HypertensionAHEAD2NCT03093532
A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
A study testing ED SBIRT-HTN and PACHT-c in people with Hypertension, run by University of Illinois Chicago.
Trial summary
Effective interventions that can address uncontrolled hypertension, particularly in underrepresented populations that use the emergency department (ED) for primary care, are critically needed. Read more about this study
- Who is it for?
- Ages 30 to 64 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ED SBIRT-HTN and PACHT-c
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 8 Sep 2015to 8 Sep 2017
- 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 30 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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).
- Conditions
- Hypertension
- Being tested
- ED SBIRT-HTN, PACHT-c
- Keywords
- emergency department, stage 2 hypertension, minorities
- Medical subject headings
- Hypertension, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ED SBIRT-HTNOther
Also called Screening,Brief Intervention,Referral for Treatment HTN
Participants in the ED-SBIRT-HTN group will receive the following interventions:
- 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).
PACHT-cOther
Also called Post Acute Care Hypertension Transition Clinic
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | The Usual Care group arm will received pre-printed discharge instructions and an outpatient referral. (This group represents standard of care.) |
| ED SBIRT-HTN | Active comparator | 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). Receives: Other: ED SBIRT-HTN |
| E SBIRT-HTN + PACTH-c | Active comparator | 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. Receives: Other: ED SBIRT-HTN; Other: PACHT-c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Control (BP < 140/90 mmHg) at 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.
Measured: 6 months
Secondary outcomes (3)
Change from Baseline Blood Pressure (Systolic/Diastolic mm Hg) at 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.
Measured: 0, 6 months
Change in Hypertension Knowledge at 6 Months (Hypertension Knowledge Survey)
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.
Measured: 0, 6 months
Change in Treatment Adherence at 6 Months (Modified Morisky Scale)
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.
Measured: 0, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start8 Sep 2015
- Primary completion30 Jul 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Heather Prendergast, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093532
- Sponsor's protocol ID
- 2015-0323
- Other IDs
- R56HL126657
- Acronym
- AHEAD2
- Status last verified
- Apr 2020
- First submitted
- 6 Mar 2017
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities
- ClinicalTrials.gov ID
- NCT03093532
- Acronym / sponsor ID
- AHEAD2 / 2015-0323
- Conditions
- Hypertension
- Keywords
- emergency department, stage 2 hypertension, minorities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 8 Sep 2015 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 28 Mar 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –The Usual Care group arm will received pre-printed discharge instructions and an outpatient referral. (This group represents standard of care.) |
| ED SBIRT-HTN | Active comparator | Other: ED SBIRT-HTNThe 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). |
| E SBIRT-HTN + PACTH-c | Active comparator | Other: ED SBIRT-HTN, Other: PACHT-cParticipants 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. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 SBIRT-HTNAlso: Screening,Brief Intervention,Referral for Treatment HTNParticipants 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 | E SBIRT-HTN + PACTH-c, ED SBIRT-HTN |
| PACHT-cAlso: Post Acute Care Hypertension Transition ClinicParticipants 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 | E SBIRT-HTN + PACTH-c |
Primary outcome
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.
3 secondary outcomes
Change from Baseline Blood Pressure (Systolic/Diastolic mm Hg) at 6 Months
Time frame: 0, 6 months
Change in Hypertension Knowledge at 6 Months (Hypertension Knowledge Survey)
Time frame: 0, 6 months
Change in Treatment Adherence at 6 Months (Modified Morisky Scale)
Time frame: 0, 6 months
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 16 Apr 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing ED SBIRT-HTN and PACHT-c in people with Hypertension, run by University of Illinois Chicago.
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 3 inclusion and 5 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 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Blood Pressure Control (BP < 140/90 mmHg) at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2020.