An implementation toolkit for the use of hydroxyurea in the treatment of sickle cell aneamia in Ugandan children

使用羟基脲治疗乌干达儿童镰状细胞贫血症的实施工具包

• 批准号: 10414915
• 负责人: Robert Opoka
• 金额: $ 17.55万
• 依托单位: GLOBAL HEALTH UGANDA, LTD
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-06-07 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10414915
• 关键词: Administrator; Adult; Africa; Africa South of the Sahara; Bacterial Infections; Caregivers; Caring; Characteristics; Child; Child Care; Childhood; Clinic; Clinical; Clinical Research; Clinical assessments; Clinical trial protocol document; Code; Collection; Complication; Consolidated Framework for Implementation Research; Controlled Study; Country; Data; Disease; District Hospitals; Dose; Elements; Evaluation; Event; Family; Family health status; Family member; Feedback; Focus Groups; Fright; Funding; Guidelines; Health; Health Status; Health system; Healthcare; High Prevalence; Hospital Referrals; Improve Access; Infection; Intervention; Interview; Knowledge; Letters; Maps; Monitor; Morbidity - disease rate; Motivation; Outcome; Patients; Pharmaceutical Preparations; Phase; Prevalence; Process; Provider; Quality of Care; Research Personnel; Research Project Grants; Resource-limited setting; Resources; Risk; Role; Safety; Schedule; Services; Sickle Cell; Sickle Cell Anemia; Site; Structure; System; Techniques; Testing; Time; Training; Transfusion; Uganda; Work; ancillary care; authority; barrier to care; base; effectiveness implementation trial; effectiveness study; effectiveness trial; efficacy trial; experience; formative assessment; future implementation; hydroxyurea; implementation determinants; implementation efforts; implementation framework; implementation process; implementation strategy; implementation trial; improved; innovation; learning materials; malaria infection; member; mortality; routine care; scale up; success; tool

Sickle cell disease (SCD) is a significant contributor to the high childhood mortality in Uganda and other countries in sub-Saharan Africa. Hydroxyurea has been used safely in the US to moderate the effects of SCD- related morbidities but is still not widely used in Africa where SCD prevalence is highest. The efficacy and safety for hydroxyurea in sub-Saharan Africa have now been documented in several efficacy and effectiveness trials. Based on these results, the Ugandan Ministry of Health (MOH) is invested in making hydroxyurea available to SCD patients and is in the process of drafting clinical guidelines supporting the use of hydroxyurea in SCA children. The implementation of routine use of hydroxyurea still has numerous challenges to overcome. Critical questions to inform an implementation strategy include how to develop and sustain clinical expertise in routine care settings to support the use of hydroxyurea with acceptable safety and efficacy. Patient and family barriers to care encountered outside controlled study settings will also inform implementation efforts. This study will use a broad implementation framework to develop a set of implementation supports for scaling up hydroxyurea use that can be used in a larger implementation trial while also simultaneously preparing for the capacity building phase required in ongoing implementation. For Aim 1, the study team will assemble and pilot an implementation toolkit for use of hydroxyurea in two Ugandan health units: a regional referral hospital and a district hospital. Clinical experts and trained facilitators will help each site establish process and outcomes monitoring systems that will both support quality improvement efforts to sustain high quality services over time and to support the collection of treatment reach, safety, and efficacy data in a subsequent implementation-effectiveness trial. In Aim 2, the study team will conduct a formative evaluation of the implementation toolkit and supports. In this evaluation, investigators will identify key barriers and motivating factors for hydroxyurea use in the Uganda healthcare context and use the information to finalize the toolkit and overarching implementation strategy. The evaluation will include interviews with MOH to conceptualize national, regional, and health unit-level implementation factors. Interviews, focus groups, and site observations with site leaders and staff will illuminate inner setting factors influencing hydroxyurea use. Finally interviews and focus groups with family members and patients will allow the team to conceptualize the experience of the direct user of hydroxyurea treatment. Using rapid qualitative coding techniques, we will analyze themes and map findings to better inform the implementation strategy elements required, including finalizing the toolkit. The study’s Aim 3 will involve planning for implementation capacity building to support the continued advancement of hydroxyurea therapy in low resource settings. This planning phase will include assessment of clinical knowledge strengths and gaps at pilot sites, establishing ideal characteristics and roles for champions, and identifying strategic advisory board members to guide future implementation.

镰状细胞疾病（SCD）是乌干达和其他儿童死亡率高的重要原因 撒哈拉以南非洲的国家。羟基脲已在美国安全使用，以缓和SCD-的影响 相关的病毒性，但在SCD患病率最高的非洲仍未广泛使用。效率和 现在已经记录了撒哈拉以南非洲羟基脲的安全性 试验。根据这些结果，乌干达卫生部（MOH）投资用于制造羟基脲 可用于SCD患者，并在起草临床准则的过程中支持使用羟基脲 在SCA儿童中。羟基脲常规使用的实施仍然存在许多挑战。 通知实施策略的关键问题包括如何发展和维持临床专业知识 常规护理设置以可接受的安全性和效率支持使用羟基脲。病人和家人 在受控学习设置外面遇到的护理障碍也将为实施工作提供信息。 这项研究将使用广泛的实施框架来为 扩展可以在更大的实施试验中使用的羟基脲的使用 为正在进行的实施所需的能力建设阶段做准备。对于AIM 1，学习团队将 组装和驾驶实施工具包，用于在两个乌干达健康部门使用羟基脲：一个地区 转诊医院和地区医院。临床专家和受过训练的促进者将帮助每个网站建立 流程和结果监测系统，这些系统都将支持质量改进的工作以维持高 随着时间的推移，优质的服务，并支持收集治疗范围，安全性和效率数据 随后的实施效果试验。在AIM 2中，研究团队将对 实施工具包和支持。在此评估中，调查人员将确定关键障碍并激励 在乌干达医疗保健环境中使用羟基脲的因素，并使用信息来最终确定工具包和 总体实施策略。评估将包括对MOH的访谈以概念化 国家，区域和卫生单位级实施因素。访谈，焦点小组和现场观察 随着现场领导者和员工的启发，将阐明内部设置因素会影响羟基脲的使用。终于面试 与家人和患者的焦点小组将允许团队概念化 羟基脲治疗的直接用户。使用快速的定性编码技术，我们将分析主题和 地图调查结果可以更好地告知所需的实施策略要素，包括最终确定工具包。这 研究的目标3将涉及计划实施能力建设以支持持续进步 低资源环境中的羟基脲治疗。这个计划阶段将包括临床评估 试点站点的知识优势和差距，确立冠军的理想特征和角色，以及 确定战略咨询委员会成员来指导未来的实施。