A ED-based Intervention to Improve Antihypertensive Adherence

Study Overview
=================
Brief Summary
-----------------
Despite great strides, hypertension remains an incredibly important disease and public health problem. This study addresses this critical need among ED patients, a unique population of patients who are (a) likely to benefit from an antihypertensive adherence intervention due to their high prevalence of uncontrolled blood pressure and poor adherence, and (b) at high risk for poor cardiovascular outcomes. The protocol provides for a multicomponent intervention bundle to be tested among ED patients. Successful clinic-based behavioral interventions generally target a combination of barriers to adherence; bundled interventions have shown success in a wide range of settings and diseases. In some cases, bundled components were necessary to achieve blood pressure benefit in a primary care setting; isolated educational efforts have had mixed success in the ED.

Detailed Description
-----------------
More than 37 million Americans have uncontrolled hypertension, with associated costs of $93.5 billion in 2010. Emergency department visits for hypertension rose 25% from 2006 to 2011. According to the Centers for Disease Control and Prevention, improved hypertension control…require[s] an expanded effort and an increased focus on blood pressure from health-care systems, clinicians, and individuals. ED visits among patients with uncontrolled blood pressure are often missed opportunities for the ED to serve as an additional healthcare touchpoint and opportunity to impact chronic disease control by complementing chronic care. The ED is a common access point into the healthcare system, with more than 120 million visits annually among 20% of Americans. ED visits specifically for hypertension are also common, with more than 5 million visits per year and rising rapidly as more newly insured and chronically ill patients seek ED care. Elevated blood pressure (BP) is noted in 15-25% of all ED visits and cannot be attributed solely to pain. An ED-based intervention places focus on patients who are at increased risk for poor clinical outcomes and who are likely to gain benefit from interventions. Medication adherence, or taking medications as prescribed, is crucial for BP control. Until now, measuring antihypertensive adherence in the ED has been limited to self-report, which is influenced by recall and social desirability biases and lack of an established patient-provider relationship. As a result, little is known regarding factors related to antihypertensive adherence or optimal interventions to improve adherence among ED patients. This project utilizes a validated mass spectrometry plasma assay as a measure of antihypertensive adherence to overcome these limitations. This tool will be combined with a conceptual framework in order to test our understanding of how adherence relates to blood pressure control among ED patients. The conceptual framework is based on work by Krousel-Wood, Bosworth, Murray, and Gellad and is grounded in the Information-Motivation-Behavioral Skills model of health behavior change, Social Cognitive Theory, and successful clinic-based adherence interventions.

Official Title
-----------------
A Randomized, ED-based Intervention to Improve Antihypertensive Adherence

Conditions
-----------------
Hypertensive Emergency, Hypertension, Blood Pressure

Intervention / Treatment
-----------------
* Behavioral: ED-based behavioral intervention
* Behavioral: ED usual care plus education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <6 hours since initial evaluation by a treating physician in the ED Prescribed only antihypertensives detected by the mass spectrometry plasma assay Prescribed at least 1 antihypertensive detected by the mass spectrometry plasma assay Functioning peripheral IV, available left over (after clinical testing) blood, or willing to undergo venipuncture to obtain blood Anticipated discharge from the ED, per ED attending Elevated blood pressure in the ED, including triage systolic blood pressure of at least 140 mmHg or triage diastolic blood pressure of at least 90 mmHg, or 2 or more elevated BP measurements after triage (>=140/90 mmHg) Able and willing to complete  45 minutes of surveys, discussion in the ED as well as return for 2 follow up visits (i.e., no plans to move away or change medical providers in the next 6 months) Willing to receive reminder messages via chosen method (e.g., text, phone call, or letter) for 45 days after enrollment Has a healthcare provider who prescribes blood pressure medication, defined as having had a clinic visit within the past year Age ≥21 years and <85 years Exclusion Criteria: Received vasoactive medication (including prescribed BP medications) in the ED prior to enrollment Previously enrolled End stage renal disease or on hemodialysis Known pregnancy or anticipated pregnancy within 6 months Sepsis, acute blood loss, acute alcohol withdrawal, or inability to tolerate medications in the 24 hours prior to arrival Unable to provide informed consent (e.g., altered mental status, chronic dementia, prisoner, or inability to speak/understand English) Enrolled in home health or other chronic care coordination management plan

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ED usual care plus education<br>ED usual care plus education | Behavioral: ED usual care plus education<br>* Data collection, antihypertensive adherence assay, antihypertensive interview, EHR review, and usual care education.<br>|
| Experimental: Intervention<br>Subjects will receive the ED-based behavioral intervention | Behavioral: ED-based behavioral intervention<br>* Data collection, antihypertensive adherence assay, antihypertensive interview and EHR review, barrier identification, personalized goal setting, communication with PCP, and reminder messages/engagement messages.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-month Blood Pressure | The primary outcome is change in Blood Pressure, measured by BPTru, one month after enrollment. | 1-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-month Change in Adherence Measured by Assay | Change in adherence as measured by the plasma assay. | 1-month | 
| 1-month Change in Adherence Measured by Patient-report | Change in adherence as measured by patient-report. | 1-month | 
| 3-month Change in Blood Pressure | 3-month Change in Blood Pressure, measured by BPTru | 3-month | 
| 3-month Change in Adherence Measured by Patient-report | BP and patient-reported adherence will evaluate longer-term impact of the intervention. | 3-month | 
| Proportion of patients with controlled BP | Compare the proportion of patients who achieve controlled BP at 1-month | 1-month | 
| Proportion of patients with controlled BP | Compare the proportion of patients who achieve controlled BP at 3-month | 3-month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antihypertensive adherence, Emergency medicine, Antihypertensives