Effectiveness and Acceptability of Availing Skilled Birth Attendance (SBA) Services Through Community Reproductive Health Nurses (CORN) to a Household Level at Rural Communities of Ethiopia; A Cluster Community Trial in Gedeo Zone, SNNPR
Condition: Maternal Care Patterns
Study type: Interventional

Summary: 
      Rationale: Every year, 287,00 million women, and 3.1 million neonates continue to die, and
      the majority of these deaths have been identified as being avoidable. A proxy indicator of
      Millennium Development Goal (MDG) 5, birth with skilled attendance is low in Sub-Saharan
      Africa(47%) and the lowest (13%) is for Ethiopia, with the greatest number of maternal
      deaths. The Ethiopia health system has established a vast network of health infrastructure
      that extends to rural areas with the establishment of over 15,000 health posts and deployment
      of over 30,000 health extension workers throughout the country. Although these unprecedented
      situations made health services more accessible than ever, it is yet to be exploited for
      improving rural women's access to clean and safe delivery and postpartum care. Lack of usage
      of delivery care in the country is related not only to accessibility but also acceptability
      of the services. In fact, the vast majority of women with home deliveries saw institutional
      delivery as "unnecessary" and a "non-customary practice". Therefore, instituting an
      innovative, culturally sensitive, and practically amenable strategy, deployment of CORNs for
      example might be the best remedy, in this case.

      Objective: To evaluate the effectiveness and acceptability of availing Home based Skilled
      Birth Attendance (SBA) Services through Community Reproductive Health Nurses (CORN) in rural
      communities of Ethiopia.

      Study design: Cluster Randomized Controlled Community Trial that will be conducted in four
      phases.

      Study population: Study participants will be all pregnant women who will give birth at home
      and health facility (including health post) during the study period.

      Intervention: The study will be conducted in four phases as discussed below. During the first
      (preparatory) phase, sensitization of relevant stakeholders and recruitment of trainees will
      be conducted. In the second phase, formative and baseline assessment as well as training of
      CORNs will take place. In the third phase, which will be actual intervention phase,
      deployment of CORNs in their respective study site will be done and in the final phase, final
      evaluation and dissemination of study findings will be done. The intension behind deploying
      CORNs to the grassroots level is just to give a backup skilled delivery and other MNH
      services to poor rural mothers who have difficult of accessing modern health facilities for
      various reasons; it has no any intention to promote or encourage home deliveries or replace
      institutional deliveries. Perhaps it will help to assimilate rural mothers to modern health
      facilities Main study parameters/endpoints: The main study end point is percentage of skilled
      birth attendance which is very low in local and national level. In addition secondary study
      parameters are percentage changes of maternal & related services uptakes. These include
      focused Antenatal; care (ANC), long term family planning, Prevention of Mother to Child
      Transmission of HIV (PMTCT) and postnatal care.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: the burden and risks associated with participation to the study is very minimal.
      To mention few; physical examinations (Leopold manoeuvre) or the routine investigations of
      pregnancy this will be anonymous except for the CORNs keeping the principles of shared
      confidentiality in mind. Similarly all questionnaires or medical charts will be kept
      confidential. All CORNs will obtain intensive training on ethical principles that will help
      to minimize any physical and physiological discomfort associated with participation, the
      risks associated with the investigation treatment.

      The study period and Budget: the study will be carried out in a total of 18 months which
      holds a period from the development of protocol to the terminal evaluation and submission of
      reports. The overall study budget will be 99, 987.95 USD (Ninety nine thousands, nine hundred
      eighty seven dollars and ninety five cents
    

Detailed description: 
      Introduction Every year, 287,000 women die during pregnancy or childbirth, and 6.9 million
      children die before reaching their fifth birthday. Almost all these deaths occur in
      developing countries where mothers, children and newborns lack access to basic health care.
      While child mortality rates have declined in recent decades, 19,000 mothers still mourn the
      loss of a child each and every day - an unthinkable number of heartbreaks. This is especially
      tragic since most of these deaths could be prevented at a modest cost.

