Blood Pressure, Hypertension
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
24 practices will be randomized to either Intervention or Control. We will include in the analysis patients who meet the following Inclusion Criteria: 1. Medical Group Medical Home Population: 1 visit with Primary Care Physician (PCP) in past 2 years (rolling 24 months) and Patient has a medical group PCP as their EPIC General PCP 2. Current age 18-85 years 3. Hypertension diagnosis on EPIC Problem list OR at least 2 visits (office/telehealth/telephonic) with an encounter diagnosis of hypertension on different dates, with any during the last 24 months (rolling dates) performing provider 4. Latest outpatient/ambulatory (exclude urgent care) systolic blood pressure ≥140 or diastolic blood pressure ≥90 (12 months rolling) (lowest measure if more than one taken at the same time)
Exclusion criteria
* Patients not meeting the inclusion criteria above will not be included in the analysis of the study. No other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Blood Pressure | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Well-controlled Blood Pressure | 12 months | 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 |
| Percentage of Patients With Intensification of Medication | 12 months | Percentage of patients with intensification of medication in the 12-month follow-up period, defined by addition of therapy or increasing dose. |
| Percentage of Patients With Guideline-concordant Medications | 12 months | Percentage of patients with guideline-concordant medications ordered in the follow-up period |
| Change in Diastolic Blood Pressure | 12 months | Change in diastolic blood pressure from identification to 12-month follow-up, measured using values in the EHR |
| Systolic Blood Pressure Differences | 12 months | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24,747 |
| Control Arm Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice. | 24,463 |
| Total | 49,210 |
Baseline characteristics
| Characteristic | Intervention Arm | Control Arm | Total |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 12.5 | 64.7 years STANDARD_DEVIATION 12.5 | 64.6 years STANDARD_DEVIATION 12.5 |
| Baseline diastolic blood pressure | 80.4 mmHg STANDARD_DEVIATION 10.8 | 80.6 mmHg STANDARD_DEVIATION 10.7 | 80.5 mmHg STANDARD_DEVIATION 10.8 |
| Baseline systolic blood pressure | 145.4 mmHg STANDARD_DEVIATION 14.3 | 145.3 mmHg STANDARD_DEVIATION 14.3 | 145.4 mmHg STANDARD_DEVIATION 14.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2922 Participants | 1929 Participants | 4851 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21079 Participants | 21890 Participants | 42969 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 746 Participants | 644 Participants | 1390 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 162 Participants | 213 Participants | 375 Participants |
| Race (NIH/OMB) Asian | 1093 Participants | 1458 Participants | 2551 Participants |
| Race (NIH/OMB) Black or African American | 13997 Participants | 10803 Participants | 24800 Participants |
| Race (NIH/OMB) More than one race | 126 Participants | 127 Participants | 253 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 173 Participants | 127 Participants | 300 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 905 Participants | 598 Participants | 1503 Participants |
| Race (NIH/OMB) White | 8291 Participants | 11137 Participants | 19428 Participants |
| Sex: Female, Male Female | 14977 Participants | 14143 Participants | 29120 Participants |
| Sex: Female, Male Male | 9770 Participants | 10320 Participants | 20090 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 24,747 | 0 / 0 |
| other Total, other adverse events | 17 / 24,747 | 0 / 0 |
| serious Total, serious adverse events | 24 / 24,747 | 0 / 0 |
Outcome results
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
Population: Patients identified as eligible were included in the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change in Systolic Blood Pressure | -11.0 mmHg | Standard Deviation 19.2 |
| Control Arm | Change in Systolic Blood Pressure | -11.0 mmHg | Standard Deviation 19.1 |
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
Population: Patient identified as eligible for analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Change in Diastolic Blood Pressure | -4.4 mmHg | Standard Deviation 10.8 |
| Control Arm | Change in Diastolic Blood Pressure | -4.3 mmHg | Standard Deviation 10.9 |
Percentage of Patients With Guideline-concordant Medications
Percentage of patients with guideline-concordant medications ordered in the follow-up period
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 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
Population: Patients identified as eligible were included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Arm | Percentage of Patients With Well-controlled Blood Pressure | 16910 Participants |
| Control Arm | Percentage of Patients With Well-controlled Blood Pressure | 16441 Participants |
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