PedsBP CDS Tool for High Blood Pressure

Overseen By Elyse O Kharbanda, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Must not be taking: Antihypertensives

Disqualifiers: Pregnancy, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve how doctors identify high blood pressure in children, particularly in rural areas with limited access to specialists. It tests a web-based tool called PedsBP CDS, which assists doctors in making better treatment decisions for high blood pressure. The trial includes three groups: one receiving standard care, one with basic access to the tool, and another with enhanced access and training. Children aged 6-17 who have had their blood pressure checked during a regular doctor visit may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions in pediatric healthcare.

Will I have to stop taking my current medications?

If you are currently taking antihypertensive medication (medicine for high blood pressure), you cannot participate in this trial. The trial does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that the PedsBP CDS tool is safe for use in identifying high blood pressure in youth?

Research shows that the PedsBP Clinical Decision Support (CDS) tool safely identifies high blood pressure in children and teens. This online tool connects to electronic health records and has been tested in various settings to ensure smooth and safe operation. It aids doctors in improving the measurement and recognition of high blood pressure.

Studies report no direct negative effects from using the PedsBP CDS tool. They primarily highlight its role in assisting doctors with repeat measurements and accurate diagnosis of high blood pressure. This indicates that the tool is well-tolerated and safe for users.

Since this research involves a decision support tool, it is generally considered safe for participants. The tool helps doctors make better decisions rather than introducing a new drug or invasive procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PedsBP CDS tool for managing high blood pressure in pediatric patients because it offers a cutting-edge approach to clinical decision support. Unlike the conventional treatments that rely solely on healthcare providers' expertise and traditional protocols, the PedsBP tool integrates real-time data to guide treatment decisions. This tool is being tested in two ways: a low-intensity implementation with standard training and a high-intensity implementation featuring enhanced training and regular feedback. These features aim to optimize treatment precision and potentially improve patient outcomes in managing high blood pressure from a young age.

What evidence suggests that the PedsBP CDS tool is effective for identifying high blood pressure in youth?

This trial will evaluate the PedsBP Clinical Decision Support (CDS) tool in various implementation settings. Research has shown that the PedsBP CDS tool effectively identifies high blood pressure in children. One study found that the tool increases the likelihood of healthcare providers taking another blood pressure reading if the first one is high, aiding in early detection. Additionally, 92% of users reported it as helpful for spotting high blood pressure, and 94% agreed it saved time in diagnosing these cases. The tool proves especially useful in rural areas where access to specialists is limited. Overall, the PedsBP CDS tool enables healthcare providers to diagnose high blood pressure in children more accurately and quickly. ^{1 3 4 6 7}

Who Is on the Research Team?

Catherine Benziger, MD, MPH

Principal Investigator

Essentia Health

Elyse O Kharbanda, MD, MPH

Principal Investigator

HealthPartners Institute

Are You a Good Fit for This Trial?

This trial is for children aged 6-17 with high blood pressure, who are not pregnant or postpartum, and have no prior diagnosis of hypertension or use of antihypertensive medication. It's open to patients in certain primary care clinics without a general consent opt-out for research.

Inclusion Criteria

Not opted out of use of their data for research via general consent prior to performing analyses

Not pregnant or postpartum

Primary care providers practice at a randomized primary care clinic

Exclusion Criteria

I am currently pregnant or have recently given birth.

Opted out of use of their data for research via general consent prior to performing analyses

I have been diagnosed with high blood pressure or am taking medication for it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of PedsBP CDS in primary care clinics with varying intensity levels of training and feedback

24 months

Regular clinic visits as per standard care

Follow-up

Participants are monitored for the effectiveness of the CDS tool in recognizing and managing hypertension

6 months

What Are the Treatments Tested in This Trial?

Interventions

• PedsBP CDS

Trial Overview The study tests a web-based tool called PedsBP CDS designed to identify high blood pressure in youth. It will be implemented in rural primary care clinics across three states to see how well it works and the best way to introduce it.

How Is the Trial Designed?

Group I: Low-Intensity Implementation Experimental Treatment 1 Intervention

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.

Group II: High-Intensity Implementation Experimental Treatment 1 Intervention

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.

Group III: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Essentia Health

Collaborator

Trials

27

Recruited

107,000+

Published Research Related to This Trial

The SMART-BP trial is evaluating the effectiveness of a mobile app (SMBP-App) that provides tailored recommendations for blood pressure management compared to standard self-monitoring of blood pressure (SMBP) in 180 patients with hypertension over a 24-week period.

The primary goal is to determine if the SMBP-App can lead to greater reductions in mean home systolic blood pressure and improve medication adherence compared to SMBP alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Monitoring of Blood Pressure and Feed-back Using APP in TReatment of UnconTrolled Hypertension (SMART-BP): A Randomized Clinical Trial. Choi, DJ., Park, JJ., Yoon, M., et al.[2023]

The MeasureBP study group is working to establish evidence-based equivalences between automated blood pressure measurement (BPM) and standardized manual measurements, addressing a significant gap in hypertension management.

By synthesizing existing research and conducting meta-analyses, the study aims to provide clear treatment targets and thresholds for automated BPM, which could enhance the effectiveness of hypertension guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MEthods of ASsessing blood pressUre: identifying thReshold and target valuEs (MeasureBP): a review & study protocol. Blom, KC., Farina, S., Gomez, YH., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05126082

NCT05126082 | PedsBP Clinical Decision Support Tool The goal of the PedsBP CDS research project is to adapt a previously tested web-based clinical decision support tool that appropriately identifies high ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11027719/

Adapting a clinical decision support system to improve ... The PedsBP tool was designed to address barriers in recognizing HTN and has shown that it increases repeat BP measurement after a first hypertensive level BP ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423002161

Adapting a clinical decision support system to improve ... This report focuses on the design and feasibility of adapting and implementing PedsBP in a rural primary care setting.

4. link.springer.com link.springer.com/article/10.1007/s11906-020-01083-9

Clinical Decision Support for the Diagnosis and ... CDS can detect elevated BP or BP-percentile readings at clinic visits, and support clinicians in making a diagnosis, evaluating secondary causes ...

5. publications.aap.org publications.aap.org/pediatrics/article/141/2/e20172954/38080/Clinical-Decision-Support-for-Recognition-and

Clinical Decision Support for Recognition and ... Of those who reported using the CDS, 92% thought it was useful in identifying patients with elevated BP or hypertension, 94% agreed that time ...

6. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.15182

Abstract 15182: Evaluation of an Electronic Clinical ... Study outcomes include repeat BP measurement at an index visit and diagnosis of hypertension within 6 months of meeting clinical criteria.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7450038/

Clinical Decision Support for the Diagnosis and Management ... To review literature from 2016 to 2019 on clinical decision support (CDS) for diagnosis and management of hypertension in children and adults.