifaceted intervention. It will also assess the acceptability and scalability of the intervention and the capacity for empowerment among women and providers alike. Trial registration: ISRCTN67214403 We will use a pragmatic hybrid effectiveness-implementation type III [12] design to test our implementation strategy while observing and gathering information on the QUALI-DEC intervention’s impact on relevant outcomes. Using a quasi-experimental design (interrupted time series and before-after study), we will assess effectiveness and safety outcomes [13, 14]. A process evaluation will be carried out using mixed qualitative and quantitative approaches [15]. We used the Standards for Reporting Implementation Studies (STaRI) checklist to report our research protocol [16]. The multifaceted intervention will be implemented in facilities in Argentina, Burkina Faso, Thailand, and Vietnam. These four countries illustrate various degrees of rates in LMICs (Table ​(Table3)3) and present specific challenges for QUALI-DEC implementation. Within these four countries, Argentina has the highest level of CS at the national level and, more generally, of the biomedicalization of childbirth. Thailand has very low fertility, which may add pressure in favor of CS. A favorable socioeconomic context may also facilitate the preference for CS. Vietnam is interesting for its demographic impact (size of the population) and its performance in health indicators given its level of national income. However, the national CS rate has been continuously increasing over the past few decades, exceeding any reasonable level for medical needs and large inequalities in the use of CS. Burkina Faso has a low CS rate at the national level that may hide inequalities [17] and that suggests a great potential for further increase and consequently represents an opportunity to prevent the phenomenon before it aggravates. Main health indicators at country level *Latest estimation according to the following source of information: (1) WHO Statistical Information System : https://www.who.int/whosis/indicators/en/; (2) World Bank national accounts data: https://data.worldbank.org/indicator/NY.GDP.PCAP.PP. CD Maternal mortality ratio: number of maternal deaths per 100,000 live births Neonatal mortality rate: number of newborn deaths per 1000 live births Impoverishing expenditure is defined as direct out-of-pocket payments for surgical and anesthesia care which drive people below a poverty threshold (using a threshold of $1.25 PPP/day). Risk of impoverishing is the proportion of population at risk of impoverishing expenditure when surgical care is required The study will be conducted from January 2020 to December 2024, in 32 healthcare facilities (8 per country) with high CS rates. Facilities were selected purposely with country investigators to reflect the range of contexts, such as secondary and tertiary levels of care, public and private hospitals, and teaching and nonacademic facilities (Table ​(Table4).4). The intervention directly targets healthcare providers involved in obstetric care and all women who give birth in the participating hospitals during the study period. We have defined providers as obstetricians and nurses/midwives working in the maternity ward in the study facilities. Women will be eligible if they give birth to a newborn (birthweight ≥ 500 g in Argentina and Vietnam or ≥ 1000 g in Burkina Faso and Thailand), alive or dead, and with or without malformations. The intervention does not target patients admitted for abortion or miscarriage or those who delivered at home or in another facility that is not a participating hospital. Characteristics of participating hospitals by country A multifaceted intervention was developed based on existing evidence (Table ​(Table1)1) and WHO recommendations on nonclinical interventions to reduce unnecessary CS [18]. Baseline formative research [19] informed by the ecological framework [9] will be conducted to improve our understanding of the different levels of factors affecting CS rates and to adapt the multifaceted intervention to each country. The four components of QUALI-DEC will be implemented simultaneously in each participating hospital during the 2-year implementation period (Fig. ​(Fig.11): Component 1—opinion leader (OL)—one OL in each facility has been identified by peers and local authorities. OLs are gynecologists-obstetricians with proven communication skills and a reputable influence on their colleagues. The OLs will take part in a 5-day training session at the beginning of the implementation period. This training will include 1 day training for each of the following topics: (1) mobilizing OLs on the power/interaction model of interpersonal influence; (2) selecting evidence-based clinical protocols for CS decision-making; (3) audit and feedback including external review of medical records and use of Robson classification as a feedback tool; (4) use of decision-analysis tool; and (5) implementing continuous companionship during labor. After the initial training, OLs will create local committees, launch the audit and feedback, and encourage the use of the DAT and companionship during labor in their own hospitals. OLs will undergo a refresher 3-day training session during the 2-year intervention period. The aim of this session is to refresh OLs’ knowledge, update them on the use of evidence-based clinical guidelines and process of the