A ED-based Intervention to Improve Antihypertensive Adherence
Status: | Completed |
---|---|
Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Hospital |
Therapuetic Areas: | Cardiology / Vascular Diseases, Other |
Healthy: | No |
Age Range: | 21 - 85 |
Updated: | 8/15/2018 |
Start Date: | February 2016 |
End Date: | June 2018 |
A Randomized, ED-based Intervention to Improve Antihypertensive Adherence
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.
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.
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.
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.
Inclusion Criteria:
1. <6 hours since initial evaluation by a treating physician in the ED
2. Prescribed only antihypertensives detected by the mass spectrometry plasma assay
3. Prescribed at least 1 antihypertensive detected by the mass spectrometry plasma assay
4. Functioning peripheral IV, available left over (after clinical testing) blood, or
willing to undergo venipuncture to obtain blood
5. Anticipated discharge from the ED, per ED attending
6. 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)
7. 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)
8. Willing to receive reminder messages via chosen method (e.g., text, phone call, or
letter) for 45 days after enrollment
9. Has a healthcare provider who prescribes blood pressure medication, defined as having
had a clinic visit within the past year
10. Age ≥21 years and <85 years
Exclusion Criteria:
1. Received vasoactive medication (including prescribed BP medications) in the ED prior
to enrollment
2. Previously enrolled
3. End stage renal disease or on hemodialysis
4. Known pregnancy or anticipated pregnancy within 6 months
5. Sepsis, acute blood loss, acute alcohol withdrawal, or inability to tolerate
medications in the 24 hours prior to arrival
6. Unable to provide informed consent (e.g., altered mental status, chronic dementia,
prisoner, or inability to speak/understand English)
7. Enrolled in home health or other chronic care coordination management plan
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
Click here to add this to my saved trials