Severe HypertensionEDIT-SBPNCT07777237
Emergency Department-Initiated Team-Based Care for Severe Hypertension
A study testing Emergency Department-Initiated Team-Based Care in people with Severe Hypertension and Hypertension, run by Henry Ford Health System at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Severe Hypertension, Hypertension
- What is being tested?
- Emergency Department-Initiated Team-Based Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Oct 2026to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Henry Ford Medical Center - Fairlane Emergency Department
Dearborn, Michigan, 48126
Henry Ford Hospital Emergency Department
Detroit, Michigan, 48202
Henry Ford St. John Hospital Emergency Department
Detroit, Michigan, 48236
Henry Ford Wyandotte Hospital Emergency Department
Wyandotte, Michigan, 48192
About this study
Official title: Emergency Department-Initiated, Team-Based Care to Reduce Severely Elevated Blood Pressure
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.
Read the detailed description
Severe hypertension is common in emergency departments and identifies patients at high risk for persistent uncontrolled blood pressure, recurrent emergency care, and cardiovascular events after discharge. Current ED care appropriately emphasizes identification of hypertensive emergencies, but patients without acute target-organ injury are often discharged without a standardized pathway for medication initiation or titration, home blood pressure monitoring, or connection to longitudinal hypertension care.
EDIT-SBP is a pragmatic, single-blind, randomized, parallel-assignment clinical trial conducted at participating Henry Ford Health emergency departments. Adults aged 18 to 85 years with at least two ED blood pressure readings of systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 110 mm Hg, a history of episodic or fragmented hypertension management, and an anticipated ED discharge will be considered. Patients with hypertensive emergency, acute target-organ injury requiring inpatient care, or other protocol-defined safety exclusions will not be enrolled. Seven hundred participants will be randomized 1:1 after consent and baseline assessments.
Participants assigned to team-based care will receive guideline-concordant antihypertensive prescribing by a study physician or clinical pharmacist during the ED visit or within 24 hours after discharge when clinically appropriate; a validated cellular home blood pressure monitor; structured home monitoring; an initial virtual clinical pharmacist visit within 7 to 14 days and approximately monthly medication-management visits through month 6; and community health worker/patient navigator support for medication access, appointments, primary care linkage, insurance, transportation, social needs, and monitoring barriers. Participants assigned to usual care will receive standard ED evaluation, discharge instructions, prescriptions if independently ordered by treating clinicians, and outpatient follow-up recommendations. Clinically indicated care is not withheld in either arm, and care-access support described in the protocol is available when needed.
The primary outcome is mean systolic blood pressure at 6 months, measured in person using a standardized protocol by outcome assessors masked to treatment assignment. Secondary outcomes include blood pressure control and other blood pressure measures at 6 and 12 months, emergency department encounters, hospitalizations, major adverse cardiovascular events, adverse events, medication adherence, health-related quality of life, healthcare utilization, and economic outcomes through 12 months. An independent data and safety monitoring board will oversee trial conduct and safety.
- Conditions
- Severe Hypertension, Hypertension
- Being tested
- Emergency Department-Initiated Team-Based Care, Usual Care
- Keywords
- Emergency Department, Team-Based Care, Remote Patient Monitoring, Clinical Pharmacist, Community Health Worker, Blood Pressure Control, Severe Hypertension
- Medical subject headings
- Hypertension, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Department-Initiated Team-Based CareOther
Also called Team-Based Care, TBC
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.
Usual CareOther
Also called Standard Care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomization
Secondary outcomes (17)
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.
Measured: 6 and 12 months after randomization
Mean diastolic blood pressure
Diastolic blood pressure in mm Hg measured during the standardized in-person research blood pressure assessment.
Measured: 6 and 12 months after randomization
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.
Measured: 6 and 12 months after randomization
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.
Measured: 12 months after randomization
Proportional change in systolic blood pressure from baseline
Participant-level proportional change in standardized systolic blood pressure from the baseline research value to each specified follow-up visit.
Measured: 6 and 12 months after randomization
Proportional change in mean arterial pressure from baseline
Participant-level proportional change in mean arterial pressure from baseline to each specified follow-up visit.
