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

Hypertension Clinical Trial

— REDUCE-BP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05030467
• Other study ID #: 2021P002479
• Secondary ID: R01MD014874
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 17116
• Est. completion date: November 1, 2024
• Est. primary completion date: May 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Advocate Health Care	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	12 months
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	12 months
Secondary	Percentage of patients with well-controlled blood pressure	Percentage of patients with well-controlled blood pressure (<140/88mmHg) in the 12-month follow-up period, using values in the EHR from ambulatory care encounters	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	12 months
Secondary	Percentage of patients with guideline-concordant medications	Percentage of patients with guideline-concordant medications ordered in the follow-up period	12 months
Secondary	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
Secondary	Systolic blood pressure differences	Change in the gap in systolic blood pressure between Black and Hispanic/Latino patients and non-Hispanic patients from identification to the end of the 12-month follow-up, measured using values in the EHR from ambulatory care encounters	12 months