Emergency Department-Initiated, Team-Based Care to Reduce Severely Elevated Blood Pressure
Emergency Department-Initiated, Team-Based Care to Reduce Severely Elevated Blood Pressure
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.
Inclusion Criteria:
Exclusion Criteria:
jmiller6@hfhs.org313-404-9110
Severe hypertension is common in emergency departments and identifies patients at high risk for persistent uncontrolled blood pressure, recurrent emergency care, and cardiovascular events after discharge. Current ED care appropriately emphasizes identification of hypertensive emergencies, but patients without acute target-organ injury are often discharged without a standardized pathway for medication initiation or titration, home blood pressure monitoring, or connection to longitudinal hypertension care.
EDIT-SBP is a pragmatic, single-blind, randomized, parallel-assignment clinical trial conducted at participating Henry Ford Health emergency departments. Adults aged 18 to 85 years with at least two ED blood pressure readings of systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 110 mm Hg, a history of episodic or fragmented hypertension management, and an anticipated ED discharge will be considered. Patients with hypertensive emergency, acute target-organ injury requiring inpatient care, or other protocol-defined safety exclusions will not be enrolled. Seven hundred participants will be randomized 1:1 after consent and baseline assessments.
Participants assigned to team-based care will receive guideline-concordant antihypertensive prescribing by a study physician or clinical pharmacist during the ED visit or within 24 hours after discharge when clinically appropriate; a validated cellular home blood pressure monitor; structured home monitoring; an initial virtual clinical pharmacist visit within 7 to 14 days and approximately monthly medication-management visits through month 6; and community health worker/patient navigator support for medication access, appointments, primary care linkage, insurance, transportation, social needs, and monitoring barriers. Participants assigned to usual care will receive standard ED evaluation, discharge instructions, prescriptions if independently ordered by treating clinicians, and outpatient follow-up recommendations. Clinically indicated care is not withheld in either arm, and care-access support described in the protocol is available when needed.
The primary outcome is mean systolic blood pressure at 6 months, measured in person using a standardized protocol by outcome assessors masked to treatment assignment. Secondary outcomes include blood pressure control and other blood pressure measures at 6 and 12 months, emergency department encounters, hospitalizations, major adverse cardiovascular events, adverse events, medication adherence, health-related quality of life, healthcare utilization, and economic outcomes through 12 months. An independent data and safety monitoring board will oversee trial conduct and safety.