Clinical trial NCT02672787: A ED-based Intervention to Improve Antihypertensive Adherence
Official title: A Randomized, ED-based Intervention to Improve Antihypertensive Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertensive Emergency
Hypertension
Blood Pressure
Keywords: Antihypertensive adherence
Emergency medicine
Antihypertensives
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-02-03
Enrollment: 220
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-month Blood Pressure
timeFrame: 1-month
Secondary outcomes:
measure: 1-month Change in Adherence Measured by Assay
timeFrame: 1-month
measure: 1-month Change in Adherence Measured by Patient-report
timeFrame: 1-month
measure: 3-month Change in Blood Pressure
timeFrame: 3-month
measure: 3-month Change in Adherence Measured by Patient-report
timeFrame: 3-month
measure: Proportion of patients with controlled BP
timeFrame: 1-month
measure: Proportion of patients with controlled BP
timeFrame: 3-month
Other outcomes:
measure: Association of death with antihypertensive adherence measured by the blood mass spectrometry assay
timeFrame: 1 year, minimum
measure: Association of death with antihypertensive adherence measured by patient report
timeFrame: 1 year, minimum
measure: Association of repeat ED visits with antihypertensive adherence measured by the blood mass spectrometry assay
timeFrame: 1 year, minimum
measure: Association of hospitalization with antihypertensive adherence measured by the blood mass spectrometry assay
timeFrame: 1 year, minimum
measure: Impact of the intervention on patient trust, measured by the Primary Care Assessment Survey (PCAS), at 3 months, by study arm
timeFrame: 3 months
measure: Relationship between intervention vs. usual care plus education on the change in measured side effects of antihypertensives (TOMHS survey) at 3 months
timeFrame: 3 months
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Candace McNaughton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spieker AJ, Nelson LA, Rothman RL, Roumie CL, Kripalani S, Coco J, Fabbri D, Levy P, Collins SP, Wang T, Liu D, McNaughton CD. Feasibility and Short-Term Effects of a Multi-Component Emergency Department Blood Pressure Intervention: A Pilot Randomized Trial. J Am Heart Assoc. 2022 Mar;11(5):e024339. doi: 10.1161/JAHA.121.024339. Epub 2022 Feb 23.
citation: Nelson LA, Spieker AJ, Kripalani S, Rothman RL, Roumie CL, Coco J, Fabbri D, Levy P, Collins SP, McNaughton CD. User preferences for and engagement with text messages to support antihypertensive medication adherence: Findings from a pilot study evaluating an emergency department-based behavioral intervention. Patient Educ Couns. 2022 Jun;105(6):1606-1613. doi: 10.1016/j.pec.2021.10.011. Epub 2021 Oct 12.