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Emergency Department-Initiated Team-Based Care for Severe Hypertension

Emergency Department-Initiated, Team-Based Care to Reduce Severely Elevated Blood Pressure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be followed for 12 months for blood pressure, emergency care use, cardiovascular events, safety, quality of life, healthcare utilization, and economic outcomes."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether care from a team started in the emergency department lowers blood pressure better than usual care. It is for adults with very high blood pressure who can safely go home and have not had steady blood pressure care. Team care includes blood pressure medicine, home monitoring, and remote support.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 85.
  • At least two blood pressure readings in the emergency department with a top number of 180 or higher, or a bottom number of 110 or higher.
  • Blood pressure care has not been steady. Examples include repeated urgent visits, no regular doctor or follow-up, or no medicine changes despite high readings.
  • If you have no diagnosed high blood pressure, at least two past healthcare visits with readings above 160/90 can show this pattern of care.
  • Able to speak English fluently.
  • Your doctor expects you to go home, with no blood pressure emergency, sudden organ damage, or other problem needing hospital care or different immediate treatment.

Who can't join

  • A blood pressure emergency, sudden organ damage, or another problem needing hospital care or an urgent procedure.
  • Unable to explain the study back to the team to show you understand it, or a serious mental health problem, dementia, or another condition that makes joining unsafe or impractical.
  • Pregnant or planning pregnancy in the next year.
  • High blood pressure mainly caused by uncontrolled pain or anxiety; you may be checked again after treatment. Also excluded if it is linked to another medical cause, medicine, drugs, or stimulants and needs different care.
  • Blood pressure below 140/90 when measured for the study, taking four or more blood pressure medicines, or unable or unwilling to check blood pressure at home as required.
  • Stage 3B kidney disease or a kidney filtering rate below 45; heart failure with a pumping measure below 40%; or any past transplant.
  • Drinking 21 or more alcoholic drinks a week for men, or 14 or more for women.
  • Any other condition the study doctor believes could harm your safety, your ability to give informed consent, or the accuracy of study results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age 18 through 85 years. 2. Two or more emergency department blood pressure measurements with systolic blood pressure \>=180 mm Hg or diastolic blood pressure \>=110 mm Hg. 3. 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. 4. Verbal fluency in English. 5. 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. Exclusion Criteria: 1. 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. 2. Unable to verbalize comprehension of the study or complete the teach-back consent process. 3. Pregnant or planning to become pregnant during the next year. 4. 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. 5. Standardized research blood pressure below 140/90 mm Hg. 6. Stage 3B chronic kidney disease or estimated glomerular filtration rate below 45 mL/min/1.73 m2. 7. Severe blood pressure elevation thought to be due to secondary hypertension, medication effect, or drug or stimulant use requiring a different management pathway. 8. Excessive alcohol use, defined as 21 or more drinks per week for men or 14 or more drinks per week for women. 9. Systolic heart failure with known left ventricular ejection fraction below 40%. 10. Prior transplant of any type. 11. Major psychiatric disorder, dementia, or another condition that in the investigator's judgment would make participation unsafe or impractical. 12. Inability or unwillingness to perform home blood pressure monitoring according to protocol. 13. Currently prescribed four or more antihypertensive medications. 14. Any other condition that, in the investigator's judgment, would compromise participant safety, informed consent, or data integrity.

Study sites (4)

MI