Background: Maternal, fetal and neonatal mortality are higher in low-income compared to high-income countries due to weak health systems including poor access and utilization of health services. Despite enormous recent improvements in maternal, neonatal and under 5 health indicators, more rapid progress is needed to meet the targets including the Development Goal 3(SDG). In Kenya these indicators are still high and comprehensive systems are needed to attain the targets of the SDG 3 by 2030. We describe the structure and methods of a study to assess the impact of an innovative system approach on maternal, neonatal and under-five children outcomes. This will be implemented in two clusters in the Counties of Busia and Bungoma in Kenya. There will be 4 control clusters in Kakamega, UasinGishu, Trans Nzoia and Elgeyo Marakwet Counties in Kenya. The study population will be pregnant women, newborns and under-five children identified over the study period. The objective of the study is to improve access, utilization and quality of Maternal and Child Health care through a predesigned Enhanced Health Care System (EHC) that embodies six WHO pillars of the health system and community owned initiatives including Community Based Organisations and Income Generating Activities. Methods/Design: A five year quasi-experimental design will be used to compare the outcomes of the implementation of the EHC using the Find Link Treat and retain (FLTR) strategy in one cluster, community owned initiatives in one cluster and four control clusters at baseline and at the end of the study. A Baseline survey will be conducted in year one and an endline in the fifth year in which maternal, neonatal and underfive childhood outcomes will be compared. Discussion: The expected findings from the study include showing trends in improvement in the intervention clusters for morbidity, mortality, health service utilization and access indicators. Use of the health systems approach in health care provision is expected to provide a holistic improvement in the quality of care in the study populations in the intervention clusters that will lead to improved health indicators including morbidity and mortality. It is expected that the findings will inform health policy of the national and county governments in Kenya and worldwide.
We are implementing a quasi-experimental community trial. This design allows a comparison of outcomes between the intervention and control arms (Table (Table5).5). This quasi-experimental design entails: Programme monitoring and evaluation framework We shall utilise 6 of the 11 counties that Moi University frequently utilises for its health oriented outreach and extension activities. The six are Uasin Gishu, ElgeyoMarakwet, Trans Nzoia, Bungoma, Busia and Kakamega. The other counties used by the University not selected include Nandi, Baringo, West Pokot, Vihiga and Kisumu. One Dispensary was randomly selected from each of the six selected counties from the list in the e-Health Kenya platform. The study population will be all pregnant women living within the catchment population of the dispensary which is a location (Cluster) headed by a Chief, their newborns and under-five children born during the life of the project. Two clusters will be randomly selected. One cluster will used as the intervention cluster for the implementation of the EHC through the FLTR strategy over a 3 year period. The other will be used to implement the community owned and driven health care by encouraging the formation of income generating activities and community based organisations that will be used to fund the level 1 and level 2 health care services over the 3 year period of implementations. The remaining four clusters and affiliated dispensaries shall be the control clusters in which only baseline and endline/evaluation data will be collected in years 1 and 5 respectively with no intervention implemented. The heath centres, sub-county and county hospitals will be evaluated in the baseline and endline/evaluation phases of the study in all the 6 clusters. Previous studies in these areas have shown an estimated 600 pregnant/newborn dyads per cluster per year. We shall therefore expect to enrol 1800 pregnant women/newborn dyads in each intervention cluster (EHC/FLTR intervention cluster and the Partnership using IGAs/CBOs cluster). The expected underfive year old population to be followed up during the study period will be about 5400 for each of the two intervention clusters. In the control clusters we expect to collect data for 6 months in each cluster and therefore obtain information for about 1200 pregnant women/newborns in all the three clusters at baseline and a similar number at endline. Conduct baseline survey on current levels of maternal and child health indicators, status of health system and existing programs in the study areas. We aim to map the structure and functions of the primary health care system. In Tier 1, this will be achieved by documenting the numbers, structures, functions and activities of the community units in the selected counties. Key stakeholders including among others, CHWs and community midwives will be identified as well as mechanisms for incentivizing them for their engagement. At Tier 2, we will assess the functionality of each of the facility using the Structure, Process and Outcome approach as described in the Kenya Quality Model (KHSSP, 2013–2017). In terms of Structure the specific variables of interest include among