The REACH-OUT Trial

NCT07540143 | Not Yet Recruiting DMC

• 1 other identifier: STU00223582
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure

  Blood pressure (BP) will be measured three times at baseline and 3 months. Participants will be seated and rested for 5 minutes before measurement. The mean of the 2nd and 3rd readings will be used for analysis. Measurements will follow standard research procedures regarding arm selection, and patient positioning. Remote guidance via Zoom will be provided as needed to ensure proper technique.

  3 months

Secondary Outcomes (4)

• Adherence to Refills and Medication Survey (ARMS)

  3 months

• Biochemical Adherence to Antihypertensive Medications

  3 months

• Pill Count Adherence to Antihypertensive Medications

  3 months

• Use of Contraindicated Medications

  3 months

Study Arms (2)

REACH-OUT

EXPERIMENTAL

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.

Other: Health literacy-informed patient education materials; Behavioral: BP monitor, brief orientation, and portal tools; Other: The MeDS assessment; Other: Patient navigator support

Usual Care

NO INTERVENTION

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 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.

REACH-OUT

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.

REACH-OUT

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.

REACH-OUT

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.

REACH-OUT

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

MeSH Terms

Conditions

Hypertension; Reproductive Behavior

Interventions

Blood Pressure Monitors

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Sphygmomanometers; Diagnostic Equipment; Equipment and Supplies

Study Officials

• Stacy C Bailey, PhD, MPH

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Sadiya Khan, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stacy C Bailey, PhD MPH

CONTACT

(312) 503-3272; stacy-bailey@northwestern.edu

Guisselle Wismer, MPH

CONTACT

guisselle.wismer@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Final submission and release of study data will occur approximately 12 months following the end of data collection. Study data deposited in BioLINCC will be available to the research community in perpetuity or for as long as supported by BioLINCC.
• Access Criteria: All deidentified study data will made available as public use data to the research community in BioLINCC. Users of BioLINCC must register and agree to the Terms of Use, which are designed to protect study participants by limiting data use to scientific research and aggregate statistical reporting, prohibiting attempts to identify study participants, and requiring immediate reporting of and disclosure of study participant identity. Data users also agree not to share or redistribute any data downloads.