Clinical trial NCT05000970: Telehealth Referral to Improve Outcomes
Official title: Telehealth Referral to Improve Outcomes for Asymptomatic Hypertension in the Emergency Department
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Hypertension
Keywords: Asymptomatic hypertension
Referral
Telehealth
Remote patient monitoring
Emergency Department
blood pressure
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: AT&T and Vital Tech
First posted: 2021-08-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 6 months
measure: Recruitment rate
timeFrame: 12 months
measure: Retention rate
timeFrame: 6 months
measure: Retention rate
timeFrame: 12 months
measure: Attrition rate
timeFrame: 6 months
measure: Attrition rate
timeFrame: 12 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 6 months
measure: Blood pressure
timeFrame: 12 months
measure: Number of participant who had follow up care
timeFrame: 6 months
measure: Number of participant who had follow up care
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital Center Emergency Dept
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Kimberly Souffront, PhD, APRN
role: PRINCIPAL_INVESTIGATOR
References: