Implementation research on management of sick young infants with possible serious bacterial infection when referral is not possible in Jimma Zone, Ethiopia: Challenges and solutions

Introduction Of 2.5 million newborn deaths each year, serious neonatal infections are a leading cause of neonatal death for which inpatient treatment is recommended. However, manysick newborns in sub-Saharan Africa and south Asia do not have access to inpatientcare. A World Health Organization (WHO) guideline recommends simplified antibiotic treatment atan outpatient level for young infants up to two months of age with possible serious bacterial infection (PSBI), when referral is not feasible.We implemented this guidelinein Ethiopia to increase coverage of treatment and to learn about potential facilitating factors and barriers for implementation. Methods We conducted implementation research in two districts (Tiro Afata and Gera) in Jimma Zone, Ethiopia, to learn about the feasibility of implementing the WHO PSBI guideline within a programme setting using the existing health care structure. We conducted orientation meetings and policy dialogue with key stakeholders and trained health extension workers and health centre staff to identify and manage sick young infants with PSBI signs at a primary health care unit. We established a Technical Support Unit (TSU) to facilitate programme learning, built health workers’ capacity and provided support for quality control, monitoring and data collection.We sensitized the community to appropriate care-seeking and supported the health care system in implementation. The research team collected data using structured case recording forms. Results From September 2016 to August 2017, 6185 live births and 601 sick young infants 0-59 days of age with signs of PSBI were identified. Assuming that 25% of births were missed (total births 7731) and 10% of births had an episode of PSBI in the first two months of life, the coverage of appropriate treatment for PSBI was 77.7% (601/773). Of 601 infants with PSBI, fast breathing only (pneumonia) was recorded in 432 (71.9%) infants 7-59 days of age; signs of clinical severe infection (CSI) in 155 (25.8%) and critical illnessin 14 (2.3%). Of the 432 pneumonia cases who received oral amoxicillin treatment without referral, 419 (97.0%) were successfully treated without any deaths. Of 169 sick young infants with either CSI or critical illness, only 110 were referred to a hospital; 83 did not accept referral advice and received outpatient injectable gentamicin plus oral amoxicillin treatment either at a health post or health centre. Additionally, 59 infants who should have been referred, but were not received injectable gentamicin plus oral amoxicillin outpatient treatment. Of infants with CSI, 129 (82.2%) were successfully treated as outpatients, while two died (1.3%). Of 14 infants with critical illness, the caregivers of five accepted referral to a hospital, and nine were treated with simplified antibiotics on an outpatient basis. Two of 14 (14.3%) infants with critical illness died within 14 days of initial presentation. Conclusion In settings where referral to a hospital is not feasible, young infants with PSBI can be treated on an outpatient basis at either a health post or health centre, which can contribute to saving many lives. Scaling-up will require health system strengthening including community mobilization. Ethiopia has a decentralized three-tier health care system of primary, secondary and tertiary level care characterized by a Primary Health Care Unit (PHCU) composed of five satellite health posts, one health centre and one primary hospital. Above the PHCU are either general or specialized hospitals. A PHCU serves a population of up to 100000, while general and specialized hospitals each serve up to 1.5 and 5 million people, respectively [17–19]. See Box 1 for more details. A health centre is staffed with a team of mid-level health professionals including public health officers, nurses, midwives, environmental health experts, pharmacists and laboratory technicians. A health centre provides comprehensive primary health care which includes promotive, preventive and curative services. One health centre supervises and receives referrals from five satellite health posts. The Health Extension Programme (HEP) is a programme with its deep root in the community through which several preventive and selected curative services are provided to the community under the 16 essential health packages and within the umbrella of PHCU. The HEWs constitute the core of the HEP, whereas other key actors include model households, the health development army (HDA), the community and the government, which also play significant roles in the implementation of the HEP. Model households are those households that are trained in the HEP packages, implementing these packages after the training, and able to influence their neighbours to adopt the same practices. A health post is an operational centre for two female health extension workers (HEWs) serving one kebele, which is the lowest administrative unit in Ethiopia and is comprisedof approximately 1000 households or 5000 people. Each HEW is required to spend 75% of her time conducting outreach activities in her respective kebele, and 25% of her time at a health post. All HEWs have completed high school, received additional training for one year on 16 health packages, including maternal and