Intervention to iMProve AdherenCe equiTably (IMPACT TRIAL)

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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.