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Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents

Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01760239
Enrollment
31579
Registered
2013-01-04
Start date
2014-04-30
Completion date
2017-04-16
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Obesity, Pre Hypertension

Keywords

Adolescent Hypertension, Adolescent Pre Hypertension, Adolescent Pre Hypertension and Obesity

Brief summary

The goal of this project is to improve detection and management of elevated blood pressure in adolescents. It (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support (CDS) to providers at the point of care, (b) assesses the impact of this intervention on identification and clinical care of hypertension in adolescents, and (c) assesses the impact of the intervention on costs of care.

Detailed description

Hypertension (HT) during adolescence tracks into adulthood, contributing to adult cardiovascular morbidity and mortality. National guidelines for the diagnosis and treatment of hypertension in children and adolescents were developed by the National High Blood Pressure Education Program (NHBPEP); their Fourth Report was published in 2004. Despite heightened awareness of hypertension in pediatric populations, most adolescents with elevated blood pressure remain clinically unrecognized. Factors that contribute to this gap in care include: the need to translate adolescent blood pressure (BP) measures into blood pressure percentiles on the basis of age, gender, and height, lack of familiarity with National High Blood Pressure Education Program (NHBPEP) clinical guidelines, and competing demands at clinical encounters. Electronic health record (EHR)-based clinical decision support (CDS) can be used to address these barriers and support better care of elevated blood pressure (BP) and Hypertension (HT) in adolescents. In this project, the investigators integrate EHR-extracted data with sophisticated Web-based CDS algorithms to provide patient-specific point-of-care clinical recommendations, in accordance with NHBPEP guidelines. To evaluate the impact of this innovation on quality and cost of care, the investigators randomize 18 clinics with their 130 pediatric care providers (PCP) and their estimated 17,000 adolescent patients to receive or not receive this EHR-based CDS intervention. The investigators hypothesize that the intervention will improve recognition and early management of elevated BP and that short-term increases in outpatient care costs will be offset by longer-term clinical benefits, estimated using established econometric models. This innovative project (a) addresses the under-recognized high-risk patient population of adolescents, (b) integrates EHR and Web-based CDS technology to provide sophisticated patient-specific point-of-care CDS, (c) develops and implements novel and intuitive visual interfaces to communicate CDS recommendations to PCPs, and (d) provides both clinical and cost outcome data useful to clinicians and policymakers. If the EHR-based CDS intervention improves adherence to NHBPEP recommendations, it will provide a much-needed tool to combat the burgeoning problem of rising cardiovascular risk factors in children and adolescents. Further, regardless of outcome, the technology that is developed and tested will provide many useful insights to advance the science of EHR-based CDS. This will, in turn, help translate the massive public and private investments in EHR technology into improved adolescent health outcomes.

Interventions

The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the EHR. The CDS tool includes six key features: (i) prompts regarding the need for height data to classify the BP by percentile (ii) prompts to repeat any BP that is ≥90% or ≥120/80 mm Hg (iii) classification of BPs by percentile, including classification of those in pre-HT, stage 1 HT and stage 2 HT range (iv) review of previous HT diagnoses and BPs in order to classify elevated BPs as incident (first or second elevated BP) or persistent (third or greater elevated BP) (v) tailored CDS based on HT category and previous diagnoses (vi) graphical representation of current and historical BP data by age and BP percentile.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
HealthPartners Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Adolescents age 10-17 * Pediatric and Family Medicine Providers

Exclusion criteria

* Pregnant adolescents * Within 12 weeks post partum

Design outcomes

Primary

MeasureTime frameDescription
Participants With Clinical Recognition of Hypertension6 monthsClinical recognition of hypertension as determined by one or more of the following; 1) hypertension or elevated BP as discharge diagnosis, 2) hypertension or elevated BP in the clinical note, 3) hypertension or elevated BP in discharge instructions, 4) hypertension or elevated BP added to the problem list.
Participants With Appropriate Workup for Secondary Causes of Hypertension6 monthsAppropriate workup for those with incident hypertension included an initiated workup for secondary causes of hypertension or end organ damage, defined as referral to cardiology, nephrology, or endocrinology, and/or orders for echocardiogram, ECG, or renal ultrasound.
Participants With Appropriate Lifestyle Referral6 monthsAppropriate lifestyle referral is defined as referral to dietitian, weight loss, or exercise program within 6 months of meeting criteria for incident hypertension.

Countries

United States

Participant flow

Recruitment details

Primary care providers (physicians, physician assistants,nurse practitioners) as of April 2014 were eligible. Providers received a letter inviting them to complete surveys (pre and post intervention). Completing surveys was considered implied consent. Patient consent was waived as no direct contact between patients and study team occurred.

