Improving the quality of maternal and newborn health outcomes through a clinical mentorship program in the Democratic Republic of the Congo: Study protocol

Background: The Democratic Republic of the Congo (DRC) boasts one of the highest rates of institutional deliveries in sub-Saharan Africa (80%), with eight out of every ten births also assisted by a skilled provider. However, the maternal and neonatal mortality are still among the highest in the world, which demonstrates the poor in-facility quality of maternal and newborn care. The objective of this ongoing project is to design, implement, and evaluate a clinical mentorship program in 72 health facilities in two rural provinces of Kwango and Kwilu, DRC. Methods: This is an ongoing quasi-experimental study. In the 72 facilities, 48 facilities were assigned to the group where the clinical mentorship program is being implemented (intervention group), and 24 facilities were assigned to the group where the clinical mentorship program is not being implemented (control group). The groups were selected and assigned based on administrative criteria, taking into account the number of deliveries in each facility, the coverage of health zones, accessibility, and ease of implementation of a clinical mentorship program. The main activities are organizing and training a national team of mentors (including senior midwives, obstetricians, and pediatricians) in clinical mentoring, deploying them to mentor all health providers (mentees) performing maternal and newborn health (MNH) services, and providing in-service training in routine and Emergency Obstetrical and Newborn Care (EmONC) to the mentees in health facilities over an 18-month period. Baseline and endline assessments are carried out to evaluate the effectiveness of the clinical mentorship program on the quality of MNH care and the effective coverage of key interventions to reduce maternal and neonatal mortality. Findings will be disseminated nationwide and internationally, as scientific evidence is scarce. A national strategy, guidelines, and tools for clinical mentorship in MNH will be developed for replication in other provinces, thus benefitting the entire country. Discussion: This is the largest project on clinical mentorship aimed to improving the quality of MNH care in Africa. This program is expected to generate one of the first pieces of scientific evidence on the effectiveness of a clinical mentorship program in MNH on a scientifically designed and sustainable model.

This is an ongoing, quasi-experimental study design. The project is currently being conducted in 72 health facilities (60 primary healthcare clinics and their 12 general referral hospitals) in the provinces of Kwango and Kwilu, DRC. Each province is comprised of health zones, and each health zone has at least one general reference hospital (GRH) and other health centers (HC). In these 72 facilities, 48 facilities were assigned to the clinical mentorship implementation group (i.e., intervention group), and 24 facilities were assigned to the group without clinical mentorship implementation (i.e., control group). Assignment of the two groups of health facilities was not performed randomly but according to administrative criteria. The intervention group is also balanced over the existing World Bank-funded Performance-Based Financing intervention (PBF) randomized control trial. Among the 48 health facilities where clinical mentorship is implemented, 24 were selected from PBF health zones and 24 were selected from non-PBF health zones (Fig. 1). This was done to limit the potential interference of the clinical mentorship program with the PBF project’s existing randomized trial. The primary outcomes are indicators of MNH care providers’ skills, knowledge, and attitudes. The secondary outcomes are maternal and infant outcomes (e.g., preeclampsia, forceps assisted delivery, cesarean-section, or blood transfusion, maternal deaths, infant deaths). Overall study design The baseline survey collected information on primary and secondary outcomes, as well as information on facility conditions (e.g., equipment, medicine, structure) and an Emergency Obstetric and Newborn Care Needs Assessment (EmONC) at these 72 facilities. After completion of the baseline survey, we began implementation of an 18-month clinical mentorship period in the 48 intervention facilities. Process and outcome variables are being collected to assess the performance of the clinical mentors and mentees, as well as the clinical mentorship program. Upon completion of the clinical mentoring period, endline surveys will be conducted in the 72 facilities to collect the same primary and secondary outcomes and other variables. Effectiveness of the clinical mentorship program will be assessed through comparison of the primary and secondary outcomes between the baseline and endline surveys and between the intervention and control groups. The study requires 36 months (3 years) to complete. Figure 2 presents the timeline and summarizes key activities of the project. Timeline of study development. Each number corresponds to one calendar month and is representative of the 36 month timeline for the study development and implementation In Kwango and Kwilu provinces, 72 health facilities from six health zones, including 12 general referral hospitals (GRHs) and 60 health centers (HCs), were selected. The selection and allocation of the health facilities were based on the following administrative criteria: All healthcare providers who provide MNH care and services in the 72 health facilities are eligible to participate as mentees in this clinical mentorship program. Written consent was obtained to collect data on their performance of routine MNH care [7]. The WHO defines clinical mentoring (for HIV care and antiretroviral therapy) as “a system of practical training and consultation that fosters ongoing professional development to yield sustainable high-quality clinical care outcomes … [that is] critical to building successful district networks of trained health care workers [9].” The clinical mentorship program developed for this project combines the WHO model of quality of care and UNICEF’s Every Mother Every Newborn (EMEN) guide for quality improvement [20, 21]. The mentoring program was designed to meet two core principles. First, to continuously optimize performance of MNH services, given the resources at hand, through clinical mentorship in the context of the DRC. Second, to support the MNH services