Trial Outcomes & Findings for Prioritized Clinical Decision Support (CDS) to Reduce Cardiovascular Risk (NCT NCT01420016)

NCT ID: NCT01420016

Last Updated: 2018-09-21

Results Overview

Ten year cardiovascular risk was calculated at each post index visit from the most recent clinical and laboratory values in the EMR. The Framingham lipid equation was used when a lipid value was available in the previous 5 years; otherwise the Framingham BMI equation was used. The primary outcome was the annualized rate of change (slope) in 10-year CVR, estimated for each treatment group from the time and time-by-treatment parameters of a mixed regression model which predicted post-index CVR values from time elapsed since index, treatment group and the time by treatment interaction.

Recruitment status

COMPLETED

Study phase

Target enrollment

7914 participants

Primary outcome timeframe

Index to 14 months post index

Results posted on

2018-09-21

Participant Flow

All adult primary care providers (physicians, PAs, NPs) employed full-time as of August 2012 were eligible for the study. Providers received a letter from the study PI inviting them to participate with a link to the consent form. Patient consent was waived by HPI IRB since there was no direct contact between the patient and the study team.

13381 subjects were assessed for eligibility for the Primary analysis; a partially overlapping population of 11551 subjects were passively monitored for safety outcomes. Consent was waived for all participants. The total number of participants is unknown; therefore, the enrollment only counts participants who were included in the final analysis.

Participant milestones

Participant milestones
Measure	Prioritized Clinical Decision Support- Primary Analysis After entry of BP data, relevant EHR data were extracted from the EHR, encrypted, and processed through Web-based clinical algorithms that (a) determined if the patient met intervention eligibility criteria, (b) identified evidence-based treatment options for any uncontrolled CVR factors, and (c) prioritized treatment recommendations based on potential CV risk reduction. CV risk factors addressed in these study participants were control of lipids, BP, weight, tobacco, and appropriate aspirin use. Personalized treatment recommendations were printed given to PCP and patient immediately before the visit.	Usual Care- Primary Analysis Patients and providers at control clinics did not have access to the prioritized clinical decision support system.	Prioritized Clinical Decision Support- Safety Analysis The Prioritized Clinical Decision Support (CV Wizard) intervention is a protocol driven clinical decision support system linked within the EMR that identifies patients with high cardiovascular risk and provides tailored, prioritized decision support to the provider and patient at the point of care. The CV Wizard was printed at intervention sites and i) compiled lab data (most recent A1c, SBP, and LDL levels), BMI, smoking status, and aspirin use, (ii) calculated a 10-year risk for stroke or heart attack using the Framingham Risk Score, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to renal and liver function, creatine kinase level, and previous diagnoses (CHF, CVD, DM), and (v) provided recommendations for intensification of therapy for A1c, SBP and/or LDL if not at goal. Recommendations were based on evidenced-based protocols including JNC-8, ADA, and Institute for Clinical Systems Improvement (ICSI).	Usual Care- Safety Analysis Patients and providers at control clinics did not have access to the CV Wizard clinical decision support system.
Primary Analysis STARTED	6970	6411	0	0
Primary Analysis COMPLETED	4043	3871	0	0
Primary Analysis NOT COMPLETED	2927	2540	0	0
Safety Analysis STARTED	0	0	6392	5159
Safety Analysis COMPLETED	0	0	6392	5159
Safety Analysis NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prioritized Clinical Decision Support (CDS) to Reduce Cardiovascular Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prioritized Clinical Decision Support n=4043 Participants The Prioritized Clinical Decision Support (CV Wizard) intervention is a protocol driven clinical decision support system linked within the EMR that identifies patients with high cardiovascular risk and provides tailored, prioritized decision support to the provider and patient at the point of care. The CV Wizard was printed at intervention sites and i) compiled lab data (most recent A1c, SBP, and LDL levels), BMI, smoking status, and aspirin use, (ii) calculated a 10-year risk for stroke or heart attack using the Framingham Risk Score, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to renal and liver function, creatine kinase level, and previous diagnoses (CHF, CVD, DM), and (v) provided recommendations for intensification of therapy for A1c, SBP and/or LDL if not at goal. Recommendations were based on evidenced-based protocols including JNC-8, ADA, and Institute for Clinical Systems Improvement (ICSI).	Usual Care n=3871 Participants Usual care.	Total n=7914 Participants Total of all reporting groups
Age, Continuous	58.7 years STANDARD_DEVIATION 8.5 • n=5 Participants	58.5 years STANDARD_DEVIATION 8.6 • n=7 Participants	58.6 years STANDARD_DEVIATION 8.5 • n=5 Participants
Sex: Female, Male Female	1067 Participants n=5 Participants	1013 Participants n=7 Participants	2080 Participants n=5 Participants
Sex: Female, Male Male	2976 Participants n=5 Participants	2858 Participants n=7 Participants	5834 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	83 Participants n=5 Participants	49 Participants n=7 Participants	132 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3960 Participants n=5 Participants	3822 Participants n=7 Participants	7782 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	28 Participants n=5 Participants	11 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) Asian	87 Participants n=5 Participants	145 Participants n=7 Participants	232 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	601 Participants n=5 Participants	355 Participants n=7 Participants	956 Participants n=5 Participants
Race (NIH/OMB) White	3061 Participants n=5 Participants	3210 Participants n=7 Participants	6271 Participants n=5 Participants
Race (NIH/OMB) More than one race	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	255 Participants n=5 Participants	137 Participants n=7 Participants	392 Participants n=5 Participants
Systolic Blood Pressure	144.6 mmHg STANDARD_DEVIATION 21.1 • n=5 Participants	145.3 mmHg STANDARD_DEVIATION 21.7 • n=7 Participants	144.9 mmHg STANDARD_DEVIATION 21.4 • n=5 Participants
Diastolic Blood Pressure	86.2 mmHg STANDARD_DEVIATION 12.8 • n=5 Participants	85.8 mmHg STANDARD_DEVIATION 13.4 • n=7 Participants	86.0 mmHg STANDARD_DEVIATION 13.1 • n=5 Participants
Smoking status	2296 Participants n=5 Participants	2061 Participants n=7 Participants	4357 Participants n=5 Participants
Aspirin use	767 Participants n=5 Participants	744 Participants n=7 Participants	1511 Participants n=5 Participants
LDL Cholesterol	125.0 mg/dL STANDARD_DEVIATION 36.7 • n=5 Participants	127.7 mg/dL STANDARD_DEVIATION 36.9 • n=7 Participants	126.4 mg/dL STANDARD_DEVIATION 36.8 • n=5 Participants
Body Mass Index (BMI)	30.1 kg/m2 STANDARD_DEVIATION 6.2 • n=5 Participants	30.4 kg/m2 STANDARD_DEVIATION 6.4 • n=7 Participants	30.3 kg/m2 STANDARD_DEVIATION 6.3 • n=5 Participants

