Primary Prevention of Stroke in Children With Sickle Cell Anaemia in Nigeria in the Community (SPRING-COM)

The overall goal of this feasibility study is to establish a standard of care stroke prevention program for children with sickle cell anemia in a community hospital by task shifting stroke detection and transcranial Doppler ultrasound screening to nurses. It is estimated that among each birth cohort, 15,000 children will have stroke annually in Nigeria. Regular blood transfusion for children with SCD identified to be at risk of stroke is considered standard of care for primary stroke prevention in high-income countries. This is not a viable option for primary stroke prevention in most low-income settings, including Nigeria, where over 50% of the 300,000 children with SCA are born annually. The American Society of Hematology (ASH) Central Nervous System Guidelines recommends moderate dose hydroxyurea (20mg/kg) to children with SCA with abnormal TCD measurements, living in resource-constrained settings where regular blood transfusions are not readily available. Currently, primary stroke prevention is done mostly by physicians in academic centers. For more children with SCA to have access to this service a standard of care stroke prevention program in a community hospital will be initiated. The investigators will initially conduct a needs assessment to identify the barriers and facilitators that will influence the adaptability of the evidence based practice; Build capacity of nurses on stroke detection and TCD screening and then iii) conduct an Implementation-Effectiveness feasibility trial. The investigators will test the hypothesis that the task-shifted site for primary stroke prevention team in a community hospital will have a non-inferior effectiveness in identifying children with abnormal TCD measurements when compared to a primary stroke prevention team in a teaching hospital in Kaduna, Nigeria. The following specific aims will be used to test the hypothesis:

1. Identify barriers and facilitators that influence the adaptability of the transported Evidence Based Practice intervention, including implementation process (year 1). To accomplish this aim, the following activities will be conducted: The investigators will use a qualitative study design to conduct a needs assessment using the Consolidated Framework for Implementation Research (CIFR) Framework, by conducting focus groups with doctors and nurses and key informant interviews with Hospital Administrators (Chief Medical Director, Director of Administration, Chief Accountant and Chief Matron) using qualitative methods at the community hospital. Outcome measures will be identification of barriers and facilitators that will be used to develop interventions for aims 2 and 3. Qualitative methods based upon principles from grounded theory using both inductive and emergent coding strategies will be used to analyze the data.

2. Build capacity for stroke detection and prevention in SCA in a community hospital (year 2).

   To accomplish this aim, the following activities will be conducted: i) Apply previously established education program for stroke detection in children in nurses and generalist in a community hospital. ii) Apply previously established TCD certification program to nurses in a community hospital. This will be a pre-post study design where the outcome measure will be a change in knowledge after the education and training is completed and certification for both the stroke detection and TCD training. Data analysis will include spearman's correlation between trainer and trainee.

3. Conduct a feasibility trial comparing the effectiveness of a physician-based primary stroke prevention program in an academic site to a task-shifted primary stroke prevention program in a community site(year 3-5). To accomplish this aim, the following activities will be conducted: a) Record the recruitment, retention and adherence rates of children with abnormal TCD measurements initiated on hydroxyurea (Year 3). b) Use the Reach (participation rate: children with SCA receiving TCD) and Effectiveness (clinical outcomes, e.g. stroke aversion by starting hydroxyurea between community (n=200 screened) and academic site (n=200 screened) components of the RE-AIM framework to evaluate implementation outcomes between the academic and community sites (Years 3-5). This will be a non-Randomized single arm prospective feasibility implementation trial. For the feasibility of the trial, the outcomes are; Recruitment rate is defined as the proportion of participants who agreed to participate in the study out of the total number of persons approached; Retention rate is defined as the percentage of the study participants who completed the study protocol at the end of 12 months; and Adherence rate is defined as the proportion of children that have laboratory evidence of sustained hydroxyurea therapy (primary measure), measured by an increase in mean cell volume of at least 10 fl from baseline, and secondarily, by the percentage of pills returned from the total amount administered to the pharmacy every 3 month.

The implementation outcomes are the Reach; proportion of children that received TCD measurement at least once in each hospital and; Effectiveness; stroke aversion (primary outcome) and stroke, pain crises, acute chest syndrome, fever, severe anemia and death (secondary outcomes). Data will be analyzed using descriptive, comparative, and correlational statistics to measure these outcomes.