The REACH-OUT Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorNorthwestern University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Health literacy-informed patient education materials

    Other intervention

    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.

  • BP monitor, brief orientation, and portal tools

    Behavioral

    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 assessment

    Other intervention

    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.

  • Patient navigator support

    Other intervention

    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.

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: REACH-OUTExperimental treatment 4 interventions
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

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.

Time frame
3 months

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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