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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Emergency Department-Initiated Team-Based Care
Other interventionA 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.
Usual Care
Other interventionStandard 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.
Treatment groups
700 Participants
are divided into 2 treatment groupsGroup A: Team-Based CareExperimental treatment 1 intervention
Group B: Usual CareActive comparator 1 intervention
Trial outcomes
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.
Time frame
6 months after randomizationSecondary outcomes
1
Proportion of participants with blood pressure below 130/80 mm Hg
Proportion of participants whose standardized in-person research blood pressure is systolic blood pressure below 130 mm Hg and diastolic blood pressure below 80 mm Hg at each specified visit.
Time frame
6 and 12 months after randomization2
Mean diastolic blood pressure
Diastolic blood pressure in mm Hg measured during the standardized in-person research blood pressure assessment.
Time frame
6 and 12 months after randomization3
Mean arterial pressure
Mean arterial pressure in mm Hg calculated from standardized in-person research blood pressure measurements using the prespecified Statistical Analysis Plan method.
Time frame
6 and 12 months after randomization4
Mean systolic blood pressure at 12 months
Systolic blood pressure in mm Hg measured in person using the same validated device model, cuff-sizing procedures, positioning requirements, and averaging rules used for the baseline and 6-month assessments.
Time frame
12 months after randomizationOther outcomes
1
Antihypertensive prescription completed within 24 hours of ED discharge
Proportion of participants assigned to team-based care for whom a guideline-concordant antihypertensive prescription is completed during the ED visit or within 24 hours after discharge.
Time frame
Within 24 hours after ED discharge2
Remote blood pressure monitoring engagement
Number of valid monitoring periods, completed measurement sessions, and transmitted blood pressure readings during the active intervention period.
Time frame
From randomization through 6 months3
Clinical pharmacist intervention exposure
Number and timing of completed clinical pharmacist contacts and medication-management visits.
Time frame
From randomization through 6 months4
Antihypertensive medication intensification
Number and type of antihypertensive medication initiations, dose increases, medication additions, or regimen consolidations documented during the active intervention period.
Time frame
From randomization through 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Henry Ford Health System
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov
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