Emergency Department-Initiated Team-Based Care for Severe Hypertension

Conditions

• Hypertension
• Severe Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Emergency Department-Initiated Team-Based Care — OTHER
  A multicomponent care-delivery strategy that combines prompt guideline-based antihypertensive prescribing, remote blood pressure monitoring, clinical pharmacist-led virtual medication management, and community health worker/patient navigator support during the 6-month active intervention period.
• Usual Care — OTHER
  Standard ED discharge care and outpatient hypertension follow-up at clinician and participant discretion, without protocolized study pharmacist medication management or study remote monitoring during the first 6 months.

Study Details

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.

Key Dates

First listed

Aug 20, 2026

Start date

Oct 30, 2026

Status verified

Aug 2026

Primary completion

Dec 30, 2030

Completion

Jun 30, 2031

Study Design

Enrollment

700 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Team-Based Care
  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.
• Active Comparator: Usual Care
  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.

Primary Outcome Measure

Mean systolic blood pressure at 6 months [ Time Frame: 6 months after randomization ]

Central Contacts

• Joseph Miller, MD, MS
  313-404-9110
  [email protected]

Locations (4)

Find similar trials in Dearborn, MI

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