Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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.
|
| No Intervention: Control Patients in this group will receive usual care from their clinic. The CDS tool will not be activated. |
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Adolescents age 10-17
-
Pediatric and Family Medicine Providers
Exclusion Criteria:
-
Pregnant adolescents
-
Within 12 weeks post partum
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HealthPartners Medical Group | Minneapolis | Minnesota | United States | 55440 |
Sponsors and Collaborators
- HealthPartners Institute
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Principal Investigator: Elyse O Kharbanda, MD, HealthPartners Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- 11-090
- R01HL115082
Study Results
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 Detail | 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. |
| Arm/Group Title | Clincal Decision Support (CDS) | Control |
|---|---|---|
| Arm/Group Description | The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the electronic health record (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, 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-hypertension, stage 1 hypertension and stage 2 hypertension range (iv) review of previous hypertension 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 hypertension category and previous diagnoses (vi) graphical representation of current and historical BP data by age and BP percentile. | Patients in this group will receive usual care from their clinic. The CDS tool will not be activated. |
| Period Title: Overall Study | ||
| STARTED | 17037 | 14542 |
| COMPLETED | 296 | 226 |
| NOT COMPLETED | 16741 | 14316 |
Baseline Characteristics
| Arm/Group Title | Clincal Decision Support (CDS) | Control | Total |
|---|---|---|---|
| Arm/Group Description | 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. | Patients in this group will receive usual care from their clinic. The CDS tool will not be activated. | Total of all reporting groups |
| Overall Participants | 296 | 226 | 522 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
14.5
(2.1)
|
14.4
(2.0)
|
14.5
(2.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
171
57.8%
|
125
55.3%
|
296
56.7%
|
| Male |
125
42.2%
|
101
44.7%
|
226
43.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
28
9.5%
|
14
6.2%
|
42
8%
|
| Not Hispanic or Latino |
268
90.5%
|
212
93.8%
|
480
92%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
9
3%
|
8
3.5%
|
17
3.3%
|
| Asian |
25
8.4%
|
25
11.1%
|
50
9.6%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
0.4%
|
1
0.2%
|
| Black or African American |
53
17.9%
|
45
19.9%
|
98
18.8%
|
| White |
195
65.9%
|
131
58%
|
326
62.5%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
14
4.7%
|
16
7.1%
|
30
5.7%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
296
100%
|
226
100%
|
522
100%
|
| Body Mass Index (BMI) (Count of Participants) | |||
| Body Mass Index <85th |
104
35.1%
|
68
30.1%
|
172
33%
|
| Body Mass Index 85-<=95th |
67
22.6%
|
51
22.6%
|
118
22.6%
|
| Body Mass Index >=95th |
125
42.2%
|
107
47.3%
|
232
44.4%
|
Outcome Measures
| Title | Participants With Clinical Recognition of Hypertension |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Clinical Decision Support (CDS) | Control |
|---|---|---|
| Arm/Group Description | 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. | Patients in this group will receive usual care from their clinic. The CDS tool will not be activated. |
| Measure Participants | 296 | 226 |
| Count of Participants [Participants] |
160
54.1%
|
51
22.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Clinical Decision Support (CDS), Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 4.51 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Participants With Appropriate Workup for Secondary Causes of Hypertension |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Clincal Decision Support (CDS) | Control |
|---|---|---|
| Arm/Group Description | 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. | Patients in this group will receive usual care from their clinic. The CDS tool will not be activated. |
| Measure Participants | 296 | 226 |
| Count of Participants [Participants] |
29
9.8%
|
10
4.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Clinical Decision Support (CDS), Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .046 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 2.36 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Participants With Appropriate Lifestyle Referral |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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/Group Title | Clincal Decision Support (CDS) | Control |
|---|---|---|
| Arm/Group Description | 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. | Patients in this group will receive usual care from their clinic. The CDS tool will not be activated. |
| Measure Participants | 296 | 226 |
| Count of Participants [Participants] |
55
18.6%
|
10
4.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Clinical Decision Support (CDS), Control |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Odds Ratio (OR) |
| Estimated Value | 5.13 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | Safety events were passively monitored every 6 months during the 2 year intervention period. Patients were monitored for events occurring within 3 months of meeting hypertension criteria. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | We conducted passive safety surveillance for patients in control and intervention sites using routinely collected electronic health record data to monitor for potential safety events. Neurological complications were not identified but include increased intracranial pressure, hypertensive encephalopathy, or cerebral edema at any point during the intervention period. Since no cases were identified, they are pooled here for the sake of simplicity. | |||
| Arm/Group Title | Clincal Decision Support (CDS) | Control | ||
| Arm/Group Description | 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. | Patients in this group will receive usual care from their clinic. The CDS tool will not be activated. | ||
All Cause Mortality |
||||
| Clincal Decision Support (CDS) | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Clincal Decision Support (CDS) | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/296 (0.7%) | 1/226 (0.4%) | ||
| Eye disorders | ||||
| Hypertensive retinopathy | 0/296 (0%) | 0/226 (0%) | ||
| Nervous system disorders | ||||
| Neurological complications | 0/296 (0%) | 0/226 (0%) | ||
| Renal and urinary disorders | ||||
| Acute renal failure | 0/296 (0%) | 0/226 (0%) | ||
| Vascular disorders | ||||
| Very high blood pressure | 2/296 (0.7%) | 1/226 (0.4%) | ||
| Stroke/transient ischemic attack (TIA) | 0/296 (0%) | 0/226 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Clincal Decision Support (CDS) | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 32/296 (10.8%) | 15/226 (6.6%) | ||
| Cardiac disorders | ||||
| Left ventricular hypertrophy | 0/296 (0%) | 0/226 (0%) | ||
| General disorders | ||||
| Hospitalization for any cause | 11/296 (3.7%) | 8/226 (3.5%) | ||
| Renal and urinary disorders | ||||
| Elevated serum creatinine | 3/296 (1%) | 3/226 (1.3%) | ||
| Abnormality on renal ultrasound | 0/296 (0%) | 0/226 (0%) | ||
| Surgical and medical procedures | ||||
| Echocardiogram conducted | 7/296 (2.4%) | 1/226 (0.4%) | ||
| Renal ultrasound conducted | 8/296 (2.7%) | 2/226 (0.9%) | ||
| Vascular disorders | ||||
| New medication for hypertension | 3/296 (1%) | 1/226 (0.4%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Elyse Kharbanda, MD MPH |
|---|---|
| Organization | HealthPartners Institute |
| Phone | 952-967-5038 |
| Elyse.O.Kharbanda@healthpartners.com |
- 11-090
- R01HL115082