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| Name | Class |
|---|---|
| Essentia Health | OTHER |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PedsBP CDS | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Within 6 months of the index primary care encounter at which criteria for incident hypertension were met. |
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Inclusion Criteria:
Patients will be eligible for the PedsBP CDS if
Patients must meet these eligibility criteria to be included into study analyses:
Primary care providers must meet these eligibility criteria to participate in this study:
Exclusion Criteria:
Patients will be excluded from analyses if the following criteria are met:
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| Name | Affiliation | Role |
|---|---|---|
| Elyse O Kharbanda, MD, MPH | HealthPartners Institute | Principal Investigator |
| Catherine Benziger, MD, MPH | Essentia Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essentia Health | Duluth | Minnesota | 55805 | United States |
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Providers did not give consent and are not included in the enrollment number. Only patient participants were considered enrolled. Patient participants received care in line with the study arm/group assignment of the primary care clinic in which they received care.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Primary care clinics were assigned to control arm clinics and will engage in the current standard of care, without access to the PedsBP clinical decision support tool. Providers at those clinics will provide the usual standard of care. |
| FG001 | Low-Intensity Implementation | Primary care clinics in the low-intensity arm will have access to the PedsBP clinical decision support tool and provider and clinic staff will receive standard training and training resources using the health systems standard training platform. PedsBP CDS: 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. |
| FG002 | High-Intensity Implementation | Primary care clinics in the high-intensity arm will have access to the PedsBP clinical decision support tool and providers and clinic staff will receive enhanced training and training resources, and regular feedback from the project team regarding CDS use rates. PedsBP CDS: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline data was not collected on the providers. We report provider actions at the patient level in the outcomes section.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Providers and patients in control arm clinics will engage in the current standard of care, without access to the PedsBP clinical decision support tool. |
| BG001 | Low-Intensity Implementation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This is the subset of patients with elevated blood pressure. | Posted | Number | participants | Within the index primary care encounter |
|
Safety events were passively monitored every 6 months during the 18-month intervention period and 12-month follow up period. Patients were monitored for events occurring within 6 months of index visit newly meeting stage 1 and 2 hypertension criteria.
We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. We did not gather safety information on providers.
Safety data was gathered on all 596 patients who newly met criteria for hypertension.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Providers and patients in control arm clinics will engage in the current standard of care, without access to the PedsBP clinical decision support tool. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Echocardiogram conducted | Surgical and medical procedures | Systematic Assessment |
The study was conducted in a large, primarily rural health system. Study results may not be generalizable to other health systems, especially those with different structures or urban settings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elyse Kharbanda | HealthPartners Institute | 952-967-5038 | Elyse.O.Kharbanda@HealthPartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2025 | May 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
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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.
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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.
PedsBP CDS: 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.
| BG002 | High-Intensity Implementation | 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. PedsBP CDS: 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Unknown Sex: Control: 1 Low: 2 High: 2 | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | High-Intensity Implementation | 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. PedsBP CDS: 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. |
|
|
|
| Primary | 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. | The analytic sample is the subset of patients who newly met criteria for hypertension and had height measured. | Posted | Number | participants | Within 6 months of the index primary care encounter at which criteria for incident hypertension were met. |
|
|
|
|
| 0 |
| 97 |
| 0 |
| 97 |
| 4 |
| 97 |
| EG001 | Low-Intensity Implementation | 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. PedsBP CDS: 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. | 0 | 189 | 0 | 189 | 7 | 189 |
| EG002 | High-Intensity Implementation | 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. PedsBP CDS: 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. | 0 | 310 | 0 | 310 | 28 | 310 |
| Transient Ischemic Attack | Vascular disorders | Systematic Assessment |
|
| Acute Renal Failure | Renal and urinary disorders | Systematic Assessment |
|
| Hypertensive Crisis | Vascular disorders | Systematic Assessment |
|
| Renal Ultrasound Conducted | Surgical and medical procedures | Systematic Assessment |
|
| Hospitalization for any cause | General disorders | Systematic Assessment |
|
| Order for anti-hypertensive medication | Vascular disorders | Systematic Assessment |
|
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| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Generalized linear mixed models (logit link and binomial error distribution) were used to test the effect of the intervention on hypertension recogntion. A planned contrast of the Low vs High study arms was tested in a model that included pre-specified covariates and a random intercept for clinic. The test of the contrast was 2-sided with p<0.05 considered statistically significant. | Mixed Models Analysis | Denominator degrees of freedom for fixed effects in the model take into account the cluster-randomized design. | 0.03 | Adjusted OR | 2.31 | 2-Sided | Superiority |