Pre-assignment details

31,579 patients 10-17 years of age with \>=1 BP measurement were assessed for eligibility for the primary analysis. After excluding for non-incident hypertension, and restricting to patients with BPs at \>=3 visits with BP \>=95th percentile who meet case definitions for new onset hypertension, the analytic denominator equals 522.

Participants by arm

ArmCount
Clincal Decision Support (CDS)
The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the EHR. Data is exchanged between the EHR and the CDS that runs the data through algorithms and returns a response with appropriate action to the EHR. The CDS tool, called Peds & TeenBP, includes six key features: (i) prompts regarding the need for height data to classify the BP by percentile (ii) prompts to repeat any BP that is ≥90% or ≥120/80 mm Hg (iii) classification of BPs by percentile, including classification of those in pre-HT, stage 1 HT and stage 2 HT range (iv) review of previous HT diagnoses and BPs in order to classify elevated BPs as incident (first or second elevated BP) or persistent (third or greater elevated BP) (v) tailored CDS based on HT category and previous diagnoses (vi) graphical representation of current and historical BP data by age and BP percentile.
296
Control
Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
226
Total522

Baseline characteristics

CharacteristicClincal Decision Support (CDS)TotalControl
Age, Continuous14.5 years
STANDARD_DEVIATION 2.1
14.5 years
STANDARD_DEVIATION 2.1
14.4 years
STANDARD_DEVIATION 2
Body Mass Index (BMI)
Body Mass Index 85-<=95th
67 Participants118 Participants51 Participants
Body Mass Index (BMI)
Body Mass Index <85th
104 Participants172 Participants68 Participants
Body Mass Index (BMI)
Body Mass Index >=95th
125 Participants232 Participants107 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
28 Participants42 Participants14 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
268 Participants480 Participants212 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
9 Participants17 Participants8 Participants
Race (NIH/OMB)
Asian
25 Participants50 Participants25 Participants
Race (NIH/OMB)
Black or African American
53 Participants98 Participants45 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
14 Participants30 Participants16 Participants
Race (NIH/OMB)
White
195 Participants326 Participants131 Participants
Region of Enrollment
United States
296 participants522 participants226 participants
Sex: Female, Male
Female
171 Participants296 Participants125 Participants
Sex: Female, Male
Male
125 Participants226 Participants101 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
32 / 29615 / 226
serious
Total, serious adverse events
2 / 2961 / 226

Outcome results

Primary

Participants With Appropriate Lifestyle Referral

Appropriate lifestyle referral is defined as referral to dietitian, weight loss, or exercise program within 6 months of meeting criteria for incident hypertension.

Time frame: 6 months

Population: The sample was restricted to patients with BPs at \>=3 visits with BP \>=95th percentile, who were then passively monitored for study endpoints. Patients with a previous HT diagnosis were excluded.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Clinical Decision Support (CDS)Participants With Appropriate Lifestyle Referral55 Participants
ControlParticipants With Appropriate Lifestyle Referral10 Participants
p-value: 0.001Mixed Models Analysis
Primary

Participants With Appropriate Workup for Secondary Causes of Hypertension

Appropriate workup for those with incident hypertension included an initiated workup for secondary causes of hypertension or end organ damage, defined as referral to cardiology, nephrology, or endocrinology, and/or orders for echocardiogram, ECG, or renal ultrasound.

Time frame: 6 months

Population: The sample was restricted to patients with BPs at \>=3 visits with BP \>=95th percentile, who were then passively monitored for study endpoints. Patients with a previous HT diagnosis were excluded.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Clinical Decision Support (CDS)Participants With Appropriate Workup for Secondary Causes of Hypertension29 Participants
ControlParticipants With Appropriate Workup for Secondary Causes of Hypertension10 Participants
p-value: 0.046Mixed Models Analysis
Primary

Participants With Clinical Recognition of Hypertension

Clinical recognition of hypertension as determined by one or more of the following; 1) hypertension or elevated BP as discharge diagnosis, 2) hypertension or elevated BP in the clinical note, 3) hypertension or elevated BP in discharge instructions, 4) hypertension or elevated BP added to the problem list.

Time frame: 6 months

Population: The sample was restricted to patients with blood pressures at \>=3 visits with blood pressure \>=95th percentile, who were then passively monitored for study endpoints. Patients with a previous hypertension diagnosis were excluded.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Clinical Decision Support (CDS)Participants With Clinical Recognition of Hypertension160 Participants
ControlParticipants With Clinical Recognition of Hypertension51 Participants
p-value: <0.001Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026