Telehealth Referral to Improve Outcomes

Not Applicable

Suspended

• Conditions: Hypertension
• Interventions: Device: blood pressure cuff PLUS tablet; Other: Telehealth Consult

• Registration Number: NCT05000970
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

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 Timeline

• Study First Submitted: 2021-04-28
• Study Start: 2021-07-12
• Study First Submitted QC: 2021-08-10
• Study First Posted: 2021-08-11
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-05-01
• Primary Completion: 2024-01
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
TRIO PLUS Tablet and nurse at day 3 and 7	blood pressure cuff PLUS tablet	Virtual nurse encounter at 3 days and 7 days
TRIO PLUS Tablet and nurse at day 3 and 7	Telehealth Consult	Virtual nurse encounter at 3 days and 7 days
TRIO PLUS Group	blood pressure cuff PLUS tablet	No encounter
TRIO PLUS tablet and nurse at day 3	Telehealth Consult	Virtual nurse encounter at 3 days
TRIO PLUS tablet and nurse at day 3	blood pressure cuff PLUS tablet	Virtual nurse encounter at 3 days

Primary Outcome Measures

Name	Time	Method
Retention rate	12 months	retention rate of patients enrolled in TRIO at 12-months.
Recruitment rate	12 months	recruitment rate of patients enrolled in TRIO at 12-months.
Attrition rate	12 months	attrition rate of patients enrolled in TRIO at 12-months.

Secondary Outcome Measures

Name	Time	Method
Number of participant who had follow up care	12 months	Primary Care Engagement to be defined as having follow up care (yes/no) at 12 months
Blood pressure	12 months

Trial Locations

Locations (1)

Mount Sinai Hospital Center Emergency Dept; 🇺🇸 New York, New York, United States