PRIMARY outcome

Timeframe: Index to 14 months post index

Population: The patients whose data were included in the primary outcomes analyses met each of the following eligibility criteria. Each patient had an index visit; their first post-implementation primary care visit in a randomized clinic at which they were eligible for the CV Wizard intervention. Visits were intervention eligible based on the CDS algorithms.

Outcome measures

Outcome measures
Measure	Prioritized Clinical Decision Support n=4043 Participants The Prioritized Clinical Decision Support (CV Wizard) intervention is a protocol driven clinical decision support system linked within the EMR that identifies patients with high cardiovascular risk and provides tailored, prioritized decision support to the provider and patient at the point of care. The CV Wizard was printed at intervention sites and i) compiled lab data (most recent A1c, SBP, and LDL levels), BMI, smoking status, and aspirin use, (ii) calculated a 10-year risk for stroke or heart attack using the Framingham Risk Score, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to renal and liver function, creatine kinase level, and previous diagnoses (CHF, CVD, DM), and (v) provided recommendations for intensification of therapy for A1c, SBP and/or LDL if not at goal. Recommendations were based on evidenced-based protocols including JNC-8, ADA, and Institute for Clinical Systems Improvement (ICSI).	Usual Care n=3871 Participants Usual care.
Predicted Annual Rate of Change in 10-year Risk of Fatal or Nonfatal Heart Attack or Stroke	-0.59 annualized change in 10 year % cv risk Interval -1.43 to 0.26	1.66 annualized change in 10 year % cv risk Interval 0.81 to 2.52

