ImpleMEntation of a Digital-first care deLiverY model for heart failure in Uganda (MEDLY Uganda)

在乌干达实施数字优先的心力衰竭护理服务模式 (MEDLY Uganda)

• 批准号: 10568129
• 负责人: Joseph Antony Cafazzo
• 金额: $ 59.13万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10568129
• 关键词: Address; Adherence; Adoption; Africa South of the Sahara; Algorithms; Area; Cardiac; Caring; Cellular Phone; Center for Translational Science Activities; Cessation of life; Clinical; Clinical effectiveness; Cluster randomized trial; Collaborations; Communities; Cost Analysis; Cost Effectiveness Analysis; Country; Data; Diet; Effectiveness; Ensure; Equity; Evidence based intervention; Exercise; Goals; Government; Health; Health Priorities; Healthcare; Heart failure; Hospital Referrals; Hospitalization; Hybrids; Inequity; Infrastructure; International; Internet; Interview; Knowledge; Learning; Location; Maintenance; Mental Health; Metadata; Methods; Monitor; Morbidity - disease rate; National Heart, Lung, and Blood Institute; Nurses; Outcome; Outpatients; Patient Education; Patient Outcomes Assessments; Patients; Pattern; Pharmaceutical Preparations; Phase; Physicians; Process; Protocols documentation; Provider; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Reporting; Research Personnel; Secure; Self Care; Service delivery model; Shapes; Site; Solar Energy; Structure; Symptoms; Syndrome; Time; Uganda; Universities; Work; cost; cost effectiveness; cost-effectiveness ratio; dashboard; design; digital; digital health; disabling symptom; empowerment; evidence base; health equity; health related quality of life; hybrid type 2 design; implementation context; implementation evaluation; implementation facilitation; implementation fidelity; implementation process; implementation science; implementation strategy; implementation/effectiveness; improved; incremental cost-effectiveness; indexing; innovation; insight; low and middle-income countries; mHealth; mobile application; mortality; patient-level barriers; pilot trial; primary outcome; process evaluation; provider-level barriers; social determinants; sociodemographic disparity; standard of care; symptom management; tool; treatment arm; uptake

PROJECT SUMMARY/ABSTRACT In sub-Saharan Africa, heart failure (HF), a clinical syndrome that causes multiple debilitating symptoms and results in poor health-related quality of life, has a 34% 1-year mortality rate, the highest of any region globally. Major care gaps and sociodemographic disparities exist throughout the continuum of HF care. Self-care is an evidence-based intervention that can improve clinical and patient-reported outcomes in HF and is widely endorsed by international bodies. Self-care holds particular promise in low- and middle-income countries (LMIC) because it shifts fundamental care tasks from providers and facilities to patients while empowering patients to better care for themselves. However, self-care is underutilized in LMIC where providers lack knowledge, tools, and time to support patients in self-care and where inequities in self-care implementation among patients and providers are not well known. The overarching goal of our work is to improve HF care in LMIC. In this Type 2 hybrid study, we will implement a digital-first strategy (Medly Uganda) to improve self-care in HF at 6 Ugandan Regional Referral Hospital outpatient departments and evaluate both implementation and clinical outcomes. All study aims are guided by the RE-AIM framework and PRISM extension, involve mixed methods, and are designed to prioritize health equity. First, we will assess the implementation and clinical effectiveness of Medly Uganda to improve HF self-care in Uganda (Aim 1). To do this, we will conduct a stepped-wedge, cluster randomized trial that includes a control period followed by a basic evidence-based package to support HF care, followed by Medly Uganda. The co-primary outcomes will be the Self-Care of HF Index (implementation) and the composite of mortality and HF hospitalization (clinical effectiveness). In parallel to this, we will conduct a mixed methods process evaluation to inform iterative adjustments to the implementation processes (Sub-Aim 1.1) using a community-engaged approach to systematically collect qualitative and quantitative process data at pre- determined time points based on the Learn-As-You-Go design and make contextually appropriate implementation adaptations. Next, we will evaluate the implementation fidelity and context of Medly Uganda with a focus on reach, adoption, and maintenance (Aim 2) using a deviance approach based on Medly Uganda meta data from patients and providers, focusing on how social determinants might shape equity in implementation. We will also explore patient and provider impacts beyond HF, such as mental health and healthcare autonomy. Then, we will explore cost, cost effectiveness, and sustainability factors for Medly Uganda (Aim 3), including an examination of cost, cost-effectiveness, and equity of Medly Uganda from a financial and societal perspective (Sub-Aim 3.1) and an exploration of patient and provider perspectives on the sustainability of Medly Uganda (Sub-Aim 3.2). This study will generate important insights to support implementation of innovative, locally relevant strategies to improve HF care in LMIC and aligns with NHLBI's Center for Translation Research and Implementation Science priorities.

项目总结/摘要 在撒哈拉以南非洲，心力衰竭（HF）是一种引起多种衰弱症状的临床综合征， 导致与健康相关的生活质量低下，1年死亡率为34%，是全球任何地区中最高的。 主要的护理差距和社会人口差异存在于整个HF护理的连续性。自我照顾是一种 循证干预可以改善HF的临床和患者报告的结局，并广泛应用于 得到国际机构的认可。自我保健在低收入和中等收入国家（LMIC）特别有希望 因为它将基本的护理任务从提供者和设施转移到患者身上，同时使患者能够 更好地照顾自己。然而，自我保健在LMIC中没有得到充分利用，因为提供者缺乏知识，工具， 和时间来支持患者的自我护理，以及患者之间自我护理实施的不公平， 供应商并不知名。我们工作的首要目标是改善LMIC的HF护理。在这种类型2 混合研究，我们将实施数字优先战略（Medly Uganda），以改善6岁以上HF患者的自我护理 区域转诊医院门诊部，并评估实施和临床结果。所有 研究目标由RE-AIM框架和PRISM扩展指导，涉及混合方法， 旨在优先考虑健康公平。首先，我们将评估Medly的实施和临床效果 乌干达将改善乌干达的HF自我保健（目标1）。为了做到这一点，我们将进行一个阶梯楔，集群 一项随机试验，包括一个对照期，随后是一个支持HF护理的基本循证包， 其次是Medly乌干达。共同主要结局将是HF自我护理指数（实施）和 死亡率和HF住院的复合终点（临床有效性）。与此同时，我们将进行一次混合 方法过程评估，以告知对实施过程的迭代调整（子目标1.1）， 采用社区参与的方法，系统地收集前期的定性和定量过程数据， 根据“随学随用”设计确定时间点， 实施调整。接下来，我们将评估Medly Uganda的实施保真度和背景， 使用基于Medly Uganda Meta的偏差方法，重点关注覆盖、采用和维护（目标2） 来自患者和提供者的数据，重点是社会决定因素如何影响执行中的公平。 我们还将探讨HF以外的患者和提供者的影响，例如心理健康和医疗自主权。 然后，我们将探讨Medly Uganda（目标3）的成本、成本效益和可持续性因素，包括 从财务和社会角度审查Medly乌干达的成本、成本效益和公平性 （子目标3.1），并探讨患者和提供者对Medly Uganda可持续性的看法 （次级目标3.2）。这项研究将产生重要的见解，以支持实施创新的， 改善LMIC HF护理的相关策略，并与NHLBI的翻译研究中心保持一致， 实施科学优先事项。