Trial Outcomes & Findings for Electronic Health Record-Based Clinical Decision Support to Improve Blood Pressure Management in Adolescents (NCT NCT01760239)

Last Updated: 2019-10-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

31579 participants

Primary outcome timeframe

6 months

Results posted on

2019-10-22

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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 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.	Control Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
Overall Study STARTED	17037	14542
Overall Study COMPLETED	296	226
Overall Study NOT COMPLETED	16741	14316

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Clincal Decision Support (CDS) n=296 Participants 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.	Control n=226 Participants Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.	Total n=522 Participants Total of all reporting groups
Age, Continuous	14.5 years STANDARD_DEVIATION 2.1 • n=5 Participants	14.4 years STANDARD_DEVIATION 2.0 • n=7 Participants	14.5 years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	171 Participants n=5 Participants	125 Participants n=7 Participants	296 Participants n=5 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	101 Participants n=7 Participants	226 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	28 Participants n=5 Participants	14 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	268 Participants n=5 Participants	212 Participants n=7 Participants	480 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Asian	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	53 Participants n=5 Participants	45 Participants n=7 Participants	98 Participants n=5 Participants
Race (NIH/OMB) White	195 Participants n=5 Participants	131 Participants n=7 Participants	326 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	296 participants n=5 Participants	226 participants n=7 Participants	522 participants n=5 Participants
Body Mass Index (BMI) Body Mass Index <85th	104 Participants n=5 Participants	68 Participants n=7 Participants	172 Participants n=5 Participants
Body Mass Index (BMI) Body Mass Index 85-<=95th	67 Participants n=5 Participants	51 Participants n=7 Participants	118 Participants n=5 Participants
Body Mass Index (BMI) Body Mass Index >=95th	125 Participants n=5 Participants	107 Participants n=7 Participants	232 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Clincal Decision Support (CDS) n=296 Participants 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.	Control n=226 Participants Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
Participants With Clinical Recognition of Hypertension	160 Participants	51 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Clincal Decision Support (CDS) n=296 Participants 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.	Control n=226 Participants Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
Participants With Appropriate Workup for Secondary Causes of Hypertension	29 Participants	10 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Clincal Decision Support (CDS) n=296 Participants 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.	Control n=226 Participants Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
Participants With Appropriate Lifestyle Referral	55 Participants	10 Participants

Adverse Events

Clincal Decision Support (CDS)

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Clincal Decision Support (CDS) n=296 participants at risk 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.	Control n=226 participants at risk Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
Vascular disorders Very high blood pressure	0.68% 2/296 • 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. 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.	0.44% 1/226 • 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. 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.
Vascular disorders Stroke/transient ischemic attack (TIA)	0.00% 0/296 • 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. 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.	0.00% 0/226 • 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. 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.
Renal and urinary disorders Acute renal failure	0.00% 0/296 • 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. 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.	0.00% 0/226 • 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. 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.
Nervous system disorders Neurological complications	0.00% 0/296 • 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. 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.	0.00% 0/226 • 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. 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.
Eye disorders Hypertensive retinopathy	0.00% 0/296 • 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. 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.	0.00% 0/226 • 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. 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.

Other adverse events

Other adverse events
Measure	Clincal Decision Support (CDS) n=296 participants at risk 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.	Control n=226 participants at risk Patients in this group will receive usual care from their clinic. The CDS tool will not be activated.
Renal and urinary disorders Elevated serum creatinine	1.0% 3/296 • 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. 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.	1.3% 3/226 • 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. 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.
Surgical and medical procedures Echocardiogram conducted	2.4% 7/296 • 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. 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.	0.44% 1/226 • 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. 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.
Cardiac disorders Left ventricular hypertrophy	0.00% 0/296 • 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. 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.	0.00% 0/226 • 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. 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.
Surgical and medical procedures Renal ultrasound conducted	2.7% 8/296 • 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. 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.	0.88% 2/226 • 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. 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.
Renal and urinary disorders Abnormality on renal ultrasound	0.00% 0/296 • 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. 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.	0.00% 0/226 • 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. 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.
Vascular disorders New medication for hypertension	1.0% 3/296 • 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. 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.	0.44% 1/226 • 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. 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.
General disorders Hospitalization for any cause	3.7% 11/296 • 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. 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.	3.5% 8/226 • 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. 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.

Additional Information

Elyse Kharbanda, MD MPH

HealthPartners Institute

Phone: 952-967-5038

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place