HypertensionNCT05126082
Pediatric Blood Pressure Clinical Decision Support Tool (PedsBP CDS)
A study testing PedsBP CDS in people with Hypertension, run by HealthPartners Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- PedsBP CDS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41,054 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Recognition and Management of Hypertension in Youth: Comparing Approaches for Extending Effective CDS for Use in a Large Rural Health System
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.
Read the 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).
- Conditions
- Hypertension
- Being tested
- PedsBP CDS
- Keywords
- Clinical Decision Support, Hypertension, Cardiovascular Disease
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PedsBP CDSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: PedsBP CDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 6 months of the index primary care encounter at which criteria for incident hypertension were met.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Aug 2022
- Primary completion31 Jan 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 41,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Essentia Health, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Elyse O Kharbanda, MD, MPH, Principal investigator, HealthPartners InstituteCatherine Benziger, MD, MPH, Principal investigator, Essentia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126082
- Sponsor's protocol ID
- EH 20669
- Status last verified
- Jan 2026
- First submitted
- 7 Oct 2021
- Last updated
- 22 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Recognition and Management of Hypertension in Youth: Comparing Approaches for Extending Effective CDS for Use in a Large Rural Health System
- ClinicalTrials.gov ID
- NCT05126082
- Acronym / sponsor ID
- EH 20669
- Conditions
- Hypertension
- Keywords
- Clinical Decision Support, Hypertension, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41,054 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Essentia Health, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Posted 22 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: PedsBP CDSProviders 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. |
| High-Intensity Implementation | Experimental | Behavioral: PedsBP CDSProviders 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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
- have at least one index visit with a primary care provider at a randomized clinic in the intervention period
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PedsBP CDSThe 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. | Behavioural | High-Intensity Implementation, Low-Intensity Implementation |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elyse O Kharbanda, MD, MPH principal investigator
HealthPartners Institute
Catherine Benziger, MD, MPH principal investigator
Essentia Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PedsBP CDS in people with Hypertension, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Remeasurement (time frame: Within the index primary care encounter). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.