The REACH-OUT Trial

Purpose

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.

Conditions

  • Hypertension
  • Reproductive Behavior
  • Primary Health Care
  • Electronic Health Record

Eligibility

Eligible Ages
Between 18 Years and 44 Years
Eligible 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Other: Health literacy-informed patient education materials
    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.
  • Behavioral: BP monitor, brief orientation, and portal tools
    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.
  • Other: The MeDS assessment
    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.
  • Other: Patient navigator support
    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.
No Intervention
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.

Recruiting Locations

Northwestern University
Chicago, Illinois 60611
Contact:
Guisselle Wismer, MPH
(312) 503-3272
guisselle.wismer@northwestern.edu

More Details

Status
Recruiting
Sponsor
Northwestern University

Study Contact

Stacy C Bailey, PhD MPH
(312) 503-3272
stacy-bailey@northwestern.edu

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.