[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652679":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":81,"collaborators":83,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":41,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":114,"whyStopped":41,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Henry Ford Health System","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002Fpatient navigator support addresses medication access, appointments, primary care linkage, transportation, insurance, social needs, and monitoring barriers.",[13],"Other: Emergency Department-Initiated Team-Based Care",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: Usual Care",[21,27],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Emergency Department-Initiated Team-Based Care","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\u002Fpatient navigator support during the 6-month active intervention period.",[9],[9,26],"TBC",{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[15],[31],"Standard Care",[33],{"name":34,"affiliation":35,"role":36},"Joseph Miller, MD, MS","Henry Ford Health","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","313-404-9110",null,"jmiller6@hfhs.org",[44,57,66,72],{"facility":45,"status":41,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":41},"Henry Ford Medical Center - Fairlane Emergency Department","Dearborn","Michigan","48126","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-83.17631,42.32226,{"lat":55,"lon":54},{"facility":58,"status":41,"city":59,"state":47,"zip":60,"country":49,"countryCode":50,"cosmosGeoPoint":61,"geoPoint":65,"contacts":41},"Henry Ford Hospital Emergency Department","Detroit","48202",{"type":52,"coordinates":62},[63,64],-83.04575,42.33143,{"lat":64,"lon":63},{"facility":67,"status":41,"city":59,"state":47,"zip":68,"country":49,"countryCode":50,"cosmosGeoPoint":69,"geoPoint":71,"contacts":41},"Henry Ford St. John Hospital Emergency Department","48236",{"type":52,"coordinates":70},[63,64],{"lat":64,"lon":63},{"facility":73,"status":41,"city":74,"state":47,"zip":75,"country":49,"countryCode":50,"cosmosGeoPoint":76,"geoPoint":80,"contacts":41},"Henry Ford Wyandotte Hospital Emergency Department","Wyandotte","48192",{"type":52,"coordinates":77},[78,79],-83.14992,42.21421,{"lat":79,"lon":78},{"type":82,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[84],{"name":85,"class":86},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100652679","emergency-department-initiated-team-based-care-for-severe-hypertension-100652679",false,"NCT07777237","Emergency Department-Initiated Team-Based Care for Severe Hypertension","Emergency Department-Initiated, Team-Based Care to Reduce Severely Elevated Blood Pressure","EDIT-SBP","Inclusion Criteria:\n\n1. Age 18 through 85 years.\n2. Two or more emergency department blood pressure measurements with systolic blood pressure \\>=180 mm Hg or diastolic blood pressure \\>=110 mm Hg.\n3. 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\u002F90 mm Hg.\n4. Verbal fluency in English.\n5. 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.\n\nExclusion Criteria:\n\n1. 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.\n2. Unable to verbalize comprehension of the study or complete the teach-back consent process.\n3. Pregnant or planning to become pregnant during the next year.\n4. 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.\n5. Standardized research blood pressure below 140\u002F90 mm Hg.\n6. Stage 3B chronic kidney disease or estimated glomerular filtration rate below 45 mL\u002Fmin\u002F1.73 m2.\n7. Severe blood pressure elevation thought to be due to secondary hypertension, medication effect, or drug or stimulant use requiring a different management pathway.\n8. Excessive alcohol use, defined as 21 or more drinks per week for men or 14 or more drinks per week for women.\n9. Systolic heart failure with known left ventricular ejection fraction below 40%.\n10. Prior transplant of any type.\n11. Major psychiatric disorder, dementia, or another condition that in the investigator's judgment would make participation unsafe or impractical.\n12. Inability or unwillingness to perform home blood pressure monitoring according to protocol.\n13. Currently prescribed four or more antihypertensive medications.\n14. Any other condition that, in the investigator's judgment, would compromise participant safety, informed consent, or data integrity.","ALL","18 Years","85 Years",{"count":99,"type":100},700,"ESTIMATED","INTERVENTIONAL",[103],"NA","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\u002Fpatient 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.",[106,107],"Severe Hypertension","Hypertension",[109,9,110,111,112,113,106],"Emergency Department","Remote Patient Monitoring","Clinical Pharmacist","Community Health Worker","Blood Pressure Control","NOT_YET_RECRUITING","2026-08-14",{"date":117,"type":118},"2026-08-20","ACTUAL",{"date":120,"type":100},"2026-10-30",{"date":122,"type":100},"2031-06-30",{"name":5,"class":6},4]