The REACH-OUT Study
Title:
A technology-based, primary care strategy to optimize blood pressure before pregnancy: The REACH-OUT Trial
Dates:
September 2025 – June 2030
Funding Source:
National Heart, Lung, and Blood Institute (NHLBI)
Grant Number:
R01HL178127
Background:
Nearly 1 in 6 women of reproductive age have chronic hypertension (HTN) and are at increased risk of premature cardiovascular disease (CVD) and death. Women with hypertension who become pregnant also face higher risks of maternal morbidity and mortality with 1 in 3 experiencing an adverse pregnancy-related event. Young Black women are 3 times more likely to have hypertension, are twice as likely to die prematurely from CVD, and are 4 times more likely to experience hypertension -related maternal mortality compared to White women. Optimal blood pressure (BP) control can reduce these cardiovascular and reproductive risks and mitigate unacceptable racial disparities.
Medication challenges are present in this population even after appropriate prescribing. Young women are more likely to have poor antihypertension adherence than older adults, often citing causes unique to this group (e.g., caregiving demands, stigma, negative medication beliefs). Yet, adherence is rarely assessed in primary care, or the causes of nonadherence identified. As a result, clinicians lack information needed to inform and tailor clinical intervention. In studies among older adults, home blood pressure monitoring has been shown to accurately measure blood pressure, prompt timely interventions, and improve adherence. Yet home blood pressure monitoring remains understudied among young women with hypertension.
Abstract:
We developed a multicomponent, electronic health record (EHR)-based strategy to promote the REproductive And Cardiovascular Health Of Underserved Patients with HyperTension (REACH-OUT). Our strategy seeks to promote safe antihypertension and contraceptive use among women with hypertension and to create an infrastructure to monitor antihypertension adherence and blood pressure to inform clinical decision-making. For clinicians, REACH-OUT includes [1] EHR-based clinical decision support that: a) elicits pregnancy intention in a non-judgmental manner, b) facilitates review of prescribed antihypertension medications and contraceptives to identify contraindications, and c) prompts targeted counseling on medication safety, adherence, and blood pressure for young women. For patients, REACH-OUT provides [2] educational materials, printed with after visit paperwork, to reinforce clinician counseling, [3] a blood pressure monitor, training, and access to a patient portal-based tool where home blood pressure measures can be recorded, and [4] a brief, portal-based survey to assess antihypertension use and ‘phenotype’ causes of poor adherence. Blood pressure and survey results are delivered directly to the care team via the EHR; structured protocols will guide clinic response.
While REACH-OUT is designed to be largely automated, patients may need additional support to engage with the portal and monitoring activities. Our strategy will therefore utilize a ‘stepped care’ approach, wherein [5] a patient navigator will provide tailored support for any patient who has not initiated monitoring within 1 month. This approach is consistent with evidence showing home blood pressure monitoring is most effective when integrated with clinical care.
We will test REACH-OUT vs. usual care in a clinic-randomized trial among Federally Qualified Health Centers in Chicago, IL. We will enroll English or Spanish-speaking, non-pregnant women on antihypertension therapy, with blood pressure >130/80 mmHg (N=350). Our aims are to:
Aim 1: Test the effectiveness of REACH-OUT, compared to usual care, to:
H1: lower systolic blood pressure within 3 months (primary outcome)
H2: improve adherence to antihypertensive therapy
H3: reduce use of contraindicated medications, including: a) teratogenic antihypertensive drugs if pregnancy is intended or likely to occur, and b) combined hormonal contraceptives that increase blood pressure.
Aim 2: Assess the reach, adoption, implementation, maintenance, and costs of REACH-OUT components.
Aim 3: Explore the dose-response effect of REACH-OUT on blood pressure, adherence to antihypertensive therapy, and use of contraindicated antihypertensives and/or contraceptives over 12 months.
Contact:
• Principal Investigators: Stacy Cooper Bailey, PhD MPH
• Project Manager: Guisselle Wismer, MPH