Adverse Events

Prioritized Clinical Decision Support

Serious events: 253 serious events

Other events: 601 other events

Deaths: 0 deaths

Usual Care

Serious events: 151 serious events

Other events: 403 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prioritized Clinical Decision Support n=6392 participants at risk The Prioritized Clinical Decision Support (CV Wizard) intervention is a protocol driven clinical decision support system linked within the EMR that identifies patients with high cardiovascular risk and provides tailored, prioritized decision support to the provider and patient at the point of care. The CV Wizard was printed at intervention sites and i) compiled lab data (most recent A1c, SBP, and LDL levels), BMI, smoking status, and aspirin use, (ii) calculated a 10-year risk for stroke or heart attack using the Framingham Risk Score, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to renal and liver function, creatine kinase level, and previous diagnoses (CHF, CVD, DM), and (v) provided recommendations for intensification of therapy for A1c, SBP and/or LDL if not at goal. Recommendations were based on evidenced-based protocols including JNC-8, ADA, and Institute for Clinical Systems Improvement (ICSI).	Usual Care n=5159 participants at risk Patients and providers at control clinics did not have access to the CV Wizard clinical decision support system.
Vascular disorders Hypotensive emergency, urgency	1.7% 110/6392 • Number of events 150 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	1.5% 76/5159 • Number of events 96 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
Vascular disorders Hypertensive emergency, urgency	0.11% 7/6392 • Number of events 9 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	0.06% 3/5159 • Number of events 3 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
Renal and urinary disorders Acute renal failure	1.5% 95/6392 • Number of events 131 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	0.95% 49/5159 • Number of events 65 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
General disorders Myositis	0.09% 6/6392 • Number of events 7 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	0.04% 2/5159 • Number of events 3 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
Endocrine disorders Hypoglycemia	0.36% 23/6392 • Number of events 23 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	0.31% 16/5159 • Number of events 19 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
Endocrine disorders Hyperglycemia	0.19% 12/6392 • Number of events 12 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	0.04% 2/5159 • Number of events 2 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
Gastrointestinal disorders GI bleed	0.00% 0/6392 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	0.04% 2/5159 • Number of events 2 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
General disorders ASA allergy-acute anaphylaxis	0.00% 0/6392 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	0.02% 1/5159 • Number of events 1 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.

Other adverse events

Other adverse events
Measure	Prioritized Clinical Decision Support n=6392 participants at risk The Prioritized Clinical Decision Support (CV Wizard) intervention is a protocol driven clinical decision support system linked within the EMR that identifies patients with high cardiovascular risk and provides tailored, prioritized decision support to the provider and patient at the point of care. The CV Wizard was printed at intervention sites and i) compiled lab data (most recent A1c, SBP, and LDL levels), BMI, smoking status, and aspirin use, (ii) calculated a 10-year risk for stroke or heart attack using the Framingham Risk Score, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to renal and liver function, creatine kinase level, and previous diagnoses (CHF, CVD, DM), and (v) provided recommendations for intensification of therapy for A1c, SBP and/or LDL if not at goal. Recommendations were based on evidenced-based protocols including JNC-8, ADA, and Institute for Clinical Systems Improvement (ICSI).	Usual Care n=5159 participants at risk Patients and providers at control clinics did not have access to the CV Wizard clinical decision support system.
Cardiac disorders Any lipid related event	2.6% 169/6392 • Number of events 177 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	2.0% 103/5159 • Number of events 105 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
Endocrine disorders Any glycemic related event	1.6% 104/6392 • Number of events 110 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	1.4% 74/5159 • Number of events 80 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
Metabolism and nutrition disorders Hyperkalemia	0.81% 52/6392 • Number of events 71 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	0.72% 37/5159 • Number of events 48 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
Metabolism and nutrition disorders Hypokalemia	1.7% 110/6392 • Number of events 167 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	1.7% 88/5159 • Number of events 153 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
Metabolism and nutrition disorders Hyponatremia	0.89% 57/6392 • Number of events 75 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	0.62% 32/5159 • Number of events 49 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
General disorders Any aspirin related event	0.00% 0/6392 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	0.06% 3/5159 • Number of events 3 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
General disorders BP drug interaction	0.83% 53/6392 • Number of events 53 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	0.72% 37/5159 • Number of events 37 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
General disorders Glycemic drug interaction	1.1% 71/6392 • Number of events 75 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	1.1% 57/5159 • Number of events 59 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
General disorders Lipid drug interaction	2.6% 163/6392 • Number of events 170 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	2.0% 101/5159 • Number of events 102 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
Vascular disorders Any blood pressure related event	6.0% 385/6392 • Number of events 656 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	5.2% 267/5159 • Number of events 451 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.
Metabolism and nutrition disorders Metabolic disturbance	3.1% 198/6392 • Number of events 313 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.	2.8% 144/5159 • Number of events 250 • We monitored rates of occurrence by study arm (blinded by study arm) every 6 months, from 6 months pre, through the end of the 24-month intervention period. Randomization occurred at the clinic level and all providers at the clinics had access to the CDS tool. We monitored all patients receiving care at randomized clinics regardless of their exposure to the intervention. We conducted passive safety surveillance for all patients in all randomized clinics using routinely collected EMR data to monitor for potential safety events. This means that the safety data population (N=11,551) is a larger population than the analysis population (N=7,914). We identified, a priori, events related to more intensive BP or lipid treatment: hypotensive or hypertensive urgency or emergency, syncope, hyperkalemia, hypokalemia, hyponatremia, myositis, and rhabdomyolysis.

Additional Information

Dr. Patrick O'Connor

HealthPartners Institute

Phone: 952-967-5034

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place