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

41263 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

How does the PedsBP CDS Tool for High Blood Pressure differ from other treatments?

The PedsBP CDS Tool is unique because it likely involves a clinical decision support system that uses automated blood pressure measurement technology, which is different from traditional manual methods. This approach may provide more accurate and consistent blood pressure readings, helping to improve the management of high blood pressure in children. ^{1 2 3 4 5}

What data supports the effectiveness of the PedsBP CDS treatment for high blood pressure?

The PedsBP CDS tool has been shown to help primary care clinicians better recognize high blood pressure in children, which is important for early treatment and reducing future heart disease risk. ^{3 6 7 8 9}

Who Is on the Research Team?

Elyse O Kharbanda, MD, MPH

Principal Investigator

HealthPartners Institute

Catherine Benziger, MD, MPH

Principal Investigator

Essentia Health

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 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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Adapting a clinical decision support system to improve identification of pediatric hypertension in a rural health system: Design of a pragmatic trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

MEthods of ASsessing blood pressUre: identifying thReshold and target valuEs (MeasureBP): a review & study protocol. [2018]

3. Korea (South) 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. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Assessing Data Adequacy for High Blood Pressure Clinical Decision Support: A Quantitative Analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of an Electronic Clinical Decision Support Tool for Incident Elevated BP in Adolescents. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Considerations for simulation-based evaluation of noninvasive blood pressure monitors. [2019]

7. Tunisia pubmed.ncbi.nlm.nih.gov

Prognostic value of ambulatory blood pressure monitoring in treated hypertensive patients. [2023]

8. Portugal pubmed.ncbi.nlm.nih.gov

[Use of spreadsheet for statistical and graphical processing of records from the ambulatory blood pressure monitor Spacelabs 90207]. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Automated Office-Based Blood Pressure Measurement: an Overview and Guidance for Implementation in Primary Care. [2020]