child health (MCH), and are employed in the government health system. The MCH services provided by HEWs include i) identification and counselling of pregnant mothers; ii) linking to or providing antenatal care; iii) encouraging institutional deliveries; iv) carrying out birth surveillance, and v) providing postnatal care for the mother-infant pair. HEWs also provide integrated community case management (iCCM) targeting common childhood illnesses. Since 2013, Community-based Newborn Care (CBNC) was introduced to the health extension programme (HEP) package in which, beyond routine birth and pregnancy surveillance, the HEWs are expected to provide newborn care including identifying and referring sick young infants to higher-level health facilities. Since 2016, HEWs have also been trained to assess, classify and treat young infants with PSBI when the referral is not feasible. Similar to the health centre staff, the HEWs lead community-based activities such as community mobilization and public health campaigns. Since its establishment in 2003, the Ethiopian HEP has achieved several successes in the areas of maternal, neonatal and child health and several other preventive aspects of community health. Remarkable achievements have been obtained in the areas of family planning, immunization, antenatal care (ANC), malaria prevention and control, TB/HIV prevention and control as well as treatment of common childhood illnesses like diarrheal diseases and acute respiratory tract infections (ARI). Additionally, through the HEP, significant improvements have been demonstrated concerning service utilization, community’s knowledge and care-seeking, and latrine construction and utilization [17, 19]. Health Development Army (HDA) is an organized movement of communities forged through participatory learning and action meetings which are designed to improve the implementation capacity of the health sector by engaging communities to identify local challenges, find solutions to these challenges and facilitates scaling up best practices. A functional HDA requires the establishment of health development teams that comprise up to 30 households residing in the same neighbourhood which is further divided into smaller groups of six members, the one-to-five networks. Leaders of the health development teams and one-to- five networks are selected by their team members. In Ethiopia, the management of PSBI when referral is not feasible is provided under the umbrella of the CBNC programme. The HEWs refer sick young infants with any sign of PSBI to the nearest health centre, which in turn refers the infant to a nearby hospital if PSBI is confirmed. If referral isnot accepted, the HEWs treat the sick young infants with oral amoxicillin and injectable gentamicin for seven days, whereas the health centre staff treat such cases with injectable ampicillin and gentamicin for seven days (Box 2). PSBI is defined as a young infant 0–59 days old presenting with any of the following signs: fast breathing (respiratory rate ≥ 60 breaths per minute), severe chest indrawing, no movement at all or movement only when stimulated, not able to feed at all or not feeding well/stopped feeding well, convulsions, high body temperature (≥38°C) or low body temperature (<35.5°C). Classification of PSBI: Fast breathing pneumonia–infant 7–59 days old presenting with only fast breathing (60 or more breaths per minute) Treatment Ethiopia recently adopted the policy of treatment of sick young infants with CSI signs when a referral is not feasible with twice-daily oral amoxicillin and once-daily injectable gentamicin for seven days (14 doses of amoxicillin and seven injections of gentamicin). This treatment includes infants 0–6 days old presenting with fast breathing only, which is a little different than the WHO guideline where it is a separate category [12]. The Ethiopian Ministry of Health was interested in evaluating the two-day gentamicin regimen, which was an option recommended by the WHO for infants presenting with CSI (Box 2). Hence, Tiro Afata District was selected to implement the two-day injectable gentamicin plus seven-day oral amoxicillin regimen while Gera District was selected to implement the seven-day injectable gentamicin plus seven-day oral amoxicillin regimen. Fast breathing only in infants 7–59 days old was treated with twice-daily oral amoxicillin for seven days in both districts. Tiro Afata and Gera were selected from the 20 districts (woreda) of Jimma Zone, in consultation with the Jimma Zone Health Department, Oromia Regional Health Bureau (RHB) and the implementing partner, John Snow Inc. Last 10 Kilometres (JSI/L10k) Project. Tiro Afata has a population of 152238 with 23 health posts, five health centres and 50 HEWs. Gera has a population of 143555 served by 29 health posts, five health centres and 55 HEWs. There are no hospitals in the selected districts, but two primary hospitals and one specialized hospital in the surrounding districts are referral facilities. In this implementation research, we prospectively collected quantitative and observational data at different levels. The population comprises sick young infants up to 2 months of age with any sign of PSBI.We collected data from all the health posts and health centres in the two districts. However, we were unable to collect information from the referral hospitals in the surrounding districts. The interventions included policy dialogue, standardization