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The REACH-OUT Trial
Sponsor: Northwestern University
Summary
We will 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.
Official title: A Technology-based, Primary Care Strategy to Optimize Blood Pressure Before Pregnancy: The REACH-OUT Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 44 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2026-05-01
Completion Date
2030-06-30
Last Updated
2026-04-20
Healthy Volunteers
No
Interventions
Health 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.
BP 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.
The 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.
Patient 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.