An interventional study of Health literacy-informed patient education materials and BP monitor, brief orientation, and portal tools in Hypertension, Reproductive Behavior and Primary Health Care, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Northwestern University · Not applicable, Interventional, and Health services research
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.
The investigator team has worked with the FQHC partners to co-develop a multicomponent, technology-based strategy to promote the REproductive And Cardiovascular Health Of Underserved Patients with HyperTension (REACH-OUT). Clinicians at participating study sites will receive EHR-based clinical decision support that facilitates review of prescribed antihypertensives (antiHTNs) and contraceptives to identify contraindications and prompts targeted counseling on medication safety, adherence, and BP for young women with hypertension (HTN). For patients in the intervention arm, REACH-OUT also provides [1] educational materials to reinforce clinician counseling, [2] a BP monitor, training, and access to a patient portal-based tool where home BP measures can be recorded, and [3] a brief, portal-based survey to assess antiHTN use and 'phenotype' causes of poor adherence for clinic review. For patients who have difficulty monitoring their BP and adherence at home, [4] a patient navigator will provide tailored support and help troubleshoot any challenges.
This study will test REACH-OUT vs. usual care in a patient-randomized trial. 350 English or Spanish-speaking, non-pregnant women on antiHTN therapy with elevated BP will be enrolled in the study. The study aims are to: 1) Test the effectiveness of REACH-OUT, compared to usual care, to lower systolic BP, improve antiHTN adherence, and reduce use of contraindicated medications within 3 months; 2) Assess the reach, adoption, implementation, maintenance, and costs of REACH-OUT components; and 3) Explore the dose-response effect of REACH-OUT on BP, antiHTN adherence, and use of contraindicated medications over 12 months.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's planned enrollment of 350 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
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.
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.
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.
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.
Time frame: 3 months
Adherence to Refills and Medication Survey (ARMS)
Adherence to antihypertensive medications will be assessed using the 12-item Adherence to Refills and Medications Survey (ARMS-12). Each item is scored from 1 (none of the time) to 4 (all of the time), with total scores ranging from 12 to 48. Lower scores indicate better adherence, while higher scores reflect poorer adherence.
Time frame: 3 months
Biochemical Adherence to Antihypertensive Medications
Presence of prescribed antihypertensive medications or their metabolites will be assessed via saliva, blood, or urine using volumetric absorptive microsampling (VAMS) devices. Participants will collect small-volume samples remotely using provided kits and return them by mail. Samples will be stored at -20°C or -80°C until analysis. Liquid chromatography-tandem mass spectrometry (LCMS) will be used to detect antihypertensive drug compounds.
Time frame: 3 months
Pill Count Adherence to Antihypertensive Medications
Adherence will be measured using pill counts. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication. Adherence will be analyzed dichotomously, with PT/PP ≥ 80% considered adherent .
Time frame: 3 months
Use of Contraindicated Medications
Use of contraindicated medications, including (a) teratogenic antihypertensive drugs for participants who are pregnant or planning pregnancy, and (b) combined hormonal contraceptives that may increase blood pressure.
Time frame: 3 months
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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