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PedsBP Clinical Decision Support Tool

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PedsBP CDS
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Clinical Decision Support, Hypertension, Cardiovascular Disease

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients will be eligible for the PedsBP CDS if

  1. 6-17 years of age
  2. BP measured and entered in the vital sign section during an ambulatory primary care visit in a randomized primary care clinic
  3. not pregnant or postpartum

Patients must meet these eligibility criteria to be included into study analyses:

  1. have at least one index visit with a primary care provider at a randomized clinic in the intervention period
  2. meet eligibility for PedsBP CDS at index visit (a-c above)
  3. no previous HT diagnosis prior to index visit
  4. not taking antihypertensive medication prior to index visit
  5. not opted out of use of their data for research via general consent prior to performing analyses

Primary care providers must meet these eligibility criteria to participate in this study:

  1. practice at a randomized primary care clinic
  2. be a pediatric or family medicine care provider (pediatrician, family physician, nurse practitioner or physician assistant), and
  3. provide ongoing clinical care for children and adolescents

Exclusion Criteria:

Patients will be excluded from analyses if the following criteria are met:

  1. outside of the inclusion age range (<6 years and ≥18 years) at index visit
  2. pregnant or postpartum adolescents during study period
  3. known HT diagnosis or taking antihypertensive medication at index visit
  4. opted out of use of their data for research via general consent prior to performing analyses

Sites / Locations

  • Essentia HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Low-Intensity Implementation

High-Intensity Implementation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Proportion of elevated blood pressure (BP) measurements that are repeated during the same clinic visit
Repeat BP measurement during the same clinic encounter, within 2 hours of an initial BP that is ≥95th percentile for children 6-12 years or ≥130/80 mmHg for adolescents 13-17 years. This must be recorded in the vitals section of the electronic health record (EHR).
Proportion of patients who newly meet clinical criteria for hypertension who are clinically recognized.
Clinical recognition is defined as a new diagnosis of HT (ICD-10: I10) or elevated BP (ICD-10: R03), adding HT or elevated BP to the problem list.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2021
Last Updated
October 16, 2023
Sponsor
HealthPartners Institute
Collaborators
Essentia Health, Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT05126082
Brief Title
PedsBP Clinical Decision Support Tool
Official Title
Improving Recognition and Management of Hypertension in Youth: Comparing Approaches for Extending Effective CDS for Use in a Large Rural Health System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
Essentia Health, Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Clinical Decision Support, Hypertension, Cardiovascular Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
45 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Low-Intensity Implementation
Arm Type
Experimental
Arm Description
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.
Arm Title
High-Intensity Implementation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PedsBP CDS
Intervention Description
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 Outcome Measure Information:
Title
Proportion of elevated blood pressure (BP) measurements that are repeated during the same clinic visit
Description
Repeat BP measurement during the same clinic encounter, within 2 hours of an initial BP that is ≥95th percentile for children 6-12 years or ≥130/80 mmHg for adolescents 13-17 years. This must be recorded in the vitals section of the electronic health record (EHR).
Time Frame
During the same clinic encounter, within 2 hours of the initial elevated BP
Title
Proportion of patients who newly meet clinical criteria for hypertension who are clinically recognized.
Description
Clinical recognition is defined as a new diagnosis of HT (ICD-10: I10) or elevated BP (ICD-10: R03), adding HT or elevated BP to the problem list.
Time Frame
Within 6 months of meeting criteria for hypertension.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients will be eligible for the PedsBP CDS if 6-17 years of age BP measured and entered in the vital sign section during an ambulatory primary care visit in a randomized primary care clinic not pregnant or postpartum Patients must meet these eligibility criteria to be included into study analyses: have at least one index visit with a primary care provider at a randomized clinic in the intervention period meet eligibility for PedsBP CDS at index visit (a-c above) no previous HT diagnosis prior to index visit not taking antihypertensive medication prior to index visit not opted out of use of their data for research via general consent prior to performing analyses Primary care providers must meet these eligibility criteria to participate in this study: practice at a randomized primary care clinic be a pediatric or family medicine care provider (pediatrician, family physician, nurse practitioner or physician assistant), and provide ongoing clinical care for children and adolescents Exclusion Criteria: Patients will be excluded from analyses if the following criteria are met: outside of the inclusion age range (<6 years and ≥18 years) at index visit pregnant or postpartum adolescents during study period known HT diagnosis or taking antihypertensive medication at index visit opted out of use of their data for research via general consent prior to performing analyses
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elyse O Kharbanda, MD, MPH
Phone
952-967-5038
Email
Elyse.O.Kharbanda@HealthPartners.Com
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Benziger, MD, MPH
Phone
218-786-3443
Email
Catherine.Benziger@EssentiaHealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elyse O Kharbanda, MD, MPH
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Benziger, MD, MPH
Organizational Affiliation
Essentia Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Essentia Health
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine P Benziger, MD, MPH
Phone
218-786-3443
Email
catherine.benziger@essentiahealth.org
First Name & Middle Initial & Last Name & Degree
Clayton Allen
Phone
2187863936
Email
clayton.allen@essentiahealth.org
First Name & Middle Initial & Last Name & Degree
Catherine P Benziger, MD, MPH
First Name & Middle Initial & Last Name & Degree
Elyse O Kharbanda, MD, MPH

12. IPD Sharing Statement

Plan to Share IPD
No

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