Clinical trial NCT03404999: Clinical-Decision Support to Improve Hypertension Care in Primary Care
Official title: Automated Clinical-Decision Support to Improve Hypertension Care Among Overweight Children in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Blood Pressure
Overweight and Obesity
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 2803
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Four-month time series trial
Primary purpose: SCREENING

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: High blood pressure addressed
timeFrame: 4-month time series analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center, Parkland Medical Center, and (pilot took place at Children's Health)
state: Texas
Study officials:
References: