Hypertension, Obesity, Pre Hypertension
Conditions
Keywords
Adolescent Hypertension, Adolescent Pre Hypertension, Adolescent Pre Hypertension and Obesity
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.
Interventions
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.
Sponsors
Study design
Eligibility
Inclusion criteria
* Adolescents age 10-17 * Pediatric and Family Medicine Providers
Exclusion criteria
* Pregnant adolescents * Within 12 weeks post partum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Clinical Recognition of Hypertension | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Primary care providers (physicians, physician assistants,nurse practitioners) as of April 2014 were eligible. Providers received a letter inviting them to complete surveys (pre and post intervention). Completing surveys was considered implied consent. Patient consent was waived as no direct contact between patients and study team occurred.
Pre-assignment details
31,579 patients 10-17 years of age with \>=1 BP measurement were assessed for eligibility for the primary analysis. After excluding for non-incident hypertension, and restricting to patients with BPs at \>=3 visits with BP \>=95th percentile who meet case definitions for new onset hypertension, the analytic denominator equals 522.
Participants by arm
| Arm | Count |
|---|---|
| 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. Data is exchanged between the EHR and the CDS that runs the data through algorithms and returns a response with appropriate action to the EHR. The CDS tool, called Peds & TeenBP, 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. | 296 |
| Control Patients in this group will receive usual care from their clinic. The CDS tool will not be activated. | 226 |
| Total | 522 |
Baseline characteristics
| Characteristic | Clincal Decision Support (CDS) | Total | Control |
|---|---|---|---|
| Age, Continuous | 14.5 years STANDARD_DEVIATION 2.1 | 14.5 years STANDARD_DEVIATION 2.1 | 14.4 years STANDARD_DEVIATION 2 |
| Body Mass Index (BMI) Body Mass Index 85-<=95th | 67 Participants | 118 Participants | 51 Participants |
| Body Mass Index (BMI) Body Mass Index <85th | 104 Participants | 172 Participants | 68 Participants |
| Body Mass Index (BMI) Body Mass Index >=95th | 125 Participants | 232 Participants | 107 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 42 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 268 Participants | 480 Participants | 212 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 17 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 50 Participants | 25 Participants |
| Race (NIH/OMB) Black or African American | 53 Participants | 98 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 30 Participants | 16 Participants |
| Race (NIH/OMB) White | 195 Participants | 326 Participants | 131 Participants |
| Region of Enrollment United States | 296 participants | 522 participants | 226 participants |
| Sex: Female, Male Female | 171 Participants | 296 Participants | 125 Participants |
| Sex: Female, Male Male | 125 Participants | 226 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 32 / 296 | 15 / 226 |
| serious Total, serious adverse events | 2 / 296 | 1 / 226 |
Outcome results
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.
Time frame: 6 months
Population: The sample was restricted to patients with BPs at \>=3 visits with BP \>=95th percentile, who were then passively monitored for study endpoints. Patients with a previous HT diagnosis were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Decision Support (CDS) | Participants With Appropriate Lifestyle Referral | 55 Participants |
| Control | Participants With Appropriate Lifestyle Referral | 10 Participants |
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.
Time frame: 6 months
Population: The sample was restricted to patients with BPs at \>=3 visits with BP \>=95th percentile, who were then passively monitored for study endpoints. Patients with a previous HT diagnosis were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Decision Support (CDS) | Participants With Appropriate Workup for Secondary Causes of Hypertension | 29 Participants |
| Control | Participants With Appropriate Workup for Secondary Causes of Hypertension | 10 Participants |
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.
Time frame: 6 months
Population: The sample was restricted to patients with blood pressures at \>=3 visits with blood pressure \>=95th percentile, who were then passively monitored for study endpoints. Patients with a previous hypertension diagnosis were excluded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinical Decision Support (CDS) | Participants With Clinical Recognition of Hypertension | 160 Participants |
| Control | Participants With Clinical Recognition of Hypertension | 51 Participants |