Intervention to iMProve AdherenCe equiTably (IMPACT TRIAL)

公平地提高依从性的干预（影响试验）

• 批准号: 10437181
• 负责人: DAWN HERSHMAN
• 金额: $ 68.44万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-24 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10437181
• 关键词: Address; Adherence; Adult; Antihypertensive Agents; Attention; Behavior; Blood Pressure; Breast Cancer survivor; Cardiovascular Diseases; Caring; Cause of Death; Cellular Phone; Chemosensitization; Chronic; Chronic Disease; Clinic; Clinical; Communities; Community Health Aides; Community Health Systems; Community Healthcare; Complex; Consolidated Framework for Implementation Research; Disease Outcome; Dose; Drug Prescriptions; Effectiveness of Interventions; Ethnic Origin; Event; Feedback; Focus Groups; Frequencies; Generations; Health; Health Personnel; Health system; Heart Diseases; High Prevalence; Hispanics; Hormones; Hospitalization; Human; Hybrids; Income; Intervention; Interview; Justice; LDL Cholesterol Lipoproteins; Latina; Low income; Low-Density Lipoproteins; Malignant Neoplasms; Medical; Methods; Minority; Minority Groups; Monitor; Outcome; Patient Noncompliance; Patients; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Policies; Poverty; Process; Provider; Race; Randomized Clinical Trials; Randomized Controlled Trials; Regimen; Research; Risk Factors; Self Efficacy; Social support; Structure; Surveys; Testing; Training; Underrepresented Minority; Woman; behavior change wheel; black women; cardiovascular disorder risk; cardiovascular effects; cohort; community center; comorbidity; contextual factors; cost; design; disparity reduction; effective intervention; effectiveness evaluation; effectiveness implementation design; effectiveness testing; health care disparity; health disparity; health equity; health training; high risk; hormone therapy; implementation science; improved; improved outcome; informant; innovation; malignant breast neoplasm; medication compliance; medication nonadherence; modifiable risk; mortality; mortality risk; motivational enhancement therapy; multi-component intervention; multiple chronic conditions; novel; patient portal; pragmatic trial; primary outcome; satisfaction; social health determinants; theories; therapy design; treatment as usual

This project will test the effectiveness and equity of a multicomponent adherence intervention on adherence to medications prescribed for two common chronic conditions, breast cancer (BC) and cardiovascular disease (CVD). Among adults with chronic illness, 30% to 50% of medications are not taken as prescribed, and this medication nonadherence is associated with higher risk of death, hospitalizations, and high costs. Race, ethnicity, and income are consistent predictors of nonadherence and poor health outcomes. Thus, improving adherence has the potential to reduce health disparities. For both BC and CVD, there are large disparities in health outcomes. Black and Hispanic adults have the highest risk of inadequate CVD risk factor control, and BC mortality rate is 40% higher in Black women compared to White women. Decades of research have revealed that those few medication adherence interventions that are effective have been complex, costly, and difficult to scale. Further, there has been insufficient attention paid to considering equity during intervention design. The scientific premise is that an equity and design-informed adherence intervention will increase adherence to BC and CVD medication. To accomplish this, we will refine a theory-informed intervention with input from a diverse group of patient and provider stakeholders as part of human-centered “design with justice” process. We will then conduct a pragmatic randomized controlled trial in 300 patients with comorbid BC and CVD risk factors to determine the effectiveness of a targeted, personalized multicomponent adherence intervention versus usual care on adherence to CVD (statins and antihypertensives) and BC (endocrine therapy) medications. Key components of the intervention are expected to include pharmacist-directed medication regimen optimization, patient portal access and training, optional smartphone reminder application, pharmacy fill adherence monitoring and feedback, with optional step-up in care to community healthcare worker-led motivational interviewing for persistently nonadherent patients. We will evaluate the intervention’s effectiveness on combined medication adherence (primary outcome) as well as clinical outcomes (blood pressure, LDL) and proposed mechanisms of action (regimen complexity, medication adherence self-efficacy), and will assess equity by comparing outcomes among patients in underrepresented minorities and low-income groups. Finally, we will use mixed methods to assess determinants of equitable implementation and to determine barriers and facilitators to implementation and sustainability at the patient, clinic, and health system level. To our knowledge, this will be the first pragmatic trial to investigate an intervention to equitably improve adherence to medications for multiple chronic conditions in a diverse cohort of patients. If successful, this intervention will result in an intervention that can be disseminated across our network and to the broader health system.

该项目将测试多组分遵守干预措施的有效性和公平性 针对乳腺癌(BC)和心血管疾病这两种常见慢性病的药物处方 (CVD)。在患有慢性病的成年人中，30%到50%的药物没有按处方服用，而这 不坚持用药与更高的死亡风险、住院和高昂的费用相关。种族， 种族和收入是不遵守规定和健康结果不佳的一致预测因素。因此，改善 坚持这一原则有可能缩小健康差距。对于BC和CVD，在 健康结果。黑人和西班牙裔成年人心血管疾病风险因素控制不足的风险最高， 与白人女性相比，黑人女性的BC死亡率高出40%。几十年的研究已经证明 据透露，那些少数有效的药物依从性干预措施是复杂、昂贵和 难以规模化。此外，在干预过程中考虑公平问题也没有得到足够的重视 设计。科学的前提是公平和设计知情的遵守干预将增加 坚持BC和CVD药物治疗。为了实现这一点，我们将完善一种基于理论的干预措施 来自不同的患者和提供者利益相关者群体的意见，作为以人为中心的“公正设计”的一部分 进程。然后，我们将在300名合并BC和BC的患者中进行一项务实的随机对照试验 心血管疾病风险因素，以确定有针对性的、个性化的多成分坚持的有效性 对心血管疾病(他汀类药物和抗高血压药)和BC(内分泌药物)依从性的干预与常规护理 治疗)药物。预计干预的关键组成部分将包括药剂师指导 药物治疗方案优化、患者门户访问和培训、可选的智能手机提醒应用程序、 药房提供遵从性监测和反馈，可选地加强对社区医疗保健的护理 以员工为主导的激励性访谈对顽固不化的患者。我们将评估干预措施的 联合用药依从性(主要结果)和临床结果(血液)的效果 压力、低密度脂蛋白)和拟议的作用机制(方案复杂性、服药依从性自我效能)， 并将通过比较未被充分代表的少数族裔和低收入人群的结果来评估公平性 组。最后，我们将使用混合方法来评估公平执行的决定因素，并 确定患者、诊所和卫生系统实施和可持续发展的障碍和促进者 水平。据我们所知，这将是第一次调查公平改善干预措施的务实试验 在不同的患者队列中坚持对多种慢性病进行药物治疗。如果成功，这将是 干预将导致一种干预，可以在我们的网络中传播，并对更广泛的健康产生影响 系统。