Emergency Department-Initiated Team-Based Care for Severe Hypertension
(EDIT-SBP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
EDIT-SBP is a pragmatic, randomized clinical trial evaluating whether an emergency department (ED)-initiated team-based care program improves blood pressure control among adults discharged from the ED after severe hypertension without hypertensive emergency. Participants will be assigned 1:1 to team-based care or usual care. Team-based care includes guideline-based antihypertensive prescribing during the ED visit or within 24 hours after discharge, a cellular home blood pressure monitor, structured remote monitoring, virtual clinical pharmacist medication management through 6 months, and community health worker/patient navigator support. Usual care consists of standard ED discharge care and outpatient follow-up at the treating clinician's discretion. The primary outcome is mean systolic blood pressure measured in person at 6 months by blinded outcome assessors. Participants will be followed for 12 months for blood pressure, emergency care use, cardiovascular events, safety, quality of life, healthcare utilization, and economic outcomes.
Who Is on the Research Team?
Joseph Miller, MD, MS
Principal Investigator
Henry Ford Health
Are You a Good Fit for This Trial?
What Are the Treatments Tested in This Trial?
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants receive protocol-directed, guideline-concordant outpatient hypertension care initiated from the ED. A study physician or clinical pharmacist reviews eligibility, medications, allergies, comorbidities, laboratory values, and pregnancy status when applicable and sends an antihypertensive prescription during the ED visit or within 24 hours after discharge when clinically appropriate. Participants receive a validated cellular home blood pressure monitor and perform home monitoring through month 6. Clinical pharmacists conduct an initial virtual visit within 7-14 days and approximately monthly visits through month 6, adjusting medications based on blood pressure, symptoms, adherence, and laboratory results. Community health worker/patient navigator support addresses medication access, appointments, primary care linkage, transportation, insurance, social needs, and monitoring barriers.
Participants receive standard ED evaluation, discharge instructions, prescriptions if independently ordered by treating clinicians, and outpatient follow-up recommendations. Hypertension management by primary care or specialty clinicians occurs at clinician and participant discretion. The study does not provide protocolized pharmacist medication management or study remote patient monitoring during the first 6 months. Clinically indicated care is not withheld. Research contacts and outcome assessments are performed, and assistance addressing care-access barriers is available as described in the protocol.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
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