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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD014874 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension. |
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| Control Arm | No Intervention | Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REDUCE-BP Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Percentage of Patients With Intensification of Medication |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Niteesh K Choudhry, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Health Care | Chicago | Illinois | 60515 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Arm | Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This is the number of patients who met eligibility criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Patients identified as eligible were included in the analysis | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated SAE | Blood and lymphatic system disorders | Systematic Assessment | All SAEs were deemed unrelated to the intervention |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unrelated AE | Blood and lymphatic system disorders | Systematic Assessment | All AEs were deemed unrelated to the intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Niteesh Choudhry | Brigham and Women's Hospial | 617-278-0930 | nkchoudhry@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 4, 2024 | Apr 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Percentage of patients with intensification of medication in the 12-month follow-up period, defined by addition of therapy or increasing dose. |
| 12 months |
| Percentage of Patients With Guideline-concordant Medications | Percentage of patients with guideline-concordant medications ordered in the follow-up period | 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 | 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 | 12 months |
| BG001 | Control Arm | Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline systolic blood pressure | Mean | Standard Deviation | mmHg |
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| Baseline diastolic blood pressure | Mean | Standard Deviation | mmHg |
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| OG001 | Control Arm | Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice. |
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| Secondary | 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 | Patients identified as eligible were included in the analysis | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | 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. | Not Posted | 12 months | Participants |
| Secondary | Percentage of Patients With Guideline-concordant Medications | Percentage of patients with guideline-concordant medications ordered in the follow-up period | Not Posted | 12 months | Participants |
| Secondary | Change in Diastolic Blood Pressure | Change in diastolic blood pressure from identification to 12-month follow-up, measured using values in the EHR | Patient identified as eligible for analysis | Posted | Mean | Standard Deviation | mmHg | 12 months |
|
|
|
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| Secondary | 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 | Not Posted | 12 months | Participants |
| 3 |
| 24,747 |
| 24 |
| 24,747 |
| 17 |
| 24,747 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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