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

项目摘要 药物依从性被许多供应商和研究人员认为是最重要的自我保健 行为，但它也是最有问题的。药物依从性差可导致生活质量（QoL）差， 住院和死亡。在美国，每年约有12.5万人死于贫困。 药物依从性和高达50%的心力衰竭（HF）患者在治疗后6个月内再次住院。 既往HF加重，最常见的原因之一是药物依从性差。终身且 HF患者通常需要复杂的药物治疗方案，但40-60%的HF患者 药物依从性欠佳。健康素养在次优药物依从性中起着重要作用。 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。 尽管一些干预措施改善了HF患者的依从性，但改善幅度很小， 没有得到支持。为了加强和维持干预效果，我们将采用一种方法，即扫盲- 具有敏感性，并包含社会支持。使用患者和CP易于理解的语言，我们将 测试护士提供的互动、行为、以家庭为中心和识字敏感（FamLit）干预， 结合基于证据的多组分（例如，反馈、指导、角色扮演、目标设定）， 让患者和CP参与改善和维持药物依从性和健康结果。我们 将进行一项随机对照试验，以评估FamLit干预对药物治疗的有效性 依从性、住院、死亡和QoL。我们将随机分配164对患者和他们的主要 CP（patients-CP），分为FamLit干预组和注意力控制组。两组都将有一个在- 基线后1个月的个人会话（在诊所预约当天进行定期随访） 每隔一周打一次电话，持续三个月FamLit小组会议将重点关注改善 药物依从性和对照组会议将侧重于一般健康问题。我们的目标是：1）测试 与注意力控制组相比，FamLit干预对结果的功效（即，主要： 药物依从性，次要：a）HF住院或全因死亡，B）QoL，c）社会支持，以及 d）沟通）超过12个月; 2）确定TPB相关的中间结果（态度，主观 规范，感知行为控制）介导干预对药物依从性的影响; 3） 检查每个二元组成员的a）健康素养，B）社会支持和c）沟通是否适度 FamLit干预对药物依从性的影响;以及4）确定每个二元组成员的 态度、主观规范、感知行为控制、社会支持和沟通影响他们自己的行为。 和他们的合作伙伴的生活质量超过12个月使用创新的演员合作伙伴相互依赖模型。的 家庭干预如果有效，有可能改善/维持药物依从性， 住院和死亡。我们下一步将进行有效性-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.