CRADLE-5: a stepped-wedge type 2 hybrid implementation-effectiveness cluster randomised controlled trial to evaluate the real-world scale-up of the CRADLE Vital Signs Alert intervention into routine maternity care in Sierra Leone-study protocol.

BACKGROUND: The CRADLE Vital Signs Alert intervention (an accurate easy-to-use device that measures blood pressure and pulse with inbuilt traffic-light early warning system, and focused training package) was associated with reduced rates of eclampsia and maternal death when trialled in urban areas in Sierra Leone. Subsequently, implementation was successfully piloted as evidenced by measures of fidelity, feasibility and adoption. The CRADLE-5 trial will examine whether national scale-up, including in the most rural areas, will reduce a composite outcome of maternal and fetal mortality and maternal morbidity and will evaluate how the CRADLE package can be embedded sustainably into routine clinical pathways. METHODS: CRADLE-5 is a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care across eight rural districts in Sierra Leone (Bonthe, Falaba, Karene, Kailahun, Koinadugu, Kono, Moyamba, Tonkolili). Each district will cross from control to intervention at six-weekly intervals over the course of 1 year (May 2022 to June 2023). All women identified as pregnant or within six-weeks postpartum presenting for maternity care in the district are included. Primary outcome data (composite rate of maternal death, stillbirth, eclampsia and emergency hysterectomy) will be collected. A mixed-methods process and scale-up evaluation (informed by Medical Research Council guidance for complex interventions and the World Health Organization ExpandNet tools) will explore implementation outcomes of fidelity, adoption, adaptation and scale-up outcomes of reach, maintenance, sustainability and integration. Mechanisms of change and contextual factors (barriers and facilitators) will be assessed. A concurrent cost-effectiveness analysis will be undertaken. DISCUSSION: International guidance recommends that all pregnant and postpartum women have regular blood pressure assessment, and healthcare staff are adequately trained to respond to abnormalities. Clinical effectiveness to improve maternal and perinatal health in more rural areas, and ease of integration and sustainability of the CRADLE intervention at scale has yet to be investigated. This trial will explore whether national scale-up of the CRADLE intervention reduces maternal and fetal mortality and severe maternal adverse outcomes and understand the strategies for adoption, integration and sustainability in low-resource settings. If successful, the aim is to develop an adaptable, evidence-based scale-up roadmap to improve maternal and infant outcomes. TRIAL REGISTRATION: ISRCTN 94429427. Registered on 20 April 2022.

Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption.

BACKGROUND: The CRADLE (Community blood pressure monitoring in Rural Africa: Detection of underLying pre-Eclampsia) Vital Signs Alert device-designed specifically to improve maternity care in low resource settings-had varying impact when trialled in different countries. To better understand the contextual factors that may contribute to this variation, this study retrospectively evaluated the adoption of CRADLE, during scale-up in Sierra Leone. METHODS: This was a mixed methods study. A quantitative indicator of adoption (the proportion of facilities trained per district) was calculated from existing training records, then focus groups were held with 'CRADLE Champions' in each district (n = 32), to explore adoption qualitatively. Template Analysis was used to deductively interpret qualitative data, guided by the NASSS (non-adoption, abandonment, scale-up, spread, sustainability) Framework. FINDINGS: Substantial but non-significant variation was found in the proportion of facilities trained in each district (range 59-90%) [X2 (7, N = 8) = 10.419, p = 0.166]. Qualitative data identified complexity in two NASSS domains that may have contributed to this variation: 'the technology' (for example, charging issues, difficulty interpreting device output and concerns about ongoing procurement) and 'the organisation' (for example, logistical barriers to implementing training, infighting and high staff turnover). Key strategies mentioned to mitigate against these issues included: transparent communication at all levels; encouraging localised adaptations during implementation (including the involvement of community leaders); and selecting Champions with strong soft skills (particularly conflict resolution and problem solving). CONCLUSIONS: Complexity related to the technology and the organisational context were found to influence the adoption of CRADLE in Sierra Leone, with substantial inter-district variation. These findings emphasise the importance of gaining an in-depth understanding of the specific system and context in which a new healthcare technology is being implemented. This study has implications for the ongoing scale-up of CRADLE, and for those implementing or evaluating other health technologies in similar contexts.

