Targeting of UnControlled Hypertension in Emergency Department (TOUCHED)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 574
- 试验地点
- 2
- 主要终点
- Mean Systolic Blood Pressure (SBP) Difference at 6 Months Post-intervention Compared to Usual Care.
研究概览
简要总结
The proposed project underscores the following: 1) The prevalence of uncontrolled/undiagnosed hypertension (HTN) in underrepresented groups presenting to the ED is alarmingly high, and 2) ED engagement and early risk assessment/stratification is a cost-effective, feasible innovation to help close health disparity gaps in HTN. This proposal involves a two-arm randomized controlled trial of up to 770 patients from the Emergency Department at University of Illinois Hospital with elevated blood pressure (BP). The primary objective is to determine the effectiveness of an emergency department-initiated Educational and Empowerment (E2) intervention with a Post Acute Care Hypertension Consultation (PACHT-c) intervention (arm 2) on the primary outcome of mean systolic blood pressure (SBP) differences between the two trial arms at 6-months post intervention. Secondary objectives include evaluating the effectiveness of this ED education and empowerment intervention on mean SBP and diastolic blood pressure (DBP) differences at 3-months, and mean DBP differences at 6-months.
详细描述
The study is a single-site randomized controlled trial (RCT) focused on a high-risk ED population with evidence of moderately elevated BP (≥140/90 mmHg) at discharge. ED patients will be recruited and randomized into two arms: 1) usual care (preprinted discharge instructions and 48-72 hour referral to a federally qualified health center (FQHC) or assigned provider as appropriate); 2) ED-initiated E2 intervention program followed by 48-72 hour referral to a FQHC (or assigned health center). Based on the ED population demographics (70% ethnic minorities), the majority of participants will be underrepresented minorities (NHB and Hispanic) and low-income individuals. The investigators propose the following specific aims and hypotheses:
Aim 1: Evaluate the effectiveness of an ED-based E2 + PACHT-c intervention (arm 2) on the primary outcome of mean SBP difference at 6-months post-intervention compared to usual care (arm 1).
H1: The mean SBP difference (from baseline) will be significantly greater in the E2+ PACHT-c group (arm 2) compared to the usual care group (arm 1) at 6- months post-randomization, i.e., SBP change in arm 2 > arm 1 at 6-months post-randomization.
Aim 2: Evaluate the effectiveness of an ED-based E2 intervention with PACHT-c on the secondary outcome of mean SBP and DBP differences at 3-months, and mean DBP differences at 6 months post-intervention compared to usual care.
H2: The mean SBP and DBP differences from baseline to 3- months post-intervention and mean DBP at 6-months post intervention will be significantly greater in the ED-based E2 intervention compared to the usual care group, i.e., SBP and DBP change in arm 2 > arm 1 at 3 -months post-intervention and DBP change in arm 2 > arm 1 at 6 -months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
盲法说明
Research Assistants are blinded to study arm assignment of participant when assessing outcomes measures.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BP>=140/90 and <=180/110 mm Hg at time of discharge from ED
- •Verbal fluency in English or Spanish
- •Age 18-75 years
排除标准
- •Unable to verbalize comprehension of study, impaired decision-making or documented dementia
- •Plans to move from Chicago area within the next year
- •Pregnant or trying to get pregnant
- •COVID-19 positive within the past 14 days
结局指标
主要结局
Mean Systolic Blood Pressure (SBP) Difference at 6 Months Post-intervention Compared to Usual Care.
时间窗: Baseline, 6 months after baseline
Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.
次要结局
- Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Differences at 3 Months Post-intervention Compared to Usual Care.(Baseline, 3 months after baseline)
- Diastolic Blood Pressure (DBP) Difference at 6 Months Post-intervention Compared to Usual Care.(Baseline, 6 months after baseline)
研究者
Heather Prendergast
Professor (CT), Associate Head for Academic Affairs, Resident Research Director, Emergency Medicine
University of Illinois at Chicago