NCT07777237Not yet recruiting
Emergency Department-Initiated Team-Based Care for Severe Hypertension
Emergency Department-Initiated, Team-Based Care to Reduce Severely Elevated Blood Pressure
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- First submitted
- 14 Aug 2026
- Start date
- 30 Oct 2026
- Primary completion date
- 30 Dec 2030
- Lead sponsor
- Henry Ford Health System
- Diseases
- High blood pressure
- NCT number
- NCT07777237
What you commit to
- Study type: Interventional
- Planned participants: 700
- From 30 Oct 2026 to the primary completion date, 30 Dec 2030
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior transplant of any type.
- Currently prescribed four or more antihypertensive medications.
Other illness
- 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.
- Stage 3B chronic kidney disease or estimated glomerular filtration rate below 45 mL/min/1.73 m2.
- Severe blood pressure elevation thought to be due to secondary hypertension, medication effect, or drug or stimulant use requiring a different management pathway.
- Major psychiatric disorder, dementia, or another condition that in the investigator's judgment would make participation unsafe or impractical.
- Any other condition that, in the investigator's judgment, would compromise participant safety, informed consent, or data integrity.
Lab values
- Systolic heart failure with known left ventricular ejection fraction below 40%.
Other
- 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.
- Standardized research blood pressure below 140/90 mm Hg.
- Excessive alcohol use, defined as 21 or more drinks per week for men or 14 or more drinks per week for women.
- Inability or unwillingness to perform home blood pressure monitoring according to protocol.
Who the study is looking for
- 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.
- The treating clinician expects discharge rather than inpatient admission and does not identify hypertensive emergency syndrome, acute target-organ injury requiring inpatient care, or another condition requiring admission or alternative immediate management.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Henry Ford Medical Center - Fairlane Emergency Department Coordinator of this site? Confirm its status | Dearborn | United States | Unknown status |
| Henry Ford Hospital Emergency Department Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Henry Ford St. John Hospital Emergency Department Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Henry Ford Wyandotte Hospital Emergency Department Coordinator of this site? Confirm its status | Wyandotte | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.