EHR-Based Clinical Decision Support to Improve BP Management in Adolescents
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| ClinicalTrials.gov Identifier: NCT01760239 |
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Recruitment Status :
Completed
First Posted : January 4, 2013
Last Update Posted : June 12, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypertension Pre Hypertension Obesity | Behavioral: Clinical Decision Support (CDS) | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 529 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | EHR-Based Clinical Decision Support to Improve BP Management in Adolescents |
| Study Start Date : | April 2014 |
| Actual Primary Completion Date : | April 16, 2016 |
| Actual Study Completion Date : | April 16, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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 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.
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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. |
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No Intervention: Control
Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
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- Follow up of an elevated blood pressure within recommended interval [ Time Frame: 1 month ]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 ]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 ]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 ]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 ]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.
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| Ages Eligible for Study: | 10 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Adolescents age 10-17
- Pediatric and Family Medicine Providers
Exclusion Criteria:
- Pregnant adolescents
- Within 12 weeks post partum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760239
| United States, Minnesota | |
| HealthPartners Medical Group | |
| Minneapolis, Minnesota, United States, 55440 | |
| Principal Investigator: | Elyse O Kharbanda, MD | HealthPartners Institute |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | HealthPartners Institute |
| ClinicalTrials.gov Identifier: | NCT01760239 History of Changes |
| Other Study ID Numbers: |
11-090 R01HL115082 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 4, 2013 Key Record Dates |
| Last Update Posted: | June 12, 2017 |
| Last Verified: | June 2017 |
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Adolescent Hypertension Adolescent Pre Hypertension Adolescent Pre Hypertension and Obesity |
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Hypertension Prehypertension Vascular Diseases Cardiovascular Diseases |