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Prioritized Clinical Decision Support (CDS) to Reduce Cardiovascular Risk

Prioritized Clinical Decision Support (CDS) to Reduce Cardiovascular Risk

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01420016
Enrollment
7914
Registered
2011-08-19
Start date
2012-08-20
Completion date
2014-08-19
Last updated
2018-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Cardiovascular Risk Factor, Diabetes, Hyperlipidemia, Hypertension, Smoking

Keywords

Cardiovascular risk, Clinical Decision Support, Electronic Health Records, Primary Care, Quality of Care

Brief summary

The objective of this project is to develop and implement sophisticated point-of-care Electronic Health Record (EHR)-based clinical decision support that (a) identifies and (b) prioritizes all available evidence-based treatment options to reduce a given patient's cardiovascular risk (CVR). After developing the EHR-based decision support intervention, the investigators will test its impact on CVR, the components of CVR, in a group randomized trial that includes 18 primary care clinics, 60 primary care physicians, and 18,000 adults with moderate or high CVR. This approach, if successful, will (a) improve chronic disease outcomes and reduce CVR for about 35% of the U.S. adult population, (b) maximize the clinical return on the massive investments that are increasingly being made in sophisticated outpatient EHR systems, and (c) provide a model for how to use EHR technology support to deliver personalized medicine in primary care settings

Detailed description

This project developed and implemented a sophisticated point-of-care EHR-based clinical decision support that (a) identified and (b) prioritized all available evidence-based treatment options to reduce a given patient's cardiovascular risk (CVR). The prioritized list of treatment options is provided in different formats to both the primary care physician (PCP) and patient at the time of each office visit made by a patient with moderate to high CVR and sub-optimally controlled and potentially reversible CVR factors. Available evidence-based treatment options are prioritized based on the magnitude of potential CVR reduction of each treatment option. This intervention strategy, referred to as Prioritized Clinical Decision Support (CDS), is specifically designed for widespread use in primary care settings and has the potential to substantially augment current efforts to control CVR in the 35% of American adults with 10-year Framingham CVR of 10% or higher. To assess the ability of the CDS intervention to reduce CVR in adults, we randomized 18 primary care clinics with 60 primary care physicians (PCPs) and approximately 18,000 eligible adults with baseline Framingham 10-year risk of a major CV event (either heart attack or stroke) of 10% or more into one of two experimental conditions: Group 1 includes 9 clinics (with 30 PCPs and 9,000 patients) that received prioritized clinical decision support (CDS) to reduce CVR at the time of each clinical encounter made by an eligible adult. Group 2 includes 9 clinics (with 30 PCPs and 9,000 patients) that received no study intervention and constitute a usual care (UC) control group. The study formally tested the hypothesis that after control for baseline CVR, post-intervention 10-year Framingham CVR will be better in Group 1 than Group 2 at 12 months after start of the intervention. In addition, impact of the intervention on specific components of CVR (BP, lipids, glucose, aspirin use, and smoking) was assessed, and the cost-effectiveness of the intervention will be quantified. This innovative project builds upon 10 years of prior work by our research team, and extends prior successful EHR clinical decision support interventions by introducing prioritization, by providing decision support to both patients and PCPs at the time of the office visit, and by extending the decision support across the broad and critically important clinical terrain of CVR reduction. The results of this project, whether positive or negative, will extend our understanding of how to maximize the clinical return on massive public and private sector investments now being made in sophisticated outpatient EHR systems. If successful, this decision support tool could be broadly used to both standardize and personalize care delivered by case managers, pharmacists, and other providers in a wide range of care delivery configurations.

Interventions

Eighteen primary care clinics were blocked on size and on patient characteristics. Each clinic was randomly assigned to one of 2 study arms. All consenting PCPs were allocated to the study arm that their clinic was assigned to and the estimated 400 eligible adults with 10-year CVR \>= 10% under the care of each consenting physician were allocated to the same treatment arm as their PCP.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
HealthPartners Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Practicing general internist or family physician at HealthPartners Medical Group (HPMG) * Provide ongoing care for 200 or more adult patients with 10 year CVR \>=10%

Exclusion criteria

* PCP not practicing in HPMG clinic * Patient age greater than 80 years * Patient Charlson comorbidity score greater than 3

Design outcomes

Primary

MeasureTime frameDescription
Predicted Annual Rate of Change in 10-year Risk of Fatal or Nonfatal Heart Attack or StrokeIndex to 14 months post indexTen 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.

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
Prioritized Clinical Decision Support
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).
4,043
Usual Care
Usual care.
3,871
Total7,914

Baseline characteristics

CharacteristicUsual CarePrioritized Clinical Decision SupportTotal
Age, Continuous58.5 years
STANDARD_DEVIATION 8.6
58.7 years
STANDARD_DEVIATION 8.5
58.6 years
STANDARD_DEVIATION 8.5
Aspirin use744 Participants767 Participants1511 Participants
Body Mass Index (BMI)30.4 kg/m2
STANDARD_DEVIATION 6.4
30.1 kg/m2
STANDARD_DEVIATION 6.2
30.3 kg/m2
STANDARD_DEVIATION 6.3
Diastolic Blood Pressure85.8 mmHg
STANDARD_DEVIATION 13.4
86.2 mmHg
STANDARD_DEVIATION 12.8
86.0 mmHg
STANDARD_DEVIATION 13.1
Ethnicity (NIH/OMB)
Hispanic or Latino
49 Participants83 Participants132 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3822 Participants3960 Participants7782 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
LDL Cholesterol127.7 mg/dL
STANDARD_DEVIATION 36.9
125.0 mg/dL
STANDARD_DEVIATION 36.7
126.4 mg/dL
STANDARD_DEVIATION 36.8
Race (NIH/OMB)
American Indian or Alaska Native
11 Participants28 Participants39 Participants
Race (NIH/OMB)
Asian
145 Participants87 Participants232 Participants
Race (NIH/OMB)
Black or African American
355 Participants601 Participants956 Participants
Race (NIH/OMB)
More than one race
9 Participants10 Participants19 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
4 Participants1 Participants5 Participants
Race (NIH/OMB)
Unknown or Not Reported
137 Participants255 Participants392 Participants
Race (NIH/OMB)
White
3210 Participants3061 Participants6271 Participants
Sex: Female, Male
Female
1013 Participants1067 Participants2080 Participants
Sex: Female, Male
Male
2858 Participants2976 Participants5834 Participants
Smoking status2061 Participants2296 Participants4357 Participants
Systolic Blood Pressure145.3 mmHg
STANDARD_DEVIATION 21.7
144.6 mmHg
STANDARD_DEVIATION 21.1
144.9 mmHg
STANDARD_DEVIATION 21.4

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
601 / 6,392403 / 5,159
serious
Total, serious adverse events
253 / 6,392151 / 5,159

Outcome results

Primary

Predicted Annual Rate of Change in 10-year Risk of Fatal or Nonfatal Heart Attack or Stroke

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.

Time frame: 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.

ArmMeasureValue (NUMBER)
Prioritized Clinical Decision SupportPredicted 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
Usual CarePredicted Annual Rate of Change in 10-year Risk of Fatal or Nonfatal Heart Attack or Stroke1.66 annualized change in 10 year % cv risk
p-value: <0.0595% CI: [-3.45, -1.04]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026