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Completed

NCT Number: NCT05126082

Pediatric Blood Pressure Clinical Decision Support Tool (PedsBP CDS)

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Essentia Health

Duluth, Minnesota, 55805, United States

About this study

Hypertension (HT) in youth tracks into adulthood, contributing to adult cardiovascular morbidity and mortality. National guidelines for the diagnosis and treatment of HT in children and adolescents were last updated in 2017, with definitions for HT that vary by age. To date, most children and adolescents with elevated blood pressure (BP) or HT are not diagnosed or inadequately treated. Factors that contribute to these deficits in care include: the need to translate pediatric BP measures into BP percentiles, lack of clinician familiarity with pediatric HT guidelines, and competing demands at clinical encounters.

Electronic health record (EHR)-linked clinical decision support (CDS) can be used to address these barriers and improve the identification and management of elevated BP and HT in children and adolescents. In a previous study, the investigators developed, implemented, and evaluated a sophisticated web-based, EHR-linked CDS to provide patient-specific clinical care recommendations in real time and in accordance with national guidelines for BP management in youth. In a 2-year cluster randomized trial in 20 urban and suburban primary care clinics in an integrated health system in Minnesota, the investigators demonstrated that the CDS increased repeat measurement of elevated BP during a visit and more than doubled clinician recognition of HT, while promoting dietitian referrals and additional next steps in care consistent with national guidelines. The CDS system was well accepted by providers and as such, is now standard of care in 55 primary care and 17 subspecialty clinics serving children across our health system. Implementation of this CDS in a new health system is a logical next step, yet optimal strategies for adaptation and implementation of CDS in clinics serving rural populations have not been well described.

In this study, the investigators will implement PedsBP CDS in a large health system with many clinics located in rural regions of Minnesota, Wisconsin and North Dakota. In order to compare approaches to implementation of PedsBP CDS to usual care, the investigators will randomly assign 15 primary care clinics to receive high-intensity implementation (CDS with online and in-person training, and audit-feedback), 15 clinics to receive low-intensity implementation (CDS with online training only), and 15 clinics will continue with usual care (no CDS).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients will be eligible for the PedsBP CDS if

  • 6-17 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

Exclusion criteria

Patients will be excluded from analyses if the following criteria are met:

  • outside of the inclusion age range (<6 years and ≥18 years) at index visit
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Blood Pressure Remeasurement

    Time frame: Within the index primary care encounter

    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.

  2. Hypertension Recognition

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

    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.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Essentia Health

Registry information

Official study title

Improving Recognition and Management of Hypertension in Youth: Comparing Approaches for Extending Effective CDS for Use in a Large Rural Health System

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2021
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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