Reach Out Emergency Department: A Randomized Factorial Trial to Determine the Optimal Mobile Health Components to Reduce Blood Pressure.

BACKGROUND: Mobile health (mHealth) strategies initiated in safety-net Emergency Departments may be one approach to address the US hypertension epidemic, but the optimal mHealth components or dose are unknown. METHODS: Reach Out is an mHealth, health theory-based, 2×2×2 factorial trial among hypertensive patients evaluated in a safety-net Emergency Department in Flint, Michigan. Reach Out consisted of 3 mHealth components, each with 2 doses: (1) healthy behavior text messaging (yes versus no), (2) prompted self-measured blood pressure (BP) monitoring and feedback (weekly versus daily), and (3) facilitated primary care provider appointment scheduling and transportation (yes versus no). The primary outcome was a change in systolic BP from baseline to 12 months. In a complete case analysis, we fit a linear regression model and accounted for age, sex, race, and prior BP medications to explore the association between systolic BP and each mHealth component. RESULTS: Among 488 randomized participants, 211 (43%) completed follow-up. Mean age was 45.5 years, 61% were women, 54% were Black people, 22% did not have a primary care doctor, 21% lacked transportation, and 51% were not taking antihypertensive medications. Overall, systolic BP declined after 6 months (-9.2 mm Hg [95% CI, -12.2 to -6.3]) and 12 months (-6.6 mm Hg, -9.3 to -3.8), without a difference across the 8 treatment arms. The higher dose of mHealth components were not associated with a greater change in systolic BP; healthy behavior text messages (point estimate, mmHG=-0.5 [95% CI, -6.0 to 5]; P=0.86), daily self-measured BP monitoring (point estimate, mmHG=1.9 [95% CI, -3.7 to 7.5]; P=0.50), and facilitated primary care provider scheduling and transportation (point estimate, mmHG=0 [95% CI, -5.5 to 5.6]; P=0.99). CONCLUSIONS: Among participants with elevated BP recruited from an urban safety-net Emergency Department, BP declined over the 12-month intervention period. There was no difference in change in systolic BP among the 3 mHealth components. Reach Out demonstrated the feasibility of reaching medically underserved people with high BP cared for at a safety-net Emergency Departments, yet the efficacy of the Reach Out mHealth intervention components requires further study. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03422718.

Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial.

BACKGROUND: Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to impact difficult-to-reach populations. There are 136 million visits to the Emergency Department each year and nearly all have at least one blood pressure measured and recorded. Additionally, an increasing number of African Americans and socioeconomically disadvantaged patients are overrepresented in the Emergency Department patient population. In the age of electronic health records and mobile health, the Emergency Department has the potential to become an integral partner in chronic disease management. The electronic health records in conjunction with mobile health behavior interventions can be leveraged to identify hypertensive patients to impact otherwise unreached populations. METHODS: Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population. Potential participants are identified by automated alerts from the electronic health record and, following consent, receive a blood pressure cuff to take home. During the initial screening phase, they are prompted to submit weekly blood pressure readings. Responders with persistent hypertension are then randomized into one of three component arms, consisting of varying intensity levels: (1) healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no). If participants are randomized to receive facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center. Participants are followed for 12 months. DISCUSSION: The Reach Out study is designed to determine which behavioral intervention components or 'dose' of components contributes to a reduction in systolic blood pressure after 1 year (Aim 1). The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2). Ideally, the Reach Out system will contribute to hypertension management, serving as a model for safety net hospitals and Federally Qualified Health Centers to improve chronic disease management in underserved communities. TRIAL REGISTRATION: This study was registered at clinicaltrials.gov, identifier NCT03422718. The record was first available to the public on January 30, 2018 prior to the enrollment of patients on March 25, 2019.