Development of a complex quality improvement intervention for timely blood transfusions for the management of post-partum haemorrhage in Africa

Catastrophic bleeding after childbirth-post-partum haemorrhage-is a leading cause of deaths among mothers worldwide. It is especially problematic in poor regions, such as Sub-Saharan Africa, where it causes almost 50,000 deaths each year. When a woman has severe post-partum haemorrhage, she often needs a blood transfusion, ideally within one hour, to survive. However, blood does not always get to the women who need it, when they need it. This is because of many factors, starting from communities' reluctance to donate blood due to fear and stigma, women not seeking maternity care when they need it, health facility staff not recognising when a woman needs blood after birth, and blood not being safe or available. These problems must be tackled not only at transfusing facilities (facilities that provide blood transfusions) and blood banks, but in communities too. We are proposing a main study that aims to overcome barriers across the health system to increase births in health facilities that provide transfusions and to improve the supply and timely use of blood for the management of post-partum haemorrhage. However, some developmental work is necessary to design the best main study possible.

This early-phase study will allow us to identify health facilities in Ghana and Uganda that are actively carrying out blood transfusions, or serving as blood banks, and to understand the key problems that these health facilities and communities face when it comes to providing timely blood transfusions for women with post-partum haemorrhage. In each country, information about barriers to providing high quality blood transfusion services will be obtained by speaking with staff from10 transfusing facilities or blood banks, 48-64 community members, and 4-5 representatives from the national blood transfusion services and the ministries of health. We will then convene national meetings to engage local stakeholders-community members, transfusing facility and blood bank staff, and staff from national blood transfusion services and ministries of health-so that they can input into the design of the main study. These meetings will harmonise stakeholders' knowledge of these barriers to providing transfusions for women with post-partum haemorrhage to guide the main study's activities. In the main study, community members and transfusing facility or blood bank staff will engage in quality improvement-identifying problems and creating and implementing solutions to these-to overcome those barriers. These processes will then be documented to help build scalable "packages" of solutions that can be implemented nationally to improve the quality of blood transfusion services. Stakeholder inputs will help design a main study intervention that will be feasible and acceptable to participants. Further, these inputs will be important for designing an intervention that will continue after the study funding has finished. Part of this continuation will come from the involvement of mentors who are already working within a leadership capacity with transfusing facilities and blood banks, rather than external facilitators from the study team, who will provide leadership and support to these facilities throughout the intervention. Overall, there will be enhanced links across the lower tiers of the health system, including communities, to increase childbirth in transfusing facilities, especially for women who most need it, and to improve the timeliness and quality of blood transfusions.

Post-partum haemorrhage causes almost 50,000 deaths per year in Sub-Saharan Africa. To improve timely access to blood transfusion for management of post-partum haemorrhage, a 36-month quasi-experimental effectiveness quality improvement trial will be carried out in Ghana and Uganda. In two intervention districts in each country, there will be quality improvement activities at the community (participatory action cycles) and health facility levels (standards-based audit), with leadership and mentorship from the district/region, aimed at synergistically overcoming barriers linked to timely, quality blood transfusion and uptake of care for high risk (e.g. anaemic) women.

An early-phase study will enable our study team to carry out necessary development work to design the most robust trial possible. It will map all transfusing facilities and blood banks in each study district in the main trial and determine key quality measures of transfusion provision (e.g. blood stock outs, transfusion reagents availability). To do so, a health facility assessment will be carried out in 16-24 transfusing facilities and blood banks in each country. A qualitative study to identify and prioritise key challenges to be addressed through quality improvement in the main study will collect data through focus group discussions with community members (8 per country) and transfusing facility/blood bank staff (6 per country) and key informant interviews with staff from ministries of health and national blood transfusion services (4-5 per country). To consolidate stakeholder buy-in, a meeting will be held in each country to review data from the facility assessment and the qualitative study and to collate stakeholders' inputs to the design of the main trial.

The key beneficiaries and potential impacts on them of our early-phase, and eventually our main, studies are:

Women with, or at high risk of, post-partum haemorrhage
- In partnership with these women and their communities we will identify the barriers they face in recognising severe anaemia and post-partum haemorrhage (PPH), and in seeking rapid, formal health care. We will focus on their experience accessing timely blood transfusions, and interventions for overcoming problems with access to transfusions such as distance to a transfusing facility, inability to find a replacement donor, and lack of knowledge about transfusions.
- Potential impact: Improved awareness among women, and their communities, about the risks of anaemia and PPH; earlier care-seeking from formal medical providers for anaemia to mitigate against the risks of severe bleeding; and reduction in barriers to rapidly accessing transfusions to reduce mortality from PPH.

Communities, especially those members who provide informal advice to pregnant women such as mothers, mothers-in-law, and other elders
- Our project promotes involvement of community members in identifying and solving problems related to anaemia in pregnancy, increased vulnerability to PPH and death, unnecessary deaths from blood shortages, and the need for more blood and blood donors. Further, community members will be capacitated to carry out participatory action cycles, which may have transferrable benefits to all aspects of community life.
- Potential impact: Community level actions to encourage good nutrition and compliance with iron and folate supplements in pregnancy for reduced anaemia; more appropriate and rapid uptake of care from transfusing facilities for post-partum bleeding or symptoms of severe anaemia; reduction in perceived and real barriers to blood donations and increase in first-time and regular blood donors from study communities; and development of a problem-solving skill set through learning and applying participatory action cycles for use more broadly.

Transfusing facility and blood bank staff and their patients
- The main study will capacitate staff from transfusing facilities and blood banks to use standards-based audit to overcome barriers related to the provision of timely, quality blood transfusion services.
- Potential impact: Empowered staff who are motivated to improve the quality of services or care they provide; better availability of safe blood for all those that need it, including young children and trauma and cancer patients; transferable expertise in techniques (standards-based audit) to improve and strengthen health systems and improve the quality of services, which will ultimately have broad beneficial effects on health outcomes well beyond PPH; and improved workplace environment and service delivery, leading to increased staff satisfaction and retention.

Staff and systems of the National Blood Transfusion Services and the Ministries of Health in Ghana and Uganda
- Our identification of hospitals that are, or have recently, provided a transfusion service and our assessment of the quality of their transfusion service will provide new information, especially relating to private and faith-based facilities. Expertise that will be developed through the project in tools such as audit cycles is highly transferable and complements the focus in our partner countries on using these skills to improve patient outcomes.
- Potential impact: Knowledge to plan more equitable access to blood transfusions for women with PPH; identification of areas for improving quality of blood and blood services; strengthening of networks of transfusing facilities across study sites; creating a scalable model for capacitating health facility staff in standards-based audit, and liaising with communities to make improvements in care