Telehealth Referral to Improve Outcomes

NCT ID: NCT05000970

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-12

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

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

Study Groups

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TRIO PLUS tablet and nurse at day 3

Virtual nurse encounter at 3 days

Group Type EXPERIMENTAL

blood pressure cuff PLUS tablet

Intervention Type DEVICE

all arms

Telehealth Consult

Intervention Type OTHER

Telehealth consult with an RN

TRIO PLUS Tablet and nurse at day 3 and 7

Virtual nurse encounter at 3 days and 7 days

Group Type EXPERIMENTAL

blood pressure cuff PLUS tablet

Intervention Type DEVICE

all arms

Telehealth Consult

Intervention Type OTHER

Telehealth consult with an RN

TRIO PLUS Group

No encounter

Group Type PLACEBO_COMPARATOR

blood pressure cuff PLUS tablet

Intervention Type DEVICE

all arms

Interventions

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blood pressure cuff PLUS tablet

all arms

Intervention Type DEVICE

Telehealth Consult

Telehealth consult with an RN

Intervention Type OTHER

Other Intervention Names

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wireless BP monitor and tablet

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AT&T and Vital Tech

UNKNOWN

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Kimberly T Souffront

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kimberly Souffront, PhD, APRN

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Mount Sinai Hospital Center Emergency Dept

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 20-01947

Identifier Type: -

Identifier Source: org_study_id

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