to deliver “safe, effective, timely, efficient, equitable, and people-centered services” [21]. The clinical mentorship program was designed to cover the EMEN 10 standards of care (see Panel: EMEN 10 criteria). These principles guided the development of the questionnaires used in the project’s monitoring and evaluation. The primary assessment was centered around the first three points: the provision of evidence-based practices during antenatal care, labor and childbirth, and postnatal care [21]. The clinical mentoring program was created in conjunction with an international consultant. Given that clinical mentorship for the improvement of MNH care is a new approach in the DRC, an orientation on quality improvement and clinical mentorship was organized for the key national and provincial stakeholders. Stakeholders included, but were not limited to, national and international partners, policy makers, program managers, and professional associations. A National Steering Committee was created under the umbrella of the national Maternal Newborn Child and Adolescent Health (MNCAH) Task Team. The committee meets quarterly, and a regional workshop was organized with experts in clinical mentoring to oversee, develop, and implement the clinical mentorship program. A provincial subcommittee participated in the design of the clinical mentoring program and assists with the coordinating and monitoring of the project. The teams of the “Provincial Division of Health” of the two targeted provinces and the “Health Zone Framework Teams” of the eight targeted health zones are oriented and receive key information on the project. Their role is to coordinate and supervise the mentors’ field activities during their routine supervision of the health facilities during the 18 months of the clinical mentorship implementation, with the support of UNICEF provincial offices. UNICEF and MOH recruited a team of “super mentors” through a nationwide competitive process. Super mentors include currently practicing midwives, obstetricians, and pediatricians with extensive clinical experience in MNH care. The team of super mentors recruited highly skilled and actively practicing medical doctors and midwives to act as clinical mentors; they are now providing training and supervision of the clinical mentors throughout the project. The clinical mentors are experienced and skilled MNH care providers recruited from Kwango and Kwilu provinces. Their key responsibilities, while providing clinical mentorship, are to: (1) disseminate clinical practice guidelines and information to enhance patient outcomes; (2) assist in the ongoing training of mentees in the core clinical competencies in Emergency Obstetric and Neonatal Care; (3) integrate mentees’ clinical skills, knowledge, attitudes, and clinical decision-making; (4) provide effective feedback to mentees; and (5) determine if performance standards are being met. Figure ​Figure33 outlines mentor selection and implementation. Schematic of clinical mentoring implementation Mentees are health professionals performing MNH care in the selected GRH and HC facilities. Most of them have had little pre- and/or in-service training in the evidenced-based care previously mentioned. The general practitioners and nurses working in GRHs may have a stronger background, but they infrequently receive clinical support from professionals with advanced training like obstetricians and paediatricians. Therefore, continuing education through the clinical mentoring program to all consenting health professionals performing deliveries in the 48 intervention facilities is vital to evidence-based practice. Among the team of clinical mentors, medical doctors provide mentorship in GRH facilities and midwives provide mentorship in HC facilities. At the intervention facilities, one mentor is responsible for visiting several facilities over the course of the 18-month clinical mentoring period. While visiting a facility, mentors remain at the facility for the duration of each clinical mentoring session. Mentors conduct a minimum of five mentoring sessions, each lasting at least 10-days, over the course of the 18-month intervention period, for a total of 6–8 weeks of clinical mentoring for each facility. Mentoring is begun after the baseline data collection is completed. At each facility, the clinical mentors are responsible for: (1) strengthening mentees’ knowledge, attitudes, and skills through observation and review; (2) assessing routine MNH practices; (3) guiding mentees through a re-examination of their ideas and values; and (4) ensuring the learning and personal/professional development of mentees. In addition to in-person mentoring, mentors are accessible by phone and web to provide advice or answer mentee’s patient care questions. Before the start of the clinical mentoring program, selected mentors were trained in quality assurance and in clinical mentorship by the super mentors, who are national experts in the DRC. During the 18-month clinical mentorship implementation period, the performance of the clinical mentors and mentees is monitored and evaluated. The key monitoring questions are: (1) Is the implementation of the CM program being conducted as planned? (2) Are the clinical mentors performing according to the standards? (3) Are the mentees performing according to the expectations? (4) How is the clinical mentoring program impacting key MNH outcomes? Table 1 is a summary of the instruments and data collection tools used in monitoring and evaluating the clinical mentorship program implementation. The DRC Ministry of Health Coordinator for each province is responsible for sending a monthly summary report of clinical mentors’ visits to the facilities, including the number of mentees completing the clinical mentoring sessions and the qualitative issues noted by the clinical mentor. A summary of the instruments and data collection tools for monitoring clinical mentorship program athe same tools used during baseline surveys [7] Both the baseline and endline surveys collect data on the primary and secondary outcomes indicated above and facility conditions (equipment, medicine, structure). Data collectors use a pre-programmed, smartphone-based application, Open Data Kit [22] (ODK Collect v1.16), to complete the following checklists or questionnaires: The baseline survey has been completed and published [7]. All data baseline and endline collection tools/questionnaires for the surveys are available for public access [23]. During