Trial Outcomes & Findings for Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction (NCT NCT03923790)
NCT ID: NCT03923790
Last Updated: 2022-11-09
Results Overview
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
6 months after enrollment
Results posted on
2022-11-09
Participant Flow
Participant milestones
| Measure |
STOP Model
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
|
Usual Care
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Educational Packet: The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
41
|
|
Overall Study
COMPLETED
|
27
|
17
|
|
Overall Study
NOT COMPLETED
|
15
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction
Baseline characteristics by cohort
| Measure |
STOP Model
n=42 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
|
Usual Care
n=41 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Educational Packet: The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 11.6 • n=99 Participants
|
53.4 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
54.5 years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Number of participants who are insured
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months after enrollmentPopulation: Data for this outcome measure were not collected for 16 in the STOP Model arm and 25 in the Usual Care arm.
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Outcome measures
| Measure |
STOP Model
n=26 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
|
Usual Care
n=16 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Educational Packet: The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
|
|---|---|---|
|
Daytime Ambulatory Systolic Blood Pressure
|
123.6 millimeters of mercury (mmHg)
Standard Deviation 16.7
|
128.3 millimeters of mercury (mmHg)
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for this outcome measure were not collected for 16 in the STOP Model arm and 25 in the Usual Care arm.
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Outcome measures
| Measure |
STOP Model
n=26 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
|
Usual Care
n=16 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Educational Packet: The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
|
|---|---|---|
|
Daytime Ambulatory Diastolic Blood Pressure
|
75.1 millimeters of mercury (mmHg)
Standard Deviation 9.6
|
76.5 millimeters of mercury (mmHg)
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for this outcome measure were not collected for 16 in the STOP Model arm and 29 in the Usual Care arm.
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Outcome measures
| Measure |
STOP Model
n=26 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
|
Usual Care
n=12 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Educational Packet: The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
|
|---|---|---|
|
Night Time Ambulatory Systolic Blood Pressure
|
117.3 millimeters of mercury (mmHg)
Standard Deviation 16
|
119.3 millimeters of mercury (mmHg)
Standard Deviation 19.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for this outcome measure were not collected for 16 in the STOP Model arm and 29 in the Usual Care arm.
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Outcome measures
| Measure |
STOP Model
n=26 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
|
Usual Care
n=12 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Educational Packet: The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
|
|---|---|---|
|
Nighttime Diastolic Blood Pressure
|
69.4 millimeters of mercury (mmHg)
Standard Deviation 8.9
|
68 millimeters of mercury (mmHg)
Standard Deviation 13.7
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data for this outcome measure were not collected for 22 in the STOP Model arm and 29 in the Usual Care arm.
BMI will be calculated from height and weight.
Outcome measures
| Measure |
STOP Model
n=20 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
|
Usual Care
n=12 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Educational Packet: The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
|
|---|---|---|
|
Body Mass Index(BMI)
|
33.8 kilograms/meter^2 (kg/m^2)
Standard Deviation 7.4
|
27.7 kilograms/meter^2 (kg/m^2)
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: 6 monthsRecurrent vascular events include stroke, myocardial infarction, or acute cardiac death.
Outcome measures
| Measure |
STOP Model
n=42 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
|
Usual Care
n=41 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Educational Packet: The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
|
|---|---|---|
|
Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsAcute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care.
Outcome measures
| Measure |
STOP Model
n=42 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
|
Usual Care
n=41 Participants
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Educational Packet: The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
|
|---|---|---|
|
Number of Participants With Acute Healthcare Utilization
|
2 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineOutcome measures
Outcome data not reported
Adverse Events
STOP Model
Serious events: 4 serious events
Other events: 1 other events
Deaths: 1 deaths
Usual Care
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
STOP Model
n=27 participants at risk
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
|
Usual Care
n=17 participants at risk
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Educational Packet: The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
|
|---|---|---|
|
General disorders
Hospitalization
|
7.4%
2/27 • Number of events 2 • 6 months
Mortality data were collected for all participants who were randomized. Serious Adverse Event data and Other (Not Including Serious) Adverse Event data were collected for participants who completed the study.
|
11.8%
2/17 • Number of events 2 • 6 months
Mortality data were collected for all participants who were randomized. Serious Adverse Event data and Other (Not Including Serious) Adverse Event data were collected for participants who completed the study.
|
|
General disorders
Hospitalization due to injury from fall
|
3.7%
1/27 • Number of events 1 • 6 months
Mortality data were collected for all participants who were randomized. Serious Adverse Event data and Other (Not Including Serious) Adverse Event data were collected for participants who completed the study.
|
0.00%
0/17 • 6 months
Mortality data were collected for all participants who were randomized. Serious Adverse Event data and Other (Not Including Serious) Adverse Event data were collected for participants who completed the study.
|
|
General disorders
Death
|
3.7%
1/27 • Number of events 1 • 6 months
Mortality data were collected for all participants who were randomized. Serious Adverse Event data and Other (Not Including Serious) Adverse Event data were collected for participants who completed the study.
|
0.00%
0/17 • 6 months
Mortality data were collected for all participants who were randomized. Serious Adverse Event data and Other (Not Including Serious) Adverse Event data were collected for participants who completed the study.
|
Other adverse events
| Measure |
STOP Model
n=27 participants at risk
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad and will also receive educational messages every other week by phone. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is \< 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.
|
Usual Care
n=17 participants at risk
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Educational Packet: The patient will receive an educational packet.
Phone call at 72 hours by discharge nurse navigator: Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
|
|---|---|---|
|
General disorders
Fall
|
3.7%
1/27 • Number of events 1 • 6 months
Mortality data were collected for all participants who were randomized. Serious Adverse Event data and Other (Not Including Serious) Adverse Event data were collected for participants who completed the study.
|
11.8%
2/17 • Number of events 2 • 6 months
Mortality data were collected for all participants who were randomized. Serious Adverse Event data and Other (Not Including Serious) Adverse Event data were collected for participants who completed the study.
|
Additional Information
Anjail Sharrief, MD, MPH, Associate Professor
The University of Texas Health Science Center at Houston
Phone: 713-500-6538
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place