HypertensionNCT01760239

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

A study testing Clinical Decision Support (CDS) in people with Hypertension and Pre Hypertension, run by HealthPartners Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 10 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension, Pre Hypertension, Obesity
What is being tested?: Clinical Decision Support (CDS)
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31,579 participants
Where: 1 siteUnited States
Study dates: Apr 2014to 16 Apr 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Adolescents age 10-17
Pediatric and Family Medicine Providers

Who cannot join

Pregnant adolescents
Within 12 weeks post partum

Trial locations and contacts

1 site in 1 country.

United States1 site

HealthPartners Medical Group
Minneapolis, Minnesota, 55440

Other trials in United States

About this study

Read the 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.

Conditions: Hypertension, Pre Hypertension, Obesity
Being tested: Clinical Decision Support (CDS)
Keywords: Adolescent Hypertension, Adolescent Pre Hypertension, Adolescent Pre Hypertension and Obesity
Medical subject headings: Hypertension, Prehypertension, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clinical Decision Support (CDS)Behavioural
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.

Study groups in NCT01760239
Study group	Role	What they receive
Clinical Decision Support (CDS)	Experimental	The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the EHR during any visit to a family practice or pediatric clinic (including both preventive care and sick visits, excluding prenatal and postpartum visits). The algorithm will be embedded in the EHR. In most cases, when a normal BP <90% and <120/80 mm Hg is entered, no alerts will be triggered. In some cases, clinical staff may receive up to two alerts, either to measure height or to repeat a first elevated BP reading. In cases with confirmed elevated BP measures, providers will receive a single CDS message summarizing that patient's current BP status and recommending specific clinical actions. Receives: Behavioral: Clinical Decision Support (CDS)
Control	No intervention	Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201416 Apr 2017

First posted4 Jan 2013 (estimated)
Study startApr 2014
Primary completion16 Apr 2016
Study completion16 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 31,579 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01760239
Sponsor's protocol ID: 11-090
Other IDs: R01HL115082
Status last verified: Jun 2017
First submitted: 2 Jan 2013
Last updated: 22 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76. No abstract available.
PubMed 15286277
Kharbanda EO, Asche SE, Sinaiko AR, Ekstrom HL, Nordin JD, Sherwood NE, Fontaine PL, Dehmer SP, Appana D, O'Connor P. Clinical Decision Support for Recognition and Management of Hypertension: A Randomized Trial. Pediatrics. 2018 Feb;141(2):e20172954. doi: 10.1542/peds.2017-2954.
PubMed 29371241

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents
ClinicalTrials.gov ID: NCT01760239
Acronym / sponsor ID: 11-090
Conditions: Hypertension, Pre Hypertension, Obesity
Keywords: Adolescent Hypertension, Adolescent Pre Hypertension, Adolescent Pre Hypertension and Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 31,579 participants (actual)
Lead sponsor: HealthPartners InstituteUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Apr 2014
Primary completion: 16 Apr 2016 (actual)
Study completion: 16 Apr 2017 (actual)
First posted: 4 Jan 2013 (estimated)
Results: Posted 22 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Clinical Decision Support (CDS)	Experimental	Behavioral: Clinical 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 during any visit to a family practice or pediatric clinic (including both preventive care and sick visits, excluding prenatal and postpartum visits). The algorithm will be embedded in the EHR. In most cases, when a normal BP <90% and <120/80 mm Hg is entered, no alerts will be triggered. In some cases, clinical staff may receive up to two alerts, either to measure height or to repeat a first elevated BP reading. In cases with confirmed elevated BP measures, providers will receive a single CDS message summarizing that patient's current BP status and recommending specific clinical actions.
Control	No intervention	–Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.

Who may qualify

Ages: 10 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Adolescents age 10-17
Pediatric and Family Medicine Providers

Key exclusion criteria (2 listed)

Pregnant adolescents
Within 12 weeks post partum

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clinical 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. 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.	Behavioural	Clinical Decision Support (CDS)

Primary outcome

Participants With Clinical Recognition of Hypertension
Time frame: 6 months
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.
Participants With Appropriate Workup for Secondary Causes of Hypertension
Time frame: 6 months
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.
Participants With Appropriate Lifestyle Referral
Time frame: 6 months
Appropriate lifestyle referral is defined as referral to dietitian, weight loss, or exercise program within 6 months of meeting criteria for incident hypertension.

Results and safety

Results posted to the registry on 22 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Clincal Decision Support (CDS)	17,037	296
Control	14,542	226

Primary outcome: Participants With Clinical Recognition of Hypertension

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Clinical Decision Support (CDS) n = 296	Control n = 226
Value	160	51

Clinical Decision Support (CDS) vs Control: Odds Ratio (OR): 4.51, p <.001, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Participants With Appropriate Workup for Secondary Causes of Hypertension

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Clincal Decision Support (CDS) n = 296	Control n = 226
Value	29	10

Clincal Decision Support (CDS) vs Control: Odds Ratio (OR): 2.36, p = .046, Mixed Models Analysis

Population analysed: 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.

Primary outcome: Participants With Appropriate Lifestyle Referral

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Clincal Decision Support (CDS) n = 296	Control n = 226
Value	55	10

Clincal Decision Support (CDS) vs Control: Odds Ratio (OR): 5.13, p = .001, Mixed Models Analysis

Adverse events

Time frame: Safety events were passively monitored every 6 months during the 2 year intervention period. Patients were monitored for events occurring within 3 months of meeting hypertension criteria.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Clincal Decision Support (CDS)	2 of 296 (0.7%)	32 of 296 (10.8%)	Not reported
Control	1 of 226 (0.4%)	15 of 226 (6.6%)	Not reported

Limitations and caveats (from the sponsor): Because this study was conducted at a single medical group, generalizability of results to other care delivery systems or patient populations is uncertain.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15286277National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents. The fourth report on the diagnosis, evaluation, and treatment of high blood pressure in children and adolescents. Pediatrics. 2004 Aug;114(2 Suppl 4th Report):555-76. No abstract available.
Derived from this study: PubMed 29371241Kharbanda EO, Asche SE, Sinaiko AR, Ekstrom HL, Nordin JD, Sherwood NE, Fontaine PL, Dehmer SP, Appana D, O'Connor P. Clinical Decision Support for Recognition and Management of Hypertension: A Randomized Trial. Pediatrics. 2018 Feb;141(2):e20172954. doi: 10.1542/peds.2017-2954.

Related trials for Hypertension

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elyse O Kharbanda, MD principal investigator

HealthPartners Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Decision Support (CDS) in people with Hypertension and Pre Hypertension, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participants With Clinical Recognition of Hypertension (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01760239, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2019.