Measured: 6 and 12 months after randomization
Number of all-cause emergency department encounters
Count of all-cause ED encounters identified through participant report, electronic health records, health information exchange data, and billing or encounter data.
Measured: From randomization through 12 months
Number of hypertension-related emergency department encounters
Count of ED encounters classified as hypertension related using prespecified definitions in the Statistical Analysis Plan and endpoint adjudication materials.
Measured: From randomization through 12 months
Number of all-cause hospitalizations
Count of inpatient hospitalizations identified through participant report, electronic health records, health information exchange data, and billing or encounter data.
Measured: From randomization through 12 months
Time to first major adverse cardiovascular event
Time to the first occurrence of acute heart failure or pulmonary edema requiring ED or hospital care, acute myocardial infarction or acute coronary syndrome, ischemic or hemorrhagic stroke, urgent coronary revascularization, or all-cause death. Potential events will undergo blinded physician adjudication.
Measured: From randomization through 12 months
Incidence of adverse events, serious adverse events, and adverse events of special interest
Number and proportion of participants with adverse events, serious adverse events, and prespecified adverse events of special interest, including symptomatic hypotension, syncope or presyncope, falls, severe dizziness, acute kidney injury or clinically significant worsening of kidney function, electrolyte abnormalities, angioedema or allergic reaction, severe edema leading to medication change, medication error, pregnancy, and clinically important device malfunction.
Measured: From informed consent through 30 days after the final study contact, up to approximately 13 months
Change in 12-item Short Form Health Survey score
Change in SF-12 physical and mental component summary scores from baseline to the 12-month assessment.
Measured: Baseline to 12 months after randomization
Medication adherence measured by the Adherence to Refills and Medications Scale
ARMS total score and change from baseline, calculated according to the instrument scoring method. Lower scores generally indicate better adherence.
Measured: Baseline, 6 months, and 12 months after randomization
Change in estimated 10-year cardiovascular disease risk
Change in the prespecified 10-year ASCVD and/or PREVENT risk estimate among participants with the variables required for calculation, using methods specified in the Statistical Analysis Plan.
Measured: Baseline to 12 months after randomization
Total healthcare utilization costs
Total healthcare utilization costs derived from encounter, billing, reimbursement, and pharmacy data using the prespecified economic evaluation methods.
Measured: From randomization through 12 months
Quality-adjusted life-years
Quality-adjusted life-years estimated from SF-12-derived health utility values and survival during follow-up, using methods specified in the health economic analysis plan.
Measured: From randomization through 12 months
Incremental cost-effectiveness ratio for team-based care versus usual care
Incremental cost per quality-adjusted life-year gained for team-based care compared with usual care, with uncertainty estimated using prespecified health economic methods.
Measured: From randomization through 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe HypertensionStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Joseph Miller, MD, MS, Principal investigator, Henry Ford Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777237
- Sponsor's protocol ID
- EDIT-SBP-001
- Other IDs
- 1R01MD020595-01A1
- Acronym
- EDIT-SBP
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data and associated metadata will be prepared for controlled-access sharing through ScHARe or another NIH-approved repository, consistent with the informed consent, institutional certification, the NIH Data Management and Sharing Plan, and applicable privacy protections.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department-Initiated, Team-Based Care to Reduce Severely Elevated Blood Pressure
- ClinicalTrials.gov ID
- NCT07777237
- Acronym / sponsor ID
- EDIT-SBP / EDIT-SBP-001
- Conditions
- Severe Hypertension, Hypertension
- Keywords
- Emergency Department, Team-Based Care, Remote Patient Monitoring, Clinical Pharmacist, Community Health Worker, Blood Pressure Control, Severe Hypertension
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Severe hypertension is common in emergency departments and identifies patients at high risk for persistent uncontrolled blood pressure, recurrent emergency care, and cardiovascular events after discharge. Current ED care appropriately emphasizes identification of hypertensive emergencies, but patients without acute target-organ injury are often discharged without a standardized pathway for medication initiation or titration, home blood pressure monitoring, or connection to longitudinal hypertension care.
