Recruiting

Blood Pressure

Sponsor:

Northwestern University

Code:

NCT07540143

Conditions

Hypertension

Reproductive Behavior

Primary Health Care

Electronic Health Record

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

Interventions

Health literacy-informed patient education materials

BP monitor, brief orientation, and portal tools

The MeDS assessment

Patient navigator support

Study Details

Brief 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.

Conditions

Hypertension

Reproductive Behavior

Primary Health Care

Electronic Health Record

Study ID

NCT07540143

Start date

Jun 16, 2026

Status verified date

Jun, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Apr 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 44

Healthy Volunteers: Not accepted

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

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

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.

Primary outcome measure

  • Systolic blood pressure [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Locations

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

More Information

Sponsor

Northwestern University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-06-22.