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

使用以家庭为中心和识字敏感的策略提高心力衰竭患者的药物依从性

• 批准号: 10501326
• 负责人: Jia-Rong Wu
• 金额: $ 53.16万
• 依托单位: UNIVERSITY OF KENTUCKY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-31 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10501326
• 关键词: Address; Adherence; Adverse effects; Affect; Appointment; Attitude; Back; Behavior; Behavior Control; Behavioral; Caring; Cause of Death; Cessation of life; Chronic; Clinic; Communication; Complex; Control Groups; Educational Materials; Event; Family; Family member; Friends; Goals; Happiness; Health; Health Promotion; Heart failure; Hospitalization; Individual; Instruction; Intervention; Language; Learning; Link; Mediating; Medical; Modeling; Morbidity - disease rate; Motivation; Nurses; Outcome; Partner Communications; Patient Care; Patients; Persons; Pharmaceutical Preparations; Planning Theory; Play; Prevention; Primary Health Care; Provider; Quality of life; Randomized; Randomized Controlled Trials; Reading; Regimen; Research; Research Personnel; Role; Role playing therapy; Self Care; Social support; Spouses; Symptoms; Telephone; Testing; Time; Treatment Efficacy; United States; Work; attentional control; base; comparison intervention; compliance behavior; effectiveness implementation study; efficacy evaluation; efficacy testing; evidence base; follow-up; fourth grade; group intervention; health literacy; high risk; improved; innovation; interest; intervention effect; literacy; medication compliance; member; mortality; multi-component intervention; older patient; pilot test; post intervention; primary outcome; secondary outcome; skills

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.

项目摘要 许多提供者和研究人员认为，药物依从性是最重要的自我保健 行为，但它也是最有问题的。药物依从性差会导致生活质量差（QOL）， 住院和死亡。在美国，每年大约125,000人死亡是由于较差 药物依从性和多达50％的心力衰竭（HF）患者在6个月内重新住院 先前的HF加剧和最常见的原因之一是药物依从性差。终身和 通常，HF患者需要复杂的药物治疗方案，但40-60％的HF患者具有 次优的药物依从性。健康素养在次优的药物依从性中起着重要作用。 护理伙伴的支持（CP；通常是家庭成员）可以改善依从性并减少住院治疗。 尽管某些干预措施提高了HF患者的依从性，但改善很小，影响 没有持续。为了增强和维持干预效果，我们将使用一种扫盲的方法 - 敏感并结合社会支持。使用易于理解的患者和CP的语言，我们将 测试由护士提供的互动性，行为，以家庭为中心和对识字敏感的（FAMLIT）干预措施， 将基于循证的，多组分（例如，教学，教练，角色扮演，目标设定）结合到 让患者和CPS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干预对药物的效率 依从性，住院，死亡和QoL。我们将随机分配164例患者及其主要 CPS（患者CP）进行FAMLIT干预或注意力控制组。两组将有一个 人会议（在诊所预约日期进行定期随访的当天），一个月后 每隔一周的电话助推器最多3个月。 Famlit小组会议将重点放在改进 药物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 与注意力控制组相比，FAMLIT干预的效率（即主要： 药物依从性和次要：a）HF住院或全因死亡，b）QOL，c）社会支持和 d）沟通）超过12个月； 2）确定与TPB相关的中间结果（态度，主观 规范，感知的行为控制）调解干预对药物依从性的影响； 3） 检查每个二元成员的a）健康素养，b）社会支持和c）沟通适度 Famlit干预对药物依从性的影响； 4）确定每个二元成员的方式 态度，主观规范，感知的行为控制，社会支持和沟通会影响自己的 以及他们的合作伙伴的QOL在12个月内使用创新的演员 - 伴侣相互依存模型。这 Famlit干预措施（如果高效）具有改善/维持药物依从性并减少的潜力 住院和死亡。我们将跟进有效性的混合试验，作为我们的下一步。