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A ED-based Intervention to Improve Antihypertensive Adherence

Primary Purpose

Hypertensive Emergency, Hypertension, Blood Pressure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ED-based behavioral intervention
ED usual care plus education
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertensive Emergency focused on measuring Antihypertensive adherence, Emergency medicine, Antihypertensives

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ED usual care plus education

Intervention

Arm Description

ED usual care plus education

Subjects will receive the ED-based behavioral intervention

Outcomes

Primary Outcome Measures

1-month Blood Pressure
The primary outcome is change in Blood Pressure, measured by BPTru, one month after enrollment.

Secondary Outcome Measures

1-month Change in Adherence Measured by Assay
Change in adherence as measured by the plasma assay.
1-month Change in Adherence Measured by Patient-report
Change in adherence as measured by patient-report.
3-month Change in Blood Pressure
3-month Change in Blood Pressure, measured by BPTru
3-month Change in Adherence Measured by Patient-report
BP and patient-reported adherence will evaluate longer-term impact of the intervention.
Proportion of patients with controlled BP
Compare the proportion of patients who achieve controlled BP at 1-month
Proportion of patients with controlled BP
Compare the proportion of patients who achieve controlled BP at 3-month

Full Information

First Posted
January 27, 2016
Last Updated
August 9, 2018
Sponsor
Vanderbilt University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02672787
Brief Title
A ED-based Intervention to Improve Antihypertensive Adherence
Official Title
A Randomized, ED-based Intervention to Improve Antihypertensive Adherence
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Emergency, Hypertension, Blood Pressure
Keywords
Antihypertensive adherence, Emergency medicine, Antihypertensives

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ED usual care plus education
Arm Type
Active Comparator
Arm Description
ED usual care plus education
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Subjects will receive the ED-based behavioral intervention
Intervention Type
Behavioral
Intervention Name(s)
ED-based behavioral intervention
Intervention Description
Data collection, antihypertensive adherence assay, antihypertensive interview and EHR review, barrier identification, personalized goal setting, communication with PCP, and reminder messages/engagement messages.
Intervention Type
Behavioral
Intervention Name(s)
ED usual care plus education
Intervention Description
Data collection, antihypertensive adherence assay, antihypertensive interview, EHR review, and usual care education.
Primary Outcome Measure Information:
Title
1-month Blood Pressure
Description
The primary outcome is change in Blood Pressure, measured by BPTru, one month after enrollment.
Time Frame
1-month
Secondary Outcome Measure Information:
Title
1-month Change in Adherence Measured by Assay
Description
Change in adherence as measured by the plasma assay.
Time Frame
1-month
Title
1-month Change in Adherence Measured by Patient-report
Description
Change in adherence as measured by patient-report.
Time Frame
1-month
Title
3-month Change in Blood Pressure
Description
3-month Change in Blood Pressure, measured by BPTru
Time Frame
3-month
Title
3-month Change in Adherence Measured by Patient-report
Description
BP and patient-reported adherence will evaluate longer-term impact of the intervention.
Time Frame
3-month
Title
Proportion of patients with controlled BP
Description
Compare the proportion of patients who achieve controlled BP at 1-month
Time Frame
1-month
Title
Proportion of patients with controlled BP
Description
Compare the proportion of patients who achieve controlled BP at 3-month
Time Frame
3-month
Other Pre-specified Outcome Measures:
Title
Association of death with antihypertensive adherence measured by the blood mass spectrometry assay
Description
Evaluate whether adherence (by assay) predicts mortality among patients enrolled in the study
Time Frame
1 year, minimum
Title
Association of death with antihypertensive adherence measured by patient report
Description
Evaluate whether adherence (by patient report) predicts mortality among patients enrolled in the study
Time Frame
1 year, minimum
Title
Association of repeat ED visits with antihypertensive adherence measured by the blood mass spectrometry assay
Description
Evaluate whether adherence (by assay) predicts repeat ED visits, in survival analysis
Time Frame
1 year, minimum
Title
Association of hospitalization with antihypertensive adherence measured by the blood mass spectrometry assay
Description
Evaluate whether adherence (by assay) predicts hospitalization, in survival analysis
Time Frame
1 year, minimum
Title
Impact of the intervention on patient trust, measured by the Primary Care Assessment Survey (PCAS), at 3 months, by study arm
Description
Evaluate whether the intervention was associated with change in the trajectory of patient trust over 3 months (longitudinal analysis)
Time Frame
3 months
Title
Relationship between intervention vs. usual care plus education on the change in measured side effects of antihypertensives (TOMHS survey) at 3 months
Description
Evaluate whether the intervention or improvement in adherence were associated with higher patient-reported side effects, measured by the TOMHS, at 3 months
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: <6 hours since initial evaluation by a treating physician in the ED Prescribed only antihypertensives detected by the mass spectrometry plasma assay Prescribed at least 1 antihypertensive detected by the mass spectrometry plasma assay Functioning peripheral IV, available left over (after clinical testing) blood, or willing to undergo venipuncture to obtain blood Anticipated discharge from the ED, per ED attending 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) 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) Willing to receive reminder messages via chosen method (e.g., text, phone call, or letter) for 45 days after enrollment Has a healthcare provider who prescribes blood pressure medication, defined as having had a clinic visit within the past year Age ≥21 years and <85 years Exclusion Criteria: Received vasoactive medication (including prescribed BP medications) in the ED prior to enrollment Previously enrolled End stage renal disease or on hemodialysis Known pregnancy or anticipated pregnancy within 6 months Sepsis, acute blood loss, acute alcohol withdrawal, or inability to tolerate medications in the 24 hours prior to arrival Unable to provide informed consent (e.g., altered mental status, chronic dementia, prisoner, or inability to speak/understand English) Enrolled in home health or other chronic care coordination management plan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candace McNaughton, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
35195015
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.
Results Reference
derived
PubMed Identifier
34690012
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.
Results Reference
derived

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A ED-based Intervention to Improve Antihypertensive Adherence

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