Many women die during pregnancy and childbirth from causes that could be prevented, and the vast majority of these deaths occur in low-resource settings. The 'CRADLE Vital Signs Alert' is a medical device that helps identify problems during pregnancy­designed specifically for healthcare professionals in low-resource settings. However, for unknown reasons, the device appears to have varying impact according to the country or setting in which it is used. This study aimed to explore in depth whether, and why, healthcare professionals in Sierra Leone adopted the device and engaged in training (or not). Between March 2020 and January 2021, the CRADLE device and training package was disseminated across 8 districts in Sierra Leone. This relied on a few healthcare workers (nominated 'CRADLE Champions') to voluntarily distribute the devices and training in their local areas. Group discussions were held with CRADLE Champions in each district after the rollout to gather their feedback. In addition, the proportion of facilities trained in each district was recorded. The study found differences in how well the device and training was adopted in each district. Common challenges reported across districts related to technological difficulties (such as issues charging the devices) and organisational barriers (such as high levels of staff turnover at facilities). These findings will help to inform future rollout of the CRADLE device and training in Sierra Leone and highlight factors that may need to be considered by those implementing other health technologies in similar settings.

Work-based risk factors and quality of life in health care workers providing maternal and newborn care during the Sierra Leone Ebola epidemic: findings using the WHOQOL-BREF and HSE Management Standards Tool.

INTRODUCTION: Before the 2014, Ebola epidemic in Sierra Leone, healthcare workers (HCWs) faced many challenges. Workload and personal risk of HCWs increased but their experiences of these have not been well explored. HCWs evaluation of their quality of life (QoL) and risk factors for developing work-based stress is important in helping to develop a strong and committed workforce in a resilient health system. METHODS: Cross-sectional study using World Health Organisation Quality of Life (WHOQOL)-BREF and Health and Safety Executive (HSE) Standards Tools in 13 Emergency Obstetric Care facilities to (1) understand the perceptions of HCWs regarding workplace risk factors for developing stress, (2) evaluate HCWs perceptions of QoL and links to risk factors for workplace stress and (3) assess changes in QoL and risk factors for stress after a stress management programme. RESULTS: 222 completed the survey at baseline and 156 at follow-up. At baseline, QoL of HCWs was below international standards in all domains. There was a significant decrease in score for physical health and psychological well-being (mean decrease (95% CI); 2.3 (0.5-4.1) and 2.3 (0.4-4.1)). Lower cadres had significant decreases in scores for physical health and social relationships (13.0 (3.6-22.4) and 14.4 (2.6-26.2)). On HSE peer-support and role understanding scored highly (mean scores 4.0 and 3.7 on HSE), workplace demands were average or high-risk factors (mean score 3.0). There was a significant score reduction in the domains relationships and understanding of role (mean score reduction (95% CI) 0.16 (0.01-0.31) and 0.11 (0.01-0.21)), particularly among lower cadres (0.83 (0.3-1.4). CONCLUSION: HCWs in low-resourced settings may have increased risk factors for developing workplace stress with low QoL indicators; further exploration of this is needed to support staff and develop their contribution to the development of resilient health systems.

Student evaluation of the impact of changes in teaching style on their learning: a mixed method longitudinal study.

