Study Stopped
funding
Telehealth Referral to Improve Outcomes
TRIO
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Jul 2021
Typical duration for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedStudy Start
First participant enrolled
July 12, 2021
CompletedFirst Posted
Study publicly available on registry
August 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedMay 1, 2023
April 1, 2023
2.5 years
April 28, 2021
April 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Recruitment rate
recruitment rate of patients enrolled in TRIO at 6-months.
6 months
Recruitment rate
recruitment rate of patients enrolled in TRIO at 12-months.
12 months
Retention rate
retention rate of patients enrolled in TRIO at 6-months.
6 months
Retention rate
retention rate of patients enrolled in TRIO at 12-months.
12 months
Attrition rate
attrition rate of patients enrolled in TRIO at 6-months.
6 months
Attrition rate
attrition rate of patients enrolled in TRIO at 12-months.
12 months
Secondary Outcomes (4)
Blood pressure
6 months
Blood pressure
12 months
Number of participant who had follow up care
6 months
Number of participant who had follow up care
12 months
Study Arms (3)
TRIO PLUS tablet and nurse at day 3
EXPERIMENTALVirtual nurse encounter at 3 days
TRIO PLUS Tablet and nurse at day 3 and 7
EXPERIMENTALVirtual nurse encounter at 3 days and 7 days
TRIO PLUS Group
PLACEBO COMPARATORNo encounter
Interventions
all arms
Telehealth consult with an RN
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- At least two\* high blood pressure readings during ED visit
- Systolic (top #) ≥140, ≤180 AND/OR
- Diastolic (bottom #) ≥ 90, ≤120
You may not qualify if:
- symptomatic hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Icahn School of Medicine at Mount Sinailead
- AT&T and Vital Techcollaborator
Study Sites (1)
Mount Sinai Hospital Center Emergency Dept
New York, New York, 10029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly Souffront, PhD, APRN
Icahn School of Medicine at Mount Sinai
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Both participant and investigator will be blinded on the study assignment group.
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 28, 2021
First Posted
August 11, 2021
Study Start
July 12, 2021
Primary Completion
January 1, 2024
Study Completion
April 1, 2024
Last Updated
May 1, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share