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

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Mass General Brigham

Status

Completed

Conditions

Hypertension
Blood Pressure

Treatments

Behavioral: REDUCE-BP Intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05030467
2021P002479
R01MD014874 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

49,210 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 exclusion criteria will be used.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49,210 participants in 2 patient groups

Intervention Arm
Experimental group
Description:
Providers within the clinics randomized to the intervention arm will receive a variety of EHR-based tools for eligible patients with uncontrolled hypertension.
Treatment:
Behavioral: REDUCE-BP Intervention
Control Arm
No Intervention group
Description:
Providers within the clinics randomized to usual care will receive no EHR tools, except those currently available in clinical practice.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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