The Nurse Champion Model for Sickle Cell Disease Early Diagnosis and Care Access

摘要 镰状细胞病（SCD）是儿童发病率和死亡率的主要原因。婴儿的预期寿命 SCD因地理位置而异。在美国，新生儿普遍筛查（NBS） 早期诊断和及时联系护理，SCD儿童的总生存率大于94%。在子- 撒哈拉非洲（SSA）每年出生的SCD儿童中约有90%将在五岁生日前死亡， 经常无法确诊。缺乏通过基于实验室的NBS项目进行早期诊断是一个主要障碍， 及时采取预防措施。紧急、新颖、廉价的床旁检测 （POCT），具有与实验室方法相当的分析特性和现场测试性能， 在初级卫生中心（PHCs）早期诊断SCD的有趣的选择。我们的研究目标是使用 第2类混合实施效果设计，以评估和试点一个城市的SCD-POCT模型， 在塞拉利昂的一个农村初级保健中心，我们现有的SCD卫生系统得到加强， 能力建设研究计划是住房。我们的基本原理是新生儿SCD的早期诊断 在生命的前5年，明显降低发病率和死亡率。在这种可行性中， 研究的目的包括发展和协助初级保健中心实施该模式;评估 模型实施的过程/决定因素;以及评估模型的有效性、可接受性和 对供应商和客户结果的影响。使用实施科学框架，我们的研究团队将 迭代地让关键利益相关者参与，为基于PHC的SCD-POCT模型的开发提供信息。的 循证护士冠军平台将制定实施模式，并将包括前/后测试 咨询、护士管理POCT和护理协调。护士将完成一个全面的提供者 在实施该模式之前，我们的研究有三个具体目标：（1）评估障碍 和促进者，以初级卫生中心提供SCD-POCT与护士冠军模式;（2）最终确定 利用实施规划和利益相关者的投入制定干预措施的实施计划;以及（3）对 护士冠军模式在两个初级卫生中心，并评估决定因素和实施成本。的 将使用实施科学框架描述开发和实施模型的过程， 民族志观察、定性访谈和执行情况摸底，以确定障碍/促进因素。 护士和客户的结果将通过焦点小组和深入访谈进行评估。模型实施将 进行定性和定量评估。可接受性、障碍和促进因素将得到定性审查 基于焦点小组和访谈的回答。初步成本评估将考虑护士和 研究经费。我们希望我们的研究能够建立SCD-POCT的可行性和可扩展性 在撒哈拉以南非洲地区的初级保健中，在现有和可持续的临床路径中进行干预。

Abstract Sickle cell disease (SCD) is a major contributor to child morbidity and mortality. Life expectancy of babies with SCD varies widely depending on geographic location. In the USA, universal newborn screening (NBS) facilitates early diagnosis and prompt linkage to care with overall survival rate in SCD children greater than 94%. In Sub- Saharan Africa (SSA) approximately 90% of the children born annually with SCD will die before their fifth birthday, often undiagnosed. The absence of early diagnosis through laboratory-based NBS program is a major barrier to implementation of timely preventive measures in SSA. Emergent, novel, inexpensive, point-of-care tests (POCTs), with analytic characteristics and field-tested performance comparable to laboratory methods offer intriguing options for early diagnosis of SCD in primary health centers (PHCs). Our study objective is to use a type-2 hybrid implementation-effectiveness design to assess and pilot a SCD-POCT model in one urban and one rural PHC over 6 months in Sierra Leone where our extant SCD health systems strengthening and human capacity building research program is housed. Our rationale is that early SCD diagnosis in neonates demonstrably decreases morbidity and mortality rates considerably in the first 5 years of life. In this feasibility study, the research aims include developing and assisting PHCs in implementing the model; evaluating processes/determinants of model implementation; and evaluating the model’s effectiveness, acceptability and effects on provider and client outcomes. Using implementation science frameworks, our research team will iteratively engage key stakeholders to inform the development of the PHC-based SCD-POCT model. The evidence-informed nurse champion platform will frame the implementation model and will include pre/post-test counseling, nurse administered POCT and care coordination. Nurses will complete a comprehensive provider training program prior to implementing the model. Three specific aims undergird our study: (1) Assess barriers and facilitators to primary health center provision of SCD-POCT with a nurse champion model; (2) Finalize an implementation plan for the intervention using Implementation Mapping and stakeholder input; and (3) pilot the nurse champion model in two primary health centers and evaluate determinants and implementation costs. The process of developing and implementing the model will be described using implementation science frameworks, ethnographic observations, qualitative interviews and implementation mapping to identify barriers/enablers. Nurse and client outcomes will be assessed by focus groups and in-depth interviews. Model implementation will be assessed qualitatively and quantitatively. Acceptability, barriers, and enablers will be examined qualitatively based on focus group and interview responses. A preliminary costing assessment will consider the nurses and research study financial outlays. We expect our study to establish the feasibility and scalability of SCD-POCT intervention within extant and sustainable clinical pathways in PHCs in the sub-Saharan African settings.