Trial Outcomes & Findings for Achieving Blood Pressure Control Through Enhanced Discharge (NCT NCT02069015)
NCT ID: NCT02069015
Last Updated: 2020-12-22
Results Overview
Systolic Blood Pressure (SDB) at 180 days post-discharge
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
139 participants
Primary outcome timeframe
180 days
Results posted on
2020-12-22
Participant Flow
Participant milestones
| Measure |
Enhanced Discharge
Patient education about hypertension delivered through a touch-screen kiosk at 4 time points in addition to standard discharge.
Patient education: Patient education on hypertension delivered through a touchscreen kiosk.
|
Standard Discharge
Standard discharge is patient instruction, instructions for follow-up to primary care and medication/prescription
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
68
|
|
Overall Study
7 Day
|
44
|
45
|
|
Overall Study
30 Day
|
38
|
43
|
|
Overall Study
90 Day
|
32
|
35
|
|
Overall Study
COMPLETED
|
31
|
35
|
|
Overall Study
NOT COMPLETED
|
40
|
33
|
Reasons for withdrawal
| Measure |
Enhanced Discharge
Patient education about hypertension delivered through a touch-screen kiosk at 4 time points in addition to standard discharge.
Patient education: Patient education on hypertension delivered through a touchscreen kiosk.
|
Standard Discharge
Standard discharge is patient instruction, instructions for follow-up to primary care and medication/prescription
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
39
|
32
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Achieving Blood Pressure Control Through Enhanced Discharge
Baseline characteristics by cohort
| Measure |
Intervention
n=71 Participants
Patient education about hypertension delivered through a touch-screen kiosk at 4 time points in addition to standard discharge. Patient education on hypertension delivered through a touchscreen kiosk.
|
Control
n=68 Participants
Standard discharge is patient instruction, instructions for follow-up to primary care and medication/prescription.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
71 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Demographics
Education : <=HS/GED
|
62 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Demographics
Education : >=Associate Degree
|
9 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Demographics
Smoking Behavior : Never Smoked
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Demographics
Smoking Behavior : Ever Smoked
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Demographics
Diabetic Diagnosis : No Diabetic
|
62 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Demographics
Diabetic Diagnosis : Diabetic
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: All participants for whom SBP were recorded at 180 days
Systolic Blood Pressure (SDB) at 180 days post-discharge
Outcome measures
| Measure |
Control Group
n=35 Participants
All participants received hypertensive regimen
|
Intervention Group
n=31 Participants
All participants received hypertensive regimen and education intervention
|
|---|---|---|
|
Blood Pressure (Systolic) at 180 Days
|
131 mmHg
Standard Deviation 18.0
|
131 mmHg
Standard Deviation 19.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Patients discharged from the ED with uncontrolled hypertension assessed for PAM.
Measure of how actively involved patient is in their medical care.
Outcome measures
| Measure |
Control Group
n=128 Participants
All participants received hypertensive regimen
|
Intervention Group
All participants received hypertensive regimen and education intervention
|
|---|---|---|
|
Patient Activation Measure (PAM)
Control · Level 1
|
3 Participants
|
—
|
|
Patient Activation Measure (PAM)
Control · Level 2
|
19 Participants
|
—
|
|
Patient Activation Measure (PAM)
Control · Level 3
|
34 Participants
|
—
|
|
Patient Activation Measure (PAM)
Control · Level 4
|
7 Participants
|
—
|
|
Patient Activation Measure (PAM)
Intervention · Level 1
|
7 Participants
|
—
|
|
Patient Activation Measure (PAM)
Intervention · Level 2
|
20 Participants
|
—
|
|
Patient Activation Measure (PAM)
Intervention · Level 3
|
27 Participants
|
—
|
|
Patient Activation Measure (PAM)
Intervention · Level 4
|
11 Participants
|
—
|
|
Patient Activation Measure (PAM)
Total · Level 1
|
10 Participants
|
—
|
|
Patient Activation Measure (PAM)
Total · Level 2
|
39 Participants
|
—
|
|
Patient Activation Measure (PAM)
Total · Level 3
|
61 Participants
|
—
|
|
Patient Activation Measure (PAM)
Total · Level 4
|
18 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 180 daysEmergency department visits related to hypertension
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 180 daysOutcome measures
Outcome data not reported
Adverse Events
Enhanced Discharge
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Discharge
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place