Telehealth Referral to Improve Outcomes (TRIO)

Mount Sinai Health System

Status: Suspended

Conditions: Hypertension

Treatments: Other: Telehealth Consult; Device: blood pressure cuff PLUS tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05000970

IRB 20-01947

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

TRIO PLUS tablet and nurse at day 3

Experimental group

Description:

Virtual nurse encounter at 3 days

Treatment:

Device: blood pressure cuff PLUS tablet

Other: Telehealth Consult

TRIO PLUS Tablet and nurse at day 3 and 7

Experimental group

Description:

Virtual nurse encounter at 3 days and 7 days

Treatment:

Device: blood pressure cuff PLUS tablet

Other: Telehealth Consult

TRIO PLUS Group

Placebo Comparator group

Description:

No encounter

Treatment:

Device: blood pressure cuff PLUS tablet