An interventional study of REDUCE-BP Intervention in Hypertension and Blood Pressure, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
A two-arm cluster randomized controlled trial targeting primary care providers will be conducted to evaluate the impact of a multicomponent electronic health record (EHR) intervention on hypertension management. Given the cluster trial design, randomization will be conducted at the site level, and in the intervention sites, all eligible providers will receive the intervention. The intervention consists of enhancing tools already available to primary care providers in the EHR system, including developing and implementing provider disparities dashboards, enhancing electronic decision support, and simplifying self-monitoring orders and communication materials. The intervention aims to improve blood pressure control and reduce health disparities in racial and ethnic minorities. Findings from this trial will provide important insight into whether a multicomponent intervention targeting providers and leveraging health information technology can reduce health disparities.
The goal of this project is to improve existing decision support for hypertension control and to reduce disparities in treatment, consistent with Advocate-specific professional guidelines and quality metrics. To achieve this, a cluster randomized trial will be conducted and evaluated to determine whether health IT tools targeted to providers improve blood pressure control for patients with uncontrolled hypertension.
The primary hypothesis is that a health IT intervention will improve systolic blood pressure (primary outcome), concordance with hypertension guidelines (secondary outcome), diastolic blood pressure (secondary outcome), treatment intensification (secondary outcome), controlled blood pressure (secondary outcome) and systolic blood pressure disparities (secondary outcome) compared with usual care.
Participating clinics will be randomly assigned to one of 2 arms: (a) Arm 1: multicomponent, intervention and (b) Arm 2: usual care (i.e. no intervention). Providers and in each arm will receive the same intervention for up to 24 months after randomization, which will demonstrate the relative effectiveness of each approach as well as its long-term impact on clinical outcomes. Primary care providers in the intervention clinics will receive electronic decision support tools to guide their care of eligible patients. Providers in usual care clinics will receive usual care at Advocate Aurora Health (AAH). Patients will not receive any intervention or outreach independent of their provider or care team. EHR data will be used to implement the EHR tools, identify study subjects, track study progress, and evaluate the effect of the interventions. Patients will only be included in the analysis and will not be directly enrolled or contacted by investigators; we expect at least 2000 patients to be included in the analysis.
6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.
This study's enrollment of 49,210 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.
Browse Hypertension studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
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24 practices will be randomized to either Intervention or Control. We will include in the analysis patients who meet the following Inclusion Criteria:
Exclusion Criteria:
Among these eligible patients, patients included in the primary analysis will be those that had an in-person visit at one of the trial clinics.
Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.
Behavioral: REDUCE-BP Intervention
Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.
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.
Change in Systolic Blood Pressure
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
Time frame: 12 months
Percentage of Patients With Well-controlled Blood Pressure
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
Time frame: 12 months
Percentage of Patients With Intensification of Medication
Percentage of patients with intensification of medication in the 12-month follow-up period, defined by addition of therapy or increasing dose.
Time frame: 12 months
Percentage of Patients With Guideline-concordant Medications
Percentage of patients with guideline-concordant medications ordered in the follow-up period
Time frame: 12 months
Change in Diastolic Blood Pressure
Change in diastolic blood pressure from identification to 12-month follow-up, measured using values in the EHR
Time frame: 12 months
Systolic Blood Pressure Differences
Change 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
Time frame: 12 months
| Milestone | Intervention Arm | Control Arm |
|---|---|---|
| Started | 24747 | 24463 |
| Completed | 24747 | 24463 |
| Not completed | 0 | 0 |
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
| mmHg | Intervention Arm | Control Arm |
|---|---|---|
| Change in Systolic Blood Pressure | -11.0 ± 19.2 | -11.0 ± 19.1 |
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
| Participants | Intervention Arm | Control Arm |
|---|---|---|
| Percentage of Patients With Well-controlled Blood Pressure | 16910 | 16441 |
Percentage of patients with intensification of medication in the 12-month follow-up period, defined by addition of therapy or increasing dose.
Results for this outcome have not been posted.
Percentage of patients with guideline-concordant medications ordered in the follow-up period
Results for this outcome have not been posted.
Change in diastolic blood pressure from identification to 12-month follow-up, measured using values in the EHR
| mmHg | Intervention Arm | Control Arm |
|---|---|---|
| Change in Diastolic Blood Pressure | -4.4 ± 10.8 | -4.3 ± 10.9 |
Change 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
Results for this outcome have not been posted.
Collected over 12 months. Non-serious events are listed at a 0.01% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Arm | 3/24,747 (0%) | 24/24,747 (0.1%) | 17/24,747 (0.1%) |
| Control Arm - Not Collected for the Adverse Event Reporting | — | — | — |
| Event | Intervention Arm | Control Arm - Not Collected for the Adverse Event Reporting |
|---|---|---|
| Unrelated SAEBlood and lymphatic system disorders | 24/24747 | — |
| Event | Intervention Arm | Control Arm - Not Collected for the Adverse Event Reporting |
|---|---|---|
| Unrelated AEBlood and lymphatic system disorders | 17/24747 | — |
This is the number of patients who met eligibility criteria.
| Age, Continuous(years) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 64.6 ± 12.5 | 64.7 ± 12.5 | 64.6 ± 12.5 |
| Sex: Female, Male(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Female | 14977 | 14143 | 29120 |
| Male | 9770 | 10320 | 20090 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 2922 | 1929 | 4851 |
| Not Hispanic or Latino | 21079 | 21890 | 42969 |
| Unknown or Not Reported | 746 | 644 | 1390 |
| Race (NIH/OMB)(Participants) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 162 | 213 | 375 |
| Asian | 1093 | 1458 | 2551 |
| Native Hawaiian or Other Pacific Islander | 173 | 127 | 300 |
| Black or African American | 13997 | 10803 | 24800 |
| White | 8291 | 11137 | 19428 |
| More than one race | 126 | 127 | 253 |
| Unknown or Not Reported | 905 | 598 | 1503 |
| Baseline systolic blood pressure(mmHg) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 145.4 ± 14.3 | 145.3 ± 14.3 | 145.4 ± 14.3 |
| Baseline diastolic blood pressure(mmHg) | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Mean | 80.4 ± 10.8 | 80.6 ± 10.7 | 80.5 ± 10.8 |
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