Emergency Department-Initiated Team-Based Care for Severe Hypertension

NCT07777237 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-08-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Emergency Department-Initiated Team-Based Care

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.

OTHER

Usual Care

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.

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH
  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Joseph Miller, MD, MS · Henry Ford Health

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-30
Primary Completion
2030-12-30
Completion
2031-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777237 on ClinicalTrials.gov