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Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents

Primary Purpose

Hypertension, Pre Hypertension, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Decision Support (CDS)
Sponsored by
HealthPartners Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypertension focused on measuring Adolescent Hypertension, Adolescent Pre Hypertension, Adolescent Pre Hypertension and Obesity

Eligibility Criteria

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

Inclusion Criteria:

  • Adolescents age 10-17
  • Pediatric and Family Medicine Providers

Exclusion Criteria:

  • Pregnant adolescents
  • Within 12 weeks post partum

Sites / Locations

  • HealthPartners Medical Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Clinical Decision Support (CDS)

Control

Arm Description

The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the EHR during any visit to a family practice or pediatric clinic (including both preventive care and sick visits, excluding prenatal and postpartum visits). The algorithm will be embedded in the EHR. In most cases, when a normal BP <90% and <120/80 mm Hg is entered, no alerts will be triggered. In some cases, clinical staff may receive up to two alerts, either to measure height or to repeat a first elevated BP reading. In cases with confirmed elevated BP measures, providers will receive a single CDS message summarizing that patient's current BP status and recommending specific clinical actions.

Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.

Outcomes

Primary Outcome Measures

Participants With Clinical Recognition of Hypertension
Clinical recognition of hypertension as determined by one or more of the following; 1) hypertension or elevated BP as discharge diagnosis, 2) hypertension or elevated BP in the clinical note, 3) hypertension or elevated BP in discharge instructions, 4) hypertension or elevated BP added to the problem list.
Participants With Appropriate Workup for Secondary Causes of Hypertension
Appropriate workup for those with incident hypertension included an initiated workup for secondary causes of hypertension or end organ damage, defined as referral to cardiology, nephrology, or endocrinology, and/or orders for echocardiogram, ECG, or renal ultrasound.
Participants With Appropriate Lifestyle Referral
Appropriate lifestyle referral is defined as referral to dietitian, weight loss, or exercise program within 6 months of meeting criteria for incident hypertension.