BACKGROUND: Maternal and Child Health Aides are the largest nursing cadre in Sierra Leone providing maternal and child health care at primary level. Poor healthcare infrastructure and persistent shortage of suitably qualified health care workers have contributed to high maternal and newborn morbidity and mortality. In 2012, 50% of the MCHAides cohort failed their final examination and the Government of Sierra Leone expressed concerns about the quality of teaching within the programmes. Lack of teaching resources and poor standards of teaching led to high failure rates in final examinations reducing the number of newly qualified nurses available for deployment. METHODS: A mixed-methods approach using semi-structured observations of teaching sessions and completion of a questionnaire by students was used. Fourteen MCHAide Training Schools across all districts of Sierra Leone, 140 MCHAide tutors and 513 students were included in the study. In each school, teaching was observed by two researchers at baseline, 3 and 6 months after the tutor training programme. Students completed a questionnaire on the quality of teaching and learning in their school at the same time points. RESULTS: A total of 513 students completed the questionnaire, 120 tutors took part in the training and 66 lessons across all schools were observed. There was a statistically significant (p < 0.05) improvement in mean student evaluation of teaching and learning in 12/19 areas tested at follow-up compared to baseline. Observation of 66 teaching sessions demonstrated an increase in the number of student-focused, interactive teaching methods used. CONCLUSION: Prior to the teaching and learning workshops there was little student-focused learning within the schools. Teaching was conducted predominantly using lectures even for practical sessions. Training tutors to move away from didactic teaching towards a more student-focused approach leads to increased student satisfaction with teaching and learning within the schools.

'Even when you are afraid, you stay': Provision of maternity care during the Ebola virus epidemic: A qualitative study.

OBJECTIVE: to explore nurse-midwives understanding of their role in and ability to continue to provide routine and emergency maternity services during the time of the Ebola virus disease epidemic in Sierra Leone. DESIGN: a hermenuetic phenomenological approach was used to discover the lived experiences of nurse-midwives through 66 face to face interviews. Following verbatim transcription, an iterative approach to data analysis was adopted using framework analysis to discover the essence of the lived experience. SETTING: health facilities designated to provide maternity care across all 14 districts of Sierra Leone. PARTICIPANTS: nurses, midwives, medical staff and managers providing maternal and newborn care during the Ebola epidemic in facilities designated to provide basic or emergency obstetric care. FINDINGS: the healthcare system in Sierra Leone was ill prepared to cope with the epidemic. Fear of Ebola and mistrust kept women from accessing care at a health facility. Healthcare providers continued to provide maternity care because of professional duty, responsibility to the community and religious beliefs. KEY CONCLUSIONS: nurse-midwives faced increased risks of catching Ebola compared to other health workers but continued to provide essential maternity care. IMPLICATIONS FOR PRACTICE: future preparedness plans must take into account the impact that epidemics have on the ability of the health system to continue to provide vital routine and emergency maternal and newborn health care. Healthcare providers need to have a stronger voice in health system rebuilding and planning and management to ensure that health service can continue to provide vital maternal and newborn care during epidemics.

Strengthening pre-service training for skilled birth attendance - An evaluation of the maternal and child health aide training programme in Sierra Leone.

BACKGROUND: The high maternal mortality rate in Sierra Leone combined with an ongoing shortage of midwives has led to the introduction of new cadres of healthcare workers. Maternal and Child Health Aides are one such cadre and now provide 56% of patient care. The quality of the education training programme for MCHA is therefore of paramount importance if high quality maternal care is to be provided. OBJECTIVE: To conduct an evaluation of the MCHAide training programme in Sierra Leone. DESIGN: Mapping of programme and focus group discussions (FGDs) with key informants. Analysis of data using a thematic approach and formulation of recommendations for national, district and individual levels. SETTING: All 14 MCHAide schools across Sierra Leone. PARTICIPANTS: The National Coordinator, Coordinators from 14 MCHAide schools and District Health Sisters from District Health Management Teams. METHODS: Focus group discussions were held with tutors facilitated by a group member to encourage a free flowing discussion. Participants were divided into 4 groups, one for each province, with 5-8 participants per group and 50min for the discussion. RESULTS: Strengths, weaknesses and opportunities of the MCHAide training programme were identified. Four major themes were identified; the need for autonomy and support within the programme from stakeholders; the effect of poor infrastructure on teaching and student learning; the need to ensure rigorous academic quality including teaching quality, curricula content and the academic ability of the students; and the benefits of community support. CONCLUSIONS: It is important that the key personnel be involved in the development and introduction of training programmes for new cadres of staff from the earliest stages of development. On-going programme review and development is essential and those implementing the programme are the best placed to lead and contribute to this. Gathering the experiences and perceptions of key informants helps provide an in-depth examination that can inform recommendations.