      On the other hand, majority of maternal and newborn deaths are caused by complications or
      conditions that could be prevented or more effectively managed through inexpensive,
      low-technology measures. Majority of maternal and new born care deaths were followed by
      unskilled delivery attended at home. A study conducted in Basra about reasons reported by
      women who delivered at home for preferring home delivery have shown that social support and
      privacy was the predominant reason given by 98.2% of the women who had home delivery of their
      present child. Fear of interventions and repeated examinations at hospitals was the concern
      of 71.9% of the women who preferred home delivery. About 17.5% had an unplanned home delivery
      as a result of quick labor or the security situation did not allow transfer to hospital.

      On the other hand, recent evidences illustrated that maternal deaths can be reduced with the
      posting of midwives (skilled attendant) if they have needed skills, supervision, and back-up
      . Evidences obtained from Bangladesh in 2004 suggested that, programme to create a cadre of
      skilled birth attendants for home births was launched by the Government . Accordingly,
      task-shifting seems to have yielded beneficial results and important insights into human
      resources planning for safe motherhood in the country. Another similar study by Ray AM on the
      impact of maternal mortality interventions using traditional birth attendants and village
      midwives showed that village midwives contribute to positive programme outcomes.

      The presence of a skilled provider during childbirth and the immediate postpartum/newborn
      period is the single most critical intervention in saving the lives of women and newborns .
      The skilled provider can assist in normal deliveries and also manage or stabilize and refer
      for complications; all of which are critical interventions in reducing maternal and newborn
      mortality. The proportion of women who delivered with the assistance of a skilled birth
      attendant is one of the proxy indicators in meeting the fifth MDG. In almost all countries
      where health professionals attend more than 80% of deliveries, Maternal Mortality Rate
      (MMR)is below 200 per 100,000 live births [11]. However, birth with skilled attendance was
      low in Southern Asia (40%) and SSA (47%), the two regions with the greatest number of
      maternal deaths.

      Though the program has addressed majority of the health problems at grass root level,
      maternal and child morbidity/ mortality rates of the nation is still one of the highest in
      the world. This is mainly attributable to the competency level of the rural health extension
      workers to provide cross-cutting maternity services on top of the deep rooted cultural,
      social and economic problems of the rural community. For example, a recent study in Tigray
      Region of Ethiopia showed that even if the HEWs have contributed substantially to the
      improvement in women's utilization of family Planning (FP), ANC and HIV testing, their
      contribution to the improvement in health facility delivery, postnatal check up and use of
      iodized salt seems insignificant.

      In addition to doubts in the skill of the rural Health Extension Worker (HEW), they are also
      expected to discharge several additional roles and responsibilities along with maternity
      related services. Moreover, they are not able and encouraged to attend skilled birth delivery
      services to mothers, rather they are expected to identify the problem and refer to next
      higher level health facility which are inaccessible (geographically, socially,
      economically...etc) to the rural community. This will definitely impend better utilization of
      modern maternity services.

      Current study findings in Ethiopia shows that skilled delivery service utilization is very
      low. Only 13% of the women who had a live birth in preceding five years of the 2011 survey
      were assisted by a skilled health worker and 12% were delivered in health facilities although
      this represented an improvement from 6.2% in 2000. This rate is in the lowest bound by
      sub-Saharan Africa standard. Skilled assistance at delivery estimated to increase at a low
      pace of 5.6% per annuum and, with this pace, the proportion that will be attended by skilled
      workers predicted at 21% by 2015. Multivariate analysis suggests rural women, uneducated, and
      poor were less likely to deliver in health institutions.(13) The major attributable reasons
      identified are geared towards the level of knowledge about maternity services, cultural
      influences and low perceived benefit of service utilization.

