Clinical-Decision Support to Improve Hypertension Care in Primary Care

Not Applicable

Completed

• Conditions: Overweight and Obesity; Blood Pressure; Hypertension
• Interventions: Other: clinical decision support

• Registration Number: NCT03404999
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study Start: 2017-07-19
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-20
• Study First Submitted: 2018-01-12
• Study First Submitted QC: 2018-01-13
• Study First Posted: 2018-01-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-15
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2803

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
clinical decision support activated	clinical decision support	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

Primary Outcome Measures

Name	Time	Method
High blood pressure addressed	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.

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center, Parkland Medical Center, and (pilot took place at Children's Health); 🇺🇸 Dallas, Texas, United States