Periodic Reporting for period 2 - ALERT (Action Leveraging Evidence to Reduce perinatal morTality and morbidity in sub-Saharan Africa)
Berichtszeitraum: 2021-07-01 bis 2022-12-31
Insufficient reductions in maternal and neonatal deaths and stillbirths in the past decade are a threat to achieving the Sustainable Development Goal 3. Overcoming the knowledge-do gap to ensure implementation of known evidence-based intervention during the intrapartum period – the period from onset of labour to immediately after childbirth – has the potential to avert at least 2.5 million deaths in mothers and their offspring annually.
ALERT aims to develop and evaluate a multifaceted health system intervention to strengthen the implementation of evidence-based interventions and responsive intrapartum care in 16 Sub-Saharan African hospitals. The intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement, supported by data from a clinical perinatal e-registry; iv) empowerment and leadership mentoring of maternity unit leaders We will evaluate the intervention through a stepped-wedge design complemented by a realist process evaluation and economic evaluation to estimate scalability and costs. The perinatal e-registry will provide data i) for the quality improvement and ii) the impact evaluation.
Our activities, in accordance with the planned work program, included 1) the set-up of the consortium and its working modalities, 2) a description and exploration of the situation in the maternity and the kick-start of the end-user participation of the intervention, 3) the examination of knowledge, skills and attitudes of maternity providers and the drafting of training materials, 4) the description of context and readiness and the development of the quality improvement and monitoring approach, 5) the set-up of the perinatal e-registry, 6) the set-up of the trial requirements, 7) the development of a theory of change and 8) development of the costing approach. We have further engaged with the wider research and implementation community. However, the COVID-19 pandemic is slowing down work and made networking and reaching out to stakeholders difficult. The project accumulated – because of the COVID-19 pandemic – an approximate 4-month delay which does not threat the project as enough time was built into the timeline.
ALERT aims to develop and evaluate a multifaceted health system intervention to strengthen the implementation of evidence-based interventions and responsive intrapartum care in 16 Sub-Saharan African hospitals. The intervention will include four main components: i) end-user participation through narratives of women, families and midwifery providers to ensure co-design of the intervention; ii) competency-based training; iii) quality improvement, supported by data from a clinical perinatal e-registry; iv) empowerment and leadership mentoring of maternity unit leaders We will evaluate the intervention through a stepped-wedge design complemented by a realist process evaluation and economic evaluation to estimate scalability and costs. The perinatal e-registry will provide data i) for the quality improvement and ii) the impact evaluation.
Our activities, in accordance with the planned work program, included 1) the set-up of the consortium and its working modalities, 2) a description and exploration of the situation in the maternity and the kick-start of the end-user participation of the intervention, 3) the examination of knowledge, skills and attitudes of maternity providers and the drafting of training materials, 4) the description of context and readiness and the development of the quality improvement and monitoring approach, 5) the set-up of the perinatal e-registry, 6) the set-up of the trial requirements, 7) the development of a theory of change and 8) development of the costing approach. We have further engaged with the wider research and implementation community. However, the COVID-19 pandemic is slowing down work and made networking and reaching out to stakeholders difficult. The project accumulated – because of the COVID-19 pandemic – an approximate 4-month delay which does not threat the project as enough time was built into the timeline.
The project is implemented in four countries of Sub-Saharan Africa, Benin, Malawi, Tanzania and Uganda facing major difficulties to provide quality maternity care to women in labor, visible by high maternal and perinatal mortality and morbidity. The projects objectives were
1) to analyse elements, domains, constructs and drivers of responsiveness and professionalism among midwifery providers and to inform the ALERT co-design .
2) to inform, develop and implement a co-designed midwifery training package and leadership mentoring
3) to analyse the health system context and implementation bottlenecks for quality intrapartum care, to develop and to support the quality improvement of the ALERT intervention,
4) to develop and implement a hospital-based clinical perinatal e-register and to provide data for the quality improvement intervention as well as the impact and process evaluation
5) to implement the trial procedures and evaluate the effect of the ALERT intervention on the specified perinatal health outcomes and the implementation of evidence-based practices,
6) to develop a program theory for the ALERT intervention and evaluate each component to understand what works, for whom, and within which context
7) to analyse the cost and cost-effectiveness of the ALERT intervention and
8) to engage national and international stakeholders throughout the project to maximise learning and utilisation; to influence policy and practice; and to maximise impact.
After setting up successfully the working modalities as a consortium and receiving ethics approval at all implementation sites as, we started to do interviews with women, companions and health providers in all countries and conceived the co-design of the intervention development (WP 2 Responsiveness and professionalism). The WP 3 (Positioning midwifery) has drafted training modules for midwifery providers. In addition, a methodology to assess care providers’ knowledge, skills and attitudes has been developed; and a protocol was published. WP 4 (Overcoming systems and implementation bottlenecks) has been implementing the context and readiness assessment including an analysis of the COVID-19 context. The preliminary analysis is finalised. WP 5 (Perinatal e-registry) has been developing the perinatal e-registry methodology and the data collection has started. WP 6 (Trial management and effect evaluation) has prepared the trial protocol and convened the first data safety and monitoring board meeting. WP 7 (Realist process evaluation) and WP 8 (Economic evaluation) have prepared the methodology. Exploitation and exchange, (WP 9 Policy exchange, learning and exploitation) with the wider community has been limited because of the COVID-19 situation. We have worked intensively to put up all the requirements for ethics, data management and convened the first data safety and monitoring board meeting and prepared strategic guidance (WP 10).
