Intervention to iMProve AdherenCe equiTably (IMPACT TRIAL)

公平地提高依从性的干预（影响试验）

基本信息

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
项目类别：
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

项目摘要

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措施的有效性和公平性治疗两种常见慢性病：乳腺癌 (BC) 和心血管疾病的药物 (CVD) 患有慢性病的成年人中，30% 至 50% 没有按处方服用药物。药物不依从性与较高的死亡风险、住院费用和高费用相关。种族和收入是不依从和不良健康结果的一致预测因素。坚持治疗有可能减少 BC 和 CVD 的健康差异。黑人和西班牙裔成年人心血管疾病危险因素控制不足的风险最高，并且数十年的研究表明，黑人女性的 BC 死亡率比白人女性高 40%。研究表明，那些少数有效的药物依从性干预措施非常复杂、成本高昂且此外，干预期间对公平性的考虑还不够重视。科学的前提是公平和设计知情的依从性干预将会增加。为了实现这一目标，我们将完善基于理论的干预措施。来自不同群体的患者和提供者利益相关者的意见，作为以人为本的“正义设计”的一部分然后，我们将对 300 名患有 BC 和 BC 共病的患者进行一项实用的随机对照试验。 CVD 风险因素，以确定有针对性的个性化多成分依从性的有效性干预与常规护理对 CVD（他汀类药物和抗高血压药物）和 BC（内分泌治疗）依从性的比较干预的关键组成部分预计包括药剂师指导。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、药房灌装依从性监测和反馈，可选择升级社区医疗保健对持续不依从的患者进行由工作人员主导的动机访谈。我们将评估干预措施的效果。联合用药依从性（主要结果）以及临床结果（血液压力、LDL）和拟议的作用机制（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族裔和低收入患者的结果来评估公平性最后，我们将使用混合方法来评估公平实施的决定因素并确定确定并促进患者、诊所和卫生系统的实施和可持续性据我们所知，这将是第一个调查干预措施以公平提高水平的务实试验。如果成功的话，在不同的患者群体中坚持治疗多种慢性病的药物。干预措施将导致可以在我们的网络和更广泛的健康领域传播的干预措施系统。