of treatment protocols at the health centre and health post levels, training of HEWs and health centre staff, provision of necessary supplies and commodities at the beginning of implementation in collaboration with JSI/L10K, provision of monthly supportive supervision and quarterly review meetings with the responsible stakeholders. Community sensitization and awareness campaigns were also carried out. A Technical Support Unit (TSU) was established to provide technical back-up to the district health offices and health workers. In collaboration with the implementing partner, the TSU facilitated learning by doing and the replenishing of necessary commodities for health facilities when needed. For the management of sick young infants, which was considered part of routine HEW activity, HEWs were asked to complete various case recording forms developed by the study team. There was no additional payment given to the HEWs for their routine work. However, a small payment (around US$ 20 per month) was made to the district health office and health centre staff for extra activities that included additional supportive supervision and data collection. For the quantitative study, data were entered into Epidata version 3.1 and then exported to and analyzed using STATA version 12.0. Descriptive statistics (proportion/percentage) were calculated which included the proportion of sick young infants identified at different levels (health posts and health centres), the proportion of infants with different classifications (fast breathing pneumonia, CSI and critical illness), the proportion of infants referred to higher-level health facilities, the proportion of infants whose caregivers accepted the referral, proportion of infants completing treatment, etc. To ensure the quality of the services provided and data collected, the TSU trained HEWs, health centre and district health office staff, as well as the study coordinators, at the beginning and the mid-point of the study. Additionally, the TSU conducted regular monthly supervision and quarterly review meetings with the HEWs and health centre staff and used the meetings to share progress and best practices, challenges and options for overcoming barriers to implementation. The implementation research was carried out in phases. At the national level, orientation and policy dialogueworkshops were held with the assistance of WHO. They involved all stakeholders working on newborn health in Ethiopia including the WHO, UNICEF, Save the Children, USAID, JSI/L10K, Ethiopian Pediatrics Society, the Federal Ministry of Health, Regional Health Bureaus, etc. The WHO PSBI management guideline and the evidence that contributed to its development [12–16] were presented and discussed. Additional policy dialogue sessions were conducted at regional, zonal and district levels, mainly by the TSU, to ensure understanding of evidence and implications for implementation. Following this activity, the Oromia RHB together with the Jimma site study team identified potential sites/districts for the study. During the policy dialogue workshops, an agreement was reached on the management of sick young infants with signs of PSBI at health posts and health centres. The HEWs would identify sick young infants in the community or at the health post, assess and classify for PSBI, refer them to health centres when required, and treat and follow up those who do not require a referral or whose caregivers refuse referral. Those infants whose care givers accept referral by the HEW would go to health centres to be reassessed and referred to a hospital if needed. At both levels, when a referral is refused, treatment would be provided according to the agreed-upon standards as shown in Box 2. i. Establishment of a Technical Support Unit (TSU). A TSU composed of three paediatricians, one reproductive health expert, one microbiologist and one sociologist (all from Jimma University) and one newborn health programme manager (from Oromia RHB) was established. To coordinate field activities, one full-time coordinator was based in each district. The coordinators provided technical support and mentored the HEWs, validated a selection of enrolled cases, assessed the outcome of treated sick young infants, collected quantitative data from the health posts and health centres and coordinated the overall study-related activities. The roles and responsibilities of the TSU were to: a) develop an implementation plan and data collection instruments; b) prepare the study sites; c) arrange and participate in stakeholders’ meetings before and during the research; d) train health care providers at health posts and health centres as well as managers; e) conduct monthly supportive supervision at health posts and health centres through performance assessment and feedback; f) assess the performance of HEWs and health centre staff and provide feedback; g) identify implementation challenges and develop interventions in collaboration with stakeholders; h) compile health post and health centre data, and i) supportcommunity sensitization. The TSU established effective communication between the study team and other stakeholders, such as JSI/L10K, zonal and district health offices, and health care providers at health posts and health centres. The district MCH coordinators oversaw the districts’ MCH activities. They conducted monthly supportive supervision of the health centres and selected health posts, compiled