Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents
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| ClinicalTrials.gov Identifier: NCT01760239 |
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Recruitment Status :
Completed
First Posted : January 4, 2013
Results First Posted : October 22, 2019
Last Update Posted : October 22, 2019
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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 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 (Clinical Trial) |
| Actual Enrollment : | 31579 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure 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: 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.
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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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- 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.
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | HealthPartners Institute |
| ClinicalTrials.gov Identifier: | NCT01760239 |
| Other Study ID Numbers: |
11-090 R01HL115082 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 4, 2013 Key Record Dates |
| Results First Posted: | October 22, 2019 |
| Last Update Posted: | October 22, 2019 |
| 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 |