We also faced difficulties: The COVID-19 pandemic limited exchange within the implementation countries and the stakeholder engagement. The project has a 4-month delay because: 1) late receipt of the ethics approvals, 2) the COVID-19 pandemic has been and continues to slow down operations and 3) because we added a COVID-19 component to the hospital readiness assessment and thus submitted an amendment during the ethics approval process. Data collection was delayed across WPs 2, 3 and 4 due to difficulties in travel within countries and operational challenges. Still, despite the challenges, we have advanced and – despite a 4-month delay – are not facing major delays. The next reporting period will hopefully provide more opportunities for exchange and also first disseminations of results.
1) to analyse elements, domains, constructs and drivers of responsiveness and professionalism among midwifery providers and to inform the ALERT co-design .
2) to inform, develop and implement a co-designed midwifery training package and leadership mentoring
3) to analyse the health system context and implementation bottlenecks for quality intrapartum care, to develop and to support the quality improvement of the ALERT intervention,
4) to develop and implement a hospital-based clinical perinatal e-register and to provide data for the quality improvement intervention as well as the impact and process evaluation
5) to implement the trial procedures and evaluate the effect of the ALERT intervention on the specified perinatal health outcomes and the implementation of evidence-based practices,
6) to develop a program theory for the ALERT intervention and evaluate each component to understand what works, for whom, and within which context
7) to analyse the cost and cost-effectiveness of the ALERT intervention and
8) to engage national and international stakeholders throughout the project to maximise learning and utilisation; to influence policy and practice; and to maximise impact.
After setting up successfully the working modalities as a consortium and receiving ethics approval at all implementation sites as, we started to do interviews with women, companions and health providers in all countries and conceived the co-design of the intervention development (WP 2 Responsiveness and professionalism). The WP 3 (Positioning midwifery) has drafted training modules for midwifery providers. In addition, a methodology to assess care providers’ knowledge, skills and attitudes has been developed; and a protocol was published. WP 4 (Overcoming systems and implementation bottlenecks) has been implementing the context and readiness assessment including an analysis of the COVID-19 context. The preliminary analysis is finalised. WP 5 (Perinatal e-registry) has been developing the perinatal e-registry methodology and the data collection has started. WP 6 (Trial management and effect evaluation) has prepared the trial protocol and convened the first data safety and monitoring board meeting. WP 7 (Realist process evaluation) and WP 8 (Economic evaluation) have prepared the methodology. Exploitation and exchange, (WP 9 Policy exchange, learning and exploitation) with the wider community has been limited because of the COVID-19 situation. We have worked intensively to put up all the requirements for ethics, data management and convened the first data safety and monitoring board meeting and prepared strategic guidance (WP 10).
We also faced difficulties: The COVID-19 pandemic limited exchange within the implementation countries and the stakeholder engagement. The project has a 4-month delay because: 1) late receipt of the ethics approvals, 2) the COVID-19 pandemic has been and continues to slow down operations and 3) because we added a COVID-19 component to the hospital readiness assessment and thus submitted an amendment during the ethics approval process. Data collection was delayed across WPs 2, 3 and 4 due to difficulties in travel within countries and operational challenges. Still, despite the challenges, we have advanced and – despite a 4-month delay – are not facing major delays. The next reporting period will hopefully provide more opportunities for exchange and also first disseminations of results.
We have established a vibrant and very active research community within our eight partners. We have recruited 5 PhD students so far – financed largely from additional funding. We also have MSc students who used our research materials in the present academic year. We meet in very regular intervals (weekly or bi-weekly) and have a journal club established to support learning throughout. Consortium members have given online lectures and workshops on the ongoing preparatory work in WP2, WP3 and WP4 and thus given young students access to the real-world processes in implementation research.
We engaged into the monitoring of the effect of the COVID-19 epidemic by adding specific research questions to our readiness assessment and submitted an abstract on this. We will continue to report on effects as far as relevant.
Key results
Publication of the methodological development to assess knowledge, skills and attitudes of maternity providers
https://reproductive-health-journal.biomedcentral.com/articles/10.1186/s12978-021-01109-8
Protocol paper describing the review of training materials https://bmjopen.bmj.com/content/11/3/e047118.
Two more papers were submitted, the main protocol paper and a methodological paper describing the realist process evaluation.
We have submitted abstracts to feature our work for International Federation of Gynecology and Obstetrics as well for other national congresses.
We engaged into the monitoring of the effect of the COVID-19 epidemic by adding specific research questions to our readiness assessment and submitted an abstract on this. We will continue to report on effects as far as relevant.
Key results
Publication of the methodological development to assess knowledge, skills and attitudes of maternity providers
https://reproductive-health-journal.biomedcentral.com/articles/10.1186/s12978-021-01109-8
Protocol paper describing the review of training materials https://bmjopen.bmj.com/content/11/3/e047118.
Two more papers were submitted, the main protocol paper and a methodological paper describing the realist process evaluation.
We have submitted abstracts to feature our work for International Federation of Gynecology and Obstetrics as well for other national congresses.