Clinical-Decision Support to Improve Hypertension Care in Primary Care

NCT ID: NCT03404999

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2803 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-19
• Study Completion Date: 2017-11-20

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.

Conditions

Hypertension; Blood Pressure; Overweight and Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

clinical decision support

Intervention Type: OTHER

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

Interventions

clinical decision support

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Lack of electronic health record

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU 052015-029

Identifier Type: -

Identifier Source: org_study_id