Telehealth Referral to Improve Outcomes

Study Overview
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Device: blood pressure cuff PLUS tablet
* Other: Telehealth Consult


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | 6 months | 
| Blood pressure |  | 12 months | 
| Number of participant who had follow up care | Primary Care Engagement to be defined as having follow up care (yes/no) at 6 months | 6 months | 
| Number of participant who had follow up care | Primary Care Engagement to be defined as having follow up care (yes/no) at 12 months | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asymptomatic hypertension, Referral, Telehealth, Remote patient monitoring, Emergency Department, blood pressure