Improving medication adherence using family-focused and literacy-sensitive strategies in patients with heart failure

项目摘要 坚持服药被许多提供者和研究人员认为是最重要的自我护理 行为，然而它也是最有问题的。服药依从性差会导致生活质量(QOL)差， 住院和死亡。在美国，每年约有12.5万人死于贫困 服药依从性和高达50%的心力衰竭(HF)患者在服药后6个月内再次住院 既往心力衰竭恶化，最常见的原因之一是服药依从性差。终身和 通常情况下，心力衰竭患者需要复杂的药物治疗方案，但40%-60%的心力衰竭患者 服药依从性不佳。健康素养在次优服药依从性中起着重要作用。 由护理伙伴(CP；通常是家庭成员)的支持可以提高依从性并减少住院人数。 虽然一些干预措施提高了心力衰竭患者的依从性，但改善幅度很小，效果也很好。 都没有持续下去。为了增强和维持干预效果，我们将使用扫盲的方法- 敏感，并包含社会支持。为患者和CPS使用通俗易懂的语言，我们将 测试由护士提供的交互式、行为、以家庭为中心和识字敏感(FamLit)干预， 结合以证据为基础的多个组成部分(例如，回教、指导、角色扮演、目标设定)来 让患者和CPS共同参与改善和维持服药依从性和健康结果。我们 将进行一项随机对照试验来评估FamLit干预对药物的疗效 依从性、住院率、死亡率和生活质量。我们将随机分配164名患者和他们的主治医生 对FamLit干预组或注意控制组进行CPS(患者-CPS)。两个集团都将有一个内部- 基线后一个月的人员会议(在诊所预约当天提供，以进行定期跟踪) 每隔一周进行一次电话助推器，最多持续3个月。FamLit小组会议将专注于改进 服药依从性和对照组会议将集中在一般健康问题上。我们的目标是：1)测试 与注意控制组相比，FamLit干预的效果(即，主要： 服药依从性，其次：a)心衰住院或全因死亡，b)生活质量，c)社会支持，以及 D)沟通)超过12个月；2)确定是否与TPB相关的中间结果(态度、主观 规范、感知行为控制)在干预对服药依从性的影响中起中介作用； 检查每个二元组成员的a)健康素养，b)社会支持，c)沟通是否适中 FamLit干预对服药依从性的影响；以及4)决定每个二元成员如何 态度、主观规范、感知的行为控制、社会支持和沟通会影响他们自己 以及他们伴侣12个月的生活质量，使用创新的参与者-伴侣相互依赖模型。这个 家庭干预，如果有效，有可能改善/维持服药依从性并减少 住院和死亡。作为下一步，我们将跟进有效性-实施混合试验。

Project Summary Medication adherence is thought by many providers and researchers to be the most important self-care behavior, yet it is also the most problematic. Poor medication adherence can cause poor quality of life (QoL), hospitalization, and death. In the United States, approximately 125,000 deaths per year are due to poor medication adherence and up to 50% of heart failure (HF) patients are re-hospitalized within 6 months of a previous HF exacerbation and one of the most common causes is poor medication adherence. Lifelong and usually complex medication regimens are needed for patients with HF, yet 40-60% of HF patients have suboptimal medication adherence. Health literacy plays a significant role in suboptimal medication adherence. Support by a care partner (CP; usually a family member) can improve adherence and reduce hospitalizations. Although some interventions have improved HF patients’ adherence, improvements were small, and effects were not sustained. To enhance and sustain intervention effects, we will use an approach that is literacy- sensitive and incorporates social support. Using easy-to-understand language for patients and CPs, we will test an interactive, behavioral, family-focused and literacy-sensitive (FamLit) intervention delivered by nurses, incorporating evidence-based, multi-components (e.g., teach-back, coaching, role-playing, goal setting) to engage both patients and CPs in improving and sustaining medication adherence and health outcomes. We will conduct a randomized controlled trial to evaluate the efficacy of FamLit intervention on medication adherence, hospitalization, death, and QoL. We will randomly assign 164 dyads of patients and their primary CPs (patients-CPs) to either the FamLit intervention or an attention-control group. Both groups will have an in- person session (delivered on the day of a clinic appointment for regular follow-up) one month after baseline and phone boosters every other week for up to 3 months. FamLit group sessions will focus on improving medication adherence, and control group sessions will focus on general health issues. Our aims are to: 1) test the efficacy of the FamLit intervention compared to an attention control group on outcomes (i.e., primary: medication adherence, and secondary: a) HF hospitalization or all-cause death, b) QoL, c) social support, and d) communication) over 12 months; 2) determine if TPB-related intermediate outcomes (attitudes, subjective norms, perceived behavioral control) mediate the effects of the intervention on medication adherence; 3) examine whether each dyad member’s a) health literacy, b) social support, and c) communication moderate the effect of the FamLit intervention on medication adherence; and 4) determine how each dyad member’s attitudes, subjective norms, perceived behavioral control, social support, and communication affect their own and their partner’s QoL over 12 months using the innovative Actor-Partner Interdependence Model. The FamLit intervention, if efficacious, holds potential to improve/sustain medication adherence and reduce hospitalizations and death. We will follow up with an effectiveness-implementation hybrid trial as our next step.