Effectiveness of Checklist based Box system Interventions (CBBSI) versus routine care on improving utilization of Maternal Health Service in North West, Ethiopia: Cluster Randomized Controlled Trial

Maternal mortality is still high in Ethiopia. Antenatal care, use of skilled delivery and postnatal care are key maternal health care services that can significantly reduce maternal mortality. However, in low and middle income countries including Ethiopia, utilization of these key services are not enough to deliver the recommended preventive, promotive and curative services. The aim of this study is to examine the effectiveness of checklist based box system interventions on improving maternal health service utilization. A community level cluster-randomized controlled trial will be conducted to compare the effectiveness of checklist based box system interventions over the routine standard of care. The intervention will use health extension program and provided by health extension workers and midwives, using a special type of health education scheduling and service utilization monitoring boxes, placed at health posts and health centers respectively. For this, 1,200 pregnant mothers, below 16 weeks of gestation, will be recruited from 30 clusters. Suspected pregnant mothers will be identified through a community survey and linked to the nearby health center. In a two weeks base, review of dropouts will be conducted at each intervention health center. Then intervention health posts (supervised by intervention health center) will be communicated for each dropout. Then, health extension workers will provide health education, using a person-centered manual prepared for this purpose. Data will be collected using ODK-Collect and analyzed using STATA version 13.0. Data will be analyzed by intention to treat analysis. Risk ration will be computed at cluster level and the summary will be compared using t-test. Outcomes between intervention and control groups will be compared with random effects logistic regression models.


Discussion -
The authors of this study expect that, the study will generate evidence on the effectiveness of checklist based box system interventions on improving utilization of maternal health care service, that are strong enough to inform policies in the country.

Background
Antenatal care (ANC), use of skilled delivery attendants and postnatal care (PNC) services are key maternal health care services (MHCS) that can significantly reduce maternal mortality [1]. Despite proven interventions that could prevent death or disability during pregnancy and childbirth, maternal mortality remains a major burden in many developing countries [2]. Although significant declines observed, progress in reducing maternal mortality in developing countries was insufficient to meet MDG 5a targets. Looking beyond 2015, the sustainable development goals offer a renewed opportunity to see improvements in maternal health [3].
Within the continuum of reproductive health care, ANC provides a platform for important health-care functions, including health promotion, screening and diagnosis, and disease prevention [4]. So, all pregnant women should have at least four ANC assessments by/under the supervision of skilled attendant [5]. Antenatal care, entry point for other MHCS, may play an indirect role in reducing maternal mortality by encouraging women to deliver in a health facility [6]. It has been argued that efforts should be based on a continuum of care perspectives and, thus, joint strengthening of antenatal, delivery and post-partum care is relevant [7,8].
Many authors agreed that, factors influencing MHCS utilization operate at various levels: individual, household, community and state level, but the role of individual, household and other factors and determinants differ from one culture, geographicand social setting to another [9][10][11].
Globally, an estimated 289,000 women died during pregnancy and childbirth in 2013, a 45% decline from 1990. Most of them died because they had no access to skilled routine and emergency care. Since 1990 there has been progress in sub-Saharan Africa, but unlike the developed world where a women's lifetime risk of dying during pregnancy and childbirth is 1/3700, the risk of maternal death is very high as 1/38 [12].
Even though effective health interventions are available, most studies in developing countries like Ethiopia indicate that the potential to deliver health information and services using MHCS still remains underutilized [13]. In Ethiopia, one explanation for poor health outcomes among women is the nonuse of modern health care service by a great proportion of women in the country [14].
A study conducted in Nepal showed that 47.7% attended at least one and 30.7%attend at least four ANC visits [15]. A study assessing PNC utilization in Pakistan also showed that, around 70% did not consult with anyone for PNC and majority (70%) mentioned that postnatal checkup was not necessary [16].A study in Nigeria showed that, 63% of the women didn't utilize PNC within 42 days after delivery and only 4% of them utilized the appropriate care according to the WHO guideline [17].
Comparison of findings from studies investigating utilization of MHCS in low and middleincome countries indicates that women are more likely to attend ANC than to deliver in health facilities. For instance, in Ethiopia, overall MHCS utilization is low, 2016 EDHS showed that 62% and 32% of pregnant women made at least one and four ANC visits; SBA and PNC are reported as 27.7% and 16.5% respectively [18]. In addition 34% dropout rate of mothers starting ANC 1 but not reach at least four visits, was observed in 2017 [19]. In addition, mothers attending ANC service are receiving the key service packages with different level of completeness. In Ethiopia, 65% of pregnant women among those reached by 2012 EPI survey received tetanus toxoid vaccination, and long-lasting insecticidal nets utilization was reported to be 42% in 2011 Malaria Indicator Survey [20][21][22][23].
The analysis of 2011 EDHS showed that, education level of women and their husbands is one of the strongest determinants of the use of MHCS. Service utilization increased consistently as the education level of women and their husbands increase.The same analysis showed that, only 26.2% of those attending ANC started their ANC visit during the recommended timing (first trimester), majority (56.4%) started during the second trimester and 16.7% started during the third trimester [1]. Similarly 2014 EMDHS showed that the average time the women start the first ANC was five month [20].
A study in southwest shoa, Ethiopia showed, the coverage of at least four ANC visits and SBA were 45.5% and 28.6% respectively [24]. A similar study conducted in rural haramaya, Ethiopia showed that 74.3%, 28.7% and 22% of mothers got the first ANC, SBA and PNC respectively [25].
In general, utilization of MHCS is not initiated as per the recommendation, and the proportion of mothers utilizing the service decreases as one go from the first ANC to the third PNC. Thus, the aim of this trial is to use the rigor of Cluster Randomized Controlled Trial for the evaluation of checklist based box system interventions on improving MHCS utilizations. The evidence from this trial is believed to contribute for programs and policies aimed to improve MHCS utilization.

