Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
NCT Number: NCT02672787
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.
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Notify Me21 year–85 year
All sexes
Interventional
Not applicable
Nashville, Tennessee, 37232, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Data collection, antihypertensive adherence assay, antihypertensive interview and EHR review, barrier identification, personalized goal setting, communication with PCP, and reminder messages/engagement messages.
Data collection, antihypertensive adherence assay, antihypertensive interview, EHR review, and usual care education.
Time frame: 1-month
The primary outcome is change in Blood Pressure, measured by BPTru, one month after enrollment.
Time frame: 1-month
Change in adherence as measured by the plasma assay.
Time frame: 1-month
Change in adherence as measured by patient-report.
Time frame: 3-month
3-month Change in Blood Pressure, measured by BPTru
Time frame: 3-month
BP and patient-reported adherence will evaluate longer-term impact of the intervention.
Time frame: 1-month
Compare the proportion of patients who achieve controlled BP at 1-month
Time frame: 3-month
Compare the proportion of patients who achieve controlled BP at 3-month
Time frame: 1 year, minimum
Evaluate whether adherence (by assay) predicts mortality among patients enrolled in the study
Time frame: 1 year, minimum
Evaluate whether adherence (by patient report) predicts mortality among patients enrolled in the study
Time frame: 1 year, minimum
Evaluate whether adherence (by assay) predicts repeat ED visits, in survival analysis
Time frame: 1 year, minimum
Evaluate whether adherence (by assay) predicts hospitalization, in survival analysis
Time frame: 3 months
Evaluate whether the intervention was associated with change in the trajectory of patient trust over 3 months (longitudinal analysis)
Time frame: 3 months
Evaluate whether the intervention or improvement in adherence were associated with higher patient-reported side effects, measured by the TOMHS, at 3 months
Vanderbilt University
Other
A Randomized, ED-based Intervention to Improve Antihypertensive Adherence
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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