NCT02672787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

2.3 years

First QC Date

January 27, 2016

Last Update Submit

August 9, 2018

Conditions

Hypertensive EmergencyHypertensionBlood Pressure

Keywords

Antihypertensive adherenceEmergency medicineAntihypertensives

Outcome Measures

Primary Outcomes (1)

  • 1-month Blood Pressure

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

    1-month

Secondary Outcomes (6)

  • 1-month Change in Adherence Measured by Assay

    1-month

  • 1-month Change in Adherence Measured by Patient-report

    1-month

  • 3-month Change in Blood Pressure

    3-month

  • 3-month Change in Adherence Measured by Patient-report

    3-month

  • Proportion of patients with controlled BP

    1-month

  • +1 more secondary outcomes

Other Outcomes (6)

  • Association of death with antihypertensive adherence measured by the blood mass spectrometry assay

    1 year, minimum

  • Association of death with antihypertensive adherence measured by patient report

    1 year, minimum

  • Association of repeat ED visits with antihypertensive adherence measured by the blood mass spectrometry assay

    1 year, minimum

  • +3 more other outcomes

Study Arms (2)

ED usual care plus education

ACTIVE COMPARATOR

ED usual care plus education

Behavioral: ED usual care plus education

Intervention

EXPERIMENTAL

Subjects will receive the ED-based behavioral intervention

Behavioral: ED-based behavioral intervention

Interventions

ED-based behavioral interventionBEHAVIORAL

Data collection, antihypertensive adherence assay, antihypertensive interview and EHR review, barrier identification, personalized goal setting, communication with PCP, and reminder messages/engagement messages.

Intervention
ED usual care plus educationBEHAVIORAL

Data collection, antihypertensive adherence assay, antihypertensive interview, EHR review, and usual care education.

ED usual care plus education

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \<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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

  • 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.

    PMID: 35195015DERIVED

  • 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.

    PMID: 34690012DERIVED

MeSH Terms

Conditions

Hypertensive CrisisHypertension

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Candace McNaughton, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 27, 2016

First Posted

February 3, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

August 13, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

Locations

US(1)