Methods/design
Design Cluster Randomized Controlled Trial study design, double-blind masking, parallel group and two arm intervention was employed to assess the effectiveness of checklist based box system interventions on improving utilization of maternal health care service utilization in East Gojjam Zone, Northwest, Ethiopia. Participant flow detail (Fig 1) Setting The study will be conducted in East Gojjam Zone, one of the administrative zones of Amhara Region, Northwest Ethiopia. According to EDHS 2016, the region's maternal health service utilization is: first and fourth ANC was found to be 67.1% and 31.5% respectively, health facility delivery was 27.1% and postnatal care was 18.4% [18]. Debre-markos, the capital city of East gojjam zone is located in the northwest direction 299 km far from the national capital Addis Ababa. According to the USAID estimate, the population of east gojjam zone was estimated to be 2,613,835 with male population 1,292,042 (49.4%) and female population 1,321,788 (50.6%) [26].
The Context: Primary Health Care Unit The Ethiopian health service is restructured into a three tier system; primary, secondary and tertiary level of care. The primary level of care includes primary hospital, health center and health post. The Primary Health care unit is composed of a health center (HC) and five satellite health posts (HPs). These provide both preventive and curative services to approximately 25,000 people altogether. HCs served as a referral center and practical training institution for HEWs. In turn, primary hospitals serve as a referral center for HCs under its catchment areas, a practical training center for nurses and other paramedical health professionals [23].
Ethiopia's Health Extension Program (HEP) is a community based strategy to deliver health promotion, disease prevention and selected curative health services at the community level. It is a mechanism to provide health service free of charge to all segment of population in the country by payed health extension workers (HEWs). HEWs are drown from the community they are going to serve, and are trained for one year. Two HEWs per health post are deployed to provide services under the 16 packages by making house-tohouse visits. Improving access and utilization of latrines, increasing contraceptive acceptance rate, antenatal care and post natal care, improved health seeking behavior, expanded vaccination services, malaria control and prevention and reduction of new HIV infection are some of the major package that are expected to be delivered by HEWs. HEWs spend 75% of their time on home-to-home visits providing promotional and preventive interventions and 25% of their time at health posts [23,27].

Participant Eligibility Criteria
The participants for this trial will be pregnant mothers residing in three of the selected districts of East Gojjam zone (Debre-Markos, Gozamin and Machakel districts). There recruitment will pass a two stage screening process: using a preset criteria the initial screening will be done at community level using Stanback et al, 1999 pregnancy screening checklist and mothers having a suspected pregnancy will have a laboratory confirmation at health center. Then those having gestational age of 16 weeks will be recruited for the study. Mothers who fulfill the above listed criteria but, who have severe psychological illness, which could interfere with, consent and study participation, those who have sever clinical complications that need hospitalization and mothers who need special type of ANC follow-up, other than the recommended focused ANC will be excluded from the study.

