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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the same clinic encounter, within 2 hours of the initial elevated bp
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am not on blood pressure medication before my first visit.
Select...
I have never been diagnosed with hormone therapy before my first visit.
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I am between 6 and 17 years old.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
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.
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Who is running the clinical trial?
Agency for Healthcare Research and Quality (AHRQ)FED
399 Previous Clinical Trials
6,775,848 Total Patients Enrolled
Essentia HealthOTHER
26 Previous Clinical Trials
61,710 Total Patients Enrolled
HealthPartners InstituteLead Sponsor
184 Previous Clinical Trials
3,669,659 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently pregnant or have recently given birth.My blood pressure was recorded during a clinic visit.I currently care for children and adolescents in a clinical setting.I am not on blood pressure medication before my first visit.I have never been diagnosed with hormone therapy before my first visit.I have been diagnosed with high blood pressure or am taking medication for it.I am either younger than 6 or 18 years old or older.I have seen a primary care provider at a clinic involved in the study.I am between 6 and 17 years old.Meet the requirements for the PedsBP CDS at the first visit.
Research Study Groups:
This trial has the following groups:- Group 1: Low-Intensity Implementation
- Group 2: Control
- Group 3: High-Intensity Implementation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are older individuals welcome to enroll in this experiment?
"This particular clinical trial is for children aged 6-17. Out of the 645 clinical trials posted, 55 are for people under 18 and 690 are for those over 65."
Answered by AI
Could I potentially participate in this experiment?
"The hypertension clinical trial, which is looking for around46500 participants, requires patients to be aged 6 to 17."
Answered by AI
Are new participants being admitted into this clinical trial?
"Yes, the information on clinicaltrials.gov suggests that this trial is actively searching for patients. The study was originally posted on 8/1/2022 and was last edited on 10/6/2022. The clinical trial is looking for 46500 participants between 1 sites."
Answered by AI
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