      According to a study on trends in maternal health in Ethiopia 2012, Women who did not deliver
      in health facilities were asked the reasons for not doing so. The Ethiopian Demographic and
      Health Survey (EDHS) 2011 data revealed that the two outstanding reasons were "not necessary"
      and "not customary", as reported by 61.4% and 29.6%, of them respectively. These were
      followed by place too far/lack of transportation (14.4%). Other reasons were reported by a
      tiny portion of the women. Only very few (2.1%) blamed service cost as a reason for not
      delivering in health facilities. Notably, the reporting of these reasons follow similar
      pattern both in the urban and rural areas. Strikingly, about two-third of the urban women who
      did not deliver in health facilities said it was not necessary and 17% said it was not
      customary.

      Mothers' reply of "not necessary" and "not customary implies the fact that they need someone
      very closer to be with them. According to the findings of couple of studies in North West and
      South-East Ethiopia, (60.9%) of mothers gave brth at home just needing for closer attention
      by family members, 57.7% said delivering at home is a usual experience, 33.4% said labor was
      short/urgent, 21.6% said they did not have any problem to go to health facilities, and 14.0%
      said influence from family members were the reasons for giving birth at home.

      What is more is, even if the number and distribution of health workers, particularly nurses,
      in the country has made progressive improvement, the country is still far behind to achieving
      maternal and child health related MDGs as the health service utilization rate is by far below
      the minimum set by the WHO which is a paradox to the above achievements.

      Therefore, what can we learn at this stage is that a novel, culturally sensitive and socially
      acceptable strategy that can overcome the shortcomings and limitations of the above facts
      must have to come in place if the nation is to achieve the MDGs and the health related Growth
      and transformation plan. May availing SBA services to the community (household) level through
      the deployment of Community Reproductive Health Nurses (CORN) at Kebele (the smallest village
      level administrative unit of Ethiopian government system) level be helpful to fill the
      majority of these gaps overlooked yet?

      2. RESEARCH QUESTIONS

        -  How effective is availing Home based SBA services by CORN in increasing births attended
           by skilled birth Attendants?

        -  What is the level of acceptability for availing Home based SBA services by the service
           providers, health service managers and the general community(clients)?

        -  What are the added advantages of deploying Skilled birth Attendants (CORN) who can
           provide SBA and other MNH services at household levels in strengthening the health
           extension program of Ethiopia?

        -  What are the added advantages of deploying Skilled Birth Attendants (CORN) in improving
           the SBA and other Reproductive Health (RH) services utilization?

           3. OBJECTIVE General Objective: To evaluate the effectiveness and acceptability of
           availing Home based Skilled Birth Attendance (SBA) Services through Community
           Reproductive Health Nurses (CORN) in rural communities of Ethiopia.

      Primary Specific Objective

        -  To determine the effect of availing home based SBA services on utilization

        -  To examine the programmatic and socio-cultural acceptability of home based delivery of
           SBA services Secondary Objectives

        -  To determine the effect of the skilled Birth Attendants(CORN) on other RH services
           utilization.

        -  To describe the effect of the Skilled Birth Attendants (CORN) in strengthening the
           Ethiopian Rural Health Extension Program.

           4. METHODS Study design

      This study is a two arm (pre-test, post test) Cluster Randomized Controlled Community Trial
      that will be conducted in four phases. The two arms are:

      Arm one : CORNs based at health center will be trained to provide skilled birth attendance
      and other RH services on demand at household levels on an outreach bases.

      Arm two : CORNs will be based and living in the community at health post /kebele/ level to
      provide SBA services either at the health post or house hold levels.

      Interventions of the first arm will be tested for effectiveness and acceptability against the
      baseline finding. A baseline evaluation and formative assessment using qualitative methods
      will also be conducted to document the situation of health service utilization and
      socio-cultural barriers affecting skilled birth attendances at all of the study sites. This
      will serve as a pretest data for the intervention and control sites. By applying similar
      techniques and tools, post test data will be collected at the end of the study at all the
      three arms. The main variable for comparisons in pretest post test data is the coverage of
      deliveries attended by SBAs in the two arms, be it by CORNS or using the existing facility
      based service delivery. Data will be collected from health institutions and the community
      within the study area. The difference between pretest and post test indicators within and
      between the intervention arms will be measured to the effect of the intervention in changing
      the SBA service uptake.

