RecruitingNot ApplicableNCT07540143

The REACH-OUT Trial

A Technology-based, Primary Care Strategy to Optimize Blood Pressure Before Pregnancy: The REACH-OUT Trial


Sponsor

Northwestern University

Enrollment

350 participants

Start Date

Jun 16, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 44 Years

Inclusion Criteria6

  • 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 Criteria2

  • not pregnant or within 3 months postpartum
  • severe, uncorrectable vision, hearing, or cognitive impairment that would preclude study consent or participation

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Interventions

OTHERHealth literacy-informed patient education materials

Health literacy-informed patient education materials will be uploaded to the patient portal and/or sent to patients by mail, email, or text message. Materials will reinforce clinician counseling and describe the importance of antiHTN adherence and BP control specifically for young women with HTN. Materials will be delivered in English or Spanish based on the preferred language.

BEHAVIORALBP monitor, brief orientation, and portal tools

A care coordinator will be notified once a patient has enrolled. For each enrolled patient: 1) a clinic care coordinator will place an order for HBPM in the EHR. This will include a hypertension flowsheet that specifies BP criteria that will trigger a clinic alert; 2) The assigned primary care clinician will review and cosign the order after verifying the patient should not be excluded on medical grounds; 3) the patient will receive a BP monitor; 4) the patient will be contacted by the care coordinator to schedule a brief training on how to measure BP (in clinic or via telehealth; easy-to-understand print instructions will also be provided); 5) Each day for 7 days, the patient will enter the date and time of a systolic, diastolic, and pulse measure into the portal tool. Data will populate automatically in the chart for clinical review. Any BP outside prespecified ranges will trigger an inbox alert to the nurse pool and clinician.

OTHERThe MeDS assessment

The MeDS is a brief survey to assess antiHTN use that 'phenotypes' root causes of poor adherence. Participants will take the survey at the end of the 7-day monitoring period; research staff will send participants the MeDS assessment via a MyChart message. This survey will only appear for enrolled patients and will only be completed once per monitoring period. An algorithm for determining which responses warrant clinic follow-up will be developed. Any flagged concern will appear in a report. Research staff will send the nurse pool and the patient's clinician an inbox message via Epic alerting them of concern. The alert will describe the type of challenge identified and recommend follow-up.

OTHERPatient navigator support

Any patient who has not initiated monitoring within 14 days of their orientation or has discontinued participation will be contacted by a clinic-based navigator, who will assess reasons for non-participation and help troubleshoot barriers. Navigators will use a structured script in Epic to identify, document, and address any barriers.


Locations(1)

Northwestern University

Chicago, Illinois, United States

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NCT07540143


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