Clinical-Decision Support to Improve Hypertension Care in Primary Care

NCT03404999 | Completed

• 1 other identifier: STU 052015-029
• Study Type: interventional
• Target: 2,803
• Locations: 1 country
• Sites: 1

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. 1.IDENTIFY AND DOCUMENT
2. 2.when a child's blood pressure is elevated, and
3. 3.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
4. 4.ORDER the next action(s) needed per guideline-based recommendations, AND per prior actions taken--including:
5. 5.laboratories and studies per 2017 updated guidelines
6. 6.follow-up interval in primary care
7. 7.referral to nephrology, when indicated, and
8. 8.patient education on diet/lifestyle modification.
9. 9.referral for sleep-apnea testing and treatment, when indicated, and
10. 10.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)

Conditions

Hypertension; Blood Pressure; Overweight and Obesity

Outcome Measures

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.

  4-month time series analysis

Study Arms (1)

clinical decision support activated

EXPERIMENTAL

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

clinical decision support OTHER

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

clinical decision support activated

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Lack of electronic health record
• Measured systolic or diastolic blood pressure \>=90th % for age/sex, or
• \>=120 mmHg systolic or \>=80 mmHg diastolic (whichever is lower)
• Diagnosis/visit for high blood pressure or hypertension in past 2 years
• Taking anti-hypertensive medication

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

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

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hypertension; Overweight; Obesity

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four-month time series trial

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: July 19, 2017
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)