Sample Size Determination
The sample size for this study was calculated based on the recommendations of sample size calculations for cluster randomized controlled trials with fixed number of clusters [28], by using the following assumptions: utilization of the third postnatal care in the control group is 16% based on previous study [29], number of clusters available-30 (15 clusters per arm), with 95% confidence interval and 80% power, intra-cluster correlation coefficient of 0.04849 [30]. The sample size was calculated to determine number of observations required per cluster, for two-sample comparison of proportions (using normal approximation), using STATA. Assuming individual randomization, sample size per arm is 194. Then allowing for cluster randomization, average cluster size required is 40, and the final sample size is 1200 pregnant mothers (600 in intervention, and 600 in control).

Screening and Enrollment
To initiate this trial, health extension workers will use the family folder (a detail record of households in the catchment of health post), to identify women of reproductive age (WRA). Then, the first level screening takes place at community level using Stanback et al, 1999 pregnancy screening checklist. Mothers having suspected pregnancy, will receive community level referral slip to be received by the near by health center. A copy of the referral slip will remain with the visiting HEW. Then the second screening will take place at Health center using beta-human chorionic gonadotropin (HCG) urine test, laboratory confirmation of pregnancy. Mothers who have known pregnancy but not initiated the first ANC will also be referred for the service. If a mother has a positive HCG result, she will be recruited for the study and on the same day she will receive the First ANC service.
Intervention Description: Trial Arm I/Intervention The intervention has both community level (behavioral change) and facility level (service utilization drop out tracing mechanism) components. Women of reproductive age were the focus of the trial. The list of WRA will be obtained from the family folder, and based on that home to home visit will be made by HEWs. While making these visits, they will do pregnancy screening using Stanback et al, 1999 checklist. Mothers having a suspected pregnancy will receive a referral slip to be received by the nearby health center and a copy will remain with HEW. In addition, these home-to-home visits will allow health extension workers to identify individual reasons for not utilizing the service. List of mothers referred will be registered with a special referral registry with the expected date of health center visit and the revisit day (for mothers not visiting HCs). The community level behavioral change component will focus on; approaching pregnant and delivering mothers for person-centered problem solving health educations. Beyond this individual based health education, the work of HEWs, identifying underlying reasons for not utilizing the service will help HEWs to make decisions by using locally generated data. This is done through a special designed health education scheduling boxes placed at health posts. Of the reasons identified, for not utilizing MHCS, reasons raised by most of the mothers will be used as a topic of discussion during platforms like, pregnant mothers conference.
Once the mothers are linked to the nearby health center, they will be followed for their subsequent attendance of consecutive maternal health care services (ANC (2-4 th visits), skilled birth attendance, and post-natal care (1-3)). This will be checked using special designed service utilization monitoring box (procured and given to intervention health centers). This box is a nine-compartment box: the first compartment is for mothers suspected for having pregnancy using the pregnancy-screening checklist. If the mothers came and confirm their pregnancy (HCG test) they will get the first ANC and their card will be transferred to the next compartment, the same procedure will be followed for the coming consecutive MHCS visits. The visits for ANC service will follow the 4-visit WHO ANC model (i.e. First ANC (before 16 weeks of gestation), second ANC (24-28 weeks), Third ANC (30-32 weeks), fourth ANC (36-40 weeks), and facility delivery assisted by skilled health care providers (health canter and above) and PNC 1 at 6 hours, PNC 2 at 6 days and PNC 3 at 6 weeks of delivery). This service utilization-monitoring box will help Midwives to identify mothers who fail to follow the above smooth transition. If a mother is identified as a 'dropout', Midwives at health centers will communicate health extension worker in which the mother is belonging. Again these mothers will be approached for person-centered health education to resume their service within the recommended time interval.

Data Collection Toolsand Techniques
Data will be collected using a semi-structuredand pre-tested questionnaire. The questionnaire used to collect data was designed by reviewing relevant literatures and related national and international standards, and the focus is on educational and ecological assessment, mother experience related to pregnancy, delivery and postnatal care, social and epidemiological assessment, behavioral and environmental assessment, general social support and social capital and health service quality components. This will be translated to Amharic version (Local Language of the study area).
Then the translated version was uploaded to kobo toolbox, and open data kit (ODK) will be used to collect data. The study will use face-to-face interview and the data will be collected using mobile devices in front of each selected mother's home. Filled questionnaires will be saved in the mobile devises, and will be sent to the central server immediately after completing the interview.In cases where the data collectors can't complete the questionaries' and when an internet connection can't be accessed the filled questionaries' will be sent when there is internet connection available. The data collection will be managed directly from Jimma university server. Each data collector and supervisor has got a code; this will make data management easily done. For both of the arms if the study participants move from the study area before the study is completed, they will be registered as dropouts to lost to follow-up. This trial will have two phases of data collection: baseline study (before the intervention is introduced) and end line study (after the intervention is introduced).

