Cardiovascular Diseases, Hypertension, Vascular Diseases
Conditions
Keywords
Emergency Department, Minorities
Brief summary
The proposed project underscores the following: 1) The prevalence of uncontrolled/undiagnosed hypertension (HTN) in underrepresented groups presenting to the ED is alarmingly high, and 2) ED engagement and early risk assessment/stratification is a cost-effective, feasible innovation to help close health disparity gaps in HTN. This proposal involves a two-arm randomized controlled trial of up to 770 patients from the Emergency Department at University of Illinois Hospital with elevated blood pressure (BP). The primary objective is to determine the effectiveness of an emergency department-initiated Educational and Empowerment (E2) intervention with a Post Acute Care Hypertension Consultation (PACHT-c) intervention (arm 2) on the primary outcome of mean systolic blood pressure (SBP) differences between the two trial arms at 6-months post intervention. Secondary objectives include evaluating the effectiveness of this ED education and empowerment intervention on mean SBP and diastolic blood pressure (DBP) differences at 3-months, and mean DBP differences at 6-months.
Detailed description
The study is a single-site randomized controlled trial (RCT) focused on a high-risk ED population with evidence of moderately elevated BP (≥140/90 mmHg) at discharge. ED patients will be recruited and randomized into two arms: 1) usual care (preprinted discharge instructions and 48-72 hour referral to a federally qualified health center (FQHC) or assigned provider as appropriate); 2) ED-initiated E2 intervention program followed by 48-72 hour referral to a FQHC (or assigned health center). Based on the ED population demographics (70% ethnic minorities), the majority of participants will be underrepresented minorities (NHB and Hispanic) and low-income individuals. The investigators propose the following specific aims and hypotheses: Aim 1: Evaluate the effectiveness of an ED-based E2 + PACHT-c intervention (arm 2) on the primary outcome of mean SBP difference at 6-months post-intervention compared to usual care (arm 1). H1: The mean SBP difference (from baseline) will be significantly greater in the E2+ PACHT-c group (arm 2) compared to the usual care group (arm 1) at 6- months post-randomization, i.e., SBP change in arm 2 \> arm 1 at 6-months post-randomization. Aim 2: Evaluate the effectiveness of an ED-based E2 intervention with PACHT-c on the secondary outcome of mean SBP and DBP differences at 3-months, and mean DBP differences at 6 months post-intervention compared to usual care. H2: The mean SBP and DBP differences from baseline to 3- months post-intervention and mean DBP at 6-months post intervention will be significantly greater in the ED-based E2 intervention compared to the usual care group, i.e., SBP and DBP change in arm 2 \> arm 1 at 3 -months post-intervention and DBP change in arm 2 \> arm 1 at 6 -months post-intervention.
Interventions
OTHERHTN Educational Video
The video will educate participants in arm 2 about high BP, how it is diagnosed, and the importance of treating it to prevent secondary complications.
OTHERVisual Echocardiogram Image Clips
Visual clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change their behavior and improve their BP. We have found that real time visualization of cardiac ultrasound images with active discussion of findings is a significant patient motivator and empowerment tool, and was a significant factor in the success of our previous pilot study.
OTHERMobile Health and Remote BP monitoring
All participants randomized to the intervention group will receive an FDA-approved HBPM kit that includes the Nokia wireless (self-inflating) BPM+ monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff and turns on the monitor to measure his/her BP. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.
OTHERPost-Acute Care HTN Transition consultation (PACHT-c)
All participants randomized to the E2 intervention will have a focused consultation with either a clinical pharmacist or an APN. During this consultation, the pharmacist/APN repeats the BP measurement; reviews the screening assessments; and reviews general principles of BP control including nutrition, exercise, and smoking cessation. BP will be managed according to the current published guidelines available at the time of funding regarding initiation of first-line antihypertensive medications. Patients with BP ≥160/100 mmHg may be started on antihypertensive medications by the provider during the consultation if appropriate.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
Research Assistants are blinded to study arm assignment of participant when assessing outcomes measures.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* BP\>=140/90 and \<=180/110 mm Hg at time of discharge from ED * Verbal fluency in English or Spanish * Age 18-75 years
Exclusion criteria
* Unable to verbalize comprehension of study, impaired decision-making or documented dementia * Plans to move from Chicago area within the next year * Pregnant or trying to get pregnant * COVID-19 positive within the past 14 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Systolic Blood Pressure (SBP) Difference at 6 Months Post-intervention Compared to Usual Care. | Baseline, 6 months after baseline | Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Differences at 3 Months Post-intervention Compared to Usual Care. | Baseline, 3 months after baseline | Blood pressure will be collected at two time points (baseline and 3 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures. |
| Diastolic Blood Pressure (DBP) Difference at 6 Months Post-intervention Compared to Usual Care. | Baseline, 6 months after baseline | Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Participants randomized to usual care will receive preprinted discharge instructions on HTN and a 48-72-hour referral to our FQHC (or other community health center if pre-assigned though Illinois Medicaid) to schedule their follow-up appointment (current standard of care) | 285 |
| Educational and Empowerment Intervention Participants receive:
1. HTN Educational Video about high BP, how it is diagnosed, and importance of treatment to prevent secondary complications.
