- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03093532
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities (AHEAD2)
Effective interventions that can address uncontrolled hypertension, particularly in underrepresented populations that use the emergency department (ED) for primary care, are critically needed. Uncontrolled hypertension (HTN) contributes significantly to cardiovascular morbidity and mortality and is more frequently encountered among patients presenting to the ED as compared to the primary care setting. EDs serve as the point of entry into the health care system for many high-risk patient populations, including minority and low-income patients. Based upon recent studies, the prevalence of uncontrolled/undiagnosed HTN in patients presenting to the ED is alarmingly high.
Thus emergency department engagement and early risk assessment/stratification is a feasible innovation to help close health disparity gaps in HTN.
This proposal involves a three-arm randomized controlled trial of 120 patients from the Emergency Department at University of Illinois Hospital with elevated blood pressure (BP) and no established primary care provider (PCP). The overarching goal is to improve follow-up rates and transition to PCP care at a federally qualified community health center (FQHC). The primary outcome will be blood pressure control. Secondary outcomes will be blood pressure improvement, treatment adherence, and hypertension knowledge. The central hypothesis of the proposal is that an ED-based screening, brief intervention, and referral for treatment program for HTN (SBIRT-HTN) using existing ED resources, coupled with a follow-up visit to an ED pharmacist-initiated Post-Acute Care Hypertension Transition Clinic (PACHT-c), can be impactful in a predominately underrepresented hypertensive population.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Effective interventions to address uncontrolled hypertension (HTN), particularly in underrepresented populations that use the emergency department (ED) for primary care, are critically needed. Uncontrolled HTN, which contributes significantly to cardiovascular morbidity and mortality, is more frequently encountered among patients presenting to the ED. EDs serve as the point of entry into the health care system for many high-risk patient populations, particularly minority and low-income individuals. Our preliminary data from a largely minority patient population presenting to the ED shows significant rates of subclinical heart disease (diastolic dysfunction and left ventricular hypertrophy) in patients with elevated blood pressure (BP). These early echocardiogram changes are reversible with existing strategies for improving BP control.
The proposed project underscores that 1) The prevalence of uncontrolled/undiagnosed HTN among ED patients from underrepresented groups who do not have a primary care physician (PCP) is alarmingly high, and 2) ED engagement and early risk assessment/stratification with facilitated PCP follow-up is a novel and feasible innovation to help address health disparity gaps in HTN. The central hypothesis of the proposal is that an ED-based screening, brief intervention, and referral for treatment program for HTN (SBIRT-HTN) using existing ED resources, coupled with a follow-up visit to an ED pharmacist-initiated Post-Acute Care Hypertension Transition Clinic (PACHT-c), will improve BP control through patient empowerment, facilitating PCP follow-up rates, and consequently improving treatment compliance in a predominately underrepresented hypertensive population. This proposal is strengthened by the existing partnership between an academic urban ED and a Federally Qualified Health Center (FQHC) as a model for integrating secondary cardiovascular prevention in a population at high risk for complications due to uncontrolled/undiagnosed HTN. Moreover, this proposal is innovative as a prospective randomized controlled trial in a high-risk ED patient population with no established PCP and persistent elevated BPs.
Eligible patients are those with elevated BP and no established PCP (or no PCP contact in the past year) who present to the University of Illinois Hospital & Health Sciences System (UI Health) ED. The three arms are: 1) usual care (current practice of passive outpatient referral for follow-up care), 2) an ED-based SBIRT-HTN program (patient empowerment tool) using existing ED resources followed by assisted referral for usual care, and 3) the ED based SBIRT-HTN coupled with a 48-hour follow-up visit to an ED pharmacist-initiated Post-Acute Care Hypertension Transition Clinic (PACHT-c) followed by assisted referral for primary care.
The aims evaluate the effectiveness of the interventions (SBIRT-HTN & PACHTC-c) on uncontrolled BP at 6 months. The primary outcome will be BP improvement. Based on the demographics of the ED population at the study site (70% of the current UI Health ED population are ethnic minorities), the majority of participants will be underrepresented minorities (African-American and Hispanic/Latino) and low-income individuals. The investigators propose the following specific aims and hypotheses:
Aim 1: Evaluate the effectiveness of an ED-initiated SBIRT-HTN program on BP control at 6 months post intervention compared to usual care.
H1: Early identification and initiation of a risk stratification algorithm that involves non-invasive assessment (limited echocardiogram) for early subclinical cardiovascular disease (combined with patient education regarding HTN & cardiovascular complications (patient empowerment) at the point-of contact in the ED (arm 2) will result in greater BP control at 6 months compared to the usual care group (arm 1).
Aim 2: Evaluate the impact of the PACHT-c component with the ED-based SBIRT-HTN program on BP control at 6 months post intervention compared to usual care and ED-SBIRT-HTN alone.
H2: The PACHT-c component (arm 3) will result in greater BP control compared to those randomized to usual care (arm 1) or ED-based SBIRT-HTN alone (arm 2).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Stage 2 Hypertension- Elevated BP of ≥160/100 at time of discharge from ED
- Verbal fluency in English or Spanish
- Age 30 to 64 years
Exclusion Criteria:
- Unable to verbalize comprehension of study or impaired decision making (e.g., dementia)
- History of heart failure, myocardial infarction, or stroke
- Lives outside Chicago communities
- Plans to move from Chicago area within the next year
- Pregnant or trying to get pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
The Usual Care group arm will received pre-printed discharge instructions and an outpatient referral.
