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)

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要在撒哈拉以南非洲，心力衰竭（HF）是一种临床综合征，会导致多种衰弱症状和导致与健康相关的生活质量较差，一年死亡率为 34%，是全球所有地区中最高的。在心力衰竭护理的整个过程中，存在着重大的护理差距和社会人口差异。自我保健是一种基于证据的干预措施可以改善心力衰竭的临床和患者报告的结果，并得到广泛应用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) 具有特别的前景因为它将基本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，中低收入国家的自我护理并未得到充分利用，因为提供者缺乏知识、工具、支持患者自我护理的时间以及患者和患者之间在自我护理实施方面存在不平等的情况供应商并不为人所知。我们工作的首要目标是改善中低收入国家的心力衰竭护理。在这个类型2中混合研究，我们将实施数字优先战略（Medly 乌干达），以改善 HF 的自我护理 6 乌干达区域转诊医院门诊部门并评估实施情况和临床结果。全部研究目标以 RE-AIM 框架和 PRISM 扩展为指导，涉及混合方法，并且是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改善乌干达的心力衰竭自我护理（目标 1）。为此，我们将进行阶梯楔形集群随机试验，包括一个对照期，然后是支持心力衰竭护理的基本循证方案，其次是 Medly 乌干达。共同主要成果将是 HF 自我护理指数（实施）和死亡率和心力衰竭住院治疗的综合数据（临床有效性）。与此同时，我们将进行混合方法过程评估，以告知对实施过程的迭代调整（子目标 1.1）社区参与的方法，系统地收集预先定性和定量的过程数据根据“边学边学”设计确定时间点，并根据具体情况进行调整实施调整。接下来，我们将评估 Medly Uganda 的实施保真度和背景使用基于 Medly 乌干达元的偏差方法，重点关注覆盖范围、采用和维护（目标 2）来自患者和提供者的数据，重点关注社会决定因素如何影响实施中的公平性。我们还将探讨心力衰竭之外的患者和医疗服务提供者的影响，例如心理健康和医疗保健自主权。然后，我们将探讨 Medly 乌干达的成本、成本效益和可持续性因素（目标 3），包括从财务和社会角度审视 Medly 乌干达的成本、成本效益和公平性（子目标 3.1）以及患者和提供者对 Medly 乌干达可持续性的看法的探索（子目标 3.2）。这项研究将产生重要的见解，以支持创新的、本地化的实施改善中低收入国家心力衰竭护理的相关策略，并与 NHLBI 翻译研究中心保持一致实施科学优先事项。