Trial record 8 of 22 for:    Open Studies | "Prehypertension"

EHR-Based Clinical Decision Support to Improve BP Management in Adolescents

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by HealthPartners Institute for Education and Research
Sponsor:
Collaborator:
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT01760239
First received: January 2, 2013
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Hypertension
Pre Hypertension
Obesity
Behavioral: CDS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: EHR-Based Clinical Decision Support to Improve BP Management in Adolescents

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute for Education and Research:

Primary Outcome Measures:
  • Follow up of an elevated blood pressure within recommended interval [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    EHR-based CDS will prompt providers to repeat incident elevated BPs at intervals, consistent with NHBPEP guidelines. Specifically, providers will be alerted as follows: (1) any BP >=99% +5 mm Hg (stage 2 HT) requires immediate evaluation (2) First or second BPs >=95% but <99% + 5 mm Hg (stage 1 HT) should be repeated within 1 or 2 weeks, and (3) Any BP >=90% or ≥120/80 mm Hg but <95% (pre-HT) should be repeated within 6 months. While follow-up of pre-HT BPs is clinically important, the long time interval between measurements makes this an impractical study outcome. Therefore, for Hypothesis 1, we measure the proportion of new (first or second) BPs >=95% (stage 1 or stage 2 HT) that are repeated within 30 days.

  • Recognition of HT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The CDS utilizes current and previous BP measurements to alert providers when patients meet definitions for stage 1 HT (three or more BPs >=95% but <99% + 5 mm Hg) and when patients have any BP at the level of stage 2 HT (>=99% + 5 mm Hg). For Hypothesis 2, we will conduct chart reviews for all patients meeting case definitions for stage 1 HT and/or any BP at the level of stage 2 HT and evaluate whether these events were clinically recognized. To compare with previous reports, we define clinical recognition as any of the following within 6 months of the index visit (when the alert was triggered): 1) adding diagnosis of HT (ICD-9 codes 401.x, 405.x) and/or elevated BP (796.2) to the problem list or as a diagnosis code for the visit, 2) initiating a workup for target organ damage and/or secondary causes of HT, (as specified in the NHBPEP Fourth Report), 3) initiating anti-hypertensive medication, or 4) documenting "elevated BP" or "HT" in the assessment portion of the clinical note.

  • Appropriate workup for those with HT [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical work-up of adolescents with HT serves two important purposes, (1) identifies youth with secondary causes of HT, (2) assesses target organ damage and (3) assesses other cardiovascular risk factors. NHBPEP guidelines regarding recommended laboratory and imaging studies for children and adolescents with newly diagnosed HT were developed largely on the basis of expert consensus. Many laboratory and imaging studies are to be considered but not routinely recommended. For our purposes, any lipid or glucose measured within 6 months of a BP >=99% +5 mm Hg or his/her third BP >=95%, will be coded as an appropriate workup.

  • Appropriate Lifestyle Referral [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    NHBPEP guidelines recommend exercise and nutritional counseling for adolescents who are overweight or obese and have persistent pre-HT or HT. The CDS will specifically alert the PCP to recommend exercise and dietary changes or referral to a nutrition health educator for patients with a BMI ≥85% and two or more BP ≥90% or ≥120/80 mm Hg. To assess provision of lifestyle referral, we will conduct chart reviews for all patients meeting criteria for new-onset HT who are overweight or obese and a subset of patients with persistent pre-HT. For patients with HT, we will review notes for all visits to pediatrics or family practice within 6 months of meeting clinical criteria for HT. For patients with persistent pre-HT, we will review notes from pediatric or family practice visits up to 6 months following their second BP ≥90% or ≥120/80 mm Hg.

  • Costs of Care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Total costs include (a) costs of developing and implementing the CDS intervention on the basis of quantification of research staff and clinical staff efforts to develop and implement the intervention, and (b) the costs of medical services attributable to the CDS (captured from insurance claims data). The CDS may induce additional follow-up visits, prescription drugs, and laboratory and radiology services related to diagnostic workup. In measuring costs of care related to the CDS, we will include outpatient services and prescription drug use, occurring within 12 months of the index elevated BP, which would be consistent with NHBPEP Fourth Report recommendations for evaluation of an adolescent with pre-HT or HT. This will allow most relevant costs to be reflected in the difference between the CDS intervention group and the non-intervention group while reducing the possibility that a meaningful difference in costs will fail to be detected due to person-level variation in unrelated costs.


Estimated Enrollment: 130
Study Start Date: January 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CDS
The 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: CDS
The 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.
No Intervention: Control

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 BP percentiles on the basis of age, gender, and height, lack of familiarity with 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 BP and 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.

  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescents age 12-19
  • Pediatric and Family Medicine Providers

Exclusion Criteria:

  • Pregnant adolescents
  • Within 12 weeks post partum
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760239

Contacts
Contact: Elyse O Kharbanda, MD 952-967-5038 elyse.o.kharbanda@healthpartners.com
Contact: Heidi L Ekstrom, MA 952-967-7602 heidi.l.ekstrom@healthpartners.com

Locations
United States, Minnesota
HealthPartners Medical Group Not yet recruiting
Minneapolis, Minnesota, United States, 55440
Principal Investigator: Elyse O Kharbanda, MD         
Sponsors and Collaborators
HealthPartners Institute for Education and Research
Investigators
Principal Investigator: Elyse O Kharbanda, MD HealthPartners Institute for Education and Research
  More Information

Publications:
Responsible Party: HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier: NCT01760239     History of Changes
Other Study ID Numbers: 11-090, R01HL115082
Study First Received: January 2, 2013
Last Updated: October 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by HealthPartners Institute for Education and Research:
Adolescent Hypertension
Adolescent Pre Hypertension
Adolescent Pre Hypertension and Obesity

Additional relevant MeSH terms:
Hypertension
Obesity
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014