intervention, discuss their roles, share their experiences, and confirm their capacity to provide leadership in their clinical settings. Component 2—audit and feedback (A&F)—audit cycles will be implemented monthly by the local committees following the different steps presented in Fig. ​Fig.2.2. Local data collectors will prospectively identifies groups of women who are admitted for childbirth using the Robson classification system 20. Then, medical records of low-risk women (Robson group 1 to 4) will be selected to audit the indications for cesarean sections. The local committee will provide a conclusive analysis that will be presented to the rest of the medical staff (feedback). It will allow for comparison and analysis of cesarean section rates within and across the different groups of women, as well as comparisons to other facilities. Additionally, it will help to ensure that cesarean sections are performed for clinically valid reasons, and identify priority areas for coaching, training, and support for healthcare providers. Audit cycle to change medical practice Component 3—decision analysis tool (DAT)—the DAT is adapted to each country and developed to be used during antenatal care (after 28 weeks of gestation) by women with a singleton pregnancy, without a previous CS and eligible for a trial of labor. It includes two sections: (i) an information section, providing a description and an explanation of the risks and benefits of each mode of birth (planned vaginal birth vs. planned CS); and (ii) an exercise section, allowing women to clarify and summarize their values and preferences with their clinician and indicate what aspects of the mode of birth are important to them. The DAT will be available as a paper booklet and an interactive web/smartphone application. The DAT is designed to supplement regular counseling and discussions with healthcare providers. They will provide detailed, specific, and personal options and outcomes in order to prepare women to make the decision about the mode of delivery. Component 4—companionship during labor—the companion can be any person chosen by the woman to provide her with continuous support during labor and childbirth. This may be someone from the woman’s family or social network, such as her spouse/partner, a female friend or relative, a community member (such as a female community leader, health worker, or traditional birth attendant) or a doula (i.e., a woman who has been trained in labor support but is not part of the healthcare facility’s professional staff). The QUALI-DEC strategy will support the use of any type of culturally appropriate companion who the woman has selected. This component will be implemented using a tailored labor companionship model that will include information on (1) eligibility criteria for women and companions, (2) identification of healthcare providers who will invite the chosen and eligible labor companion from the waiting area into the labor room, (3) identification of healthcare providers who will deliver the messages to the laboring woman and her companion, (4) how many people are allowed and when they are allowed to act as companions, (5) how physical space of the labor ward may need design modifications to accommodate a companion, and (vi) educational tools for companions on how to support women during labor and birth. The implementation strategy is aligned within the usual model of care in participating healthcare facilities. The main implementers are the local OLs and healthcare providers who are involved in the program and are supported by the country-level study coordinator. Formative research in the baseline period will assess the main drivers and barriers, and a meeting will be held among all stakeholders to discuss implementation issues. Parliamentarians and representatives of women’s associations will be involved in this meeting to consider women’s views. Then, the intervention will be introduced in each country with the 5-day training workshop addressed to OLs. OLs will receive financial incentives during the intervention period to compensate for the loss of revenues related to the decrease in their clinical activities. OL supported by local committee will encourage antenatal care providers to deliver the DAT booklet to eligible pregnant women. This will require a series of on-site meetings in all relevant facilities to inform and motivate providers and to obtain their formal commitment. In addition, a DAT application will be developed for smartphones and made available in the settings in which it is considered culturally appropriate and most acceptable and convenient for women. Posters will be displayed on the wall of the waiting room of antenatal care centers with the QR code to access the web/smartphone application. Other information, educational and communication (IEC) materials, such as flipcharts or posters, will be developed to facilitate the briefing of healthcare providers, companions, and laboring women. These IEC materials will include reminders about the importance of labor companionship, the role of companions, and the regulations of the labor wards. The country-level coordinator will conduct quarterly visits to each participating hospital during the 2-year implementation period to identify further barriers for the implementation process and possible strategies to overcome those barriers, verify data quality and document and report on the study’s progress.