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Clinical Trials/NCT05000970
NCT05000970
Suspended
Not Applicable

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

Icahn School of Medicine at Mount Sinai1 site in 1 country48 target enrollmentStarted: July 12, 2021Last updated:
ConditionsHypertension

Overview

Phase
Not Applicable
Status
Suspended
Enrollment
48
Locations
1
Primary Endpoint
Retention rate

Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Masking Description

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

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 18 years
  • At least two\* high blood pressure readings during ED visit
  • Systolic (top #) ≥140, ≤180 AND/OR
  • Diastolic (bottom #) ≥ 90, ≤120
  • \*Second blood pressure may be confirmed when approaching the patient. Before approaching, check exclusions first.

Exclusion Criteria

  • symptomatic hypertension

Outcomes

Primary Outcomes

Retention rate

Time Frame: 12 months

retention rate of patients enrolled in TRIO at 12-months.

Recruitment rate

Time Frame: 12 months

recruitment rate of patients enrolled in TRIO at 12-months.

Attrition rate

Time Frame: 12 months

attrition rate of patients enrolled in TRIO at 12-months.

Secondary Outcomes

  • Number of participant who had follow up care(12 months)
  • Blood pressure(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kimberly T Souffront

Principal Investigator

Icahn School of Medicine at Mount Sinai

Study Sites (1)

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