Data Quality Control
Training for selected data collectors and supervisors will be conducted, with the focus of making common understanding for each and every question. In addition to this a manual explaining each and every question with its response categories was prepared, this manual also include 'how to use ODK to collect data' with examples demonstrating the features of the application. The data collection will be conducted by BSC holder Midwives; and supervised by two MPH holder professionals. In addition to this,a close follow-up by the principal investigator will be done.The field data collection will be supported by ODK in which each and every question is settled to be required; help to avoid missing data. Also range checks were setted for selected data values accordingly.This ODK will also allow editing the responses in front of each interviewee. Similarly GPS coordinates of each and every interview place will be recorded at the end of each interview, which will allow to graphically representing the study site.

Analysis Plan
Data from the trial will be analyzed by intention to treat analysis at both cluster and participant levels. Participants will be assigned to the cluster they were resident in at the time the trial began. Data analysis will take place in two levels, in cluster level and in individual level. Risk ration will be computed at cluster level, and the results of this cluster summary will be compared using t-test. Primary and secondary outcomes will be compared between intervention and control groups with random effects logistic regression models, taking account of clustering/correlation. All estimates will be presented with 95% confidence intervals. STATA version 13.0 will be used to run the analysis.

Outcome Measures
Primary outcome-is continued utilization of maternal health care service, (antenatal care 1 st -4 th , institutional delivery assisted by skilled health care providers, and postnatal care 1 st -3 rd ).
Secondary outcome-secondary outcome measures will assess whether the trial has an effect on the following maternal health service utilization; onearly initiation of antenatal care (before 16 weeks of gestation), attending fourth antenatal care, attending the third postnatal care.

Dissemination Plan
Detailed study protocol will be published on open access journal. Any modifications that will be made to the protocol will be communicated to relevant parties such as trial registry and both of the ethics committees. After the result is produced, it will be submitted to the Jimma University, Amhara Region public health institute, East Gojjam zone health department and governmental and non-governmental organizations working in maternal health programs. The findings of this study will also be presented in scientific conferences. Also, manuscript will be prepared and submitted to a peer-reviewed scientific journal for possible publication.

Discussion
This trial is designed to improve continued utilization of maternal health care service and will be applied both in urban and rural settings. Unlike the routine care, pregnancy identification will take place at community level. As this trial is designed to be implemented by combining both demand creation and service utilization monitoring components the investigators believe that, the evidences generated will contribute for maternal health programs in the regional and national level.

Trial Status
Thirty clusters were selected and the preparatory activities like: development of training manuals, referral slips and registers were completed. Sensitization workshop for local health administrators and training for intervention implementers (health extension workers and Midwives) was conducted. Specification for specially designed boxes for health posts and health canters was developed and procurement and distribution was made accordingly. Baseline study was collectedin both the intervention and control clusters, and enrollment of mother as per the prespecified criterion is being conducted.

Ethics approval and Consent to participation
Ethical clearance for the study was obtained from Jimma University Institutional review board (IHRPGD/841/17) and Amhara Public Health institute. A formal letter with the detailed implementation plan for the intervention was submitted to the federal ministry of health and Amhara regional health bureau and a letter of support was obtained from both of the organizations. In communication with east gojjam zone health department, district health offices and selected health centers were communicated through formal letter.
Then, a one-day formal orientation on the implementation plan was provided to local health administrators. Participant information sheet and consent form was developed and before data collection mothers were told about the objective of the study and oral informed consent was obtained.

Consent for Publication
Not applicable.

Availability of data and materials
Not applicable. NB, the principal investigator of this study, initiated the trial idea, wrote initial draft of the proposal, developed the protocol and supervises the implementation of the intervention. NB, MG and GTare participating in maturing the implementation plan, study design and statistical design of the trial. All authors critically reviewed and approved the final study protocol.