data from the health facilities and submitted it to the TSU. ii. Roles and responsibilities of the nongovernmental organization. JSI/L10K facilitated the initial training of the HEWs, provided the initial start-up commodities and supplies necessary to assess, classify and treat sick young infants, replenished these commodities and supplies for some of the health posts, carried out supportive supervision to the health posts and conducted quarterly review meetings with the HEWs, the TSU and the district health office. iii. Roles and responsibilities of the government health department. The RHB led implementation in coordination with the district officers and took part in the review meetings as well as the supportive supervision, where progress and lessons learned were discussed. iv. Building health system capacity. Training: The TSU and JSI/L10K trained all the HEWs and health centre staff in the study districts in June 2016. Subsequently, refresher training was given with a focus on gaps identified during regular TSU and JSI/L10K supportive supervision. Tools, job aids and equipment: Tools and job aids, developed by the Federal Ministry of Health (FMOH) (CBNC chart booklet, CBNC register and family health booklet), were provided to the HEWs to support and facilitate their work. They were equipped with thermometers, respiratory rate counters and weighing scales. v. Community mobilizations. To create awareness and mobilize the community, we used the existing local government structures focusing mainly on the HEWs and the HDA. The major platforms used to mobilize the communities were the health extension workers (HEW) and health development army (HDA) linkages so that most deliveries and sick young infants are identified. Various community gatherings/meetings to deliver the necessary key messages about identification and treatment of sick young infants and the campaigns organized by the PHCU including the community health insurance, the tuberculosis screening, trachoma control, onchocerciasis control etc. These campaigns were used to disseminate the necessary information to the community when they gathered so that they could contribute to the implementation research. We have also included this under the methods section. vi. Ethical clearance. Ethical clearance for this implementation research was obtained from Jimma University Institutional Review Board and the WHO Research Ethics Review Committee. Additionally, letters of support were obtained from the respective national, regional, zonal and district government offices. Individual participant’s informed consent was waived since the implementation research was done in the routine government health system. i. Logistics and commodities. Logistics management for the health posts was handled by JSI/L10K, which provided 50 vials of gentamicin and 150 strips of oral amoxicillin dispersible tablets (10 tablets per strip) for each health post at the beginning of the study. Disposable syringes (3ccs) were also provided. The district health offices provided subsequent supplies through the routine delivery system. Although medicines at health posts were available free of charge for PSBI cases, at the health centres caregivers were expected to pay for them. The TSU was not involved in the procurement and distribution of supplies but shared observations about the availability and utilization of commodities with the district health offices and JSI/L10K. The estimation of needs and distribution was based on the annual number of live births in the catchment area of a health post using an estimated birth rate and the number of women of reproductive age, and assuming 10% of live births would develop PSBI in the first two months of life. Logistics management at the district level was carried out by the MCH coordinator, and by pharmacy personnel and HEWs at the health centre and health post level, respectively. ii. Supervision. Supportive supervision was conducted at two levels. First, health professionals from the health centres conducted supportive supervision every two weeks to the health posts in their catchment area. During supervision, HEWs and supervisors discussed issues that were challenging for the HEWs about identification, classification and treatment of sick young infants. On-the-job training, case discussion and assessment of HEWs’ knowledge, skills and practices were part of the supervision. Second, team members from the TSU conducted monthly supportive supervision for the study districts, health centres and health posts. During district-level supervision, MCH coordinators and supervisors from selected health facilities also joined the team. iii. Quality control. The performance of individual health centre staff and HEWs were reviewed during monthly supportive supervision and quarterly review meetings, and necessary feedback was provided. The parameters used during this assessment included the number of sick young infants identified, assessed and treated; the quality of assessment and treatment; the quality of record-keeping; the number of pregnancies and births identified; and the number of postnatal care visits. Additionally, the performance was compared among health facilities and feedback given. Solutions to identified implementation barriers were developed collaboratively. Better performers were encouraged to sustain and enhance their performance and share their experiences with other facilities during review meetings.