(This group represents standard of care.)
|
|
Active Comparator: ED SBIRT-HTN
The ED SBIRT-HTN (The Emergency Department Screening Brief Intervention and Referral for Treatment) arm consists of a series of risk assessment tools (surveys, video, and noninvasive bedside assessments) designed to be efficient, patient-centered and educational for participants in an emergency department setting. Through the intervention, participants will learn more about hypertension management and complications associated with uncontrolled BP. Participants in the ED-SBIRT-HTN group will receive the following interventions: 1) screening (risk assessment/stratification), 2) a limited bedside echocardiogram (looking for evidence of subclinical cardiac disease), and 3) a urine microalbumin test (marker of early cardiovascular disease). |
Participants in the ED-SBIRT-HTN group will receive the following interventions: 1) screening (risk assessment/stratification), 2) a limited bedside echocardiogram (looking for evidence of subclinical cardiac disease), and 3) a urine microalbumin test (marker of early cardiovascular disease).
Other Names:
|
Active Comparator: E SBIRT-HTN + PACTH-c
Participants randomized to the SBIRT-HTN +PACHT-c (Post-Acute Care Hypertension Transition Clinic) arm will receive all interventions of the ED SBIRT-HTN arm plus a 48-72 hour follow-up in the Post-Acute Care Hypertension Transition Clinic for repeat blood pressure assessment, review of screening assessments, and secured PCP appointment with a federally qualified health center within the study site's health system.
|
Participants in the ED-SBIRT-HTN group will receive the following interventions: 1) screening (risk assessment/stratification), 2) a limited bedside echocardiogram (looking for evidence of subclinical cardiac disease), and 3) a urine microalbumin test (marker of early cardiovascular disease).
Other Names:
Participants randomized to the SBIRT-HTN +PACHT-c (Post-Acute Care Hypertension Transition Clinic) arm will receive all interventions of the ED SBIRT-HTN arm plus a 48-72 hour follow-up in the Post-Acute Care Hypertension Transition Clinic for repeat blood pressure assessment, review of screening assessments, and secured PCP appointment with a federally qualified health center within the study site's health system.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Pressure Control (BP < 140/90 mmHg) at 6 Months
Time Frame: 6 months
|
In order to be eligible for the study, patients must have uncontrolled BP. At 6 months, we will determine if patients have controlled their BP, as evidenced by BP < 140/90 mmHg. BP measurements will be recorded on seated participants after at least five minutes in a quiet room. ED-pharmacists and trained research assistants will perform BP, measurements using digital BP meters using standardized procedures. |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Blood Pressure (Systolic/Diastolic mm Hg) at 6 Months
Time Frame: 0, 6 months
|
Blood pressure will be collected at two time points (baseline and 6 months).
BP measurements will be recorded on seated participants after at least five minutes in a quiet room.
ED-pharmacists and trained research assistants will perform BP, measurements using digital BP meters using standardized procedures.
|
0, 6 months
|
Change in Hypertension Knowledge at 6 Months (Hypertension Knowledge Survey)
Time Frame: 0, 6 months
|
The hypertension knowledge survey is a 10-item, validated tool developed to assess hypertension knowledge in low literacy patient populations.
The scale assesses respondents' knowledge in defining hypertension, lifestyle, and behaviors that may affect BP levels, and the long-term consequences of HTN.
The survey has been validated in an urban population that included a high proportion of black and Latino patients.
Scores are categorized into tertiles that indicate low (≤7), medium (8), or high (9-10) levels of HTN knowledge.
|
0, 6 months
|
Change in Treatment Adherence at 6 Months (Modified Morisky Scale)
Time Frame: 0, 6 months
|
The modified Morisky scale is a validated 4-item instrument to assess self-reported patient adherence related to antihypertensive medication.
The modified Morisky scale provides a total score with a range of 0 to 4, with higher scores indicating lower adherence to medication.
The scores of the modified Morisky scale can be classified as low compliers (3-4), medium compliers (1-2) and high compliers (0) based on its criterion validity with BP control.
|
0, 6 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-0323
- R56HL126657 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertension
-
National Taiwan University Hospital Hsin-Chu BranchRecruitingHypertension,Essential | Hypertension, MaskedTaiwan
-
University of Alabama at BirminghamTroy UniversityCompletedHypertension | Hypertension, Resistant to Conventional Therapy | Uncontrolled Hypertension | Hypertension, White CoatUnited States
-
BayerCompletedPrimary HypertensionChina
-
Addpharma Inc.Completed
-
Columbia UniversityAgency for Healthcare Research and Quality (AHRQ)Active, not recruitingWhite Coat Hypertension | Hypertension,EssentialUnited States
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Centre Chirurgical Marie LannelongueUnknownChronic Thrombo-embolic Pulmonary Hypertension and Pulmonary Arterial HypertensionFrance
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
Clinical Trials on ED SBIRT-HTN
-
Treatment Research InstitutePennsylvania Department of HealthCompletedAlcohol Use | Drug UseUnited States
-
University of Colorado, DenverNational Institute of Mental Health (NIMH); Washington State University; University...RecruitingSuicide PreventionUnited States
-
Mayo ClinicMiami Heart Research Institute Inc.Not yet recruitingHypertensionUnited States
-
University of PennsylvaniaCompleted
-
University of Central FloridaFlorida International UniversityActive, not recruitingTransgender Women | Hiv | Substance AbuseUnited States
-
VA Office of Research and DevelopmentYale UniversityCompletedAttendance at Treatment | PTSD, Substance Use, and Attendance at TreatmentUnited States
-
Yale UniversityNational Institute on Drug Abuse (NIDA); US Department of Veterans Affairs; National...Completed
-
University of PennsylvaniaCompleted
-
University of PennsylvaniaActive, not recruitingHypertension and HyperlipidemiaUnited States
-
Yale UniversityNational Institute on Drug Abuse (NIDA); US Department of Veterans Affairs; National...Active, not recruiting