About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
biologically female
age 18-44
English or Spanish-speaking
prescribed an antiHTN
Disqualifiers
not pregnant or within 3 months postpartum
severe, uncorrectable vision, hearing, or cognitive impairment that would preclude study consent or participation
Trial design
Parallel
Treatments tested in this trial
Health literacy-informed patient education materials
Other interventionHealth 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
BehavioralFor 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 assessment
Other interventionThe 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.
Patient navigator support
Other interventionAny 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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 .
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.
Sponsors and contacts
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