Emergency Department-Initiated Team-Based Care for Severe Hypertension

NCT07777237 | Not Yet Recruiting DMC

• 2 other identifiers: EDIT-SBP-0011R01MD020595-01A1
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 4

Brief 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

Severe Hypertension; Hypertension

Keywords

Emergency Department; Team-Based Care; Remote Patient Monitoring; Clinical Pharmacist; Community Health Worker; Blood Pressure Control; Severe Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean systolic blood pressure at 6 months

  Systolic blood pressure in mm Hg measured in person by trained outcome assessors masked to treatment assignment, using a validated automated device and a standardized seated measurement protocol. The mean of prespecified valid readings will define the 6-month value.

  6 months after randomization

Secondary Outcomes (17)

• Proportion of participants with blood pressure below 130/80 mm Hg

  6 and 12 months after randomization

• Mean diastolic blood pressure

  6 and 12 months after randomization

• Mean arterial pressure

  6 and 12 months after randomization

• Mean systolic blood pressure at 12 months

  12 months after randomization

• Proportional change in systolic blood pressure from baseline

  6 and 12 months after randomization

Other Outcomes (6)

• Antihypertensive prescription completed within 24 hours of ED discharge

  Within 24 hours after ED discharge

• Remote blood pressure monitoring engagement

  From randomization through 6 months

• Clinical pharmacist intervention exposure

  From randomization through 6 months

Study Arms (2)

Team-Based Care

EXPERIMENTAL

Participants receive protocol-directed, guideline-concordant outpatient hypertension care initiated from the ED. A study physician or clinical pharmacist reviews eligibility, medications, allergies, comorbidities, laboratory values, and pregnancy status when applicable and sends an antihypertensive prescription during the ED visit or within 24 hours after discharge when clinically appropriate. Participants receive a validated cellular home blood pressure monitor and perform home monitoring through month 6. Clinical pharmacists conduct an initial virtual visit within 7-14 days and approximately monthly visits through month 6, adjusting medications based on blood pressure, symptoms, adherence, and laboratory results. Community health worker/patient navigator support addresses medication access, appointments, primary care linkage, transportation, insurance, social needs, and monitoring barriers.

Other: Emergency Department-Initiated Team-Based Care

Usual Care

ACTIVE COMPARATOR

Participants receive standard ED evaluation, discharge instructions, prescriptions if independently ordered by treating clinicians, and outpatient follow-up recommendations. Hypertension management by primary care or specialty clinicians occurs at clinician and participant discretion. The study does not provide protocolized pharmacist medication management or study remote patient monitoring during the first 6 months. Clinically indicated care is not withheld. Research contacts and outcome assessments are performed, and assistance addressing care-access barriers is available as described in the protocol.

Other: Usual Care

Interventions

Emergency Department-Initiated Team-Based Care OTHER

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.

Also known as: Team-Based Care, TBC

Team-Based Care

Usual Care OTHER

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.

Also known as: Standard Care

Usual Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Standardized research blood pressure below 140/90 mm Hg.
• 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.
• Excessive alcohol use, defined as 21 or more drinks per week for men or 14 or more drinks per week for women.
• Systolic heart failure with known left ventricular ejection fraction below 40%.
• Prior transplant of any type.
• Major psychiatric disorder, dementia, or another condition that in the investigator's judgment would make participation unsafe or impractical.
• Inability or unwillingness to perform home blood pressure monitoring according to protocol.
• Currently prescribed four or more antihypertensive medications.
• Any other condition that, in the investigator's judgment, would compromise participant safety, informed consent, or data integrity.

Sponsors & Collaborators

• Henry Ford Health System: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (4)

Henry Ford Medical Center - Fairlane Emergency Department

Dearborn, Michigan, 48126, United States

Location

Henry Ford Hospital Emergency Department

Detroit, Michigan, 48202, United States

Location

Henry Ford St. John Hospital Emergency Department

Detroit, Michigan, 48236, United States

Location

Henry Ford Wyandotte Hospital Emergency Department

Wyandotte, Michigan, 48192, United States

Location

MeSH Terms

Conditions

Hypertension; Emergencies

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Joseph Miller, MD, MS

  Henry Ford Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Miller, MD, MS

CONTACT

313-404-9110; jmiller6@hfhs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and intervention personnel are not masked because the remote monitoring and pharmacist-care components are visible. Primary blood pressure outcome assessors are masked to assignment and do not deliver intervention activities. Major adverse cardiovascular event adjudicators review de-identified event packets without assignment whenever feasible, and primary analysts use masked treatment labels until prespecified models and data-quality checks are complete.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized 1:1 to a 6-month ED-initiated team-based hypertension care strategy or usual care. All participants are followed for 12 months.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 20, 2026
• Study Start (Estimated): October 30, 2026
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: After completion of the primary analyses and publication of the primary results, for the period required by the NIH-approved Data Management and Sharing Plan.
• Access Criteria: Access will be provided through a controlled-access NIH-approved repository. Requests will be reviewed under the repository's access procedures and applicable institutional requirements and must be consistent with participant consent, institutional certification, and approved data-use terms.

Locations

US (4)