Hypertensive EmergencyNCT02672787
A ED-based Intervention to Improve Antihypertensive Adherence
A study testing ED-based behavioral intervention in people with Hypertensive Emergency and Hypertension, run by Vanderbilt University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Hypertensive Emergency, Hypertension, Blood Pressure
- What is being tested?
- ED-based behavioral intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <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)
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertensive Emergency, Hypertension, Blood Pressure
- Being tested
- ED-based behavioral intervention, ED usual care plus education
- Keywords
- Antihypertensive adherence, Emergency medicine, Antihypertensives
- Medical subject headings
- Hypertensive Crisis, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED-based behavioral interventionBehavioural
Data collection, antihypertensive adherence assay, antihypertensive interview and EHR review, barrier identification, personalized goal setting, communication with PCP, and reminder messages/engagement messages.
ED usual care plus educationBehavioural
Data collection, antihypertensive adherence assay, antihypertensive interview, EHR review, and usual care education.
| Study group | Role | What they receive |
|---|---|---|
| ED usual care plus education | Active comparator | ED usual care plus education Receives: Behavioral: ED usual care plus education |
| Intervention | Experimental | Subjects will receive the ED-based behavioral intervention Receives: Behavioral: ED-based behavioral intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-month Blood Pressure
The primary outcome is change in Blood Pressure, measured by BPTru, one month after enrollment.
Measured: 1-month
Secondary outcomes (6)
1-month Change in Adherence Measured by Assay
Change in adherence as measured by the plasma assay.
Measured: 1-month
1-month Change in Adherence Measured by Patient-report
Change in adherence as measured by patient-report.
Measured: 1-month
3-month Change in Blood Pressure
3-month Change in Blood Pressure, measured by BPTru
Measured: 3-month
3-month Change in Adherence Measured by Patient-report
BP and patient-reported adherence will evaluate longer-term impact of the intervention.
Measured: 3-month
Proportion of patients with controlled BP
Compare the proportion of patients who achieve controlled BP at 1-month
Measured: 1-month
Proportion of patients with controlled BP
Compare the proportion of patients who achieve controlled BP at 3-month
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypertensive EmergencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Candace McNaughton, Vanderbilt University
- Investigators
- Candace McNaughton, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672787
- Sponsor's protocol ID
- 151384
- Other IDs
- K23HL125670
- Status last verified
- Aug 2018
- First submitted
- 27 Jan 2016
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
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.
PubMed 35195015Nelson 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.
PubMed 34690012
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, ED-based Intervention to Improve Antihypertensive Adherence
- ClinicalTrials.gov ID
- NCT02672787
- Acronym / sponsor ID
- 151384
- Conditions
- Hypertensive Emergency, Hypertension, Blood Pressure
- Keywords
- Antihypertensive adherence, Emergency medicine, Antihypertensives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ED usual care plus education | Active comparator | Behavioral: ED usual care plus educationED usual care plus education |
| Intervention | Experimental | Behavioral: ED-based behavioral interventionSubjects will receive the ED-based behavioral intervention |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- <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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ED-based behavioral interventionData collection, antihypertensive adherence assay, antihypertensive interview and EHR review, barrier identification, personalized goal setting, communication with PCP, and reminder messages/engagement messages. | Behavioural | Intervention |
| ED usual care plus educationData collection, antihypertensive adherence assay, antihypertensive interview, EHR review, and usual care education. | Behavioural | ED usual care plus education |
Primary outcome
1-month Blood Pressure
Time frame: 1-month
The primary outcome is change in Blood Pressure, measured by BPTru, one month after enrollment.
6 secondary outcomes
1-month Change in Adherence Measured by Assay
Time frame: 1-month
1-month Change in Adherence Measured by Patient-report
Time frame: 1-month
3-month Change in Blood Pressure
Time frame: 3-month
3-month Change in Adherence Measured by Patient-report
Time frame: 3-month
Proportion of patients with controlled BP
Time frame: 1-month
Proportion of patients with controlled BP
Time frame: 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Derived from this study: PubMed 35195015Spieker 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.
- Derived from this study: PubMed 34690012Nelson 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candace McNaughton, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ED-based behavioral intervention in people with Hypertensive Emergency and Hypertension, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-month Blood Pressure (time frame: 1-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02672787, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.