NCT05030467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49,210

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started May 2022

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

May 3, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1 year until next milestone

Results Posted

Study results publicly available

June 6, 2025

Completed
Last Updated

June 6, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

August 26, 2021

Results QC Date

May 2, 2025

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Percentage of Patients With Well-controlled Blood Pressure

    12 months

  • Percentage of Patients With Intensification of Medication

    12 months

  • Percentage of Patients With Guideline-concordant Medications

    12 months

  • Change in Diastolic Blood Pressure

    12 months

  • Systolic Blood Pressure Differences

    12 months

Study Arms (2)

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.

Behavioral: REDUCE-BP Intervention

Control Arm

NO INTERVENTION

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

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.

Intervention Arm

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advocate Health Care

Chicago, Illinois, 60515, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Niteesh Choudhry
Organization
Brigham and Women's Hospial

Study Officials

  • Niteesh K Choudhry, MD, PhD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 26, 2021

First Posted

September 1, 2021

Study Start

May 3, 2022

Primary Completion

May 3, 2024

Study Completion

June 1, 2024

Last Updated

June 6, 2025

Results First Posted

June 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations