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NCT07540143NARecruiting

The REACH-OUT Trial

Northwestern University

Start Date

6/16/2026

Completion Date

6/30/2030

Summary

Test the effectiveness of a technology-enabled strategy to optimize blood pressure among reproductive-aged women with hypertension receiving care in Federally Qualified Health Centers.

Detailed Description

The investigator team has worked with the FQHC partners to co-develop a multicomponent, technology-based strategy to promote the REproductive And Cardiovascular Health Of Underserved Patients with HyperTension (REACH-OUT). Clinicians at participating study sites will receive EHR-based clinical decision support that facilitates review of prescribed antihypertensives (antiHTNs) and contraceptives to identify contraindications and prompts targeted counseling on medication safety, adherence, and BP for young women with hypertension (HTN). For patients in the intervention arm, REACH-OUT also provides \[1\] educational materials to reinforce clinician counseling, \[2\] a BP monitor, training, and access to a patient portal-based tool where home BP measures can be recorded, and \[3\] a brief, portal-based survey to assess antiHTN use and 'phenotype' causes of poor adherence for clinic review. For patients who have difficulty monitoring their BP and adherence at home, \[4\] a patient navigator will provide tailored support and help troubleshoot any challenges. This study will test REACH-OUT vs. usual care in a patient-randomized trial. 350 English or Spanish-speaking, non-pregnant women on antiHTN therapy with elevated BP will be enrolled in the study. The study aims are to: 1) Test the effectiveness of REACH-OUT, compared to usual care, to lower systolic BP, improve antiHTN adherence, and reduce use of contraindicated medications within 3 months; 2) Assess the reach, adoption, implementation, maintenance, and costs of REACH-OUT components; and 3) Explore the dose-response effect of REACH-OUT on BP, antiHTN adherence, and use of contraindicated medications over 12 months.

Eligibility Criteria

Age Range: 18 years to 44 years

Inclusion Criteria: * biologically female * age 18-44 * English or Spanish-speaking * prescribed an antiHTN * have a systolic BP \>140 or diastolic BP\>90 at their index visit * have access to the internet Exclusion Criteria: * not pregnant or within 3 months postpartum * severe, uncorrectable vision, hearing, or cognitive impairment that would preclude study consent or participation

Interventions

OTHER

Health literacy-informed patient education materials

BEHAVIORAL

BP monitor, brief orientation, and portal tools

OTHER

The MeDS assessment

OTHER

Patient navigator support

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Conditions

HypertensionReproductive BehaviorPrimary Health CareElectronic Health Record

Locations

Northwestern University

Chicago, Illinois 60611

United States