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

• ClinicalTrials.gov Identifier: NCT01760239
• Recruitment Status: Completed
• First Posted: January 4, 2013
• Results First Posted: October 22, 2019
• Last Update Posted: October 22, 2019
• Sponsor: HealthPartners Institute
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): HealthPartners Institute

Tracking Information

• First Submitted Date: January 2, 2013
• First Posted Date: January 4, 2013
• Results First Submitted Date: August 16, 2019
• Results First Posted Date: October 22, 2019
• Last Update Posted Date: October 22, 2019
• Study Start Date: April 2014
• Actual Primary Completion Date: April 16, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 2, 2019)

• 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.

Original Primary Outcome Measures (submitted: January 3, 2013)

• Follow up of an elevated blood pressure within recommended interval [ Time Frame: 12 months ]
  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: 12 months ]
  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: 12 months ]
  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: 12 months ]
  NHBPEP guidelines recommend exercise and nutritional counseling for adolescents who are overweight or obese and have 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 one 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 new-onset 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 new-onset pre-HT, we will review notes from pediatric or family practice visits up to 6 months following their first BP ≥90% or ≥120/80 mm Hg.
• Costs of Care [ Time Frame: 12 months ]
  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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents
• Official Title: Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic

Condition

• Hypertension
• Pre Hypertension
• Obesity

Intervention

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. 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 Arms

• Experimental: 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.
  Intervention: Behavioral: Clinical Decision Support (CDS)
• No Intervention: Control
  Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.

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.
• 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). pii: e20172954. doi: 10.1542/peds.2017-2954.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 2, 2019): 31579
• Original Estimated Enrollment (submitted: January 3, 2013): 130
• Actual Study Completion Date: April 16, 2017
• Actual Primary Completion Date: April 16, 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnant adolescents
• Within 12 weeks post partum

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 10 Years to 17 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01760239
• Other Study ID Numbers: 11-090; R01HL115082 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: HealthPartners Institute
• Study Sponsor: HealthPartners Institute
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Elyse O Kharbanda, MD; HealthPartners Institute

• PRS Account: HealthPartners Institute
• Verification Date: June 2017