Telehealth Referral to Improve Outcomes (TRIO)

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

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.

Study Overview

• Status: Suspended
• Conditions: Hypertension
• Intervention / Treatment: Device: blood pressure cuff PLUS tablet; Other: Telehealth Consult

Detailed 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 </= 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.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Gordon, MPH; Email: lauren.gordon@mountsinai.org
• Study Contact Backup: Name: Kimberly Souffront, PhD, APRN; Phone Number: 212-824-8095; Email: kimberly.souffront@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital Center Emergency Dept

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRIO PLUS tablet and nurse at day 3; Virtual nurse encounter at 3 days	Device: blood pressure cuff PLUS tablet; all arms; Other Names: wireless BP monitor and tablet; Other: Telehealth Consult; Telehealth consult with an RN
Experimental: TRIO PLUS Tablet and nurse at day 3 and 7; Virtual nurse encounter at 3 days and 7 days	Device: blood pressure cuff PLUS tablet; all arms; Other Names: wireless BP monitor and tablet; Other: Telehealth Consult; Telehealth consult with an RN
Placebo Comparator: TRIO PLUS Group; No encounter	Device: blood pressure cuff PLUS tablet; all arms; Other Names: wireless BP monitor and tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	recruitment rate of patients enrolled in TRIO at 6-months.	6 months
Recruitment rate	recruitment rate of patients enrolled in TRIO at 12-months.	12 months
Retention rate	retention rate of patients enrolled in TRIO at 6-months.	6 months
Retention rate	retention rate of patients enrolled in TRIO at 12-months.	12 months
Attrition rate	attrition rate of patients enrolled in TRIO at 6-months.	6 months
Attrition rate	attrition rate of patients enrolled in TRIO at 12-months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure		6 months
Blood pressure		12 months
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
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: AT&T and Vital Tech
• Investigators: Principal Investigator: Kimberly Souffront, PhD, APRN, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Emergency Department; Telehealth; blood pressure; Referral; Remote patient monitoring; Asymptomatic hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: IRB 20-01947

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes