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：
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
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/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

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.

该项目将测试多组分遵守干预措施的有效性和公平性针对两种常见慢性疾病（BC）和心血管疾病的药物（CVD）。在患有慢性疾病的成年人中，没有处方30％至50％的药物，这是药物不遵守与较高的死亡风险，住院和高成本有关。种族，种族和收入是不依从性和健康状况不佳的一致预测指标。那，改善依从性有可能减少健康差异。对于BC和CVD，都有很大的差异健康结果。黑人和西班牙裔成年人的CVD风险因素控制不足，并且与白人妇女相比，黑人妇女的BC死亡率高40％。数十年的研究已经发现有效的少数药物依从性干预措施是复杂，成本高昂的，并且难以扩展。此外，在干预期间考虑公平的关注不足设计。科学的前提是公平和设计信息的依从性干预将增加遵守BC和CVD药物。为了实现这一目标，我们将完善理论上的干预措施作为以人为本的“司法设计”的一部分，来自患者和提供商利益相关者的潜水者群体的投入过程。然后，我们将在300例合并症BC患者中进行一项务实的随机对照试验 CVD风险因素确定目标个性化的多组分依从性的有效性干预与遵守CVD（他汀类药物和抗高血压）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指导药剂师药物治疗方案优化，病人门户访问和培训，可选智能手机提醒申请，药房填充依从性监测和反馈，可选的升级为社区医疗保健工人领导的动机访谈持续非遵守患者。我们将评估干预措施对综合药物依从性（主要结果）和临床结果的有效性（血液压力，LDL）和提出的作用机制（治疗疗法，药物依从性自我有效），并将通过比较代表性不足的少数族裔和低收入的患者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实施和确定在患者，诊所和卫生系统中实施和可持续性的障碍和促进者等级。据我们所知，这将是第一个调查干预措施以同样改善的务实试验在潜水员队列中，遵守多种慢性病的药物。如果成功，这干预将导致干预措施可以在我们的网络中传播，并且更广泛的健康系统。