      Study Area and period The study will be conducted in three districts of Gedeo Zone ,Southern
      Region of Ethiopia with population of density of 650 per Sq. Kms.,. The Region is one of the
      nine Regions in the country which makes 20% of national population. Gedeo Zone is one of the
      highly populated areas in Ethiopia and in Africa at large. The Zonal town, Dilla, is located
      some 365 and 92 Kms away from the national and regional capitals, Addis Ababa and Hawassa
      respectively.

      Dilla University is one of the public Universities in Ethiopia situated in the study site.
      Currently the University has 12 faculties and three Colleges including College of Health
      Sciences and a Referral Hospital. The maternal health service coverage and utilization of
      Gedeo zone is one of the lowest in the country (7, 29).

      This implementation study is expected to take around one and half year as from the time of
      securing project grant to terminal evaluation and dissemination.

      In the health institutions (health centers and health posts), the health record data on SBA
      service coverage (institutional delivery, ANC and PNC) will be checked as the secondary
      source of information. Primary data in relation to the barriers and facilitating factors will
      be collected using semi-structured questionnaire for service providers. In-depth interviews
      and focus group discussions will also be conducted, among the service providers, health
      service managers and the community separately to get insights in to the perceptions, barriers
      and facilitators of skilled birth attendance services as well as the extent and acceptability
      of deploying CORN.

      Sample size and sampling procedure A cluster randomized community trial proposes to assess
      the effectiveness of deploying CORNs to advance skilled birth attendance (delivery). A
      previous Demographic and health Survey (DHS) 2011 study showed that proportion of subjects
      who had an assisted delivery was 4% in rural settings. According to the health sector
      development plan IV of the country, it has been planned to increase the proportion of
      assisted delivery from 18.4% to 62% at the end of 2014/15 fiscal year. Hence, a
      pro-grammatically similar and important difference of 58% is expected after the deployment of
      CORNs.

      Assuming the Level of significance = 5%, Power = 80%, Type of test = two-sided Based on the
      above stated assumptions, the initial sample size required per group is 94. To estimate the
      sample size for a cluster randomized trial, we needed an estimate of the degree of clustering
      at the practice level, which was available from a previous randomized trial of postnatal care
      . Using the approach of a previous study, and taking the inter-practice correlation
      coefficient to be 0.005 as indicated in that trial, we inflated the sample size by 2.45 times
      from a non-cluster randomized trial considering the potential cluster design effect. This
      yielded an estimated sample size in each group to be 230. Hence total sample size required
      for the two arm trial is 460.

      A sample size of 460 households, 230 in each arm, is sufficient to detect a clinically
      important difference of 58% between groups in assisting delivery by deploying CORN using a
      two-tailed z-test of proportions between two groups with 80% power and a 5% level of
      significance. This 58% difference represents a 62% assisted delivery by CORNs and 4% assisted
      delivery without CORN or routine standard of community care. All other secondary outcomes
      yielded a sample size of much lower than the one stated above. Hence, for the sake of sample
      adequacy, for the analysis to be carried out for both primary and secondary outcome, the
      maximum sample size (490) is considered.

      Study Participants Study participants will be All pregnant women who will give birth at home
      and health facility (including health post) during the study period.

      Husbands, grandmothers and health workers ( for the qualitative formative assessment)

      The Intervention The study will be conducted in four phases. During the first (preparatory)
      phase, sensitization of relevant stakeholders and recruitment of trainees will be conducted.
      In the second phase, formative and baseline assessment as well as training of CORNs will take
      place. In the third phase, which will be actual intervention phase, deployment of CORNs in
      their respective study site will be done and in the final phase, final evaluation and
      dissemination of study findings will be done. The intention behind deploying CORNs to the
      grassroots level is just to give a backup skilled delivery and other Maternal and Neonatal
      health (MNH) care services to poor rural mothers who have difficult of accessing modern
      health facilities for various reasons; it has no any intention to promote or encourage home
      deliveries or replace institutional deliveries. Perhaps it will help to assimilate rural
      mothers to modern health facilities. The details of the activities for each phase are
      discussed below.