others: working hours, human resource, Number of staff and training according to the ministry of health standards, basic EMONC Equipment, supplies and commodity security. For Processes we will assess availability of job aids such as protocols and guidelines Lastly, in terms of Outcomes we will assess ANC indicators including gestation age at booking for ANC, Facility delivery, Signal functions for BEMONC. We will also assess the existence of nutritional, immunization and other IMCI services for under-five year old children. At Tier 3, we will use the same approach as for Tier 2 to assess the same parameters in addition to existence of CEMONC signal functions. Further in the baseline survey we will review the referral system from Tier 1 to Tier 3assess the strategies, referral destination, costs, types of cases referred and linkage success rate for all levels. Between Tier 2 and Tier 3, we will document the type of communication between the facilities and referral protocols and existence of ambulances. We will assess the mechanisms used for data capture for the HMIS including, the tools, data collectors, where stored, reporting and how the data is consumed locally. The baseline assessment will document information on challenges of motivating volunteers, existing and potential partnerships relevant to incentivizing CORPs and CHWs through CHUs. Appropriate information will be collected on willingness to initiate such partnerships and any past experiences relevant to their functioning and sustainability. Baseline data collection forms will be developed and data collected and entered into a data base in the computer and analysed using the STATA version 12. To assess maternal and child health indicators, status of health system and existing programs in the study areas, descriptive statistics will be used for the quantitative data while thematic areas will be derived from the qualitative data. The results of the baseline survey will be disseminated to the stakeholders. Objective 2: Intervention: Design and implement EHC package using the FLTR strategy to improve access and quality of care of maternal and child health at tier 1 and 2 in one intervention cluster. The study population will be all pregnant women living within the catchment population of the dispensary whose catchment population is a location (Cluster) headed by a Chief, their newborns and underfive children born during the life of the project. The intervention will be implemented in this one cluster through the FLTR strategy over a 3 year period. Implementation of the intervention model – We shall apply the FLTR (Find, Link, Treat, and Retain) strategy to support a successful implementation of Enhanced Health Care (EHC). This requires direct investment in health system elements that directly and indirectly contribute to efficiency of the referral system between the community and primary care levels and the County referral facilities under the new 4-tier health system. Find – will involve investment in the Human Resources for Health (HRH) component of the health system by influencing recruitment of adequate and competent CHWs from within intervention villages and skilled health workers (SHWs) to follow up. It will involve investment in improvements in management components through strengthening of supervision by trained health workers. There will be use of appropriate technologies and supplies (computers, HMIS, mobile phone and household registers) to improve efficiency and strengthen the health information system. Link – CHWs will encourage prompt ANC/MCH clinic attendance and schedule ANC/MCH clinic appointments by mobile phone device at the time of initial CHW visit (Link). This links directly to efficiency in Service delivery, investment in technologies (mobile phone) and health information for efficient management of referrals. This will create a link between level 1 and level 2 of the health system. Treat – The ANC/MCH clinics in the facilities will provide the complete EHC package to each subject and will mainly address the quality of service delivery, technologies and commodities component. These include haemoglobin testing using the haemocue machine and malaria test using the Rapid Diagnostics Tests (RDTs). Any ailments will be treated at the local facility and where referral is needed they will be referred to the higher level facility. Newborns will be given the routine vaccinations, weights taken and prenatal and vitamin A provided including all the relevant services as outlined in the EHC package. We shall be investing in improvement of quality of care through refresher training of all the skilled health workers in the study dispensary on MNCH, EmONC, ENC, customer care including public relations. The CHWs/CORPs will also be trained using the WHO guidelines on pregnancy surveillance and newborn follow up. This will include on methods of approach to household and villages and confidentiality. We shall provide essential equipment, drugs and dressings as per the essential commodities list of the Ministry of Health for the level 2 facility. We shall utilise the modified MOH SOPs for this level of care for the management of illnesses at this level. We shall also provide for acceptable waiting time for patients as recommended and will conduct an exit survey for all mothers who are treated at this facility as they leave the facility on the same day. Retain – Subjects will be tracked and if one defaults the CHW will be dispatched to the subject’s home to