Building capacity for skilled birth attendance: An evaluation of the Maternal and Child Health Aides training programme in Sierra Leone.

OBJECTIVE: Maternal and Child Health Aides (MCH Aide) in Sierra Leone provide the majority of maternity services at primary care level. To formulate recommendations for improving the quality and scale-up of MCH Aides training an evaluation of all schools across Sierra Leone was undertaken. DESIGN: Structured, direct observation of two randomly selected teaching sessions per school using pre-tested standardised review forms. Event sampling with random selection of timetabled sessions across all 14 MCH Aide Training Schools. SETTING: All MCH Aide training schools across Sierra Leone. PARTICIPANTS: Tutors across 14 MCH Aide training schools observed in August 2013. MEASUREMENTS: Assessment of four key elements of teaching and learning: (1) teaching style, (2) use of visual aids, (3) teaching environment and (4) student involvement. FINDINGS: In the majority of teaching schools there was over-crowding (11/14), lack of furniture and inconsistent electricity supply. Ten of 26 tutors used lesson plans and teaching was mostly tutor- rather than student-focused. Majority of tutors use a didactic approach rather than active learning methods. Teaching aides were rarely available (15% of lessons). Tutors were knowledgeable in their subject area and there was evidence of an excellent tutor-student relationship. KEY CONCLUSIONS: Training for Maternal and Child health Aides relies on teacher focused didactic methods, which may hinder student learning. Teaching and learning within the schools needs to be enhanced by a combination of tutor development and improvements in the learning environment. IMPLICATIONS FOR PRACTICE: Interventions to improve the quality of teaching are urgently needed and should include training on teaching techniques and student assessment for tutors, provision of audio visual equipment and teaching aides such as posters and mannequins. Monitoring and Evaluation of interventions is critical to be able to amend the programmes approach and address further challenges at an early stage.

'Twin2twin' an innovative method of empowering midwives to strengthen their professional midwifery organisations.

BACKGROUND: midwives need professional support from a national midwifery organisation to be able to provide the services that are by regulatory mechanisms and accreditation expected of them. Not all midwives in the world are united in a professional organisation. The aim of this project was to strengthen the midwifery organisations of Sierra Leone and the Netherlands. During the process of the project it was realised that the development of a platform of exchange at organisational level would be enhanced by introducing personal exchange between individual midwives. In response to this new insight the original project plan was adjusted by incorporating the twin2twin method. METHOD: twin2twin is a feminist methodology of mutual exchange between twenty pairs of midwives from different organisations (in this case Sierra Leone and the Netherlands). The method can be distinguished by 10 specific steps. It was developed, used and (re)evaluated through focus group discussions, storytelling and written evaluations. FINDINGS: twinning of organisations was strengthened by adding a human component to the process. With the use of the 'twin2twin' method, midwives were encouraged to invested in a professional and personal bond with their 'twin sister'. This bond was independent and went beyond the relatively short four year project period. Through personal engagement and mutual exchange of knowledge and skills, midwives empowered each other to build and strengthen their midwifery organisations both in Sierra Leone and the Netherlands. (Empowerment refers to the expansion in people's ability to make strategic life choices in a context where this ability was previously denied to them (Narayan, 2005); organisational empowerment includes processes and structures that enhance members' skills and provides them with the mutual support necessary to effect community level change (Zimmerman, 1995).). CONCLUSION AND IMPLICATIONS FOR PRACTICE: despite challenges we are convinced that twin2twin can be of additional benefit for the success of other projects involved in strengthening midwifery organisations in the long term. It can be used independently or alongside other forms of (co)development not only in midwifery but also in other professions.