Hypertension
Conditions
Keywords
Patient education, Hypertension, Patient activation
Brief summary
The primary aim of the study is to determine if enhanced discharge from the emergency department will improve blood pressure control and self-care management. Enhanced discharge will include a hypertension intervention delivered by a touch-screen kiosk over a three month period.
Detailed description
A targeted sample of patients with uncontrolled blood pressure at the time of their emergency department visit discharge will be randomized into either standard or enhanced discharge. To control for medication effects in achieving blood pressure control, both groups will receive similar blood pressure medication while actively participating in the study.
Interventions
BEHAVIORALPatient education
Patient education on hypertension delivered through a touchscreen kiosk.
Sponsors
Blue Cross Blue Shield of Michigan Foundation
Wayne State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Present with uncontrolled blood pressure to the emergency department (\>140/90 for non-diabetics and \>130/80 for diabetics) * Self-reported history of hypertension
Exclusion criteria
* End-stage renal disease * No history of hypertension * Do not present with uncontrolled blood pressure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure (Systolic) at 180 Days | 180 days | Systolic Blood Pressure (SDB) at 180 days post-discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Activation Measure (PAM) | Baseline | Measure of how actively involved patient is in their medical care. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department Visitation Rate | Baseline to 180 days | Emergency department visits related to hypertension |
| Cost Effectiveness | 180 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention 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. | 71 |
| Control Standard discharge is patient instruction, instructions for follow-up to primary care and medication/prescription. | 68 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 39 | 32 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Intervention | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 67 Participants | 136 Participants |
| Demographics Diabetic Diagnosis : Diabetic | 9 Participants | 12 Participants | 21 Participants |
| Demographics Diabetic Diagnosis : No Diabetic | 62 Participants | 56 Participants | 118 Participants |
| Demographics Education : >=Associate Degree | 9 Participants | 21 Participants | 30 Participants |
| Demographics Education : <=HS/GED | 62 Participants | 47 Participants | 109 Participants |
| Demographics Smoking Behavior : Ever Smoked | 47 Participants | 41 Participants | 88 Participants |
| Demographics Smoking Behavior : Never Smoked | 24 Participants | 27 Participants | 51 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 71 Participants | 68 Participants | 139 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 30 Participants | 38 Participants | 68 Participants |
| Sex: Female, Male Male | 41 Participants | 30 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 71 | 0 / 68 |
| serious Total, serious adverse events | 0 / 71 | 0 / 68 |
Outcome results
Primary
Blood Pressure (Systolic) at 180 Days
Systolic Blood Pressure (SDB) at 180 days post-discharge
Time frame: 180 days
Population: All participants for whom SBP were recorded at 180 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Blood Pressure (Systolic) at 180 Days | 131 mmHg | Standard Deviation 18 |
| Intervention Group | Blood Pressure (Systolic) at 180 Days | 131 mmHg | Standard Deviation 19 |
p-value: <0.00195% CI: [-4.781, 6.906]paired t-test
Secondary
Patient Activation Measure (PAM)
Measure of how actively involved patient is in their medical care.
Time frame: Baseline
Population: Patients discharged from the ED with uncontrolled hypertension assessed for PAM.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Control Group | Patient Activation Measure (PAM) | Control | Level 1 | 3 Participants |
| Control Group | Patient Activation Measure (PAM) | Control | Level 2 | 19 Participants |
| Control Group | Patient Activation Measure (PAM) | Control | Level 3 | 34 Participants |
| Control Group | Patient Activation Measure (PAM) | Control | Level 4 | 7 Participants |
| Control Group | Patient Activation Measure (PAM) | Intervention | Level 1 | 7 Participants |
| Control Group | Patient Activation Measure (PAM) | Intervention | Level 2 | 20 Participants |
| Control Group | Patient Activation Measure (PAM) | Intervention | Level 3 | 27 Participants |
| Control Group | Patient Activation Measure (PAM) | Intervention | Level 4 | 11 Participants |
| Control Group | Patient Activation Measure (PAM) | Total | Level 1 | 10 Participants |
| Control Group | Patient Activation Measure (PAM) | Total | Level 2 | 39 Participants |
| Control Group | Patient Activation Measure (PAM) | Total | Level 3 | 61 Participants |
| Control Group | Patient Activation Measure (PAM) | Total | Level 4 | 18 Participants |
Other Pre-specified
Cost Effectiveness
Time frame: 180 days
Other Pre-specified
Emergency Department Visitation Rate
Emergency department visits related to hypertension
Time frame: Baseline to 180 days