The REACH-OUT Trial

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07540143
Status
Recruiting
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Conditions

  • Electronic Health Record
  • Hypertension
  • Primary Health Care
  • Reproductive Behavior

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Not accepted

Interventions

  • Health literacy-informed patient education materials — OTHER
    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 — BEHAVIORAL
    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 — OTHER
    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 — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: REACH-OUT
    In addition to the CDS and home blood pressure monitor that usual care patients receive, REACH-OUT patients will receive \[1\] health literacy-informed patient education materials, \[2\] orientation to using the blood pressure monitor and portal tools, \[3\] the MeDS assessment, and \[4\] patient navigator support if needed.
  • No Intervention: Usual Care
    Clinical decision support (CDS) will be embedded in the EHR. CDS will be triggered during all routine primary care visits for eligible patients who are seeing a physician or Advanced Practice Provider. CDS will prompt clinicians to review prescribed antiHTNs and contraceptives to identify any contraindications and to counsel patients on the importance of antiHTN adherence and BP control for reproductive-aged women.

Primary Outcome Measure

Systolic blood pressure [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Guisselle Wismer, MPH
[email protected]
(312) 503-3272

Find similar trials in Chicago, IL

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Northwestern University· Chicago, IL

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