Trial Outcomes & Findings for Leveraging Electronic Health Record (EHR) Tools to Reduce Health Disparities for Patients With Uncontrolled Hypertension (NCT NCT05030467)
NCT ID: NCT05030467
Last Updated: 2025-06-06
Results Overview
Change in systolic blood pressure from identification to the end of the 12-month follow-up, using values in the EHR from ambulatory care encounters
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49210 participants
Primary outcome timeframe
12 months
Results posted on
2025-06-06
Participant Flow
24 clinics were randomized to intervention and control (1:1). Patients were identified from EHR data on the basis of their meeting eligibility criteria at the randomized clinics. Providers from these clinics were not directly enrolled in the study. Outcomes were measured at the patient level.
Unit of analysis: Clinics
Participant milestones
| Measure |
Intervention Arm
Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.
REDUCE-BP Intervention: Pre-visit:
Providers in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.
During visit:
Providers will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.
Providers will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.
Post-visit:
Patient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits.
|
Control Arm
Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.
|
|---|---|---|
|
Overall Study
STARTED
|
24747 12
|
24463 12
|
|
Overall Study
COMPLETED
|
24747 12
|
24463 12
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Leveraging Electronic Health Record (EHR) Tools to Reduce Health Disparities for Patients With Uncontrolled Hypertension
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=24747 Participants
Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.
REDUCE-BP Intervention: Pre-visit:
Providers in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.
During visit:
Providers will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.
Providers will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.
Post-visit:
Patient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits.
|
Control Arm
n=24463 Participants
Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.
|
Total
n=49210 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
64.7 years
STANDARD_DEVIATION 12.5 • n=107 Participants
|
64.6 years
STANDARD_DEVIATION 12.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14977 Participants
n=99 Participants
|
14143 Participants
n=107 Participants
|
29120 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9770 Participants
n=99 Participants
|
10320 Participants
n=107 Participants
|
20090 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2922 Participants
n=99 Participants
|
1929 Participants
n=107 Participants
|
4851 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21079 Participants
n=99 Participants
|
21890 Participants
n=107 Participants
|
42969 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
746 Participants
n=99 Participants
|
644 Participants
n=107 Participants
|
1390 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
162 Participants
n=99 Participants
|
213 Participants
n=107 Participants
|
375 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1093 Participants
n=99 Participants
|
1458 Participants
n=107 Participants
|
2551 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
173 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13997 Participants
n=99 Participants
|
10803 Participants
n=107 Participants
|
24800 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
8291 Participants
n=99 Participants
|
11137 Participants
n=107 Participants
|
19428 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
126 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
253 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
905 Participants
n=99 Participants
|
598 Participants
n=107 Participants
|
1503 Participants
n=206 Participants
|
|
Baseline systolic blood pressure
|
145.4 mmHg
STANDARD_DEVIATION 14.3 • n=99 Participants
|
145.3 mmHg
STANDARD_DEVIATION 14.3 • n=107 Participants
|
145.4 mmHg
STANDARD_DEVIATION 14.3 • n=206 Participants
|
|
Baseline diastolic blood pressure
|
80.4 mmHg
STANDARD_DEVIATION 10.8 • n=99 Participants
|
80.6 mmHg
STANDARD_DEVIATION 10.7 • n=107 Participants
|
80.5 mmHg
STANDARD_DEVIATION 10.8 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Patients identified as eligible were included in the analysis
Change in systolic blood pressure from identification to the end of the 12-month follow-up, using values in the EHR from ambulatory care encounters
Outcome measures
| Measure |
Intervention Arm
n=24747 Participants
Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.
REDUCE-BP Intervention: Pre-visit:
Providers in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.
During visit:
Providers will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.
Providers will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.
Post-visit:
Patient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits.
|
Control Arm
n=24463 Participants
Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-11.0 mmHg
Standard Deviation 19.2
|
-11.0 mmHg
Standard Deviation 19.1
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients identified as eligible were included in the analysis
Percentage of patients with well-controlled blood pressure (\<140/90mmHg) in the 12-month follow-up period, using values in the EHR from ambulatory care encounters
Outcome measures
| Measure |
Intervention Arm
n=24747 Participants
Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.
REDUCE-BP Intervention: Pre-visit:
Providers in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.
During visit:
Providers will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.
Providers will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.
Post-visit:
Patient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits.
|
Control Arm
n=24463 Participants
Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.
|
|---|---|---|
|
Percentage of Patients With Well-controlled Blood Pressure
|
16910 Participants
|
16441 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPercentage of patients with intensification of medication in the 12-month follow-up period, defined by addition of therapy or increasing dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPercentage of patients with guideline-concordant medications ordered in the follow-up period
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patient identified as eligible for analysis
Change in diastolic blood pressure from identification to 12-month follow-up, measured using values in the EHR
Outcome measures
| Measure |
Intervention Arm
n=24747 Participants
Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.
REDUCE-BP Intervention: Pre-visit:
Providers in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.
During visit:
Providers will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.
Providers will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.
Post-visit:
Patient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits.
|
Control Arm
n=24463 Participants
Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
-4.4 mmHg
Standard Deviation 10.8
|
-4.3 mmHg
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 12 monthsChange in the gap in systolic blood pressure (SBP) between Black and White patients and Hispanic/Latino and Non-Hispanic/Latino patients from identification to the end of the 12-month follow-up, measured using values in the EHR from ambulatory care encounters
Outcome measures
Outcome data not reported
Adverse Events
Intervention Arm
Serious events: 24 serious events
Other events: 17 other events
Deaths: 3 deaths
Control Arm - Not Collected for the Adverse Event Reporting
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Arm
n=24747 participants at risk
Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.
REDUCE-BP Intervention: Pre-visit:
Providers in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.
During visit:
Providers will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.
Providers will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.
Post-visit:
Patient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits.
|
Control Arm - Not Collected for the Adverse Event Reporting
Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.
Information on control clinic patients was not collected as part of the adverse event reporting.
|
|---|---|---|
|
Blood and lymphatic system disorders
Unrelated SAE
|
0.10%
24/24747 • Number of events 24 • 12 months
Deaths and adverse events are reported for intervention clinic patients who were included in the analyses for the trial; information was not collected on control clinic patients. We used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. For deaths, we identified patient deaths through a retrospective review within the EHR based on reports.
|
—
0/0 • 12 months
Deaths and adverse events are reported for intervention clinic patients who were included in the analyses for the trial; information was not collected on control clinic patients. We used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. For deaths, we identified patient deaths through a retrospective review within the EHR based on reports.
|
Other adverse events
| Measure |
Intervention Arm
n=24747 participants at risk
Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.
REDUCE-BP Intervention: Pre-visit:
Providers in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.
During visit:
Providers will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.
Providers will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.
Post-visit:
Patient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits.
|
Control Arm - Not Collected for the Adverse Event Reporting
Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.
Information on control clinic patients was not collected as part of the adverse event reporting.
|
|---|---|---|
|
Blood and lymphatic system disorders
Unrelated AE
|
0.07%
17/24747 • Number of events 17 • 12 months
Deaths and adverse events are reported for intervention clinic patients who were included in the analyses for the trial; information was not collected on control clinic patients. We used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. For deaths, we identified patient deaths through a retrospective review within the EHR based on reports.
|
—
0/0 • 12 months
Deaths and adverse events are reported for intervention clinic patients who were included in the analyses for the trial; information was not collected on control clinic patients. We used an automatic adverse event reporting system to monitor for any AEs that occurred, which were routinely reviewed by quality and safety specialists at the institution. For deaths, we identified patient deaths through a retrospective review within the EHR based on reports.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place