TRIO: Telehealth Referral to Improve Outcomes

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05000970
• Collaborator: AT&T and Vital Tech (Other)
• Enrollment: 48
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 15.7
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Device: blood pressure cuff PLUS tablet; Other: Telehealth Consult	N/A

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
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Both participant and investigator will be blinded on the study assignment group.
• Primary Purpose: Prevention
• Official Title: Telehealth Referral to Improve Outcomes for Asymptomatic Hypertension in the Emergency Department
• Actual Study Start Date: Jun 11, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TRIO PLUS tablet and nurse at day 3 Virtual nurse encounter at 3 days	Device: blood pressure cuff PLUS tablet; all arms; Other Names: wireless BP monitor and tablet ; Other: Telehealth Consult; Telehealth consult with an RN
Experimental: TRIO PLUS Tablet and nurse at day 3 and 7 Virtual nurse encounter at 3 days and 7 days	Device: blood pressure cuff PLUS tablet; all arms; Other Names: wireless BP monitor and tablet ; Other: Telehealth Consult; Telehealth consult with an RN
Placebo Comparator: TRIO PLUS Group No encounter	Device: blood pressure cuff PLUS tablet; all arms; Other Names: wireless BP monitor and tablet

Outcome Measures

Primary Outcome Measures

1. Recruitment rate [6 months]

   recruitment rate of patients enrolled in TRIO at 6-months.

2. Recruitment rate [12 months]

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

3. Retention rate [6 months]

   retention rate of patients enrolled in TRIO at 6-months.

4. Retention rate [12 months]

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

5. Attrition rate [6 months]

   attrition rate of patients enrolled in TRIO at 6-months.

6. Attrition rate [12 months]

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

Secondary Outcome Measures

1. Blood pressure [6 months]

2. Blood pressure [12 months]

3. Number of participant who had follow up care [6 months]

   Primary Care Engagement to be defined as having follow up care (yes/no) at 6 months

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Hospital Center Emergency Dept	New York	New York	United States	10029

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai
• AT&T and Vital Tech

Investigators

• Principal Investigator: Kimberly Souffront, PhD, APRN, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kimberly T Souffront, Principal Investigator, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT05000970
• Other Study ID Numbers: IRB 20-01947
• First Posted: Aug 11, 2021
• Last Update Posted: Aug 11, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Kimberly T Souffront, Principal Investigator, Icahn School of Medicine at Mount Sinai: Asymptomatic hypertension; Referral; Telehealth; Remote patient monitoring; Emergency Department; blood pressure
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Aug 11, 2021