Emergency Department-Initiated Team-Based Care for Severe Hypertension
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorHenry Ford Health System
About 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.
Eligibility criteria
Qualifiers
Age 18 through 85 years.
Two or more emergency department blood pressure measurements with systolic blood pressure >=180 mm Hg or diastolic blood pressure >=110 mm Hg.
History of episodic hypertension management, defined as evidence that hypertension care has been intermittent, fragmented, or primarily reactive rather than supported by stable longitudinal outpatient management. This includes one or more of the following: recurrent ED or urgent care visits for elevated blood pressure or blood-pressure-related concerns; no established primary care clinician or usual source of care; no documented outpatient hypertension follow-up; no recent antihypertensive medication initiation, adjustment, or titration despite persistently elevated blood pressure; or, for a person without a formal hypertension diagnosis, at least two prior healthcare encounters with blood pressure >160/90 mm Hg.
Verbal fluency in English.
Disqualifiers
Hypertensive emergency syndrome, acute target-organ injury requiring inpatient care, an acute cardiovascular, neurologic, or renal condition requiring immediate inpatient or procedural management, or any other need for hospital admission.
Unable to verbalize comprehension of the study or complete the teach-back consent process.
Pregnant or planning to become pregnant during the next year.
Severe blood pressure elevation suspected by the treating clinician to be primarily due to uncontrolled pain or anxiety; the person may be reassessed after symptom control.
Trial design
Treatments tested in this trial
- Emergency Department-Initiated Team-Based Care
- Usual Care
Treatment groups
700 Participants
are divided into 2 treatment groupsSponsors and collaborators
Henry Ford Health System
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov