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Completed

NCT Number: NCT03404999

Clinical-Decision Support to Improve Hypertension Care in Primary Care

Approaches are needed to help primary-care pediatricians address high blood pressure. This study will test whether an electronic health-record-based tool to address high blood pressure is feasible and improves the evaluation and management of high blood pressure in clinical practice. If successful, this approach can be used to address other lifestyle-related and complex health problems (e.g., dyslipidemia and diabetes), then disseminated and used nationwide.

The investigators have developed a new, electronic health-record (EHR)-based tool that is designed to help pediatricians:

1. IDENTIFY AND DOCUMENT

1. when a child's blood pressure is elevated, and 2. whether it has been elevated before--including number of prior elevations to document the correct diagnosis (for example, elevated blood pressure, vs. hypertension stage 1, vs. hypertension stage 2), THEN 2. ORDER the next action(s) needed per guideline-based recommendations, AND per prior actions taken--including:

1. laboratories and studies per 2017 updated guidelines 2. follow-up interval in primary care 3. referral to nephrology, when indicated, and 4. patient education on diet/lifestyle modification.

The investigators are working on improving this system further with addition of orders for:

1. referral for sleep-apnea testing and treatment, when indicated, and 2. blood-pressure medications (for example, initiation, titration, or addition of agents depending on blood-pressure control, comorbid conditions [e.g., diabetes], and risk for pregnancy)

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center, Parkland Medical Center, and (pilot took place at Children's Health)

Dallas, Texas, 75390, United States

About this study

The investigators' data suggest that (1) addressing obesity-related comorbidities (in combination with high BMI/overweight/obesity) and more frequent follow-up are associated with weight-status improvement in overweight (OW) children, (2) that parents rank checking for weight-related health problems as the #1 most important recommended weight-management clinical practice, but that (3) comorbidities are infrequently addressed. Thus, to improve weight status, interventions are needed to improve comorbidity identification, evaluation, and management in primary care. Because the investigators' data suggest that identification of high blood pressure is particularly poor, and that identifying blood-pressure elevations in young children at three separate encounters is complex, they are using existing underutilized data to automate addressing high blood pressure/hypertension in an electronic health record system (EPIC-based), and, if successful, applying the method to other obesity-related comorbidities in primary care.

OF NOTE: in developing and pilot-testing this decision support tool, providers wanted access to it for patients without overweight/obesity. Thus, although the trial was borne out of work in weight-management research, the initial trial will focus on all children irrespective of weight status.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Providers: Pediatric primary care providers practicing at participating clinics that have agreed to have the decision-support system implemented.

Exclusion criteria

for Providers:

  • Lack of electronic health record

Inclusion criteria

for Children:

  • Measured systolic or diastolic blood pressure >=90th % for age/sex, or
  • >=120 mmHg systolic or >=80 mmHg diastolic (whichever is lower)

Exclusion criteria

for Children:

  • Diagnosis/visit for high blood pressure or hypertension in past 2 years
  • Taking anti-hypertensive medication

Treatment and study plan

Clinical Decision Support

Other

Decision support system (see description of hypertension decision support system alerts and order sets for details)

Primary outcomes

  1. High blood pressure addressed

    Time frame: 4-month time series analysis

    Proportion of patients with high blood pressure addressed post decision-support implementation (vs. pre-), defined as proportion of patients with elevated blood pressures or higher who have one or more diagnosis or orders placed to diagnose, evaluate, or manage hypertension. We will compare the slope of the post- vs. pre-implementation periods to examine change in monthly rate of HTN eval/management (indicated elements ordered/patients eligible) related to decision support that are in excess of secular trends in clinical practice. In the post-implementation period, the denominator will be determined by tracking patient-level decision-support fires. In the pre-implementation period, the denominator will be determined by applying the decision-support algorithm to retrospective data in monthly increments to identify patients who would have been eligible.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Automated Clinical-Decision Support to Improve Hypertension Care Among Overweight Children in Primary Care

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 19, 2018
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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