A ED-based Intervention to Improve Antihypertensive Adherence
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|ClinicalTrials.gov Identifier: NCT02672787|
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : January 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hypertensive Emergency Hypertension Blood Pressure||Behavioral: ED-based behavioral intervention Behavioral: ED usual care plus education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, ED-based Intervention to Improve Antihypertensive Adherence|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2019|
Active Comparator: ED usual care plus education
ED usual care plus education
Behavioral: ED usual care plus education
Data collection, antihypertensive adherence assay, antihypertensive interview, EHR review, and usual care education.
Subjects will receive the ED-based behavioral intervention
Behavioral: ED-based behavioral intervention
Data collection, antihypertensive adherence assay, antihypertensive interview and EHR review, barrier identification, personalized goal setting, communication with PCP, and reminder messages/engagement messages.
- 1-month Blood Pressure [ Time Frame: 1-month ]The primary outcome is change in Blood Pressure, measured by BPTru, one month after enrollment.
- 1-month Change in Adherence Measured by Assay [ Time Frame: 1-month ]Change in adherence as measured by the plasma assay.
- 1-month Change in Adherence Measured by Patient-report [ Time Frame: 1-month ]Change in adherence as measured by patient-report.
- 3-month Change in Blood Pressure [ Time Frame: 3-month ]3-month Change in Blood Pressure, measured by BPTru
- 3-month Change in Adherence Measured by Patient-report [ Time Frame: 3-month ]BP and patient-reported adherence will evaluate longer-term impact of the intervention.
- Proportion of patients with controlled BP [ Time Frame: 1-month ]Compare the proportion of patients who achieve controlled BP at 1-month
- Proportion of patients with controlled BP [ Time Frame: 3-month ]Compare the proportion of patients who achieve controlled BP at 3-month
- Association of death with antihypertensive adherence measured by the blood mass spectrometry assay [ Time Frame: 1 year, minimum ]Evaluate whether adherence (by assay) predicts mortality among patients enrolled in the study
- Association of death with antihypertensive adherence measured by patient report [ Time Frame: 1 year, minimum ]Evaluate whether adherence (by patient report) predicts mortality among patients enrolled in the study
- Association of repeat ED visits with antihypertensive adherence measured by the blood mass spectrometry assay [ Time Frame: 1 year, minimum ]Evaluate whether adherence (by assay) predicts repeat ED visits, in survival analysis
- Association of hospitalization with antihypertensive adherence measured by the blood mass spectrometry assay [ Time Frame: 1 year, minimum ]Evaluate whether adherence (by assay) predicts hospitalization, in survival analysis
- Impact of the intervention on patient trust, measured by the Primary Care Assessment Survey (PCAS), at 3 months, by study arm [ Time Frame: 3 months ]Evaluate whether the intervention was associated with change in the trajectory of patient trust over 3 months (longitudinal analysis)
- Relationship between intervention vs. usual care plus education on the change in measured side effects of antihypertensives (TOMHS survey) at 3 months [ 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672787
|Contact: Candace McNaughton, MDemail@example.com|
|Contact: Karen Miller, RNfirstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Candace McNaughton, MD|
|Contact: Karen F Miller, RN email@example.com|
|Principal Investigator:||Candace McNaughton, MD||Vanderbilt University|