2. Visual Echocardiogram Image Clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change behavior and improve their BP.
3. Mobile Health and Remote BP monitoring- participants receive an FDA-approved home blood pressure monitoring (HBPM) kit that includes the monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.
4. A Post-Acute Care HTN Transition consultation (PACHT-c) with a clinical pharmacist or advanced practice nurse (APN).
Post-Acute Care HTN Transition consultation (PACHT-c): All participants randomized to the E2 intervention will have a focused consultation with either a clinical pharmacist or an APN. During this consultation, the pharmacist/APN repeats the BP measurement; reviews the screening assessments; and reviews general principles of BP control including nutrition, exercise, and smoking cessation. BP will be managed according to the current published guidelines available at the time of funding regarding initiation of first-line antihypertensive medications. Patients with BP ≥160/100 mmHg may be started on antihypertensive medications by the provider during the consultation if appropriate. | 289 |
| Total | 574 |
Baseline characteristics
| Characteristic | Usual Care | Educational and Empowerment Intervention | Total |
|---|---|---|---|
| Age, Continuous | 51.9 years STANDARD_DEVIATION 13 | 50.3 years STANDARD_DEVIATION 11.9 | 51.1 years STANDARD_DEVIATION 12.5 |
| Insurance Medicare/Medicaid | 149 Participants | 135 Participants | 284 Participants |
| Insurance Other | 7 Participants | 8 Participants | 15 Participants |
| Insurance Private | 69 Participants | 85 Participants | 154 Participants |
| Insurance Unknown/Missing | 60 Participants | 61 Participants | 121 Participants |
| Race/Ethnicity, Customized Black | 204 Participants | 209 Participants | 413 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 56 Participants | 59 Participants | 115 Participants |
| Race/Ethnicity, Customized Other | 8 Participants | 11 Participants | 19 Participants |
| Race/Ethnicity, Customized White | 17 Participants | 10 Participants | 27 Participants |
| Sex: Female, Male Female | 162 Participants | 161 Participants | 323 Participants |
| Sex: Female, Male Male | 123 Participants | 128 Participants | 251 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 285 | 0 / 289 |
| other Total, other adverse events | 0 / 285 | 0 / 289 |
| serious Total, serious adverse events | 0 / 285 | 0 / 289 |
Outcome results
Primary
Mean Systolic Blood Pressure (SBP) Difference at 6 Months Post-intervention Compared to Usual Care.
Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.
Time frame: Baseline, 6 months after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Systolic Blood Pressure (SBP) Difference at 6 Months Post-intervention Compared to Usual Care. | -9.2 mmHg | Standard Deviation 24.4 |
| Educational and Empowerment Intervention | Mean Systolic Blood Pressure (SBP) Difference at 6 Months Post-intervention Compared to Usual Care. | -14.0 mmHg | Standard Deviation 19.3 |
Secondary
Diastolic Blood Pressure (DBP) Difference at 6 Months Post-intervention Compared to Usual Care.
Blood pressure will be collected at two time points (baseline and 6 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.
Time frame: Baseline, 6 months after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Diastolic Blood Pressure (DBP) Difference at 6 Months Post-intervention Compared to Usual Care. | -1.3 mmHg | Standard Deviation 14.5 |
| Educational and Empowerment Intervention | Diastolic Blood Pressure (DBP) Difference at 6 Months Post-intervention Compared to Usual Care. | -3.3 mmHg | Standard Deviation 12.1 |
Secondary
Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Differences at 3 Months Post-intervention Compared to Usual Care.
Blood pressure will be collected at two time points (baseline and 3 months). ED-pharmacists and trained research assistants will perform BP measurements using standardized procedures.
Time frame: Baseline, 3 months after baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Differences at 3 Months Post-intervention Compared to Usual Care. | SBP | -9.8 mmHg | Standard Deviation 22.5 |
| Usual Care | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Differences at 3 Months Post-intervention Compared to Usual Care. | DBP | -1.5 mmHg | Standard Deviation 13.4 |
| Educational and Empowerment Intervention | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Differences at 3 Months Post-intervention Compared to Usual Care. | SBP | -14 mmHg | Standard Deviation 20.5 |
| Educational and Empowerment Intervention | Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Differences at 3 Months Post-intervention Compared to Usual Care. | DBP | -2.4 mmHg | Standard Deviation 11.7 |