Trial Outcomes & Findings for Implementing Hypertension Screening Guidelines in Primary Care (NCT NCT03480217)
NCT ID: NCT03480217
Last Updated: 2025-06-13
Results Overview
Patient completed out-of-office BP testing \[ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring (HBPM)\] (either Y/N) per eligible visits were tallied.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1186 participants
Primary outcome timeframe
6 months (Pre-Implementation period)
Results posted on
2025-06-13
Participant Flow
Patients were passively recruited from the electronic health record.
This 2-group, pre-post cluster randomized trial was conducted within a primary care network of 8 practices and 1186 patients (857 intervention; 329 control). Depending on the practice/clinic and the implementation period, patients will receive usual care or care that has been impacted by the multifaceted implementation strategy.
Unit of analysis: clinics
Participant milestones
| Measure |
Intervention Clinics
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive the implementation strategy before the multifaceted implementation strategy had been delivered (i.e., pre-implementation period, no exposure to intervention)
|
Control (Usual Care) Clinics
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to not receive the multifaceted implementation strategy and receive usual care before the implementation period begins (i.e., pre-implementation period, no exposure to intervention)
|
|---|---|---|
|
Pre-Implementation (12 Months)
STARTED
|
456 8
|
139 8
|
|
Pre-Implementation (12 Months)
COMPLETED
|
456 8
|
139 8
|
|
Pre-Implementation (12 Months)
NOT COMPLETED
|
0 0
|
0 0
|
|
Post-Implementation (12 Months)
STARTED
|
401 8
|
190 8
|
|
Post-Implementation (12 Months)
COMPLETED
|
401 8
|
190 8
|
|
Post-Implementation (12 Months)
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementing Hypertension Screening Guidelines in Primary Care
Baseline characteristics by cohort
| Measure |
Intervention Clinics (Pre-Implementation)
n=456 Participants
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive the implementation strategy before the multifaceted implementation strategy had been delivered (i.e., pre-implementation period, no exposure to intervention)
|
Intervention Clinics (Post-Implementation)
n=401 Participants
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive the implementation strategy after the multifaceted implementation strategy had been delivered (i.e., post-implementation period, exposure to intervention)
|
Control (Usual Care) Clinics (Pre-Implementation)
n=139 Participants
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to not receive the multifaceted implementation strategy and receive usual care before the implementation period begins (i.e., pre-implementation period, no exposure to intervention)
|
Control (Usual Care) Clinics (Post-Implementation)
n=190 Participants
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to not receive the multifaceted implementation strategy and receive usual care after the implementation period begins (i.e., post-implementation period, no exposure to intervention)
|
Total
n=1186 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
58.9 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 19.1 • n=4 Participants
|
53.6 years
STANDARD_DEVIATION 15.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
289 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
808 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
378 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
152 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
368 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
70 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
209 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
234 Participants
n=5 Participants
|
209 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
609 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
245 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
317 Participants
n=5 Participants
|
282 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
818 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
456 participants
n=5 Participants
|
401 participants
n=7 Participants
|
139 participants
n=5 Participants
|
190 participants
n=4 Participants
|
1186 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 months (Pre-Implementation period)Patient completed out-of-office BP testing \[ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring (HBPM)\] (either Y/N) per eligible visits were tallied.
Outcome measures
| Measure |
Intervention Clinics
n=529 number of visits
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive the implementation strategy.
Patients receive usual care if they come before the implementation period (pre-implementation period) and receive care that has been impacted by the multifaceted implementation strategy if they attend visits after the implementation period (post-implementation period).
|
Control Clinics
n=149 number of visits
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive usual care.
Patients receive usual care if they come before the implementation period (pre-implementation period) and receive usual care if they attend visits after the implementation period (post-implementation period).
|
|---|---|---|
|
Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Pre-Implementation Period
|
0.6 percentage of visits
|
5.4 percentage of visits
|
PRIMARY outcome
Timeframe: 6 months (Post-Implementation period)Patient completed out-of-office BP testing \[ambulatory blood pressure monitoring (ABPM) or home blood pressure monitoring (HBPM)\] (either Y/N) per eligible visits were tallied.
Outcome measures
| Measure |
Intervention Clinics
n=454 number of visits
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive the implementation strategy.
Patients receive usual care if they come before the implementation period (pre-implementation period) and receive care that has been impacted by the multifaceted implementation strategy if they attend visits after the implementation period (post-implementation period).
|
Control Clinics
n=207 number of visits
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive usual care.
Patients receive usual care if they come before the implementation period (pre-implementation period) and receive usual care if they attend visits after the implementation period (post-implementation period).
|
|---|---|---|
|
Percentage of Patient Visits With Completion of Out-of-office BP Monitoring Within 6 Months of an Eligible Visit During the Post-Implementation Period
|
5.7 percentage of visits
|
4.3 percentage of visits
|
SECONDARY outcome
Timeframe: 6 months (Pre-Implementation period)Primary care clinician ordered out-of-office BP testing \[ABPM or HBPM\] (either Y/N) for eligible visits were tallied.
Outcome measures
| Measure |
Intervention Clinics
n=529 number of visits
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive the implementation strategy.
Patients receive usual care if they come before the implementation period (pre-implementation period) and receive care that has been impacted by the multifaceted implementation strategy if they attend visits after the implementation period (post-implementation period).
|
Control Clinics
n=149 number of visits
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive usual care.
Patients receive usual care if they come before the implementation period (pre-implementation period) and receive usual care if they attend visits after the implementation period (post-implementation period).
|
|---|---|---|
|
Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Pre-Implementation Period
|
2.8 percentage of visits
|
8.7 percentage of visits
|
SECONDARY outcome
Timeframe: 6 months (Post-Implementation period)Primary care clinician ordered out-of-office BP testing \[ABPM or HBPM\] (either Y/N) for eligible visits were tallied.
Outcome measures
| Measure |
Intervention Clinics
n=454 number of visits
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive the implementation strategy.
Patients receive usual care if they come before the implementation period (pre-implementation period) and receive care that has been impacted by the multifaceted implementation strategy if they attend visits after the implementation period (post-implementation period).
|
Control Clinics
n=207 number of visits
Participants are patients with elevated office blood pressure and no prior diagnosis of hypertension who attend primary care visits at clinics that were randomly allocated to receive usual care.
Patients receive usual care if they come before the implementation period (pre-implementation period) and receive usual care if they attend visits after the implementation period (post-implementation period).
|
|---|---|---|
|
Percentage of Patient Visits With Out-of-office BP Monitoring Test Ordered by Clinician During the Post-Implementation Period
|
7.9 percentage of visits
|
9.2 percentage of visits
|
Adverse Events
Intervention Clinics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Clinics
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
Ian Kronish
Center for Behavioral Cardiovascular Health, Columbia University Irving Medical Center
Phone: 212-342-1335
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place