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The REACH-OUT Trial
NCT07540143 · Northwestern University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
A Technology-based, Primary Care Strategy to Optimize Blood Pressure Before Pregnancy: The REACH-OUT Trial
About this study
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
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
Study design
Enrollment target: 350 participants
Allocation: randomized
Masking: none
Age groups: adult
Timeline
Starts: 2026-06-16
Estimated completion: 2030-06-30
Last updated: 2026-06-22
Interventions
Other: Health literacy-informed patient education materialsBehavioral: BP monitor, brief orientation, and portal toolsOther: The MeDS assessmentOther: Patient navigator support
Primary outcomes
- • Systolic blood pressure (3 months)
Sponsor
Northwestern University · other
Contacts & investigators
ContactStacy C Bailey, PhD MPH · contact · stacy-bailey@northwestern.edu · (312) 503-3272
ContactGuisselle Wismer, MPH · contact · guisselle.wismer@northwestern.edu
InvestigatorStacy C Bailey, PhD, MPH · principal_investigator, Northwestern University
InvestigatorSadiya Khan, MD · principal_investigator, Northwestern University
All locations (1)
Northwestern UniversityRecruiting
Chicago, Illinois, United States