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临床试验/NCT05000970
NCT05000970暂停不适用

Telehealth Referral to Improve Outcomes for Asymptomatic Hypertension in the Emergency Department

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年7月12日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
48
试验地点
1
主要终点
Retention rate

研究概览

简要总结

Emergency patients often have uncontrolled asymptomatic hypertension upon discharge from the emergency department. This 3-arm randomized controlled trial will evaluate the impact of nurse telehealth encounters and remote patient monitoring, using a software called Vital Tech, on blood pressure control and primary care engagement.

详细描述

Emergency Department (ED) clinicians encounter patients with asymptomatic hypertension (HTN) on a daily basis but usually fail to intervene. This pilot study will determine the utility of a novel intervention: Telehealth Referral to Improve Outcomes (TRIO), a conceptually driven information technology tool focused on patients who are asymptomatic and hypertensive upon ED discharge. It is designed to successfully link them to a primary care provider (PCP) after ED discharge to improve blood pressure (BP) control. 48 adult ED patients who have asymptomatic HTN (BP >/= 140/90 mmg and </= 180/120 mmHg) and who will be discharged will be enrolled in the study. This study is a single-site, 3-arm randomized controlled pilot trial. All patients will receive a wireless BP monitor and tablet. Group 2 (N=16) will additionally receive a telehealth consult with an RN at day 3. Group 3 (N=16) will additionally receive a telehealth consult with an RN at day 3 and day 7. The research team will collect feasibility outcomes: (recruitment rate, retention rate, and attrition rate of patients enrolled in TRIO at 6-months and 12-months. The research team will evaluate BP control and engagement with primary care at 6-months and 12-months and compare between groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Both participant and investigator will be blinded on the study assignment group.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • At least two* high blood pressure readings during ED visit
  • Systolic (top #) ≥140, ≤180 AND/OR
  • Diastolic (bottom #) ≥ 90, ≤120
  • *Second blood pressure may be confirmed when approaching the patient. Before approaching, check exclusions first.

排除标准

  • symptomatic hypertension

结局指标

主要结局

Retention rate

时间窗: 12 months

retention rate of patients enrolled in TRIO at 12-months.

Recruitment rate

时间窗: 12 months

recruitment rate of patients enrolled in TRIO at 12-months.

Attrition rate

时间窗: 12 months

attrition rate of patients enrolled in TRIO at 12-months.

次要结局

  • Number of participant who had follow up care(12 months)
  • Blood pressure(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kimberly T Souffront

Principal Investigator

Icahn School of Medicine at Mount Sinai

研究点 (1)

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