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PedsBP CDS Tool for High Blood Pressure

N/A

Waitlist Available

Led By Elyse O Kharbanda, MD, MPH

Research Sponsored by HealthPartners Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Not taking antihypertensive medication prior to index visit

No previous HT diagnosis prior to index visit

Must not have

Pregnant or postpartum adolescents during study period

Known HT diagnosis or taking antihypertensive medication at index visit

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during the same clinic encounter, within 2 hours of the initial elevated bp

Awards & highlights

No Placebo-Only Group

Summary

This trial will adapt a web-based tool to help primary care doctors identify high blood pressure in youth, and compare how well it works in 45 clinics across 3 states.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a decision support tool rather than medication, traditional side effects are not applicable. However, there may be indirect consequences related to the management changes suggested by the tool.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not on blood pressure medication before my first visit.

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I have never been diagnosed with hormone therapy before my first visit.

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I am between 6 and 17 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently pregnant or have recently given birth.

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

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I am either younger than 6 or 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the same clinic encounter, within 2 hours of the initial elevated bp

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the same clinic encounter, within 2 hours of the initial elevated bp

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the same clinic encounter, within 2 hours of the initial elevated bp for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of elevated blood pressure (BP) measurements that are repeated during the same clinic visit

Proportion of patients who newly meet clinical criteria for hypertension who are clinically recognized.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Low-Intensity ImplementationExperimental Treatment1 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 ImplementationExperimental Treatment1 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: ControlActive Control1 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.

0 / 6Eligibility criteria met