HypertensionNCT07540143
The REACH-OUT Trial
A study testing Health literacy-informed patient education materials, BP monitor, brief orientation, and portal tools and The MeDS assessment in people with Hypertension and Reproductive Behavior, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Hypertension, Reproductive Behavior, Primary Health Care
- What is being tested?
- Health literacy-informed patient education materials, BP monitor, brief orientation, and portal tools and The MeDS assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2026to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- not pregnant or within 3 months postpartum
- severe, uncorrectable vision, hearing, or cognitive impairment that would preclude study consent or participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guisselle Wismer, MPH contact
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Guisselle Wismer, MPH, (312) 503-3272, guisselle.wismer@northwestern.edu
About this study
Official title: A Technology-based, Primary Care Strategy to Optimize Blood Pressure Before Pregnancy: The REACH-OUT 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.
Read the detailed description
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.
- Being tested
- Health literacy-informed patient education materials, BP monitor, brief orientation, and portal tools, The MeDS assessment, Patient navigator support
- Medical subject headings
- Hypertension, Reproductive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health literacy-informed patient education materialsOther
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 toolsBehavioural
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 assessmentOther
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 supportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start16 Jun 2026
- Primary completion1 Apr 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stacy C Bailey, Northwestern University
- Investigators
- Stacy C Bailey, PhD, MPH, Principal investigator, Northwestern UniversitySadiya Khan, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540143
- Sponsor's protocol ID
- STU00223582
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-based, Primary Care Strategy to Optimize Blood Pressure Before Pregnancy: The REACH-OUT Trial
- ClinicalTrials.gov ID
- NCT07540143
- Acronym / sponsor ID
- STU00223582
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REACH-OUT | Experimental | Other: Health literacy-informed patient education materials, Behavioral: BP monitor, brief orientation, and portal tools, Other: The MeDS assessment, Other: Patient navigator supportIn 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. |
| 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- not pregnant or within 3 months postpartum
- severe, uncorrectable vision, hearing, or cognitive impairment that would preclude study consent or participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health literacy-informed patient education materialsHealth 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. | Other | REACH-OUT |
| BP monitor, brief orientation, and portal toolsFor 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. | Behavioural | REACH-OUT |
| The MeDS assessmentThe 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. | Other | REACH-OUT |
| Patient navigator supportAny 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. | Other | REACH-OUT |
Primary outcome
Systolic blood pressure
Time frame: 3 months
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.
4 secondary outcomes
Adherence to Refills and Medication Survey (ARMS)
Time frame: 3 months
Biochemical Adherence to Antihypertensive Medications
Time frame: 3 months
Pill Count Adherence to Antihypertensive Medications
Time frame: 3 months
Use of Contraindicated Medications
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guisselle Wismer, MPH contact
Stacy C Bailey, PhD, MPH principal investigator
Northwestern University
Sadiya Khan, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health literacy-informed patient education materials, BP monitor, brief orientation, and portal tools and The MeDS assessment in people with Hypertension and Reproductive Behavior, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacy C Bailey, PhD MPH ((312) 503-3272, stacy-bailey@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.