A Technology-based, Primary Care Strategy to Optimize Blood Pressure Before Pregnancy: The REACH-OUT Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Northwestern University
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Systolic blood pressure
Study Overview
Brief 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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •not pregnant or within 3 months postpartum
- •severe, uncorrectable vision, hearing, or cognitive impairment that would preclude study consent or participation
Arms & Interventions
REACH-OUT
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.
Intervention: Health literacy-informed patient education materials (Other)
REACH-OUT
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.
Intervention: BP monitor, brief orientation, and portal tools (Behavioral)
REACH-OUT
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.
Intervention: The MeDS assessment (Other)
REACH-OUT
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.
Intervention: Patient navigator support (Other)
Usual Care
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Adherence to Refills and Medication Survey (ARMS)(3 months)
- Biochemical Adherence to Antihypertensive Medications(3 months)
- Pill Count Adherence to Antihypertensive Medications(3 months)
- Use of Contraindicated Medications(3 months)
Investigators
Stacy C Bailey
Professor
Northwestern University