counsel the woman/family and accompany the woman to the health facility for the ANC/MCH visit. This component of the intervention links to building efficient and effective health information system that allows for efficiency in monitoring/tracking of subjects at antenatal, delivery and postnatal care. The component will also cover cost-reduction in tracking by applying appropriate technologies such as use of mobile phone. The follow up therefore will range from 6 months to 5 years depending on the month and year of birth over the 5 year study period. This translates into the retention of the women and children in the health system throughout the period of the study. This FLTR strategy will only apply to enrolled pregnant mothers and their infants within the intervention cluster. Women who become pregnant for the second or third time during the 5 year study period will be enrolled and followed up as per protocol. There will therefore be a possible 6 month to 5 year prospective follow up of the mother infant/child dyads once enrolled. There will therefore be cohorts of varying follow up periods ranging from 6 months and 5 years depending on when they are enrolled over the life of the study. The following will be evaluated at baseline and at endline in the 1stand 5th year of the study: Objective 3: Innovative partnerships: To explore and facilitate partnerships for innovative approaches (IGAs and Chamas) to incentivize CORPs (Community owned resource persons – volunteers), CHWs and Community Midwives (CMWs) to effectively participate in increasing access and retention of pregnant women and children in the health care system in the intervention cluster. In this one cluster, we shall work with the community Health Units, village elders, Assistant chiefs and the chief in collaboration with the CHEWs and CHWs to establish income generating units (IGUs) and/or community based organizations (CBOs) in the cluster. The IGUs/CBO will be set up by the communities themselves and run through governance structures established by the communities themselves. The funds from these IGUs/CBOs will be used to incentivize the volunteer CHWs/CORPs to identify pregnant women and their newborns to the local dispensary. The primary care health facility committee will work with these CBOs and IGUs to assist in the funding of some activities including referral costs from the community to the primary care health facility and to the county referral facilities. These IGUs/CBOs will be used to address the transport and birth plans requirements of the pregnant women, their newborns and infants born during the life of the project. The study population will be all pregnant women living within the catchment population of the dispensary whose catchment population is a location (Cluster) headed by a Chief, their newborns and underfive children born during the life of the project. We will compare process and outcome indicators at baseline and at end of study for this cluster. Objective 4: Efficiency of referral system: To assess the effectiveness and sustainability of the implementation of FLTR and EHC in the improvement of the efficiency of the referral system between the community (level 1), primary care facilities (level 2) and County referral facilities (level 3) for pregnant women in the intervention area. The effectiveness and efficiency of the referral systems will be evaluated in the intervention clusters and compared at baseline to endline in the two clusters where interventions will be applied. The number of referrals, timeliness of referrals, outcomes of referrals in terms of deaths and feedback provided to the referring facility by the referral facility, access of the referred patients to the doctors and consultants, transport availability and access, availability of referral notes and the detail of the referral and the feedback to the referring facility. Interaction between the referring and referral facility in terms of visits, calls, letters, e mails, frequency of supervisory visits etc. will be recorded and analysed. Objective 5: Capacity building: To build capacity of health workers to conduct health systems research and inculcate a culture of use of evidence to strengthen the performance of health systems through on-job training, in-service certificate and degree programs. This will be done through training of masters and doctoral students within the program and beyond in the health systems discipline. These masters and doctoral students will work with thehealth workers and community health workers during the study and implement their research projects at these sites. They will participate in the training and service provision while doing their research projects. Skilled health workers in the two intervention clusters will also be trained on the job in various areas of relevance to health systems including health systems management, project management and health services management. The health workers will also be taken through refreshers courses on neonatal resuscitation, BEmONC, CEmONC, MNCH, maternal care during labour, breastfeeding, feeding for infants and older children, ENC. This is with the aim of ensuring they provide quality care. They will be standardised every six months to ensure their performance is consistent throughout the study period. Conduct endline survey/evaluation on levels of maternal and child health indicators, status of health system and existing programs in the study areas at the end of the project in all