NCT01760239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31,579

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2017

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

October 22, 2019

Completed
Last Updated

October 22, 2019

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

January 2, 2013

Results QC Date

August 16, 2019

Last Update Submit

October 2, 2019

Conditions

HypertensionPre HypertensionObesity

Keywords

Adolescent HypertensionAdolescent Pre HypertensionAdolescent Pre Hypertension and Obesity

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6 months

Study Arms (2)

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.

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.

Interventions

Clinical Decision Support (CDS)BEHAVIORAL

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.

Clinical Decision Support (CDS)

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Pregnant adolescents
  • Within 12 weeks post partum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Medical Group

Minneapolis, Minnesota, 55440, United States

Location

Related Publications (2)

  • 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.

    PMID: 15286277BACKGROUND

  • 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.

    PMID: 29371241DERIVED

MeSH Terms

Conditions

HypertensionPrehypertensionObesity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Because this study was conducted at a single medical group, generalizability of results to other care delivery systems or patient populations is uncertain.

Results Point of Contact

Title
Elyse Kharbanda, MD MPH
Organization
HealthPartners Institute
Elyse.O.Kharbanda@healthpartners.com
952-967-5038

Study Officials

  • Elyse O Kharbanda, MD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 4, 2013

Study Start

April 1, 2014

Primary Completion

April 16, 2016

Study Completion

April 16, 2017

Last Updated

October 22, 2019

Results First Posted

October 22, 2019

Record last verified: 2017-06

Locations

US(1)