Trial Outcomes & Findings for Targeting of UnControlled Hypertension in Emergency Department (NCT NCT03749499)
NCT ID: NCT03749499
Last Updated: 2025-06-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
574 participants
Primary outcome timeframe
Baseline, 6 months after baseline
Results posted on
2025-06-18
Participant Flow
Participant milestones
| Measure |
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)
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
285
|
289
|
|
Overall Study
COMPLETED
|
203
|
210
|
|
Overall Study
NOT COMPLETED
|
82
|
79
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting of UnControlled Hypertension in Emergency Department
Baseline characteristics by cohort
| Measure |
Usual Care
n=285 Participants
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)
|
Educational and Empowerment Intervention
n=289 Participants
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.
|
Total
n=574 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 13 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
162 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
323 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
204 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
413 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
56 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Insurance
Private
|
69 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Insurance
Medicare/Medicaid
|
149 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
284 Participants
n=5 Participants
|
|
Insurance
Other
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Insurance
Unknown/Missing
|
60 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months after baselineBlood 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.
Outcome measures
| Measure |
Usual Care
n=203 Participants
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)
|
Educational and Empowerment Intervention
n=210 Participants
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.
|
|---|---|---|
|
Mean Systolic Blood Pressure (SBP) Difference at 6 Months Post-intervention Compared to Usual Care.
|
-9.2 mmHg
Standard Deviation 24.4
|
-14.0 mmHg
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: Baseline, 3 months after baselineBlood 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.
Outcome measures
| Measure |
Usual Care
n=151 Participants
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)
|
Educational and Empowerment Intervention
n=157 Participants
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.
|
|---|---|---|
|
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
|
-14 mmHg
Standard Deviation 20.5
|
|
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
|
-2.4 mmHg
Standard Deviation 11.7
|
SECONDARY outcome
Timeframe: Baseline, 6 months after baselineBlood 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.
Outcome measures
| Measure |
Usual Care
n=203 Participants
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)
|
Educational and Empowerment Intervention
n=210 Participants
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.
|
|---|---|---|
|
Diastolic Blood Pressure (DBP) Difference at 6 Months Post-intervention Compared to Usual Care.
|
-1.3 mmHg
Standard Deviation 14.5
|
-3.3 mmHg
Standard Deviation 12.1
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Educational and Empowerment Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Heather M. Prendergast MD, MS, MPH, Professor, Department of Emergency Medicine
University of Chicago Illinois
Phone: 3124131214
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place