Reach Out 2: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple HealthSystems

Northwestern University At Chicago, Evanston IL

Investigators

Linked publications, trials & patents

Abstract

Hypertension is the most important modifiable risk factor for cardiovascular disease. Black Americans have the highest prevalence of hypertension and the lowest rates of blood pressure (BP) control of any racial or ethnic group in the U.S., which is associated with increased cardiovascular diseases. Low-income Americans also experience a higher prevalence of hypertension and may face unique barriers to effective treatment. To improve the health for all, new approaches to hypertension management leveraging safety-net healthcare systems are needed. One approach to addressing the hypertension epidemic is to identify and treat people undiagnosed and optimize hypertension treatment.. We did this in Reach Out 1 (R01MD011516), a mobile health (mHealth) 8-arm factorial trial of patients with hypertension recruited from a safety-net ED. Among the ~500 majority Black, mid-life participants, 43% were unemployed; 21% did not carry a diagnosis of hypertension; 51% were not taking antihypertensive medications, and 22% did not have a primary care provider. Overall, systolic BP declined by 9.2 mmHg (95% CI -12.2 to - 6.3) after 6 months, without differences across treatment arms. Reach Out 1 successfully enrolled a population with hypertension who sought care at a safety-net ED into a mHealth intervention. Despite a very large reduction in BP overall, the efficacy of the Reach Out mHealth intervention is not certain, given the lack of a control group. Reach Out 2 proposes to test the most promising components of Reach Out 1 in a randomized open, blinded-endpoint (PROBE) controlled trial. Reach Out 2, continues our work with the same safety-net ED and Federally Qualified Health Centers. In Reach Out 2, we will compare usual care, to 6-months of prompted self-monitored blood pressure (SMBP) monitoring with tailored feedback and facilitated primary care appointment and transportation. The usual care group will receive instructions to follow up with a primary care provider after ED discharge. After 6 months, the intervention participants will enter an extended treatment period of long-term SMBP monitoring. To contextualize our findings, we will use our chronic disease agent-based simulation model to estimate the reduction in myocardial infarction, stroke, and dementia if Reach Out 2 were to be implemented in safety-net EDs across the US. The overarching goal of our proposal is to determine whether a low-tech mHealth intervention will reduce BP more than usual care among patients recruited from a safety-net ED and to understand the potential national impact of such an intervention. Because safety-net EDs care for large populations of people with hypertension, mHealth strategies initiated here have tremendous potential to reducecardiovascular risk. To reach this potential, evidence-based interventions to reduce BP must be identified (aim 1), long-term engagement evaluated (aim 2), and their impact understood (aim 3).