the study clusters.Theendline survey and evaluation will be carried out in the 6 clusters that were included in the study.As in the baseline survey, we shall document the numbers, structures, functions and activities of the community units in the study counties in the fifth year of the study and the same data forms and tools used for the baseline survey will be utilised in tiers 1 and 2. In terms of Structure the specific variables of interest include among others: working hours, human resource, number of staff and training according to the ministry of health standards, basic EMONC Equipment, supplies and commodity security. For Processes we will be interested in availability of job aids such as protocols and guidelines. Lastly, in terms of Outcomes we will be interested in ANC indicators including gestation age at booking for ANC, Facility delivery, Signal functions for BEMONC. We will also assess the existence of nutritional, immunization and other IMCI services for under 5 year old children. At Tier 3, we will use the same approach as for Tier 2 to assess the same parameters in addition to existence of CEMONC signal functions. As in the baseline survey we will be interested in the referral system from Tier 1 to Tier 3. For all the levels we will be interested in the strategies, referral destination, costs, types of cases referred and linkage success rate. Between Tier 2 and Tier 3, we will also be concerned on the type of communication between the facilities and referral protocols and existence of ambulances. We will also assess the mechanisms used for data capture for the HMIS including, the tools, data collectors, where stored, reporting and how the data is consumed locally. The baseline data collection instruments will be used for the endline survey using the same methodology, data analysis and dissemination. Table Table11 shows the expected deliverables, their link to outcomes and how these will influence policy among the beneficiaries. Anticipated outputs and outcomes and their likely policy influence The dissemination plan is shown in Table Table22 to ensure the right information is shared with the right stakeholders at the right time. Dissemination plan of key messages to various target audiences Objective 1: Conduct baseline survey on current levels of maternal and child health indicators, status of health system and existing programs in the study areas. Intervention and control clusters Objective 2 : Design and implement EHC package using the FLTR to improve access and quality of care of maternal and child health at tier 1 and 2 in one intervention cluster. Objective 3: To explore and facilitate partnerships for innovative approaches (IGAs and Chama) to incentivize CORPs (Community owned resource persons – volunteers), CHWs and Community Midwives (CMWs) to effectively participate in increasing access and retention of pregnant women and children in the one intervention cluster. Objective 4: To assess the effectiveness and sustainability of the implementation of FLTR and EHC in the improvement of the efficiency of the referral system between the community (level 1), primary care facilities (level 2) and County referral facilities (level 3) for pregnant women in the intervention area Objective 5: To build capacity of health workers to conduct health systems research and inculcate a culture of use of evidence to strengthen the performance of health systems through on-job training, in-service certificate and degree programs. Objective 6: Conduct end line survey on levels of maternal and child health indicators, status of health system and existing programs in the study areas? The possible levels of improvements in the indicators is shown in Table Table44 as low, medium and high with low meaning modest improvement in indicators and high meaning significant improvement. Projected/expected Levels of project outcome/improvement Table Table55 shows what will be monitored and how it will be done including the evaluation. The contribution of the project includes improvement in quality of maternal and child health care, reduction in Maternal Mortality ratio, increase in skilled birth attendance at delivery, reduction in stunting among under-fives, reduction in the under five mortality rate, reduction in Infant mortality rate, increase in fully immunized infants at <12 months, and the number of masters and doctoral graduates. The proposal will be approved by the Institutional Research and Ethics Committee of the Moi University and by the 6 County Health Management Teams (CHMTs). The written consent will be obtained from all women enrolled into the study who accept to participate. Those mothers who will be minors (age 12 years and above) will have their consents provided by their guardians or husbands. Illiterate eligible women will have their thumb prints taken and witnessed by an independent adult. The IREC guidelines on confidentiality and on research among vulnerable groups will be followed. “This work was carried out with the financial support from the National Commission for Science, Technology and Innovation (NACOSTI) and the International Development Research Centre (IDRC) Canada. The views expressed in this work are those of the creators and do not necessarily represent those of the National Commission for Science, Technology and Innovation, and the International Development Research Centre, Canada or their Board of Governors.” The project timelines are shown on Table Table66 Proposed project timeline
N/A