        1. Phase one : Preparatory phase At the very beginning of the intervention, sensitization
           and orientation workshops will be organized to be held with relevant regional and zonal
           level health service mangers and other concerned stakeholders on the purpose of the
           study. After which another workshop will also be organized with experienced and relevant
           experts at various capacities and responsibilities to finalize the curriculum of
           trainees as per the predefined core competencies of the intervention. With this
           developed curriculum, training manual will be prepared and recruitment of candidates
           sooner commences.

           Selection of candidates will be done both from the market (Unemployed nurses or
           midwives) and from health facilities (nurses working at health centers and hospitals ,
           particularly from the maternal and Child Health (MCH) unit). This will be done because
           of the fact that during scale up of the intervention, the effect of work experience on
           the quality and success of the program might be an issue of concern. It should be clear
           that currently in Ethiopia, there is excess number of nurses trained at both government
           and private colleges. Selection and deployment will not cause and shortage of
           professionals from work place, rather it will create job opportunities for many nurses
           graduated but not yet employed.

           How do CORN Trainees be Selected? The selection of candidates is done by mainly by
           giving intake exams (both practical and theoretical) to check their favorability to
           complete the training followed by an oral interview to evaluate the readiness and
           willingness (attitude) to provide community based services at grass root level on a door
           to door basis. It will also help to determine the level of candidates' knowledge and
           clinical skills. This will be done in collaboration with Dilla University and the
           Southern Regional Health Bureau.

        2. Phase two : Pre - Implementation Phase Having identified 16 suitable candidates (some
           will be in the awaiting list, not to be enrolled to the actual intervention) for the
           training, a four months practice oriented training will be given to them at the
           University's Referral Hospital and other health facilities (health centers) in the Zone.

      The education of a CORN will be of good quality at both pre-service and in-service levels
      with a system for supportive supervision. The education of a CORN will be based on a
      ''Competency Model''(18). The International Confederation of Midwives (ICM) competency model
      is currently considered to be the international standard for provision of skilled, safe,
      professional care to childbearing women and their families. This model forms the conceptual
      framework upon which the core skills and abilities of a Skilled Birth Attendant is based
      reflecting essential knowledge, skills and behaviors expected during ante-partum,
      intra-partum, post-partum and neonatal care. Hence, the training of CORN will include
      critical components such as practical skills, problem solving, critical thinking and skills
      in decision making. These components will be thought using a large degree of student centered
      and facilitation approaches to teaching and learning.

      After candidates have successfully completed the training acquiring the expected knowledge
      and skills on major core competencies; another workshop will be organized for sensitization
      and advocacy of the role of CORN to key influential peoples in the community (political and
      community leaders, mothers and other concerned bodies). In the mean time, a baseline survey
      will be conducted to document the coverage of skilled birth attendances and other
      reproductive health services across each arm of the study. Selection of clusters and study
      site identification will also be done during this time.

      Data Collection For the baseline and end line survey (pre and post test), relevant data on:
      Socio-demographic characteristics, reproductive history, health seeking behavior, health
      service utilization, socioeconomic and socio-cultural factors affecting health service
      utilization ..etc will be collected using appropriate data collection tools. The tools will
      be pretested on 5% of study population size in non-study areas of Gedeo zone.

      ETHICAL CONSIDERATION Though the proposed formative and intervention studies are non
      -invasive by nature, since the strategy of availing skilled birth attendants at household
      level is a new initiative, it may have various ethical issues.
    

Intervention name(s): trained midwives and nurses working in the community to provide skilled SBA services
Intervention type(s): Procedure
Intervention description(s): After the completion of all the necessary preparations, trained CORNs will be deployed for ten months in their respective study sites (arms) to provide the required RH services at home, community and health posts.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: CORN were assigned into three arms namely: HP, HC and control arms
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Community; Skilled birth attendance; Rural; Ethiopia