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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stacy C Bailey, PhD MPH | Contact | (312) 503-3272 | stacy-bailey@northwestern.edu | |
| Guisselle Wismer, MPH | Contact | guisselle.wismer@northwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stacy C Bailey, PhD, MPH | Northwestern University | Principal Investigator |
| Sadiya Khan, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Recruiting | Chicago | Illinois | 60611 | United States |
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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.
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.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D043762 | Reproductive Behavior |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015924 | Blood Pressure Monitors |
| ID | Term |
|---|---|
| D019722 | Sphygmomanometers |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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| 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. |
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| 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. |
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| 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. |
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| 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. | 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 . | 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. | 3 months |