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Pediatric Blood Pressure Clinical Decision Support Tool (PedsBP CDS)

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05126082
Enrollment
41054
Registered
2021-11-18
Start date
2022-08-01
Completion date
2025-07-31
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Clinical Decision Support, Hypertension, Cardiovascular Disease

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.

Detailed description

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).

Interventions

BEHAVIORALPedsBP CDS

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.

Sponsors

HealthPartners Institute
Lead SponsorOTHER
Essentia Health
CollaboratorOTHER
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

Patients will be eligible for the PedsBP CDS if 1. 6-17 years of age 2. BP measured and entered in the vital sign section during an ambulatory primary care visit in a randomized primary care clinic 3. not pregnant or postpartum Patients must meet these eligibility criteria to be included into study analyses: 1. have at least one index visit with a primary care provider at a randomized clinic in the intervention period 2. meet eligibility for PedsBP CDS at index visit (a-c above) 3. no previous HT diagnosis prior to index visit 4. not taking antihypertensive medication prior to index visit 5. 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: 1. practice at a randomized primary care clinic 2. be a pediatric or family medicine care provider (pediatrician, family physician, nurse practitioner or physician assistant), and 3. provide ongoing clinical care for children and adolescents

Exclusion criteria

Patients will be excluded from analyses if the following criteria are met: 1. outside of the inclusion age range (\<6 years and ≥18 years) at index visit 2. pregnant or postpartum adolescents during study period 3. known HT diagnosis or taking antihypertensive medication at index visit 4. opted out of use of their data for research via general consent prior to performing analyses

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure RemeasurementWithin the index primary care encounterNumber 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.
Hypertension RecognitionWithin 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORElyse O Kharbanda, MD, MPH

HealthPartners Institute

PRINCIPAL_INVESTIGATORCatherine Benziger, MD, MPH

Essentia Health

Participant flow

Pre-assignment details

Providers did not give consent and are not included in the enrollment number. Only patient participants were considered enrolled. Patient participants received care in line with the study arm/group assignment of the primary care clinic in which they received care.

Baseline characteristics

Characteristic
Age, Continuous11.7 years
STANDARD_DEVIATION 3.6
Ethnicity (NIH/OMB)
Hispanic or Latino
1034 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39557 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
126 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1423 Participants
Race (NIH/OMB)
Asian
366 Participants
Race (NIH/OMB)
Black or African American
280 Participants
Race (NIH/OMB)
More than one race
157 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
149 Participants
Race (NIH/OMB)
Unknown or Not Reported
399 Participants
Race (NIH/OMB)
White
35874 Participants
Region of Enrollment
United States
15082 participants
Sex: Female, Male
Sex
Female
20484 Participants
Sex: Female, Male
Sex
Male
6096 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 970 / 1890 / 310
other
Total, other adverse events
4 / 977 / 18928 / 310
serious
Total, serious adverse events
0 / 970 / 1890 / 310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026