Trial Outcomes & Findings for Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health (NCT NCT03634813)
NCT ID: NCT03634813
Last Updated: 2022-11-17
Results Overview
For the primary analysis, we will estimate the proportion of subjects that had a primary care follow-up visit within 60 days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
60 days
Results posted on
2022-11-17
Participant Flow
Participant milestones
| Measure |
High Blood Pressure Monitoring and Counseling
Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure", which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.
High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)
|
Usual Care
The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.
Usual Care: Usual Care
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
51
|
|
Overall Study
COMPLETED
|
49
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perioperative Blood Pressure Screening to Improve Long-term Cardiovascular Health
Baseline characteristics by cohort
| Measure |
High Blood Pressure Monitoring and Counseling
n=49 Participants
Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure", which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.
High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)
|
Usual Care
n=51 Participants
The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure". They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.
Usual Care: Usual Care
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
64.5 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
64.9 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
80 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
|
1 Participants
n=7 Participants
|
1 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
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
72 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
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 daysFor the primary analysis, we will estimate the proportion of subjects that had a primary care follow-up visit within 60 days
Outcome measures
| Measure |
High Blood Pressure Monitoring and Counseling
n=49 Participants
Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure", which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.
High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)
|
Usual Care
n=51 Participants
The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.
Usual Care: Usual Care
|
|---|---|---|
|
Patients Reporting Primary Care Follow-up
|
36 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: 60 daysPopulation: The overall number of participants analyzed were those successfully reached or whose ehr information enabled determination of the outcome in each arm.
For the primary analysis, we will estimate the proportion reporting new/adjusted hypertension treatment within 60 days. The count of participants is the number of patients for whom it was determined that they had new or adjusted hypertension treatment.
Outcome measures
| Measure |
High Blood Pressure Monitoring and Counseling
n=31 Participants
Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure", which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.
High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)
|
Usual Care
n=36 Participants
The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.
Usual Care: Usual Care
|
|---|---|---|
|
Patients Reporting New/Adjusted Hypertension Treatment.
|
18 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 60 daysPopulation: 61 total patients that completed the questionnaire.
Patient Acceptance/Satisfaction With Blood Pressure Care. A questionnaire was provided to all participants, these data were not intended to be compared between treatment arms. The count of participants is the number of participants that reported they were moderately to very satisfied with their care.
Outcome measures
| Measure |
High Blood Pressure Monitoring and Counseling
n=31 Participants
Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure", which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.
High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)
|
Usual Care
n=30 Participants
The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.
Usual Care: Usual Care
|
|---|---|---|
|
Patient Acceptance/Satisfaction With Blood Pressure Care
|
26 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 yearPopulation: 3 of the devices were not returned.
The proportion of patients demonstrating HBPM elevation was measured. Specific cut-offs for the interpretation of home blood pressure are controversial. The mean home blood pressure threshold was \> 135/85 mmHg as indicating hypertension, in-line with recommendations from the American Heart Association.
Outcome measures
| Measure |
High Blood Pressure Monitoring and Counseling
n=46 Participants
Enrolled patients will be fitted with a HBPM device and instructed in its use. Patients will be asked to return the HBPM device on the morning of surgery. At the same time they receive the HBPM device, they will also be provided with the National Institutes of Health (NIH) booklet called "Your guide on lowering blood pressure", which has several guidelines regarding diet, exercise and lifestyle changes that can be implemented to improve blood pressure control.
High Blood Pressure Monitor: High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)
|
Usual Care
The usual care group will receive brief counseling after the PAT visit which will review their blood pressure readings taken at the clinic and how they compare with the American Heart Association (AHA) blood pressure guidelines. They will be offered the suggestion that they should follow up with their primary care doctor 2-4 weeks after their surgical episode is completed, or at their earliest convenience.
Usual Care: Usual Care
|
|---|---|---|
|
Patients Demonstrating HBPM Elevation.
|
36 Participants
|
—
|
Adverse Events
High Blood Pressure Monitoring and Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
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
Robert B. Schonberger, Director of Clinical Scientist Track Program
Yale School of Medicine
Phone: 203-785-3941
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place