Secondary Outcome Measures

Full Information

First Posted
January 2, 2013
Last Updated
October 2, 2019
Sponsor
HealthPartners Institute
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01760239
Brief Title
Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents
Official Title
Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
April 16, 2016 (Actual)
Study Completion Date
April 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this project is to improve detection and management of elevated blood pressure in adolescents. It (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support (CDS) to providers at the point of care, (b) assesses the impact of this intervention on identification and clinical care of hypertension in adolescents, and (c) assesses the impact of the intervention on costs of care.
Detailed Description
Hypertension (HT) during adolescence tracks into adulthood, contributing to adult cardiovascular morbidity and mortality. National guidelines for the diagnosis and treatment of hypertension in children and adolescents were developed by the National High Blood Pressure Education Program (NHBPEP); their Fourth Report was published in 2004. Despite heightened awareness of hypertension in pediatric populations, most adolescents with elevated blood pressure remain clinically unrecognized. Factors that contribute to this gap in care include: the need to translate adolescent blood pressure (BP) measures into blood pressure percentiles on the basis of age, gender, and height, lack of familiarity with National High Blood Pressure Education Program (NHBPEP) clinical guidelines, and competing demands at clinical encounters. Electronic health record (EHR)-based clinical decision support (CDS) can be used to address these barriers and support better care of elevated blood pressure (BP) and Hypertension (HT) in adolescents. In this project, the investigators integrate EHR-extracted data with sophisticated Web-based CDS algorithms to provide patient-specific point-of-care clinical recommendations, in accordance with NHBPEP guidelines. To evaluate the impact of this innovation on quality and cost of care, the investigators randomize 18 clinics with their 130 pediatric care providers (PCP) and their estimated 17,000 adolescent patients to receive or not receive this EHR-based CDS intervention. The investigators hypothesize that the intervention will improve recognition and early management of elevated BP and that short-term increases in outpatient care costs will be offset by longer-term clinical benefits, estimated using established econometric models. This innovative project (a) addresses the under-recognized high-risk patient population of adolescents, (b) integrates EHR and Web-based CDS technology to provide sophisticated patient-specific point-of-care CDS, (c) develops and implements novel and intuitive visual interfaces to communicate CDS recommendations to PCPs, and (d) provides both clinical and cost outcome data useful to clinicians and policymakers. If the EHR-based CDS intervention improves adherence to NHBPEP recommendations, it will provide a much-needed tool to combat the burgeoning problem of rising cardiovascular risk factors in children and adolescents. Further, regardless of outcome, the technology that is developed and tested will provide many useful insights to advance the science of EHR-based CDS. This will, in turn, help translate the massive public and private investments in EHR technology into improved adolescent health outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pre Hypertension, Obesity
Keywords
Adolescent Hypertension, Adolescent Pre Hypertension, Adolescent Pre Hypertension and Obesity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31579 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clinical Decision Support (CDS)
Arm Type
Experimental
Arm Description
The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the EHR during any visit to a family practice or pediatric clinic (including both preventive care and sick visits, excluding prenatal and postpartum visits). The algorithm will be embedded in the EHR. In most cases, when a normal BP <90% and <120/80 mm Hg is entered, no alerts will be triggered. In some cases, clinical staff may receive up to two alerts, either to measure height or to repeat a first elevated BP reading. In cases with confirmed elevated BP measures, providers will receive a single CDS message summarizing that patient's current BP status and recommending specific clinical actions.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
Intervention Type
Behavioral
Intervention Name(s)
Clinical Decision Support (CDS)
Intervention Description
The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the EHR. The CDS tool includes six key features: (i) prompts regarding the need for height data to classify the BP by percentile (ii) prompts to repeat any BP that is ≥90% or ≥120/80 mm Hg (iii) classification of BPs by percentile, including classification of those in pre-HT, stage 1 HT and stage 2 HT range (iv) review of previous HT diagnoses and BPs in order to classify elevated BPs as incident (first or second elevated BP) or persistent (third or greater elevated BP) (v) tailored CDS based on HT category and previous diagnoses (vi) graphical representation of current and historical BP data by age and BP percentile.
Primary Outcome Measure Information:
Title
Participants With Clinical Recognition of Hypertension
Description
Clinical recognition of hypertension as determined by one or more of the following; 1) hypertension or elevated BP as discharge diagnosis, 2) hypertension or elevated BP in the clinical note, 3) hypertension or elevated BP in discharge instructions, 4) hypertension or elevated BP added to the problem list.
Time Frame
6 months
Title
Participants With Appropriate Workup for Secondary Causes of Hypertension
Description
Appropriate workup for those with incident hypertension included an initiated workup for secondary causes of hypertension or end organ damage, defined as referral to cardiology, nephrology, or endocrinology, and/or orders for echocardiogram, ECG, or renal ultrasound.
Time Frame
6 months
Title
Participants With Appropriate Lifestyle Referral
Description
Appropriate lifestyle referral is defined as referral to dietitian, weight loss, or exercise program within 6 months of meeting criteria for incident hypertension.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adolescents age 10-17 Pediatric and Family Medicine Providers Exclusion Criteria: Pregnant adolescents Within 12 weeks post partum
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elyse O Kharbanda, MD
Organizational Affiliation
HealthPartners Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
HealthPartners Medical Group
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55440
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15286277
Citation
National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76. No abstract available.
Results Reference
background
PubMed Identifier
29371241
Citation
Kharbanda EO, Asche SE, Sinaiko AR, Ekstrom HL, Nordin JD, Sherwood NE, Fontaine PL, Dehmer SP, Appana D, O'Connor P. Clinical Decision Support for Recognition and Management of Hypertension: A Randomized Trial. Pediatrics. 2018 Feb;141(2):e20172954. doi: 10.1542/peds.2017-2954.
Results Reference
derived

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Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents

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