Emergency Department-Initiated, Team-Based Care to Reduce Severely Elevated Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 700
- 试验地点
- 4
- 主要终点
- Mean systolic blood pressure at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 m
- •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.
结局指标
主要结局
Mean systolic blood pressure at 6 months
时间窗: 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.
次要结局
- Proportional change in mean arterial pressure from baseline(6 and 12 months after randomization)
- 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)
- Number of all-cause emergency department encounters(From randomization through 12 months)
- Number of hypertension-related emergency department encounters(From randomization through 12 months)
- Number of all-cause hospitalizations(From randomization through 12 months)
- Time to first major adverse cardiovascular event(From randomization through 12 months)
- Incidence of adverse events, serious adverse events, and adverse events of special interest(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(Baseline to 12 months after randomization)
- Medication adherence measured by the Adherence to Refills and Medications Scale(Baseline, 6 months, and 12 months after randomization)
- Change in estimated 10-year cardiovascular disease risk(Baseline to 12 months after randomization)
- Total healthcare utilization costs(From randomization through 12 months)
- Quality-adjusted life-years(From randomization through 12 months)
- Incremental cost-effectiveness ratio for team-based care versus usual care(From randomization through 12 months)