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Clinical-Decision Support to Improve Hypertension Care in Primary Care

Primary Purpose

Hypertension, Blood Pressure, Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
clinical decision support
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypertension

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

clinical decision support activated

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 12, 2018
Last Updated
May 15, 2020
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03404999
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 19, 2017 (Actual)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

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

5. Study Description

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: IDENTIFY AND DOCUMENT when a child's blood pressure is elevated, and 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 ORDER the next action(s) needed per guideline-based recommendations, AND per prior actions taken--including: laboratories and studies per 2017 updated guidelines follow-up interval in primary care referral to nephrology, when indicated, and patient education on diet/lifestyle modification. The investigators are working on improving this system further with addition of orders for: referral for sleep-apnea testing and treatment, when indicated, and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Blood Pressure, Overweight and Obesity

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Four-month time series trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
2803 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clinical decision support activated
Arm Type
Experimental
Arm Description
TWO MED ASSIST ALERTS Enter height (when missing) Repeat BP (when high) ONE PROVIDER ALERT BP high & prior BP/BP%s Defines elev. BP, HTN stage 1-2 with button to enter diagnosis Link to tailored ordersets TAILORED ORDERSETS Elevated BP Button to schedule f-up <6 m Button for diet/lifestyle counseling/check-out instructions HTN stage 1 Buttons to order labs/studies pre-checked for stage 1 recs Button for nephrology referral Button to schedule f-up in 1-2 wk/<1 m Button for diet/lifestyle counseling/check-out instructions HTN stage 2 Buttons to order labs/studies for stage 2 Button for nephrology referral (pre-checked) Button to f-up 1 wk Button for diet/lifestyle counseling/check-out instruction
Intervention Type
Other
Intervention Name(s)
clinical decision support
Intervention Description
Decision support system (see description of hypertension decision support system alerts and order sets for details)
Primary Outcome Measure Information:
Title
High blood pressure addressed
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
University of Texas Southwestern Medical Center, Parkland Medical Center, and (pilot took place at Children's Health)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data are being obtained under a MU agreement/legal contract

Learn more about this trial

Clinical-Decision Support to Improve Hypertension Care in Primary Care

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