Prioritized Clinical Decision Support (CDS) to Reduce Cardiovascular Risk

September 17, 2018 updated by: HealthPartners Institute
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7914

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prioritized Clinical Decision Support
The Prioritized Clinical Decision Support (CDS) intervention is a protocol driven CDS 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 CDS was printed at intervention sites. It i) compiled most recent lab data (A1c, SBP, and LDL), BMI, smoking status, and aspirin use, (ii) calculated a 10-year risk for stroke or heart attack, (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.
Other: Prioritized Clinical Decision Support
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.
Other Names:
  • CV Wizard
  • Cardiovascular Wizard
No Intervention: Usual Care
Providers in the usual care arm did not have access to the prioritized clinical decision support tool.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicted Annual Rate of Change in 10-year Risk of Fatal or Nonfatal Heart Attack or Stroke
Time Frame: Index to 14 months post index
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.
Index to 14 months post index

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Patrick J O'Connor, MD, MPH, MA, HealthPartners Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2012

Primary Completion (Actual)

August 19, 2014

Study Completion (Actual)

August 19, 2014

Study Registration Dates

First Submitted

January 17, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (Estimate)

August 19, 2011

Study Record Updates

Last Update Posted (Actual)

September 21, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-096
  • R01HL102144-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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