each clinical mentoring session, mentors collect information through record review, direct observation, and patient chart review. Mentors use paper-based forms to collect the following information: The sample size including 72 health facilities (12 GRHs and 60 HCs) is an administrative decision taking into account increasing coverage of potential benefits of the clinical mentorship program to a large number of health facilities in the two participating provinces in this project. Statistical power was calculated to detect an increase of the key primary outcomes (e.g., proportion of monitoring progress of labor using partogram) or a decrease of a composite secondary outcome of severe newborn complications (e.g., low birth weight < 2.5 kg, preterm delivery, asphyxia, major infections, stillbirths, and neonatal deaths < 7 days). Based on this fixed sample size of 72 health facilities with at least 200 annual deliveries per each facility, under assumption of a significance level of the test of 0.05 and an intracluster correlation coefficient of 0.01, for example, the sample size provides more than 99% power to detect an increase of proportion of monitoring progress of labor with partogram from 50 to 75%, and a 30% reduction in the composite of severe newborn complications (from 15 to 10.5%). Prior to the implementation of the project, data collectors were trained in how to use the ODK data collection system to complete the questionnaires. To ensure a high quality of data collection, a data collection coordination office was established in the capital city of Kikwit in Kwilu province. During the baseline and endline surveys, the data coordinator organizes and supervises six data collectors to visit all 72 facilities [7]; the data coordinator is also responsible for receiving the questionnaires/forms completed by mentors and the DRC Ministry of Health coordinator during the 18-month clinical mentorship implementation. For quality control purposes, the data coordinator conducts monitoring visits to randomly selected health facilities from the intervention facilities that have already received clinical mentoring to independently verify the data on mentors and mentees’ performance and to assess any changes of facility conditions (infrastructure, equipment, medicines & supplies, water supply & electricity, and staffing) (Table ​(Table11). Hard copies of completed consent forms, questionnaires, or assessment forms are delivered to the Kikwit office, and these documents are analyzed by the Tulane University New Orleans team to ensure that the clinical mentoring program is being implemented as planned and to ensure the accuracy of data collected. Additional ongoing strategies for quality control include: 1) monthly conference calls among the project PI, Co-PIs, and key project personnel; 2) monitoring field visits to the participating health facilities and meetings/workshops with provincial project officers and coordinators, mentors, and selected mentees in the field; and 3) annual Steering Committee meetings, including all involved parties (UNICEF, Bill and Melinda Gates Foundation, Ministry of Health, national and provincial level officers, clinical mentors, and Tulane University) in the DRC. The ODK system is used for baseline and endline data collection. Data collected on smartphones is securely transmitted to a secure, cloud-based server (Google App Engin), and only key project personnel have access to the server. Hard copies of completed questionnaires/evaluation forms from clinical mentors are delivered to the data coordination office in Kikwit, and data is scanned and uploaded to a cloud-based archival location by the Kinshasa team. A Tulane University data center in New Orleans is responsible for receiving, managing, analyzing, and reporting the data after the baseline survey, on a quarterly basis during the implementation of the clinical mentorship program, and after the endline survey [7]. Data verification techniques include logic, range, and consistency checks. Data validation is implemented via electronic data entry mechanisms with input masks, conditional logic, and validation rules. Any issues are reported to all study coordinators and key personnel via weekly teleconferences. To examine if the clinical mentorship program leads to improvement in MNH indicators of providers’ skills, knowledge, and attitudes (primary outcomes), as well as provides for a reduction in maternal and neonatal morbidity and mortality (secondary outcomes), baseline and endline surveys are designed to compare changes in percentages of the primary and secondary outcomes before and after the implementation of the clinical mentoring program and between the intervention and control groups. To assess if the improvement of MNH quality of care and outcomes is due to the clinical mentorship program itself or due to PBF intervention, the indicators related to quality of care and maternal and newborn outcomes will be compared across three groups: 1) the 24 health facilities with both PBF and clinical mentorship interventions; 2) the 24 health facilities with clinical mentorship intervention only and without PBF intervention; and 3) the 24 health facilities both without PBF and clinical mentorship interventions (control group). Chi-squared tests will be used to test differences in the distributions of categorical MNH indicators and outcome measures. Then a relative risk (RR) and 95% confidence interval will be calculated. The effectiveness assessment will be presented as either a percent increase in the process indicators (e.g., % of syphilis screening, woman receives uterotonic immediately after birth of the baby, or breastfeeding) or a percent decrease in maternal and newborn outcomes (e.g., maternal deaths, stillbirths, neonatal deaths< 7 days) that are attributable to the clinical mentorship program [i.e. Effectiveness = (1-RR) %] after adjustment of potential confounding factors. Secondary, stratified analyses will be performed by health zone, type of health facilities (e.g., public vs. private or faith-based), GRH vs. HC, size or number of deliveries, 7- or 9-signal functions EmONC standards being met, type of providers (e.g., physicians, midwives, nurses), and performance of the clinical mentorship program (e.g., percentage of mentees completing the clinical mentorship program) to examine if the benefits of the clinical mentorship program are differentiated by these factors.

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