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A ED-based Intervention to Improve Antihypertensive Adherence

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ClinicalTrials.gov Identifier: NCT02672787
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : August 13, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Candace McNaughton, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Hypertensive Emergency Hypertension Blood Pressure Behavioral: ED-based behavioral intervention Behavioral: ED usual care plus education Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, ED-based Intervention to Improve Antihypertensive Adherence
Study Start Date : February 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Experimental: Intervention
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.




Primary Outcome Measures :
  1. 1-month Blood Pressure [ Time Frame: 1-month ]
    The primary outcome is change in Blood Pressure, measured by BPTru, one month after enrollment.


Secondary Outcome Measures :
  1. 1-month Change in Adherence Measured by Assay [ Time Frame: 1-month ]
    Change in adherence as measured by the plasma assay.

  2. 1-month Change in Adherence Measured by Patient-report [ Time Frame: 1-month ]
    Change in adherence as measured by patient-report.

  3. 3-month Change in Blood Pressure [ Time Frame: 3-month ]
    3-month Change in Blood Pressure, measured by BPTru

  4. 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.

  5. Proportion of patients with controlled BP [ Time Frame: 1-month ]
    Compare the proportion of patients who achieve controlled BP at 1-month

  6. Proportion of patients with controlled BP [ Time Frame: 3-month ]
    Compare the proportion of patients who achieve controlled BP at 3-month


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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



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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672787


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Candace McNaughton, MD Vanderbilt University

Responsible Party: Candace McNaughton, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02672787     History of Changes
Other Study ID Numbers: 151384
K23HL125670 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Candace McNaughton, Vanderbilt University:
Antihypertensive adherence
Emergency medicine
Antihypertensives

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Antihypertensive Agents