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

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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:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
HealthPartners Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Hypertension
Pre Hypertension
Obesity
Intervention Behavioral: Clinical Decision Support (CDS)
Enrollment 31579
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.
Arm/Group Title Clincal Decision Support (CDS) Control
Hide 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
Arm/Group Title Clincal Decision Support (CDS) Control Total
Hide 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 Number of Baseline Participants 296 226 522
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 296 participants 226 participants 522 participants
14.5  (2.1) 14.4  (2.0) 14.5  (2.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 226 participants 522 participants
Female
171
  57.8%
125
  55.3%
296
  56.7%
Male
125
  42.2%
101
  44.7%
226
  43.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 226 participants 522 participants
Hispanic or Latino
28
   9.5%
14
   6.2%
42
   8.0%
Not Hispanic or Latino
268
  90.5%
212
  93.8%
480
  92.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 226 participants 522 participants
American Indian or Alaska Native
9
   3.0%
8
   3.5%
17
   3.3%
Asian
25
   8.4%
25
  11.1%
50
   9.6%
Native Hawaiian or Other Pacific Islander
0
   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
  58.0%
326
  62.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
14
   4.7%
16
   7.1%
30
   5.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 296 participants 226 participants 522 participants
296 226 522
Body Mass Index (BMI)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 296 participants 226 participants 522 participants
Body Mass Index <85th
104
  35.1%
68
  30.1%
172
  33.0%
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%
1.Primary Outcome
Title Participants With Clinical Recognition of Hypertension
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 296 226
Measure Type: Count of Participants
Unit of Measure: Participants
160
  54.1%
51
  22.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clinical Decision Support (CDS), Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 4.51
Estimation Comments [Not Specified]
2.Primary Outcome
Title Participants With Appropriate Workup for Secondary Causes of Hypertension
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 296 226
Measure Type: Count of Participants
Unit of Measure: Participants
29
   9.8%
10
   4.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clincal Decision Support (CDS), Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .046
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.36
Estimation Comments [Not Specified]
3.Primary Outcome
Title Participants With Appropriate Lifestyle Referral
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 296 226
Measure Type: Count of Participants
Unit of Measure: Participants
55
  18.6%
10
   4.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clincal Decision Support (CDS), Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 5.13
Estimation Comments [Not Specified]
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
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Clincal Decision Support (CDS) Control
Affected / at Risk (%) Affected / at Risk (%)
Total   2/296 (0.68%)   1/226 (0.44%) 
Eye disorders     
Hypertensive retinopathy  [1]  0/296 (0.00%)  0/226 (0.00%) 
Nervous system disorders     
Neurological complications  [2]  0/296 (0.00%)  0/226 (0.00%) 
Renal and urinary disorders     
Acute renal failure  [3]  0/296 (0.00%)  0/226 (0.00%) 
Vascular disorders     
Very high blood pressure  [4]  2/296 (0.68%)  1/226 (0.44%) 
Stroke/transient ischemic attack (TIA)  [5]  0/296 (0.00%)  0/226 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Hypertensive retinopathy at any point during the intervention period.
[2]
Neurologic complications were pooled as none were identified. They include increased intracranial pressure, hypertensive encephalopathy, or cerebral edema at any point during the intervention period.
[3]
Acute renal failure at any point during the intervention period.
[4]
Blood pressure greater than 160/100 at any point in the intervention period.
[5]
Stroke or TIA occurring in any point during the intervention period.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Clincal Decision Support (CDS) Control
Affected / at Risk (%) Affected / at Risk (%)
Total   32/296 (10.81%)   15/226 (6.64%) 
Cardiac disorders     
Left ventricular hypertrophy   0/296 (0.00%)  0/226 (0.00%) 
General disorders     
Hospitalization for any cause   11/296 (3.72%)  8/226 (3.54%) 
Renal and urinary disorders     
Elevated serum creatinine   3/296 (1.01%)  3/226 (1.33%) 
Abnormality on renal ultrasound   0/296 (0.00%)  0/226 (0.00%) 
Surgical and medical procedures     
Echocardiogram conducted   7/296 (2.36%)  1/226 (0.44%) 
Renal ultrasound conducted   8/296 (2.70%)  2/226 (0.88%) 
Vascular disorders     
New medication for hypertension   3/296 (1.01%)  1/226 (0.44%) 
Indicates events were collected by systematic assessment
Because this study was conducted at a single medical group, generalizability of results to other care delivery systems or patient populations is uncertain.
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
Layout table for Results Point of Contact information
Name/Title: Elyse Kharbanda, MD MPH
Organization: HealthPartners Institute
Phone: 952-967-5038
EMail: Elyse.O.Kharbanda@healthpartners.com
Layout table for additonal information
Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT01760239    
Other Study ID Numbers: 11-090
R01HL115082 ( U.S. NIH Grant/Contract )
First Submitted: January 2, 2013
First Posted: January 4, 2013
Results First Submitted: August 16, 2019
Results First Posted: October 22, 2019
Last Update Posted: October 22, 2019