search
Back to results

Leveraging Electronic Health Record (EHR) Tools to Reduce Health Disparities for Patients With Uncontrolled Hypertension (REDUCE-BP)

Primary Purpose

Hypertension, Blood Pressure

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REDUCE-BP Intervention
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 exclusion criteria will be used.

Sites / Locations

  • Advocate Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.

Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.

Outcomes

Primary Outcome Measures

Change in systolic blood pressure
Change in systolic blood pressure from randomization to 12-month follow-up, using values in the EHR

Secondary Outcome Measures

Percentage of patients with well-controlled blood pressure
Percentage of patients with well-controlled blood pressure (<140/88mmHg) at 12 months follow-up, using values in the EHR
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
Percentage of patients with guideline-concordant medications
Percentage of patients with guideline-concordant medications ordered in the follow-up period
Clinical encounters
Clinical encounters, using number of office visits, telephone calls and patient portal interactions between AAH primary care providers and patients during the 12-month follow-up period

Full Information

First Posted
August 26, 2021
Last Updated
August 10, 2023
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
search

1. Study Identification

Unique Protocol Identification Number
NCT05030467
Brief Title
Leveraging Electronic Health Record (EHR) Tools to Reduce Health Disparities for Patients With Uncontrolled Hypertension
Acronym
REDUCE-BP
Official Title
Leveraging Electronic Health Record (EHR) Tools to Reduce Health Disparities for Patients With Uncontrolled Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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), and post-visit patient-provider follow-up (tertiary 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. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Blood Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.
Intervention Type
Behavioral
Intervention Name(s)
REDUCE-BP Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in systolic blood pressure
Description
Change in systolic blood pressure from randomization to 12-month follow-up, using values in the EHR
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of patients with well-controlled blood pressure
Description
Percentage of patients with well-controlled blood pressure (<140/88mmHg) at 12 months follow-up, using values in the EHR
Time Frame
12 months
Title
Percentage of patients with intensification of medication
Description
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
Title
Percentage of patients with guideline-concordant medications
Description
Percentage of patients with guideline-concordant medications ordered in the follow-up period
Time Frame
12 months
Title
Clinical encounters
Description
Clinical encounters, using number of office visits, telephone calls and patient portal interactions between AAH primary care providers and patients during the 12-month follow-up period
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
24 practices will be randomized to either Intervention or Control. We will include in the analysis patients who meet the following Inclusion Criteria: 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 Current age 18-85 years 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 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 exclusion criteria will be used.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niteesh K Choudhry, MD, PhD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advocate Health Care
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Leveraging Electronic Health Record (EHR) Tools to Reduce Health Disparities for Patients With Uncontrolled Hypertension

We'll reach out to this number within 24 hrs