Pediatric Blood Pressure Clinical Decision Support Tool (PedsBP CDS)

NCT05126082 | Completed Results DMC

• 1 other identifier: EH 20669
• Study Type: interventional
• Target: 41,054
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the PedsBP CDS research project is to adapt a previously tested web-based clinical decision support tool that appropriately identifies high blood pressure in youth for use in a primarily rural health system and compare approaches to CDS implementation in 45 primary care clinics treating children in 3 upper Midwest states. This project will advance implementation science and address a critical need for youth at risk for cardiovascular disease and with limited access to pediatric subspecialty care.

Conditions

Hypertension

Keywords

Clinical Decision Support; Hypertension; Cardiovascular Disease

Outcome Measures

Primary Outcomes (2)

• Blood Pressure Remeasurement

  Number of participants with blood pressure re-measurement at the index primary care encounter, among those with a first elevated blood pressure at the index primary care encounter.

  Within the index primary care encounter

• Hypertension Recognition

  Number of participants with recognition of hypertension within 6 months of meeting incident hypertension criteria. Clinical recognition of hypertension was based on having a diagnosis of elevated BP (R03) or hypertension (I10, I15) or by having these diagnoses added to the problem list.

  Within 6 months of the index primary care encounter at which criteria for incident hypertension were met.

Study Arms (3)

Control

NO INTERVENTION

Providers and patients in control arm clinics will engage in the current standard of care, without access to the PedsBP clinical decision support tool.

Low-Intensity Implementation

EXPERIMENTAL

Providers and patients in the low-intensity arm will have access to the PedsBP clinical decision support tool and will receive standard training and training resources using the health systems standard training platform.

Behavioral: PedsBP CDS

High-Intensity Implementation

EXPERIMENTAL

Providers and patients in the high-intensity arm will have access to the PedsBP clinical decision support tool and will receive enhanced training and training resources, and regular feedback from the project team regarding CDS use rates.

Behavioral: PedsBP CDS

Interventions

PedsBP CDS BEHAVIORAL

The PedsBP CDS is a sophisticated web-based electronic health record (EHR)-linked tool that can be used to address barriers and improve the identification and management of elevated blood pressure (BP) and hypertension (HT) in children and adolescents by providing patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth.

High-Intensity Implementation; Low-Intensity Implementation

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients will be eligible for the PedsBP CDS if
• years of age
• BP measured and entered in the vital sign section during an ambulatory primary care visit in a randomized primary care clinic
• not pregnant or postpartum
• Patients must meet these eligibility criteria to be included into study analyses:
• have at least one index visit with a primary care provider at a randomized clinic in the intervention period
• meet eligibility for PedsBP CDS at index visit (a-c above)
• no previous HT diagnosis prior to index visit
• not taking antihypertensive medication prior to index visit
• not opted out of use of their data for research via general consent prior to performing analyses
• Primary care providers must meet these eligibility criteria to participate in this study:
• practice at a randomized primary care clinic
• be a pediatric or family medicine care provider (pediatrician, family physician, nurse practitioner or physician assistant), and
• provide ongoing clinical care for children and adolescents

You may not qualify if:

• Patients will be excluded from analyses if the following criteria are met:
• pregnant or postpartum adolescents during study period
• known HT diagnosis or taking antihypertensive medication at index visit
• opted out of use of their data for research via general consent prior to performing analyses

Sponsors & Collaborators

• HealthPartners Institute: lead
• Essentia Health: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Essentia Health

Duluth, Minnesota, 55805, United States

Location

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Limitations and Caveats

The study was conducted in a large, primarily rural health system. Study results may not be generalizable to other health systems, especially those with different structures or urban settings.

Results Point of Contact

• Title: Dr. Elyse Kharbanda
• Organization: HealthPartners Institute

Elyse.O.Kharbanda@HealthPartners.com

952-967-5038

Study Officials

• Elyse O Kharbanda, MD, MPH

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

• Catherine Benziger, MD, MPH

  Essentia Health

  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: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 40 community-based, primary care clinics with the largest number of visits among youth 6-17 years will be balanced and randomly allocated in a 1:1:1 allocation ratio to usual care, low-intensity implementation, or high-intensity implementation of the PedsBP CDS.

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 18, 2021
• Study Start: August 1, 2022
• Primary Completion: January 31, 2025
• Study Completion: July 31, 2025
• Last Updated: January 22, 2026
• Results First Posted: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)