EDIT-SBP is a pragmatic, single-blind, randomized, parallel-assignment clinical trial conducted at participating Henry Ford Health emergency departments. Adults aged 18 to 85 years with at least two ED blood pressure readings of systolic blood pressure at least 180 mm Hg or diastolic blood pressure at least 110 mm Hg, a history of episodic or fragmented hypertension management, and an anticipated ED discharge will be considered. Patients with hypertensive emergency, acute target-organ injury requiring inpatient care, or other protocol-defined safety exclusions will not be enrolled. Seven hundred participants will be randomized 1:1 after consent and baseline assessments.
Participants assigned to team-based care will receive guideline-concordant antihypertensive prescribing by a study physician or clinical pharmacist during the ED visit or within 24 hours after discharge when clinically appropriate; a validated cellular home blood pressure monitor; structured home monitoring; an initial virtual clinical pharmacist visit within 7 to 14 days and approximately monthly medication-management visits through month 6; and community health worker/patient navigator support for medication access, appointments, primary care linkage, insurance, transportation, social needs, and monitoring barriers. Participants assigned to usual care will receive standard ED evaluation, discharge instructions, prescriptions if independently ordered by treating clinicians, and outpatient follow-up recommendations. Clinically indicated care is not withheld in either arm, and care-access support described in the protocol is available when needed.
The primary outcome is mean systolic blood pressure at 6 months, measured in person using a standardized protocol by outcome assessors masked to treatment assignment. Secondary outcomes include blood pressure control and other blood pressure measures at 6 and 12 months, emergency department encounters, hospitalizations, major adverse cardiovascular events, adverse events, medication adherence, health-related quality of life, healthcare utilization, and economic outcomes through 12 months. An independent data and safety monitoring board will oversee trial conduct and safety.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Team-Based Care | Experimental | Other: Emergency Department-Initiated Team-Based CareParticipants 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. |
| Usual Care | Active comparator | Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency Department-Initiated Team-Based CareAlso: Team-Based Care, TBCA 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. | Other | Team-Based Care |
| Usual CareAlso: Standard CareStandard 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. | Other | Usual Care |
Primary outcome
Mean systolic blood pressure at 6 months
Time frame: 6 months after randomization
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.
17 secondary outcomes
Proportion of participants with blood pressure below 130/80 mm Hg
Time frame: 6 and 12 months after randomization
Mean diastolic blood pressure
Time frame: 6 and 12 months after randomization
Mean arterial pressure
Time frame: 6 and 12 months after randomization
Mean systolic blood pressure at 12 months
Time frame: 12 months after randomization
Proportional change in systolic blood pressure from baseline
Time frame: 6 and 12 months after randomization
Proportional change in mean arterial pressure from baseline
Time frame: 6 and 12 months after randomization
Number of all-cause emergency department encounters
Time frame: From randomization through 12 months
Number of hypertension-related emergency department encounters
Time frame: From randomization through 12 months
Number of all-cause hospitalizations
Time frame: From randomization through 12 months
Time to first major adverse cardiovascular event
Time frame: From randomization through 12 months
Incidence of adverse events, serious adverse events, and adverse events of special interest
Time frame: From informed consent through 30 days after the final study contact, up to approximately 13 months
Change in 12-item Short Form Health Survey score
Time frame: Baseline to 12 months after randomization
Medication adherence measured by the Adherence to Refills and Medications Scale
Time frame: Baseline, 6 months, and 12 months after randomization
Change in estimated 10-year cardiovascular disease risk
Time frame: Baseline to 12 months after randomization
Total healthcare utilization costs
Time frame: From randomization through 12 months
Quality-adjusted life-years
Time frame: From randomization through 12 months
Incremental cost-effectiveness ratio for team-based care versus usual care
Time frame: From randomization through 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data and associated metadata will be prepared for controlled-access sharing through ScHARe or another NIH-approved repository, consistent with the informed consent, institutional certification, the NIH Data Management and Sharing Plan, and applicable privacy protections.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Miller, MD, MS principal investigator
Henry Ford Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Department-Initiated Team-Based Care in people with Severe Hypertension and Hypertension, run by Henry Ford Health System at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Miller, MD, MS (313-404-9110, jmiller6@hfhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean systolic blood pressure at 6 months (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.