CClinicalTrials.gg
CompletedNCT03404999Updated May 19, 2020

Clinical-Decision Support to Improve Hypertension Care in Primary Care

An interventional study of clinical decision support in Hypertension, Blood Pressure and Overweight and Obesity, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-05-19.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
2,803
Allocation
Not applicable
Ages
3 Years to 18 Years
Sex
All
01

Study 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)
Read the 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.

02

Conditions studied

  • Hypertension
  • Blood Pressure
  • Overweight and Obesity
03

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
04

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,803 participants (actual)

Study arms

  • Experimental
    clinical decision support activated

    TWO MED ASSIST ALERTS 1. Enter height (when missing) 2. Repeat BP (when high) ONE PROVIDER ALERT 1. BP high \& prior BP/BP%s 2. Defines elev. BP, HTN stage 1-2 with button to enter diagnosis 3. Link to tailored ordersets TAILORED ORDERSETS 1. Elevated BP 1. Button to schedule f-up \<6 m 2. Button for diet/lifestyle counseling/check-out instructions 2. HTN stage 1 1. Buttons to order labs/studies pre-checked for stage 1 recs 2. Button for nephrology referral 3. Button to schedule f-up in 1-2 wk/\<1 m 4. Button for diet/lifestyle counseling/check-out instructions 3. HTN stage 2 1. Buttons to order labs/studies for stage 2 2. Button for nephrology referral (pre-checked) 3. Button to f-up 1 wk 4. Button for diet/lifestyle counseling/check-out instruction

    Other: clinical decision support

Interventions

  • Otherclinical decision support

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

05

What researchers measure

Primary outcomes

  1. High blood pressure addressed

    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.

    Time frame: 4-month time series analysis

06

Study locations

1 site
  • University of Texas Southwestern Medical Center, Parkland Medical Center, and (pilot took place at Children's Health)
    Dallas, Texas 75390, United States
07

References and documents

Individual participant data

Plan to share: No — Data are being obtained under a MU agreement/legal contract

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03404999
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Sponsor
First posted
Jan 19, 2018
Start date
Jul 19, 2017
Primary completion
Nov 20, 2017
Completion
Nov 20, 2017
Last update
May 19, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion