Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07540143
NA

The REACH-OUT Trial

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

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

2026-06-16

Completion Date

2030-06-30

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

OTHER

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.

BEHAVIORAL

BP monitor, brief orientation, and portal tools

For each enrolled patient: 1) an order for will be placed 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) if needed, the patient will be contacted by the 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.

OTHER

The MeDS assessment

The MeDS is a brief survey to assess antiHTN use that 'phenotypes' root causes of poor adherence. An RC will send the MeDS assessment 6 weeks after initial enrollment in the intervention components; 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.

OTHER

Patient navigator support

Any patient who has not initiated monitoring within 14-30 days of their orientation or has discontinued participation will be contacted by the research team to remind them to do so and to assess reasons for non-participation and help troubleshoot barriers. If the issue is clinic related, the research team will send a message to a clinic-based navigator to assess reasons for non-participation and help troubleshoot barrier.

Locations (1)

Northwestern University

Chicago, Illinois, United States