Telehealth Referral to Improve Outcomes

Hypertension Clinical Trial

— TRIO  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05000970
• Other study ID #: IRB 20-01947
• Status: Suspended
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: April 2024

Study information

• Verified date: April 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 48
• Est. completion date: April 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• At least two* high blood pressure readings during ED visit

1. Systolic (top #) =140, =180 AND/OR

2. Diastolic (bottom #) = 90, =120 *Second blood pressure may be confirmed when approaching the patient. Before approaching, check exclusions first.

Exclusion Criteria:

• symptomatic hypertension

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• blood pressure cuff PLUS tablet
all arms

Other:
• Telehealth Consult
Telehealth consult with an RN

Locations

Country	Name	City	State
United States	Mount Sinai Hospital Center Emergency Dept	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	AT&T and Vital Tech

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	recruitment rate of patients enrolled in TRIO at 6-months.	6 months
Primary	Recruitment rate	recruitment rate of patients enrolled in TRIO at 12-months.	12 months
Primary	Retention rate	retention rate of patients enrolled in TRIO at 6-months.	6 months
Primary	Retention rate	retention rate of patients enrolled in TRIO at 12-months.	12 months
Primary	Attrition rate	attrition rate of patients enrolled in TRIO at 6-months.	6 months
Primary	Attrition rate	attrition rate of patients enrolled in TRIO at 12-months.	12 months
Secondary	Blood pressure		6 months
Secondary	Blood pressure		12 months
Secondary	Number of participant who had follow up care	Primary Care Engagement to be defined as having follow up care (yes/no) at 6 months	6 months
Secondary	Number of participant who had follow up care	Primary Care Engagement to be defined as having follow up care (yes/no) at 12 months	12 months