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: 10494225
• 负责人: DAWN HERSHMAN
• 金额: $ 68.33万
• 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/10494225
• 关键词: Address; Adherence; Adult; Antihypertensive Agents; Attention; Behavior; Black race; 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; Hispanic; Hormones; Hospitalization; 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; Reduce health disparities; Regimen; Research; Risk Factors; Self Efficacy; Social support; 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; human centered design; implementation facilitators; implementation science; improved; improved outcome; informant; innovation; long-standing disparities; malignant breast neoplasm; medication compliance; medication nonadherence; minority patient; 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.

该项目将测试多成分依从性干预对依从性的有效性和公平性， 用于两种常见慢性疾病的处方药，乳腺癌（BC）和心血管疾病 （心血管疾病）。在患有慢性病的成年人中，30%至50%的药物没有按处方服用，而这一点 药物治疗不依从性与较高的死亡、住院和高费用风险相关。种族， 种族和收入是不依从和不良健康结果的一致预测因素。从而改善 坚持有可能减少健康差距。对于BC和CVD， 健康成果。黑人和西班牙裔成年人的心血管疾病风险因素控制不足的风险最高， 黑人妇女的BC死亡率比白色妇女高40%。几十年的研究 揭示了那些少数有效的药物依从性干预措施是复杂的，昂贵的， 难以扩展。此外，在干预过程中没有充分注意考虑公平问题 设计科学的前提是，一个公平和设计知情的坚持干预将增加 坚持BC和CVD药物治疗。为了实现这一点，我们将完善一个理论知情的干预， 作为以人为本的“公正设计”的一部分，来自患者和供应商利益相关者的不同群体的意见 过程然后，我们将在300例共患BC的患者中进行一项实用的随机对照试验， CVD危险因素，以确定有针对性的、个性化的多组分依从性的有效性 干预与常规护理对CVD（他汀类药物和降压药）和BC（内分泌 治疗）药物。干预措施的关键组成部分预计将包括药剂师指导的 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， 药房填充依从性监测和反馈，可选择逐步向社区医疗保健提供护理 工作人员主导的动机访谈持续不遵守患者。我们将评估干预的效果 联合用药依从性（主要结局）以及临床结局（血液 压力，LDL）和拟定的作用机制（方案复杂性，药物依从性自我效能）， 并将通过比较代表性不足的少数民族和低收入群体患者的结果来评估公平性 组最后，我们将使用混合方法评估公平执行的决定因素， 确定患者、诊所和卫生系统实施和可持续性的障碍和促进因素 水平据我们所知，这将是第一个务实的试验，以调查干预，以公平地改善 在不同的患者队列中对多种慢性疾病的药物治疗依从性。如果成功，这 干预将导致干预，可以通过我们的网络传播，并扩大到更广泛的健康 系统