Prioritized Clinical Decision Support to Reduce Cardiovascular Risk

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by HealthPartners Institute for Education and Research
Sponsor:
Collaborator:
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT01420016
First received: January 17, 2011
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Hypertension
Hyperlipidemia
Diabetes
Smoking
Behavioral: Prioritized Clinical Decision Support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Prioritized Clinical Decision Support to Reduce Cardiovascular Risk

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute for Education and Research:

Primary Outcome Measures:
  • 12 month Cardiovascular risk reduction [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    measured according to Framingham risk score

  • 24 month Cardiovascular Risk reduction [ Time Frame: baseline, 12 and 24 months ] [ Designated as safety issue: No ]
    measured by Framingham risk score


Secondary Outcome Measures:
  • Quality adjusted life years (QALY) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prioritized Clinical Decision Support Behavioral: Prioritized Clinical Decision Support
Eighteen primary care clinics will be blocked on size and on patient characteristics, and each clinic randomly assigned to one of 2 study arms. All consenting PCPs will be allocated to the study arm that their clinic is assigned to and the estimated 400 eligible adults with 10-year CVR >= 10% under the care of each consenting physician will be allocated to the same treatment arm as their PCP.
No Intervention: Usual Care

Detailed Description:

The objective of this project is to develop and implement sophisticated point-of-care 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). 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 (PCS), 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 PCS intervention to reduce CVR in adults, we will randomize 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 will receive prioritized clinical decision support (PCS) 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 receive no study intervention and constitute a usual care control group. The study will formally test 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 and 24 months after start of the intervention. In addition, impact of the intervention on specific components of CVR (BP, lipids, glucose, aspirin use, and smoking) will be 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420016

Contacts
Contact: Patrick J O'Connor, MD, MPH 952-967-5034 patrick.j.oconnor@healthpartners.com

Locations
United States, Minnesota
HealthPartners Medical Group Recruiting
Minneapolis, Minnesota, United States, 55440
Principal Investigator: Patrick J O'Connor, MD, MPH         
Sponsors and Collaborators
HealthPartners Institute for Education and Research
Investigators
Principal Investigator: Patrick J O'Connor, MD, MPH HealthPartners Institute for Education and Research
  More Information

No publications provided

Responsible Party: HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier: NCT01420016     History of Changes
Other Study ID Numbers: 09-096, R01HL102144-01
Study First Received: January 17, 2011
Last Updated: October 11, 2013
Health Authority: United States: Federal Government

Keywords provided by HealthPartners Institute for Education and Research:
Cardiovascular risk

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014